Document: WT/DS291/R WT/DS292/R WT/DS293/R Page 109 4.576 The EC member State measures do not meet any of the four criteria set out in Article 5.7. First, the scientific evidence with respect to the products subject to the member State measures is not "insufficient".  Scientific evidence is "insufficien t," according to the Appellate Body, if it "does not allow, in quantitative or qualitative terms, the pe rformance of an adequate assessment of risks as required under Article 5.1 and as defined in Annex A to the SPS Agreement."  Here, the evidence is plainly sufficient to perform a risk assessment , because the European Communities itself has conducted positive risk assessments for each product subject to a member State measure. 4.577 Second, the member State bans were not ad opted on the basis of "available pertinent
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

4.576 The EC member State measures do not meet any of the four criteria set out in Article 5.7.
First, the scientific evidence with respect to the products subject to the member State measures is not
"insufficient". Scientific evidence is "insufficien t," according to the Appellate Body, if it "does not
allow, in quantitative or qualitative terms, the pe rformance of an adequate assessment of risks as
required under Article 5.1 and as defined in Annex A to the SPS Agreement." Here, the evidence is
plainly sufficient to perform a risk assessment , because the European Communities itself has
conducted positive risk assessments for each product subject to a member State measure.
4.577 Second, the member State bans were not ad opted on the basis of "available pertinent
information, including that from the relevant inte rnational organizations as well as from sanitary or
phytosanitary measures applied by other Members." As the United States noted in its First Written
Submission, the relevant Scientific Committee in the European Communities reviewed each of the
member State bans and concluded in each case that the information provided by the member State did
not warrant any change in the Scientific Comm ittee's earlier favourable risk assessment. Thus, the
European Communities' own scientific committees ha ve confirmed that the member State measures
are not based on "available pertinent information."
4.578 Third, the member States have not sought "t o obtain the additional information necessary for
a more objective assessment of risk." In fact, ther e is no information in the record that the member
States have sought to perform any risk assessments th at would support their bans. To the contrary, as
noted above, the European Communities' additional CD of documents contains no new information
that could constitute an assessment of the risks by the member States.
4.579 Fourth and finally, neither the member States nor the European Commission has reviewed the
import and marketing bans within a reasonable period of time. When asked by the Panel whether the
member State measures were "reviewed within a reasonable period of time," the European
Communities answered, without providing any evid ence or elaboration, that the "measures are
constantly subject to review." The conclusory st atement that a measure is "constantly subject to
review" does not come close to meeting the requirement that the measures are in fact reviewed within
a reasonable period of time of their adoption.
N. S
ECOND WRITTEN SUBMISSION OF CANADA
1. Introduction
4.580 In defending its measures in these proceedings , the European Commun ities has resorted to
obfuscation or mischaracterization of the salient fa cts and scientific evidence, and has presented legal
arguments regarding obligations under the WTO Agre ements that find little, if any, resonance in
either logic, accepted principles of treaty interp retation, textual constr uction or the relevant
jurisprudence. In its Second Written Submission, Canada demonstrates, th rough reference to the
European Communities' own documents, relevant documents from international organizations and
case law, that the European Commun ities' defences to Canada's claims are untenable in fact and in
law.
4.581 Canada notes that the European Communiti es has not yet presented any arguments with
respect to the consistency of the morato rium with a number of provisions in the SPS Agreement. The
European Communities, other than to simply assert th at the moratorium does not exist, and never did,
has not presented any arguments or evidence to refute Canada's prima facie case with respect to
violations of Articles 2.2, 2.3, 5.1, 5.5, 5.6, 7, 8, paragraph 1 of Annex B and paragraph 1(a) of
Annex C. Similarly, the European Communities has failed to present any arguments to counter

Canada's prima facie case that the product-specific marketing ba ns violate Articles 2.2, 2.3, 5.1, 5.5,
5.6, 8, and paragraph 1(a) of Annex C.
2. The moratorium
4.582 The European Communities' sole defence to Cana da's claims regarding the moratorium is the
astonishing claim that there is not and never was a moratorium. The European Communities admits
that there have been delays in the processing of bi otech applications over the last 5 years, but asserts
that these delays are not a result of a systemic su spension of approvals for biotech products. The
European Communities attempts to rationalize the delays on several grounds, including:
• The need for legislative changes to strengt hen inadequate risk assessment and risk
management provisions;

• The need for legislative changes necessary to comp ly with the European
Communities' other international obliga tions, such as those under the Biosafety
Protocol;

• The distinction between risk assessment and risk management;

• The existence of scientific uncertainty; and/or

• Requests for more information and objections by regulatory authorities.

4.583 These attempts to rationalize the obvious delays in the approval procedures for biotech
products are, in effect, veiled attempts to rationalize the moratorium.
(a) The European Communities' assertion that the moratorium does not exist is without merit
4.584 Given the facts in this case and in the light of some of the European Communities' own
assertions or explanations presented in these procee dings, that there has been a moratorium on the
approval of biotech products since October 1998 is indisputable. The critical factual issue in this case
is not whether there has been a moratorium, but whether the various attempts by the Commission to
re-start or "relaunch" the authorization process for biotech products, prior to the establishment of this
Panel in August 2003, succeeded. Canada asserts, not only that those attempts did not succeed, but
that subsequent efforts to rela unch the approvals process have also been unsuccessful, and that the
moratorium remains in place.
4.585 Various EC member States have demanded a succession of new conditions on the marketing
of biotech products before they would agree to new authorizations. As a result, the European
Communities has failed to process pending applica tions, decision-making on approvals of pending
product applications has come to a stand-still, and, despite attempts by the Commission to break this
log-jam, it has failed to convince the member States to restart the approval process.
4.586 The Commission's stated reason for proposing its so-called "interim approach" in July 2000
was precisely because the approval process had stalled. The Commission in its press release at the
time indicated that "[t]he objective [of the interim approach] is to resume the authorization process for
GMOs in the near future…" However, the "int erim approach" failed because it did not have the
political support of enough EC member States.

4.587 Then, as the European Communities got closer to enacting and implementing the revised
approval legislation, add itional conditions for restarting the approv al process emerged. Just prior to
the adoption of Directive 2001/18, Denmark, France, Greece, Italy, Luxembourg and now Austria
reaffirmed their commitment to suspend approvals , essentially claiming that the new procedures were
not adequate.
4.588 Despite the reassurances of the Commission, the entry into force of Directive 2001/18 did not
result in the lifting of the moratorium. EC member States continued to refuse to lift the moratorium
until new legislation regarding traceability and label ling was in place. In the context of specific
biotech product applications, some EC member States continued to object to the approval of products
that had been positively assessed by the lead competent authority under Directive 2001/18 , not on the
basis of safety concerns, but on the grounds that approval of GMOs should be suspended pending the
adoption of new legislation on traceability and labelling.
4.589 Five EC members States – France, Belgium, Denmark, Greece and Italy – also indicated that
they would insist on yet other prerequisites for restarting the approval process: the formulation of a
special environmental liability scheme and the adopti on of EC-wide legislation to regulate the "co-
existence" of genetically modified crops with conventionally bred and or ganic crops – conditions
which are not even relevant for pending approvals for food use or import and processing.
4.590 Given the evidence in this case, the European Communities' assertion that "the approval
procedures have never been suspended or stalled" is completely baseless. Despite the Commission's
numerous attempts to lift the moratorium, the "goalposts" keep shifting as EC member States keep
introducing new conditions.
(b) Rationalizations for the moratorium
4.591 The European Communities asserts there was a "pressing need" to revise Directive 90/220
because that Directive did not "address all issues raised by new scientific understandings and the
regulatory developments which were taking place at the international leve l" and did not include
"common/harmonised criteria on the risk assessment to be performed and did not provide for any
post-market surveillance measures." None of these ex post facto rationalizations for the moratorium
is supported by the evidence.
4.592 The European Communities' claim that "n ew scientific understandings" required new
legislation is without merit. The opposite is true, as demonstrated by legislative developments that
made the European Communities' biotech approval procedures less onerous in the light of the
advanced state of scientific understanding that had evolved since the adoption of Directive 90/220 in
1990. Commission Directive 94/15/EC, simplifying th e information requirements for notifications,
and Commission Decision 94/730/EC, simplifying the pr ocedures for approval of field trials for
biotech products, are examples of such developments.
4.593 Turning to risk management issues, the European Communities' attempt to portray the
revisions to Directive 90/220 as necessary to address ri sk management needs is equally without merit.
Directive 90/220 already provided for "detection and identification techniques", "monitoring plans
and techniques" and labelling requirements. More over, Directive 90/220 already enabled regulators
to impose conditions in relation to these issues as part of the consent to market the biotech product in
question.
4.594 The European Communities' rationale for ame nding Directive 90/220 is contradicted by the
Commission's 1996 Report on the Review of Directive 90/220. That report suggests that changes to

Directive 90/220 were required because the approval procedure was "difficult to implement, time-
consuming and cumbersome to follow both for users and authorities." One of the principal difficulties
underlying the "cumbersome" procedure was the abse nce of a means to reso lve conflicting scientific
views by member States. The European Commun ities later revised Directive 90/220 to make
consultation with an independent scientific commi ttee at the Community level mandatory in cases
where objections are raised. Contrary to the Eu ropean Communities' assertion, the role of the
scientific committee at the Community level was precisely to act as an "independent system of
conflict resolution" to resolve disagreements amongst member States on the basis of science. In short,
the rationale the European Communities now puts fo rward for revising Directive 90/220 is inaccurate
and cannot be a legitimate justification for the moratorium.
4.595 Turning to Regulation 258/97, the European Communities argues that the "delays" in
processing applications under Regula tion 258/97 were not due to an inadequate framework for risk
assessment, but rather inadequate risk management provisions. This argument is flawed for several
reasons. Regulation 258/97 already requires that GMO novel foods and food ingr edients be labelled.
More importantly, the European Communities has failed to identify any risks arising from the
scientific assessment of pending biotech applica tions that would justif y adopting traceability and
detection measures as "risk management measures" in every case, regardless of the risks involved.
Consequently, to "delay" the approval of produc ts under Regulation 258/97 on the basis that the
existing legislation does not provide for risk mana gement measures, where the risk assessments for
those products have not identified any risks that need to be managed, is unjustifiable.
4.596 For the three products that were, in the wo rds of the European Communities, "partially
affected by this situation," (maize Bt11, GA21, NK603) the relevant risk assessments conducted by
the European Communities' independent scientif ic committees under Regu lation 258/97 did not
identify any risks for which risk management measures would be justified. In all three cases, the risk
assessments, taking into consideration the objections raised by member States, concluded that the
product in question was a safe as c onventional maize. Accordingly, based on the outcome of the risk
assessments, there was no justification for imposing "risk management" measures. Consequently, the
"delays" in approving biotech products under Regulati on 258/97 were not a result of the necessity to
adopt "risk management" measures; they were a r esult of the moratorium on the approval of biotech
products imposed by the European Communities.
4.597 In an effort to minimize the importance of th e conclusions of its own independent scientific
committees, the European Communiti es goes to great pains to stress the distinction between risk
assessment strictu sensu and risk management and the respective roles of the scientific committees
and Regulatory Committee. The European Communities stresses that risk management decisions are
made by the Regulatory Committees and risk assessment strictu sensu falls to the scientific
committees. In other words, the Regulatory Comm ittees are responsible for selecting the appropriate
SPS measure. This is not particularly surprising, problematic or relevant to the issues in this case.
4.598 Even if one takes the European Communities' misleading portrayal of its regulatory regime at
face value, it follows logically that the Regulator y Committees must have evaluated the various risk
management options that might be applied in light of the risks that were identified in the risk
assessment. It is telling that the Regulatory Committee has failed to do so in every instance.
4.599
In any event, the issue in this dispute is not the respective roles of the various bodies
comprising the European Communities' regulator y process, nor is it whether the European
Communities is adhering to its own legal requirements. The issue is the failure of the European
Communities to consider and approve biotech products as a result of an across the board moratorium
and the European Communities' fa ilure to base its measures – the moratorium, the product-specific

marketing bans, and the safeguard measures – on a risk assessment that meets the requirements of
Annex A and Article 5.1 of the SPS Agreement.
4.600 The European Communities also attempts to u se the Biosafety Protocol to rationalize the
moratorium. The European Communities insinuates that measures regulating GMOs should be dealt
with "outside" the WTO Agreement because GMOs have their own "special agreement", the
Biosafety Protocol. This position is obviously w ithout merit. Nothing in the WTO Agreements
suggests that EC measures to regulate biotech produc ts should be exempt fro m obligations contained
in those agreements. Given that the complaining par ties to this dispute are not parties to the Protocol,
the Protocol is not a "relevant rule[] of interna tional law applicable in the relations between the
parties." Consequently, in this case, the Protocol should not be taken into account in the interpretation
of the obligations under the WTO Agreement. Moreover, given that the Protocol's own terms
emphasize that "this Protocol shall not be in terpreted as implying a change in the rights and
obligations of a Party under any existing international agreements," it is difficult to see how the
Protocol can be used to override the obligations of the WTO Agreement.
4.601 In any event, there is no inconsistency between the obligations of the Protocol and the WTO
obligations relevant to this dispute. The Eur opean Communities' measures – its moratorium, its
product-specific bans and its member State national bans – are stark refutations of the Protocol's
central premise that decisions regarding the importation of LMOs should be made on a case-by-case
basis, and be based on a transparent, scientifically -sound risk assessment. Furthermore, the European
Communities' assertion that it adopted its new legislation for biotech approvals only after the Protocol
was concluded, "in order to be su re that its own legislation was c onsistent with the international
approach" is inconsistent with the facts. The risk assessment provisions of Directive 90/220 were far
more detailed and onerous than those of the Pr otocol. That the European Communities submitted
numerous decisions, concerning the approvals of products under Directive 90/220, to the Bio-safety
Clearing House implies that the European Communities considered these decisions to be based on risk
assessments that were consistent with the requirements of the Protocol. Thus, if the risk assessments
conducted under Directive 90/220 met the requi rements of the Protocol, amendments to
Directive 90/220 could not have been necessary "in order to ensure that its own legislation was
consistent with the international approach."
4.602 The European Communities further attempts to rationalize the moratorium on the basis of
"scientific uncertainty." However, the European Communities presents an incomplete and misleading
portrait of the state of the relevant scientific ev idence, exaggerating the risks of biotech products in
comparison to their conventional counterparts. It is particularly striking that in presenting this
scientific context, the European Communities ignores the conclusions of its own scientific committees
reviewing individual product applications and the c onclusions of more than 20 years of EC-sponsored
research in the field of biotechnology. In essence, the European Communities, without directly saying
so, is questioning the validity of the conclusions of its own scientific experts.
4.603 In fact, the European Communities' independent scientific committees, in evaluating specific
product applications, addressed the hypothetical risks raised by the European Communities in this
proceeding. The European Communities' scientif ic committees did not identify an absence of
sufficient scientific evidence as a justification for being unable to make an objective assessment of the
evidence and reach a conclusion as to the risk s presented. To the contrary, the European
Communities' scientific committees were able to fo rm firm conclusions as to the safety of the
products in question.
4.604 In its Written Rebuttal, Canada reviews each of the hypothetical risks raised by the European
Communities and highlights how the European Co mmunities' scientific committees have addressed

these issues. Despite the European Communities' attempts to mischaracterize and exaggerate the risks
of biotech products and to insinuate that there exis ts significant and intractable scientific uncertainty,
it is abundantly clear that the European Comm unities' scientific committe es have thoroughly and
carefully assessed, on a case-by-case basis, each of these ri sks in the context of specific applications
and on the basis of sound and adequate scientific evidence. The unambiguous conclusion of the
European Communities' own scientists is that the biotech products with pe nding applications do not
pose any greater risk to human health or the environment than their conventional counterparts.
(c) The European Communities misch aracterizes risks associated with biotech products in
comparison to non-biotech products with novel traits in an attempt to justify the moratorium
4.605 The European Communities makes a number of unfounded allegati ons regarding the
comparability of the risks associated with biotech pl ants and non-biotech plants with novel traits. In
doing so, the European Communities ignores the repeated conclusions of its own scientific bodies.
4.606 Many of the scientific issues raised by the Eu ropean Communities, while true for biotech
plants, are, in fact, similar for plants derived using more conventional breeding technologies available
to plant developers. Internati onal organizations such as the FAO, the WHO and the OECD have
concluded that the use of modern biotechnology does not inherently result in foods that are less safe
than those produced by conventional techniques. Unexpected effects can o ccur with any method of
breeding. Nevertheless, in comparison to crops developed through traditional breeding or
mutagenesis, biotech crops in the European Communities are subjected to a very extensive pre-market
evaluation for potential hazards. While new varieti es of traditionally bred crops are evaluated for
agronomic and morphological traits, most have not been subjected to any kind of food safety
evaluation. In fact, the more rigorous assessment of biotech plants has highlighted the need for
further evaluation of "traditional" varieties of pl ants, which have been de veloped using a trial and
error approach. Many of the pot ential risks associated with conven tional crops received very limited
attention prior to the evaluation of transgenic crops.
4.607 In terms of genetic stability, the European Communities states that genetic engineering
introduces new genes in random locations in the genom e of a plant. This is not a phenomenon unique
to genetic engineering and can be observed in cases where plant breeders have broken the barriers that
prevent species from mating using conventional techniques.
4.608 The European Communities further asserts that there are major differences in the potential
allergenicity of GM foods as compared to othe r novel foods, making numerous vague, and ultimately
unmeritorious, allegations to suggest that GM foods hold a much greater potential for containing
allergens that have been unintentionally introdu ced via the insertion of new genetic material. Any
novel food, regardless of the method of production, coul d result in the introduction of proteins to the
human diet for which there has been no previous significant exposure and, consequently, for which
the allergenic potential is unknown.
4.609 The European Communities also asserts that "[ t]here are however significant differences for
the issue of potential invasiveness or persistence in the environment between herbicide/pesticide
resistance in GM plants and in conventional crops …" There is no legitimate scientific basis to this
assertion and it is noteworthy that the European Communities does not reference any scientific
authority for the proposition.
4.610 As a general point, the strategies for managing he rbicide resistance are the same regardless of
whether the herbicide-tolerant crop was produ ced using rDNA techniques, mutagenesis or
conventional selective breeding. As herbicide-tolerant crops do not have a selective advantage unless

the specific herbicide to which the crop is tolerant is applied ( i.e. the "relevant selection pressure is
present"), the invasiveness or persistence of a herb icide-tolerant crop in the natural environment will
be no different from its non-herbicide-tolerant counterpart if the herbicide is not applied.
4.611 The European Communities' distinction betw een non-selective and selective herbicides is
misleading. Herbicides fall on a spectrum of selectiv ity; some herbicides only control a very limited
number of plant species, while others control for a wider range of species. The European
Communities neglects to mention the several varieti es of herbicide-tolerant crops resistant to the
broad spectrum herbicide imidazolinone that have been developed through conventional breeding and
mutagenesis. Consequently, the use of broad spect rum herbicides is not limited only to herbicide-
tolerant biotech crops. Furthermore, the Eu ropean Communities discounts the fact that many
selective herbicides are far more harmful to the e nvironment than the broad spectrum herbicides the
European Communities singles out, glyphosate and gluf osinate ammonium. Similarly, the European
Communities fails to mention any of the environmenta l benefits associated with the use of herbicide
tolerant biotech crops. As the UK Royal Society ha s documented, herbicide tolerant biotech crops
may be used to benefit wildlife and provide biodivers ity in the agricultural environment. Lastly, the
European Communities fails to point out that the various risks associated with herbicide use are
comprehensively reviewed under the generally appl icable EC legislation concerning plant protection
products, Directive 91/414/EEC. Even more surprisingly, the European Communities fails to mention
that the safety of glyphosate has been fully assessed under Directive 91/414/EEC as recently as 2001.
3. Product specific marketing bans
(a) Oilseed Rape Ms1xRF1 and Ms1xRf2
4.612 Whatever the ex post facto rationalization offered by the European Communities in relation to
these particular products, the fact remains that the European Communities failed to complete the
approval procedure under Directive 90/220; the applicant has been unable to market its products in the
European Communities as a result of the failure of France to issue the letters of consent and the
consequent uncertainty regarding the legal status of the products. Therefore, the European
Communities has failed to "complete" the approval procedure without "undue delay" in patent
violation of Article 1(a) of Annex C of the SPS Agreement. Moreover, by failing to complete the
approval procedure, the European Communities h as instituted and maintained effective product-
specific marketing bans for Ms1xRf1 and M1xRf2. As these product-specific marketing bans are not
based on a risk assessment (the ri sk assessments that were conducte d supported the approval of these
products rather than the imposition of marketing bans), these measures are inconsistent with
Articles 5.1 and 2.2 of the SPS Agreement.
(b) Oilseed Rape Ms8xRf3
4.613 Oilseed rape Ms8xRf3 remains subject to a pr oduct-specific marketing ban and continues to
serve as an example of how the European Communi ties has given effect to the moratorium. Eight
years after an initial submission for approval – to Be lgium in 1996 – six years after the SCP issued its
opinion in May 1998 – and after years of safe commercial use in other parts of the world, the product
remains unapproved either for import and processing or cultivation, despite reasonably available risk
management measures. The product-specific mark eting ban violates Articles 5.1 and 2.2 of the
SPS Agreement as it is not "based on" a risk assessment and violates Article 5.6 as being more trade
restrictive than necessary to achieve the European Communities' appropriate level of protection. By
any reasonable standard, the extr aordinary length of time to pr ocess this application constitutes
"undue delay". Accordingly, the European Commun ities has acted inconsistently with paragraph 1(a)
of Annex C of the SPS Agreement, and by extension, has violated Article 8.

4.614 The European Communities' description of the hist ory of this application is both misleading
and incomplete. A review of the Chronology and Attachments submitted by the European
Communities in Exhibit EC-63 reveals that over the l ast eight years, the notifier has made sustained
and good faith efforts to respond to the ever-shi fting and increasingly unreasonable demands of the
member States. The processing of this applica tion illustrates how the European Communities has
effectively used its approval procedures to thwart the approval of this product, irrespective of the risks
to human health and the environment and regardl ess of attempts by the notifier to address the
concerns of member States. The logical conc lusion to draw from this documentation is that,
regardless of the risks, the Europ ean Communities was and is intent on blocking the approval of this
product for cultivation and is intent on imposing such onerous and unnecessary conditions as to make
the importation of the product for processing uneconomical.
(c) Oilseed Rape GT73
4.615 Oilseed rape GT73 remains subject to a product-specific marketing ban and continues to serve
as an example of how the European Communities has gi ven effect to the moratorium. Nine years after
an initial submission for approval – to France in 1995, and, as a result of France's inaction, to the
Netherlands in 1998 – and after years of safe co mmercial use in other parts of the world, the
Commission submitted the file to the Regulatory Committee for Directive 2001/18 for a vote on 16
June 2004. Neither the Commission's proposed decision to approve the product – nor a rejection of
this decision – obtained the required qualified majority. Despite entry into force of the new regulatory
framework, despite positive review by the member St ate competent authority, and despite the positive
opinion by EFSA issued as recently as February 20 04, the member States are still refusing to approve
GT73 for import and processing.
4.616 The obvious fact that the moratorium is still in place today cannot be disputed by simply
arguing that, after years of delay, there still rema in two further procedural steps after which,
theoretically, approval for this produc t could be granted. Even if one were to argue that approval
might ultimately be granted – assuming another failure by the European Communities' Council of
Ministers to come to any conclusion at a potential Council vote in or around October 2004, and
subsequent approval by the Commission – the fact that approval would occur after nine years of
mostly stalled procedures, and at the very last po ssible procedural step, after countless delays beyond
legal timelines and beyond scientific justifica tion, would be further proof for the continued existence
of the moratorium rather than anything else.
4. Mootness is not relevant
4.617 The European Communities' assertions with r espect to the relevance of the concept of
"mootness" are factually and legally incorrect or misleading. WTO jurisprudence is replete with
instances where panels made findings with respect to measures that were either removed or modified
by the responding party after the terms of referenc e had been established. A panel's jurisdiction to
consider a measure is first determined by its terms of reference. If the measure falls within its terms
of reference, the panel is to exercise its discre tion and make findings on those measures necessary to
fulfil the dispute settlement objective of "securing a positive resolution of the dispute". In cases
where the measure in question existed at the time of the establishment of the terms of reference of the
panel, the consistent practice of panels has been to at least make findings on the WTO/GATT
consistency of that measure.
4.618 From a factual standpoint, Canada contests vigorously the European Communities' assertion
that the measures before this Panel never existe d or were withdrawn by the European Communities
prior to the establishment of this Panel's terms of reference. Similarly, Canada disputes that the

European Communities' suggestion that "a case on a measure that is not in existence any longer would
be devoid of any practical purpose" applies to a situa tion, like the one at hand, where there is a real
possibility of the measure recurring.
5. The European Communities' appropriate level of protection
4.619 As the European Communities appears to admit that its appropriate level of protection in
respect of biotech products is a "high level of prot ection," Canada submits that the Panel should first
review the moratorium and the product-specific mark eting bans in relation to the obligations under
Article 5.6 of the SPS Agreement. The evidence demonstrates that the moratorium and product-
specific marketing bans are more trade restrictive than required to achieve the European Communities'
appropriate level of protection.
6. EC member State national measures ("safeguard measures")
(a) Article 5.7 of the SPS Agreement does not apply
4.620 The European Communities argues that the safeguard measures are provisional and are
therefore subject only to Article 5.7 of the SPS Agreement to the exclusion of the other provisions
cited by Canada as having been violated. The Eu ropean Communities further claims that the burden
lies on the complaining party to establish a prima facie case that the measures in question are
inconsistent with the requirements of Article 5.7, and that Canada has not met this burden. The
European Communities' arguments in this regard are completely without merit.
4.621 First, the Appellate Body has not defined the re lationship between Article 5.7, and Article 2.2
and 5.1 is "one of exclusion, not exception". E quating the relationship between Articles 2.2 and 5.1,
and Article 5.7, with the relationship between Articles 3.1 and 3.3 is inappropriate because the
purposes, and therefore the relationships between these Articles, respectively, are different.
4.622 The European Communities' argument with respect to Article 5.7 distorts the basic
architecture of the SPS Agreement, as reflected in Articles 2, 3 and 5. The European Communities
bifurcates the SPS regime on the basis of whether measures are "definitive" (or "permanent") or
"provisional". There is no basis for a bifurcation of this nature in either the text of the SPS Agreement
or the relevant jurisprudence. To th e contrary, the basic architecture of the SPS Agreement
demonstrates that the bifurcation occurs in Ar ticle 3, between measures based on international
standards, and other SPS measures. Article 3 provi des Members with two equally legitimate options.
A Member can adopt a measure that is based on a relevant international standard, where such a
standard exists. Alternatively, a Member can adopt a measure in accordance with the relevant
provisions of paragraphs 1 through 8 of Article 5, where it seeks a level of protection that is higher
than the level of protection implied by the international standard.
4.623 In essence, Articles 3.1 and 3.3 represent "separate but equal" tracks to follow in adopting an
SPS measure. Article 3.3 is not merely a "qualified exemption" from the basic obligation in
Article 3.1 to base such measures on international st andards. It is the expression of the "autonomous
right" of WTO Members to establish their own appropr iate levels of protectio n, including levels of
protection that are higher than those implied by th e relevant international standards. However, a
Member choosing the second option is obliged to meet the requirements of Article 5.1 and base its
measures on a risk assessment consistent with the definition found in Annex A.1 of the
SPS Agreement.

4.624 Where a measure is not based on a risk assessment, and therefore inconsistent with
Article 5.1, it will also, by implication, be inconsis tent with the general requirement in Article 2.2 not
to maintain SPS measures without sufficient scientifi c evidence. If it is found that the measure in
question is being maintained without sufficient sc ientific evidence, it is open to the Member
defending the measure to argue that sufficient sci entific evidence does not exist to enable it to
complete a risk assessment. This is where Article 5.7 enters the picture.
4.625 As the Appellate Body has explicitly noted, Article 5.7 "operates as a qualified exemption
from the obligation under Article 2.2 not to ma intain SPS measures without sufficient scientific
evidence". Article 5.7 enables the WTO Members, in certain, limited circumstances, to adopt and
maintain SPS measures despite the fa ct that they are not supported by sufficient scientific evidence.
Article 5.7 does not exist as an option that can be freely chosen by the Member concerned in place of
Article 2.2.
4.626 The European Communities' argument that th e threshold (or "demarcation line") for the
applicability of Article 5.7 lies with the provisional nature of the measure rather than with the
"sufficiency or insufficiency of scientific evid ence" is also without merit. The European
Communities' position is based on a number of dubious textual arguments and the flawed assertion
that the four conditions set out in Article 5.7 have "equivalent status". These assertions ignore the fact
that the first condition, insufficiency of scientific evidence, is expressed as a threshold.
4.627 While the European Communities' legislation indicates that "safeguard" measures are meant
to be temporary, the same legislation requires that a decision on the justifiability of such measures
shall be taken in reasonably short order. Of the five safeguard measures being challenged by Canada,
none has been in place less than 45 months. If su ch measures are provisional, they are so in name
only.
4.628 In any event, the mere fact that a Member labels a measure as provisional does not permit that
Member to escape the other obligations of the SPS Agreement. It is not the provisional nature of the
measure that matters, but whether the measure is being maintained without sufficient scientific
evidence. Only if the measure, whether provisional or otherwise, is found by a panel to be maintained
without sufficient scientific evidence do the consid erations under Article 5.7 come into play.
Obviously, it would be the Member invoking the provision that would have the initial burden of
demonstrating a prima facie case.
(b) Even if Article 5.7 were to apply to the EC member State national measures, it would not
exclude the application of Articles 5.5 and/or 5.6
4.629 The issue in relation to Article 5.5 is consistenc y in the application of appropriate levels of
protection in comparable situations. This is a different matter from the putative inability of the
European Communities to complete a risk assessment with respect to a particular product because of
the insufficiency of scientific evid ence. As the establishment of an appropriate level of protection
logically precedes the selection of the risk management tool – that is, the measure in question – the
main issue is whether it is possible to determine if comparable situations exist. This is a factual
matter that goes to whether the conditions of Article 5.5 have been met and does not have a bearing
on the legal interpretation of the relationship between the Articles 5.5 and 5.7.
4.630 Similarly, the European Communities' answer with respect to the relationship between
Article 5.7 and 5.6 is based upon a false premise. Noth ing in the text of either Articles 5.6, 5.7 or 2.2
supports the European Communities' argument. As a matter of practice, there can be many situations
where the risk manager, when f aced with insufficient evidence, ne vertheless has risk management

options from which to choose. In this light, Article 5.6 still has a valid role to play, even if, in a given
situation, a determination that it has been violated is factually more complicated.
(c) The EC member State national measures are not based on a risk assessment, as required by
Article 5.1
4.631 The European Communities asserts that the phr ase "as appropriate to the circumstances", as
used in Article 5.1, means that, in the context of the safeguard measures, the Panel would have to go
back to Article 5.7 "because … the circumstances are that the scientific evidence is insufficient for the
specific legislator and its specific level of protec tion". The European Communities' interpretation of
"as appropriate to the circumstances" in this rega rd is completely unsupported by the jurisprudence
and any reasonable textual construction of the te rms. While these words provide the WTO Member
flexibility in conducting the risk assessment, as the panel is Australia – Salmon concluded, the words
cannot annul or supersede the substantive obligatio n of Article 5.1 to base the measure on a risk
assessment. Moreover, Article 5.7 operates as an exce ption to Articles 2.2 and 5.1. It is only where a
panel has found that a measure is inconsistent with Article 5.1 and/or Article 2.2 that Article 5.7
comes into play, and then only if the Member seeking to uphold the measure invokes it.
4.632 The European Communities' argument that Ar ticle 5.1 does not "expressly require a 'risk
assessment' – it only requires that the Member take into account risk assessment techniques developed
by the relevant international organisations", is a bl atant distortion of both the clear text in Article 5.1
and its related jurisprudence.
4.633 In the alternative, the European Communitie s argues that the member States' safeguard
measures are based on risk assessments. In point ing, astoundingly, to the risk assessments that
formed the basis for the Eur opean Communities' approval of these products, the European
Communities claims that these ri sk assessments can serve as th e basis both for the original
Community consent and for the member State bans . However, in these circumstances, the risk
assessments in question cannot serve this dual functio n. The publicly available scientific opinions do
not equivocate in their conclusions, nor do they present diverging views of the potential risks
associated with these products. To the contrary, they clearly and unambiguously find that there is no
evidence to indicate that the products in question pose a threat to human health or the environment.
4.634 The European Communities then states that, "[ f]urthermore, the member States have made
their own assessments and further risk assessments may be forthcoming." However, for the most part,
the European Communities has failed to submit any do cumentary evidence of either the member State
"assessments" or "further risk assessments" in re lation to the five safeguard measures challenged by
Canada in this proceeding until requested to do so by the Panel. A review of the additional
information submitted by the European Communities in this regard demonstrates that the safeguard
measures do not even come close to meeting the standard established by WTO jurisprudence for
meeting the requirements of Article 5.1, and, by im plication, the requirements in Article 2.2 that SPS
measures must be based on scientific principles, and not be maintained without sufficient scientific
evidence.
(d) The EC member State national measures violate the TBT Agreement
4.635
 The European Communities' arguments that the safeguard measures do not violate the
TBT Agreement are excessively narrow and reflect a juri sprudentially untenable conception of the
scope of the definition of a "technical regulation" , and the ambit of the obligations set out in
Articles 2.1, 2.2 and 2.9. To the extent that th e EC member State measures are based on ostensible

risks that are not covered by the SPS Agreement, the measures are technical regulations, and are
therefore subject to the TBT Agreement.
(i) The EC member State national measures are "technical regulations"
4.636 The European Communities' assertion that in dividual decisions taken pursuant to the
European Communities' legislative instruments – referred to by the European Communities as
"administrative acts" – "are not themselves techni cal regulations", is bereft of any textual or
jurisprudential support. The only part of the text that the European Communities cites – the phrase
"applicable administrative provisions" – is not part icularly instructive; the absence of "applicable
administrative provisions" does not, by itself, signify that a particular measure is not a technical
regulation. The similarities between the measures at issue in this dispute and the measure at issue in
EC – Asbestos support the conclusion that the safeguard me asures are indeed "technical regulations"
as interpreted by the Appellate Body in EC – Asbestos and EC – Sardines.
4.637 The safeguard measures meet all three criteria established by the Appellate Body to determine
whether a particular measure falls within the defini tion of a "technical regulation". First, all of the
safeguard measures either identify the specific products subject to the prohibitions, or are expressed in
terms that render those products readily identifiabl e. Second, each safeguard measure proscribes
oilseed/rape and corn possessing certain characteristics or genetic materials. This is similar to the
proscription in EC – Asbestos of products – such as cement – containing the asbestos fibre. For these
reasons, the European Communities' assertion th at these measures do not prescribe or proscribe
product characteristics is untenable. Third, complia nce with the product characteristics set out in the
safeguard measures is compulsory. The European Communities' argument that "[t]here is no way for
the notified product to comply with the member State measur e" misses the point. The issue is not
whether the notified product can comply, but whether oilseed/rape or corn products can comply, in the
same sense that, in EC – Asbestos , the issue is not whether asbestos cement can comply with the
prohibition, but whether cement can comply.
(ii) The measures violate Article 2.1
4.638 Canada rebutted the arguments made in the Eu ropean Communities' First Written Submission
in Canada's answer to Panel's Question 69.
(iii) The measures violate Article 2.2
4.639 While Canada would agree with the rather obvious statement that whether a particular
measure fulfils its objective depends on what that objective is, Canada does not agree with the
European Communities' implied argument that the safeguard measures are n ecessary. Canada notes
that the European Communities' argument must be implied because nowhere does the European
Communities explicitly argue – nor does it provide any evidence – that the safeguard measures
actually fulfil a legitimate objective; the European Communities does not even indicate what level(s)
of acceptable risk the "relevant legislators" in the respective EC member States are applying.
4.640 In the light of the objectives of the safeguard measures – in so far as those objectives can
reasonably be discerned from the measures themselv es and the European Communities' legislation
relating to the assessment and approval of biotech products – and in the light of the scientific and
other evidence, Canada has demonstrated that the measures in question do not meet the requirements
of Article 2.2 of the TBT Agreement. The European Communities has not presented any arguments
with respect to the specific safeguard measures that counter Canada's prima facie case. The additional
information relating to the safeguard measures fina lly provided by the European Communities at the

request of the Panel only strengthens Canada's legal position that those measures are more trade
restrictive than necessary.
(iv) The measures violate Article 2.9
4.641 The European Communities does not contest th e substance of Canada's arguments with
respect to the inconsistency of the safeguard meas ures with Article 2.9, confining itself to making
additional arguments for why the saf eguard measures are not technical regulations. To illustrate why
these arguments are without merit, the Panel need not look any further than the measure in issue in EC
–Sardines. The measure in that case, Regulation 2136/89 , a measure that the European Communities
conceded is a technical regulation, applies to a si ngle product: preserved sardines. Clearly, therefore,
whether a measure applies to a single product or a multiplicity of them is not determinative of whether
that measure is a technical regulation or not. It also undermines the European Communities'
contention that a measure must be of a "general nature" in order to qualify as a technical regulation.
O. S
ECOND WRITTEN SUBMISSION OF ARGENTINA
1. Arguments
(a) The de facto moratorium
(i) Introduction – The existence of a de facto moratorium
4.642 In this stage of the proceedings, Argentina w ill argue that the Europ ean Communities has not
refuted any of the arguments that the complaining pa rties put forward in this dispute. The European
Communities' attitude towards our arguments consists , for instance, in dogmatic statements to the
effect that there simply is no de facto moratorium nor any suspension of the treatment of specific
applications for approval. Moreover, the Eur opean Communities affirms that, even assuming that
there were such a measure, it would not be a challengeable measure unde r the WTO Agreement.
Nonetheless, the European Communities simply decl ares that there is no measure at all, without
refuting any of the arguments concerning its ex istence and inconsistency developed by the
complaining parties.
4.643 The European Communities has indicated that ev ents occurring after the establishment of a
panel should be taken into account because the chal lenged measure may have ceased to exist, thus
implicitly admitting the existence of a de facto moratorium, at least before the establishment of this
Panel.
4.644 The European Communities also asserts that the SPS Agreement would not apply to this
dispute, because, as the European Communities understands the SPS Agreement , the issues relating to
agricultural biotech products go beyond the scope of the SPS Agreement. Despite this, the European
Communities does indeed admit that the agricultura l biotech products are partially covered by the
SPS Agreement. According to Argentina, the SPS Agreement is the Agreement to be applied, since it
refers to protection against certain risks and not against certain products.
4.645 In addition, the European Communities considers that there is legislation relevant to this
dispute outside the WTO rules, and that this should be taken into account by the Panel in settling this
case. In any event, Argentina considers that th e "extra-WTO" legislation invoked by the European
Communities does not relieve the European Communities of its obligation to have a scientific backing
for its measures.

(ii) The de facto moratorium measure
4.646 The existence of a de facto moratorium measure has been amply demonstrated, and the
European Communities has not refuted the evidence submitted, but rather tried either to reinterpret or
deny it.
4.647 The de facto moratorium has the following characteristics: (i) it has never been set forth in the
form of positive legislation; (ii) it has prevente d the approval of any new agricultural biotech product
in the European Communities since 1998, through th e systematic suspension of proceedings and the
failure to consider individual applications for authorization or approval of agricultural biotech
products; (iii) it has led to a systematic and unjus tified delay in the time-frames set forth in the
European Communities' legislation, so that procee dings are never concluded; and (iv) it entails
discrimination against agricultural biotech products.
4.648 The existence of a de facto moratorium is obvious because there have been neither approvals
nor rejections of applications for agricultural bi otech products in the European Communities since
1998, despite the fact that several applications ha ve received a favourable scientific opinion from the
European Communities' scientific committees.
4.649 Moreover, it is relevant that the existence of a de facto moratorium has been acknowledged
by senior EC officials with direct responsibility for the matters considered in this dispute.
Furthermore, at the EC member State level the existence of a de facto moratorium continued to be
acknowledged even as late as June 2004.
4.650 More recently, at the time of the curiously opp ortune Bt11 maize approval, reference was
made in the official document to the existence of a de facto moratorium, which states that the Bt11
maize approval "would bring to an end the current moratorium on genetically modified food and feed
in Europe" (italics added). The document not only rejects the European Communities' argument
regarding the non-existence of a de facto moratorium but also the argument regarding "mootness".
The European Communities' statement on "mootn ess" also contradicts the WTO jurisprudence
concerning Article 19.1 of the DSU.
4.651 The European Communities tries to play down the statements of its own senior officials by
arguing that they are not binding on the European Communities. In this respect, the European
Communities quotes jurisprudence relating to "casual statements". Nevertheless, it does not explain
how the statements of senior EC officials with di rect competence in the ma tter can constitute "casual
statements".
4.652 Furthermore, with regard to the Eu ropean Communities' statement that "it may constitute
additional evidence that the Member in question applies that measure in a specific way" , if the
European Communities is referring to the recent de cision on Bt11 maize, Argentina would point out
that this decision relates to only a single product and does not end the existence of the de facto
moratorium. This approval may have occurred precisely because of the establishment of the Panel and
should not be regarded as the normal way in which the European Communities was conducting its
approval procedures.
4.653 The European Communities also states that there have been approvals under
Regulation 258/97 after 1998. A ccording to the European Communities, this shows that the
proceedings were not suspended. Nevertheless, Argentina would like to make it clear that these
"approvals" mentioned by the European Communities are not true approvals but only notifications
under the simplified procedure of Regulation 258/97.

4.654 Regarding the argument that the complaining par ties have failed to identify any instrument or
text on the basis of which the moratorium was establi shed, Argentina has already explained in its first
written submission that the moratorium was not set forth in the form of positive legislation. The
measures referred to in Annex A:1 to the SPS Agreement are not the only sanitary or phytosanitary
measures covered by that Agreement. The Europ ean Communities also argues that, in any case, a
measure not set forth in the form of positive legisla tion could not be questioned in the WTO. On the
contrary, as described in Argentina's submission, GATT/WTO jurisprudence has consistently taken a
broad approach to the concept of "measure". In fact, the tendency has alwa ys been to extend this
concept in such a way that Members' obligations cannot be circumvented.
(iii) Not simply a delay – Disregard of scientific evidence
4.655 In these proceedings, the European Communities is trying to cut short the period which began
in 1998, thereby denying the existence of a de facto moratorium and turning all into a mere question
of delay. Argentina does not agree with the Eur opean Communties' claim that any delay would have
to end with the application of Directive 2001/18. This Directive entered into force in October 2002

and no approvals were issued afterwards despite the scientific evidence at hand.
4.656 The European Communities keeps trying to make out that the clock should be put back to
zero from that moment, regardless of the fact th at no approvals were gi ven and it stalled on all
applications by claiming that more stringent legislation was necessary, namely, on traceability and
labelling. The same applies to the European Co mmunities' response to the Panel's Question 36, in
which it states that "the re-submission represents the starting date for the reasonable period of time
needed to examine the new information and to conduct a risk assessment of the newly identified
issues". Setting the clock back to ze ro with Directive 2001/18 would imply disregarding the whole
period that had elapsed since the initial submissions of the applications, including the moment when
the positive scientific opinions were issued.
4.657 In its response to the Panel's Question 37, the European Communities is again trying to
reduce the claim to a simple question of delays. Argentina strongly objects to this "reductionist"
view. Argentina relies heavily on the scientific evidence on which any SPS measure must be based,
and this substantive requirement goes far beyond the simple question of undue delay . Both the
de facto moratorium and the "suspension and failure to consider" must meet substantive requirements,
i.e. the need for scientific evidence, and thus be cons istent with Articles 5.1, 2.2, 5.5, 2.3 and 5.6 of
the SPS Agreement.
(iv) The European Communities implements and maintains a de facto moratorium
4.658 As Argentina has already pointed out, the Eu ropean Communities has constantly made the
adoption of more stringent legislation a precondition for lifting the moratorium. Nevertheless, the
European Communities has systematically imposed additional requirements with the result that
proceedings could never be completed. As soon as they had met one set of requirements, applicants
were being asked to meet another. In fact, th e European Communities stopped approving or rejecting
applications as from 1998 because it deemed that it s legislation – at that time Directive 90/220 and
Regulation 258/97 – was inadequate. As an immediate consequence, on 4 September 1998 the
European Communities began the so-called "Inter-Service Consultation".
4.659 The European Communities keeps on denying the existence of a de facto moratorium or a
suspension of proceedings. According to the Eu ropean Communities, because of the legislative
insufficiency, a transitional mechan ism – the so-called "interim approach" – was established, to
facilitate the move towards a new regime.

4.660 This was the context in which the European Communities began the legislative procedure that
ended with the adoption of Directive 2001/18. Howe ver, before Directive 2001/18 entered into force
in October 2002, the European Communities again argue d the need for more appropriate legislation.
This prompted the begi nning of the discussion on traceability and labelling, so there have been no
approvals – or even rejections – of agricultural biotech products under Directive 2001/18 either. In
December 2003, a new "Inter-Service Consultation" phase was initiated.
4.661 Argentina will now address these issues and thei r importance in agricultural biotech product
approval proceedings, thereby dem onstrating how the lack of approvals since 1998 was deliberately
decided upon and maintained by the European Communities.
a.- The "Inter-Service Consultation" phase
4.662 From the information on the CD ROMs provide d by the European Communities it is clear
that the European Communities and/or its member States tried to refute or ignore the positive
scientific opinions of its scientific committees, in order to stall the approval or marketing of
agricultural biotech products. Furthermore, the information submitted on the above-mentioned
CD ROMs gives us a clear picture of the releva nt procedural stages for each agricultural biotech
product. There are stages with no legal basis in the approval procedures but with political relevance
as a means of stalling the procedure. This s hows that the European Communities was treating
agricultural biotech products "in baskets".
4.663 The "Inter-Service Consultation phase" effectiv ely prevented all the applications – with
positive scientific opinions in 1998 – from moving forward. In short, all the applications with
positive scientific opinions from year 1998 were sta lled in the "Inter-Service Consultation phase",
with no exception. A first group of products (Falcon GS40 Oilseed rape, MS8xRF3 Oilseed rape, and
A5/15 Fodder beet) was placed in a common "basket" in September 1998 and prevented from
reaching the Regulatory Committee voting stage until June and October 1999, when they were not
even voted on. The remaining two products (Bt 531 cotton and RRC 1445 cotton) did go to a vote but
due to the lack of the required majority they were put in a second "basket" in May 1999. The two
"baskets" were effectively stalled in the proceedings until the applications had to be resubmitted under
Directive 2001/18 in January 2003.
4.664 In its response to the Panel's Question 94, the European Communities describes how
"Interservice Consultation" might work. Arge ntina must conclude that this "Interservice
Consultation" stage is further evidence of both a de facto moratorium and of the "suspension and
failure to consider", specifically with respect to Bt-531 cotton and RRC 1445 cotton.
b.- The "Common Position" and the declaration by various member States
4.665 As has been proved, in 1998 the procedures for a pprovals and rejections of applications were
stopped because the European Communities' legislation was considered inappropriate. In this context,
in June 1999, the EU Council of Environmental Ministers drew up a document called the "Common
Position" for the reform of Directive 90/220. This document stated that there would be no approvals
until there was new legislation. The Declaration by Denmark, Greece, France, Italy and Luxembourg
stated their intention of not allowing more biotech approvals. This position was reiterated in July
2000 during an informal Environment Council meeting in Paris.
4.666 In Argentina's view, the "Common Position" reveals the European Communities' intention not
to approve any more agricultural biotech products. This element of will and intent shows that the
de facto moratorium is not merely the sum of simple delays in the approval proceedings.

4.667 In September 1998 and May 1999, the Europ ean Communities began to stop approving
agricultural biotech products by means of the "Inter-Service Consultation" phase. Shortly after that,
in June 1999, came the "Common Position" and the Declaration of the five member States, arguing
the need for reform of the approval legislation. At that point, the approval procedures were all
stopped and the European Communities had entere d a "discussion phase". Some member States –
France, Belgium, Denmark, Greece and Italy – asked for additional requireme nts before the approval
proceedings were restarted, this time calling for an environmental liability scheme. This regime had
also been recognized within the European Communities as capable of continuing the de facto
moratorium.
c.- Regarding the "Interim approach"

4.668 The European Communities' consideration of a ch ange in the legislation created uncertainty
about the approvals. As a consequence, several applicants offered to fulfil the requirements contained
in the "Common Position", since they had no other choice. After that, in July 2000, the Commission
proposed the so-called "Interim approach". This came after a long period of time without approvals
and was the result of the applicants' concerns – not of any initiative by the European Communities, as
the European Communities would have the Panel believe.
4.669 During July 2000, the Commission considered several options regarding the approval of
agricultural biotech products. The options were: (a ) the application of Directive 90/220 as it stood at
that date; (b) waiting until the member States intern alized Directive 90/200/EEC; and (c) a proactive
position to re-launch the approval system. The Eu ropean Communities chose the option apparently
aimed at re-launching the approval procedure – "Interim approach" – which consisted in anticipating
the stricter requirements of the future Directiv e 2001/18, specially those relating to monitoring,
labelling and traceability. In this context, the con cerns manifested by the European Communities and
by the member States referred to labelling and traceability, and these issues were made a conditio sine
qua non for the approval of agricultural biotech products . Under the "Interim approach" there were
neither approvals nor rejections. Moreover, the entry into force of Directive 2001/18 brought the
"Interim approach" stage to a close. To sum up, the "Interim approach" became just another
manifestation of the de facto moratorium.
d.- Further applications receive positive scientif ic opinions, before the entry into force of
Directive 2001/18
4.670 While all the applications with a positive sci entific opinion dated 1998 were stalled, new
applications were in position to be approved thanks to the positive opinion of the scientific
committees. Both Phoe6/Ac Oilseed rape a nd Bt11 maize received a positive opinion on 30
November 2000 and were to be r esubmitted under Directive 2001/18. T hus, both applications were
stalled for two years . The same can be argued with referenc e to the potato, though within a shorter
time frame since the positive scientific opinion was issued in July 2002.
4.671 In February 2001, six member States – Denmark, France, Greece, Italy, Luxembourg and
Austria – reaffirmed their co mmitment to suspending approvals, on the grounds that the new
procedures were inadequate.
4.672 By the end of October 2001, the majority of member States essentially agreed that the
moratorium should not be lifted until the full tr aceability and labelling provisions had entered into
force. At an informal meeting of the Environm ent Council, eight member States – France, Austria,
Finland, Luxembourg, Denmark, Italy, the Neth erlands, and Sweden – effectively rejected the
Commission's plan to consider new authorizations, by demanding that the new regulations be in force

first. At that time, the Commission estimated th at it would be an additional two years before any
traceability and labelling requirements could be enact ed. In December 2001, Belgium declared once
again that the de facto moratorium would have to be mainta ined until there was proper legislation on
traceability and labelling.
4.673 Consequently, the European Communities was cl early announcing its intention to maintain
the de facto moratorium, even if Directive 2001/18 entere d into force. This refutes the European
Communities' claim that any delays should have ended with the entry into force of Directive 2001/18.
e.- Claims concerning the review of Directive 90/220

4.674 With respect to the European Communities' excuses for repealing Directive 90/220, these
have basically consisted in the following: "new scientific understandings", the lack of harmonized
criteria on the risk assessment to be performed, and the lack of post-marketing surveillance measures
and labelling provisions.
4.675 The lack of harmonized criteria on risk assessment, had already been addressed in the "Report
on the Review of Directive 90/220/EEC" in the context of the Commission's Communication on
Biotechnology and the White Paper. 82 Notwithstanding what this docu ment states, in its response to
the Panel's Question 17 the European Communities asser ts that there is currently no pre-eminence of
the European Communities' scientific committees over the rest.
4.676 Argentina wishes to point out that in its res ponse to the Panel's Question 17, the European
Communities also makes reference to the jurisprudence of the Eur opean Court of Justice, which
establishes the criteria used to determine whether a scientific opinion of the relevant scientific
committee may be disregarded. The European Co mmunities has not observed the rules laid down by
its own Court of Justice. In fact, the European Communities has not provided any reason of a
scientific nature for disregarding the opinions of its own scientific committees, which favoured the
approval of agricultural biotech products.
4.677 Argentina considers this circumstance conf irms the lack of scientific support for the
application of the de facto moratorium and shows that what at a certain point was advanced as an
argument for changing the European Communities' approval system has turned into an excuse
inconsistent with WTO obligations.
4.678 Another argument used by the European Co mmunities to justify the modification of
Directive 90/220 is that relating to "post-market surveillance measures". Directive 90/220 already
dealt with "post-marketing monitoring measures" in its Annex II (V), so we are again faced with an
argument that is really just another excuse. W ith respect to the issue of the lack of labelling
provisions, Directive 90/220 already had such a provision, which applicants could only evade on good
scientific grounds.
f.- Entry into force of Directive 2001/18

4.679 In November 2003, once Directive 2001/18 had ente red into in force, NK 603 maize received
a positive scientific opinion, while GT73 oilseed rape received one in February 2004. By that time,
this WTO Panel had been established.

82 COM(96) 630 final, Brussels, 10 December 1996, "Report on the Review of Directive 90/220/EEC".

4.680 There were no approvals under Directive 2001/18 either. Moreover, at a meeting of
Agriculture Ministers held in January 2003, several EC member States set conditions on the
implementation of. Directive 2001/18, this time concerning the adoption of a labelling and traceability
regime. Additionally, a co-existence regime was also requested.
4.681 In this connection, the EC authorities have indicat ed their intention to resort to the European
Court of Justice because most member States have failed to internalise Directive 2001/18.
4.682 This is another fact which demonstrates the existence of a de facto moratorium.
g.- Regarding the traceability and labelling legislation

4.683 The need for a new traceability and labelling re gime was specifically invoked in the case of
Regulation 258/97. In this respect, the Europ ean Communities pointed out in its response to the
Panel's Question 91 that the aforementioned Regulati on was appropriate to matters relating to "risk
assessment" but that "it became clear in 1999 that there would have to be new legislation addressing
some issues such as labelling and traceability, and also the development and validation of detection
methods. These issues have been addressed th rough Regulations 183 0/2003 (labelling and
traceability) and 1829/2003 (food and feed)".
4.684 In this case, too, the European Communities' argument has become an excuse. In fact,
Regulation 258/97 does contain provisions concerning "labelling".
4.685 With respect to "traceability" and "detection me thods", the European Communities has failed
to identify the existence of a risk as prescribed by the Codex Principl es for the Risk Analysis of Food
Derived from Modern Biotechnology. Thus, th e European Communities' claims regarding
traceability and detection methods are in fact excuses to justify the de facto moratorium.
h.- Regarding the European Communities' arguments based on the Cartagena Protocol and
the so-called "precautionary principle"
4.686 The European Communities argues the relevance of an "extra-WTO" instrument and of the
so-called "precautionary principle" for dealing with the issues raised in this case.
4.687 According to Article 3.2 of the DSU, as in terpreted by the Appellate Body, any treaty
interpreter must resort to the Vienna Convention on the Law of Treaties in order to interpret the
covered agreements. In this case, with respect to the "extra-WTO" rules invoked by the European
Communities, we need to resort to Article 31 of the Vienna Convention.
4.688 The rules referred to by the European Communiti es are clearly not an agreement "relating to
the treaty which was made between all the parties in connection with the conclusion of the treaty" –
Article 31.2 (a). Nor are they an "instrument whic h was made by one or more parties in connection
with the conclusion of the treaty and accepted by the other parties as an instrument related to the
treaty" – Article 31.2 (b). Clearly, the rules cited by the European Communities are not a "subsequent
agreement between the parties rega rding the interpretation of the treaty or the applications of its
provisions" – Article 31.3(a). Nor can the Cartagena Protocol be regarded as "any relevant rule of
international law applicable in the relations between the parties" – Article 31.3(c), since the European
Communities is the only party in this WTO dispute bound by the provisions of the Protocol.

4.689 The European Communities also re fers to the so-called "precautionary principle". It should
be pointed out that the Appellate Body has addressed the status of this so-called "principle" in EC-
Hormones.
4.690 Finally, the Cartagena Protocol states, in one of its recitals:
"Emphasizing
 that this Protocol shall not be in terpreted as implying a change in the
rights and obligations of a Party under any existing international agreements"
What it is relevant in this case is that the Cartagena Protocol does not allow the European
Communities to circumvent its WTO obligations, an d that the European Communities' arguments in
this respect have been just a nother excuse to maintain the de facto moratorium, because the European
Communities has also said that Directive 2001/18 woul d not be adopted until the conclusion of the
Cartagena Protocol, to enable it to adapt its legislation to that Protocol.
4.691 It should be recalled that the Cartagena Protocol establishes the obligation to undertake a risk
assessment. Comparing Annexes I and III to the Cart agena Protocol with Directive 90/220, we note a
great consistency.
4.692 From the above it is clear that the European Communities' arguments are, once again, mere
excuses.
(v) The de facto moratorium is inconsistent with Article 10.1 of the SPS Agreement
4.693 As a developing country, Argentina must again stress the relevance of the SPS Article 10
provisions as they establish special and differential treatment for developing country Members.
4.694 Argentina would like to comment on the European Communities' statement to the effect that
"The European Communities does not doubt the importance of these provisions and can assure
Argentina that it bears them in mind when developing and applying its legislation, including, where
relevant, its GMO legislation". First of all, Argentina welcomes that the European Communities
recognizes the importance of these provisions. Nevert heless, we do not agree with the rest of the
statement, especially the words " where relevant". Argentina must again point out that Article 10 is
mandatory for WTO Members.
4.695 Argentina reiterates that the European Comm unities has failed to present any proof that it
took into account the special needs of developing country Members when drafting and applying its
legislation relating to agricultural biotech products.
4.696 Furthermore, Argentina disagrees with the Eu ropean Communities' characterization that
"Argentina's argument seem to come to nothing more than saying that since the European
Communities has violated other provisions of the agre ements and this affects Argentina, a developing
country, it has consequently also failed to comply with its obligations of special and differential
treatment towards developing countries". The European Communities is wrong in claiming that
Argentina's argument is based on an interpretation of a consequential obligation. Argentina has
argued that the European Communities' adoption of the de facto moratorium omitted all consideration
of the obligations of developed countri es arising out of Article 10.1 of the SPS Agreement, and
specifically the obligation to take account of th e special needs of developing country Members.
Furthermore, even taking into account the EC legisla tion itself, a reading of the main provisions on
the subject – Directives 90/220, 2001/18 and Regula tion 257/98 – reveals no reference to developing

country Members' biotech products, still less any re ference to those countries' special needs being
taken into account.
4.697 Argentina reiterates that the de facto moratorium applied by the European Communities since
1998 has had the effect of closing the EC market to agricultural biotech products not approved before
that date. The trade flows or imports to whic h the European Communities appears to refer cannot
actually include any new post-1998 agricultural biot ech products since no product has been approved
– or rejected – because of the way in which the de facto moratorium has been operating.
4.698 Neither has the European Communities denied Argentina's claim that the lack of
consideration of the special needs of developing coun tries is aggravated in the case of the European
Communities because it is not just a national market but a market that now has 25 member States. In
addition, the last ten States to join the European Communities have had to accept the "acquis
communautaire", which includes the de facto moratorium.
4.699 Argentina thus reiterates its request for the Pa nel to find that the European Communities is
violating Article 10.1 of the SPS Agreement.
(b) The "suspension of processing and failure to c onsider individual applications for specific
products of particular interest to Argentina"
(i) General comments
4.700 As previously stated, since the de facto moratorium affects all applications, these relevant
additional stages also apply to the products of interest of Argentina, namely, Bt-531 cotton, RRC
1445 cotton, NK 603 maize, GA 21 maize and soy lines A2704-12 and A5547-127.
4.701 On the other hand, having examined the in formation finally submitted by the European
Communities in the CD ROMs, Argentina finds th at this information does not match the positive
scientific opinions from the European Communities' sci entific committees. First of all, most of the
information provided by the Europ ean Communities is political rather than scientific in nature.
Secondly, most of the documents listed by the European Communities are dated before
 the issuance
of the positive scientific opinions. Accordingly, Argentina believes that the scientific committees
were aware of all these documents and issued a positive opinion anyway. Furthermore, as only
observations published in indexed scientific jour nals with peer review procedures should be
considered in the analysis, opinions without this basis are not to be taken into account.
4.702 In any event, as regards specifi c comments on issues Argentina considers to be relevant from
a scientific point of view, we enclose comments c onfirming that the additional information which the
European Communities kept talking about, which the European Communities never submitted until
the Panel and the Parties requested it in the Firs t Substantive Meeting, which it provided without
proper translations thereby delaying the procedures, and on which the European Communities said it
had based its measures on the specific products of in terest to Argentina, nevertheless does not refute
the positive scientific opinions issued by the Eu ropean Communities' scientific committees which
favour the approval of all these products.
4.703 This having been said, we will now deal with the applications individually.

(ii) Specific products
a.- Bt 531 cotton and RRC 1445 cotton

4.704 The European Communities has acknowledged that the application for approval of both
cotton types was stalled in the proceedings: th ese products obtained a positive opinion from the
European Communities' Scientific Committee on 14 Ju ly 1998 and were submitted to the Regulatory
Committee, where there was no qualified majority , in February 1999. The European Communities
admitted this, but it also acknowledged that there were certain stages within the proceedings with no
legal basis that were capable of stalling the pr oceedings: specifically, the European Communities
admits that, after the positive scientific opinion of 14 July 1998, on 4 September 1998 the so-called
"Inter-Service Consultation" phase began . In February 1999, in the absence of a qualified majority,
the Regulatory Committee had to submit, without dela y, a draft measure to the Council. Instead of
that, the so-called "Inter-Service Consulta tion" phase took place again – 7 May 1999 – stalling the
procedure. The applications had to be resubmitted under Directive 2001/18 in January 2003.
Comments on the information provided in the CD ROMs
4.705 In Argentina's view, the information provided by the European Comm unities does not refute
the decisive, positive scientific opinions dated 14 July 1998.
4.706 Regarding Bt-531 cotton under Directive 90/220 , the documentation provided by the
European Communities is the following: the objections from Germany (February 1998); the outcome
of the written procedure (April 1999); the statement by Austria; Denmark's position; the Opinion of
the Commission du Génie Biomoléculaire (January 1999); the letter by the Commissie Genetische
Modificatie (December 1998); the statement of the Swedish Board of Agriculture (February 1998);
the letter to the Commission from Swedish Board of Ag riculture (February 1998); the response to the
European Communities by the United Kingdom (February 1998 and February 1999). These
documents are either of a non-scientific nature or pre-date the issuance of the positive scientific
opinion by the EC Scientific Committee in July 1997 or do favour the approval of Bt-531 cotton or
are specifically refuted by the scientific arguments submitted by Argentina.
4.707 Regarding RRC 1445 cotton under Directive 90/220
, the documentation provided by the
European Communities is the followi ng: the outcome of the written procedure (February 1998); the
statement by Austria; Denmark's statement; the objections from France (February 1998); the
Opinion of the Commission du Génie Biomoléculaire (January 1999); the letter by the Commissie
Genetische Modificatie (December 1998); the ex cerpt from the minutes of the ScP meeting of
COGEM (January 1998); the statement by Swedish Board of Agriculture (February 1998); and the
response of the United Kingdom. These documents are either of a non-scientific nature or pre-date
the issuance of the positive scientific opinion by th e EC Scientific Committee in July 1997 or do
favour the approval of RRC 1445 cotton or are speci fically refuted by the scientific arguments
submitted by Argentina.
Rebuttal of European Communities' responses to the Panel
4.708 The European Communities states in its response to the Panel's questions that "the internal
procedures for the preparation of a Commission proposal for decision were ongoing"; referring to
paragraphs 225 (Bt-531 cotton) a nd 232 (RRC 1445 cotton). Argentina considers that: (a) both
specific products had obtained a positive scientific opinion in July 1998; (b) the European
Communities' comment relates to the period after the positive scientific opinions had been issued;
and (c) that period was followed by the "Common Po sition" when applicants were asked to prepare

for the future legislation – Directive 2001/18. This being the case, Argentina doubts that the internal
procedures were ongoing, since so many additional requirements were constantly introduced

4.709 Furthermore, the entry into force of Direc tive 2001/18 did not change the fact that the
applications were not ongoing, since both Bt-531 cotton and RRC 1445 cotton were stalled in their
respective procedures.
4.710 In its response to the questions put by the Panel, the European Communities describes how
"Interservice Consultation" might work. Argentina considers that this "Interservice Consultation"
stage – dealing with informal steps, seeking opini ons from other areas on a text to be proposed, and
capable of being repeated for a second time if needed – is proof of "suspension ", specifically with
respect to Bt-531 cotton and RRC 1445 cotton.
b.- NK 603 maize
4.711 This procedure was started in the year 200 0 and received a positive scientific opinion from
the scientific committee in November 2003. Desp ite this, shortly afterwards, on 8 December 2003,
the European Communities once again started an "Inter-Service Consultation".
4.712 Argentina recalls that the "Inter-Service Consu ltation" phase was used to stall the procedures
for Bt-531 cotton and RRC 1445 cotton under Direc tive 90/220, until the applications had to be
resubmitted under Directive 2001/18. In the case of NK-603 maize, with a positive scientific opinion
"already" issued under Directive 2001/18, the Euro pean Communities recommen ced this procedural
stage, thereby declaring once again its political in tention of not allowing th e approval proceeding to
be completed: in fact, on 18 February 2004, ther e was no qualified majority within the Regulatory
Committee.
Comments on the information provided on the CD ROMs
4.713 Regarding NK 603 maize under Directive 2001/18 , with reference to the information
provided by the European Communities on the CD ROMs, Argentina considers that none of these
documents match the positive scientific opinion of the scientific committees dated November 2003.
Although the European Communities submits information of a scientific nature, almost all of it pre-
dates the positive scientific opinion: the response by Austria to the European Communities (August
2003); the additional comments of the SBB (April 2003); the SBB evaluation (no date); the SBB
evaluation of the additional information (August 2003) ; the Opinion of AFSSA; the Opinion of the
Commission du Génie Biomoléculaire; and the le tters by AFSSA (March 2003, March 2003 and July
2003, respectively); the statement by the Swedish Board of Agriculture (February 2003); the ACRE
advice (March 2003 and August 2003); the Annex B of ACRE advice (March 2003). The Scientific
Committee must have taken all this information into account when it issued its positive opinion.
4.714 Regarding NK 603 maize under Regulation 258/97 , though some of the information provided
may be of a scientific nature, it pre-dates the positive scientific opinion of November 2003: the
objection by Austria (no date); the SBB letter (Feb ruary 2003); the SBB evaluation (no date); the
Opinion by AFSSA (February 2003). The Scientific Committee must have taken all this information
into account when it issued its positive opinion. The only remaining document – dated April 2004 –
explains the minutes of the meeting within the Re gulatory Committee and does not refute the positive
scientific opinion.

c.- GA 21 maize

4.715 Although the application for GA 21 maize was withdrawn in September 2003, Argentina
regards its withdrawal as a perfect illustration of the effect of the de facto moratorium and the
"suspension or failure to consid er". As already stated, GA 21 ma ize received a positive scientific
assessment both under Directive 90/220– September 2000 – and under Regulati on 258/97 – February
2002. Five years and two months had elapsed under Directive 90/220 and Directive 2001/18, and
three years and eight months had elapsed under Re gulation 258/97, before the applications were
withdrawn.
Comments on the information provided on the CD ROMs
4.716 The European Communities only submits info rmation regarding the procedure under
Regulation 258/97. None of this information refutes the positive scientific opinion by the Scientific
Committee of February 2002, since it is all dated earlie r: the position of Austria (no date); the SBB
report (September 1998); the letter and paper from the Danish Ministry for AGRI (April 2000); the
letter from the National Food Administration (April 2000); the letter from the United Kingdom to the
Commission (April 2000). The scientific committee must have taken all this information into account
when it issued its positive opinion.
(c) "Undue delay"
4.717 Argentina reiterates that the European Co mmunities has infringed its obligations under
Article 8 and Annex C of the SPS Agreement in applying its contro l, inspection and approval
procedures to the treatment of the various agricultural biotech product applications filed since 1998.
Argentina will not repeat arguments already subm itted, but feels it necessary to clarify and answer
some of arguments contained in the European Communities' first written submission and oral
statement.
4.718 Argentina completely agrees with the statemen t that: "The European Communities does not
exclude that an omission or failure to act could be subject to the SPS Agreement (...)", and certainly
Argentina also agrees that: "Whether a specific omissi on or failure to act constitutes a violation of the
SPS Agreement depends on the nature of the obligation in question which is alleged to have been
violated".
4.719 The European Communities argues that two cond itions must be met for a determination of
undue delay: firstly, the approval system must be a sanitary or phytosanitary measure within the
meaning of Article 1 of the SPS Agreement and, secondly, the delay must be inconsistent with the
corresponding obligations set out in the SPS Agreement. Argentina agrees with this EC explanation,
and believes that both conditions are met. Th e European Communities itself, as well as the
complaining parties, have accepted that the a pproval system set up under the relevant EC GMO
legislation is "a procedure to check and ensure the fulfilment of sanitary or phytosanitary measures".
4.720 The EC legislation specifically contemplat es time-frames for the different institutions
involved in the complex and detailed procedure. The European Communities has not even tried to
specify the reasons for its failure to consider, ap prove or reject products within the time-frames
provided by its own legislation.
4.721 The Article 8 also requires all Members, "in th e operation of control, inspection and approval
procedures", to "ensure" the consistency of their procedures with the provisions of the
SPS Agreement. Argentina reiterates its contention that the European Communities has not followed

the procedures envisaged in its legislation, and this has led to infringements of Article 8 and Annex C
of the SPS Agreement.
4.722 Argentina stresses that the European Communities has not refuted the evidence with regard to
undue delay, either generally or in particular, for each product of particular interest to Argentina.
4.723 Among the arguments put forward by the European Communities, one relates to force
majeure, and this obviously cannot be applied to the present case; another expresses the idea "that
delays are due to scientific considerations". Nevert heless, the basis of the scientific considerations is
not identified in the European Co mmunities' submissions with respect to any of the products of
special interest to Argentina. The opinions of the scientific committees demonstrate precisely the
opposite, since the majority of these committees issued their scientific opinions within the time limits
foreseen by the legislation. Despite that, there w as a lack of consideration or approval by the "non-
scientific" institutions.
4.724 With respect to Annex C, paragraph 1(a), in order to verify and ensure how sanitary and
phytosanitary measures are implemented, Argentina has compared the different treatments given to
agricultural biotech products before and after 1998. The European Communities has failed to
demonstrate that from 1998 onwards the proceedings to verify and ensure the implementation of
sanitary and phytosanitary measures were begun and co mpleted without delay, and, at the same time,
in such a way as to result in a situation not less favourable for the imported agricultural biotech
products.
4.725 With respect to Annex C, paragraph 1(b), Arge ntina rejects the European Communities' claim
that "Argentina and the United States offer not hing beyond mere assertion that the European
Communities has not done what it is required to do under the different obligations". In its First
Written Submission, Argentina analyses Annex C, pa ragraph 1(b). Argentina rejects the European
Communities' interpretation and reiterates the ar guments proposed in its First Written Submission
with reference to Annex C, paragraph 1(c). The procedures and information requirements are
established within this legislative framework. A close scrutiny of the chronologies reveals the
numerous occasions on which additional information was required from the applicant in connection
with the products of special interest to Argentina. With regard to Annex C 1(e), Argentina again
points out that paragraph 1(e) applies the term "reasonable and necessary" to the requirements for the
control, inspection and approval of individual specimens of a product.
4.726 In this case, as previously explained, there is no basis for the Europ ean Communities' claims
about the need to introduce changes in the control, inspection and approval procedures for agricultural
biotech products. Argentina does not find it reasona ble to ask for "additional" requirements, since
these supposedly "additional" requirements were already envisaged in the former legislation and/or in
the scientific committee opinions.
4.727 In conclusion, Argentina respectfully requests the Panel to find the European Communities'
"undue delay" in each of the respective approval proceedings for agricultural biotech products of
particular interest to Argen tina to be inconsistent with Article 8 and with Anne x C, paragraphs 1(a),
1(b), 1(c) and 1(e) of the SPS Agreement.
(d) Bans by various member States
4.728 Finally, with reference to the measures imposed by Germany, Austria, Italy and Luxembourg,
Argentina first reaffirms what it stated in its Fi rst Written Submission. Moreover, since in its First

Oral Statement Argentina reserved the right to develop arguments relating to Article 5.7 of the
SPS Agreement, we would also like to make the following observations.
(i) Article 5.7 as a defence for measures that would otherwise infringe Articles 2.2 and 5.1
4.729 Argentina does not accept the role that the Eu ropean Communities proposes to attribute to
Article 5.7, when it states that the complaining pa rties should have begun with an infringement of that
Article before considering an infringement of Articl es 5.1 and 2.2. Article 5.7 is a defence against the
alleged infringement of, in this case, Articles 5.1 and 2.2, and is not to be invoked otherwise. The
Appellate Body in Japan – Agricultural Products II has explicitly confirmed the character of
Article 5.7 as an exception. It is up to the Europ ean Communities to invoke this defence, not up to the
complaining parties to raise any infringement of Article 5.7.
4.730 With respect to the application of Articles 5.7 and 5.1, Argentina takes the following view of
the European Communities' statement that Article 5.7 applies to "provisional measures": Article 5.7 is
not applicable to any measure merely called or de emed to be "provisional" but rather establishes a
first and fundamental requirement for any measure to be adopted provisionally; there has to be
insufficient relevant scientific evidence.
4.731 This being said, Argentina maintains that as fa r as the member State measures are concerned
the relevant scientific evidence was not insufficient, since there were specific scientific opinions by
the EC committees first favouring the approval of th ese products and later rejecting the member State
measures. Secondly, Argentina does not agree with the European Communities' affirmation that the
phrase "as appropriate to the circumstances" in Articl e 5.1 would send the Panel back to Article 5.7.
Therefore, we believe that Article 5.1 does apply in this case. Furthermore, we do not agree with the
European Communities' statement that the risk assessment "carried out at the time when the original
Community consent was given" can "serve, at least temporarily
, as a basis both for the original
Community consent, and for the member State provisional measures".
4.732 With regard to the relationship between Ar ticles 5.7 and 2.2, Argentina would like to
comment on the European Communities' asserti on concerning the "demarcation line" between
provisional measures under Article 5.7 and definitiv e measures under Article 2.2, which emphasizes
the words "maintained" and "provisionally adopt" . We do not agree with this. The "demarcation line"
should rather be based on whether there is or is not sufficient sc ientific evidence for the intended
measure – Article 2.2 establishes basic rights and oblig ations, and in particular that "any" sanitary or
phytosanitary measure must be based on scientific principles, and not on whether the measure is
intended to be "definitive" or "provisional".
4.733 When a Member meets the four conditions of Artic le 5.7, this Member is entitled to adopt a
measure under Article 5.7, but a failure to meet the first of these conditions will not cause an
infringement of Article 5.7, but rather preven t the Member from "flipping out" of the general
conditions of Article 2.2.
4.734 As indicated above, it is up to the European Communities to invoke Article 5.7 as a defence,
and hence to bear the burden of proof. Argentina therefore considers that the member State bans
infringe Article 5.1 and Article 2.2 and are not covered by the exception of Article 5.7 of the
SPS Agreement.
4.735 Thus, there was a positive scientific opinion in favour of approving these products.
Nevertheless, the member States may have considered this not to be sufficient and therefore adopted
their own measures. Two of the four measures were not even meant to be pr ovisional, although the

European Communities claims that they were me ant to be: the Austrian and Luxembourg measures
explicitly refer to "prohibitions". And the other tw o, despite referring to "suspensions" had not even
been lifted as of June 2004.
4.736 We rebut the European Communities' claim that "the issue of fact is whether or not the
member States are or are not provisional measures". Argentina considers that the issue of fact is
whether the scientific evidence was or was not sufficient. We also strongly reject the European
Communities' suggestion that "On the contrary, the complaining parties have actually asserted that the
member State measures are
 provisional measures". Argentina has never asserted this.
(ii) Article 5.7, Article 5.5 and Article 5.6
4.737 Referring to the European Communities' respon se to the Panel's Question 19, Argentina once
again points out that, Article 5.7 does not precl ude the application of Article 5.5 of the
SPS Agreement. Argentina considers that these articles re late to different obligations: whereas
Article 5.7 relates to the amount of information n eeded to apply a measure and to the provisional
character of that measure, Article 5.5 refers to di stinctions in levels of protection which entail
discrimination or disguised trade restrictions, and Ar ticle 5.6 concerns the degree of trade restriction
resulting from the measure. On the same grounds, Argentina rebuts the European Communities'
attempt to represent Article 5.7 as an article capa ble of excluding Articles 5.1, 5.5 and 5.6. We
consider that Article 5.7 is not the pivotal article.
(iii) Article 5.7
4.738 With regard to the requirements of Article 5.7, we recall the WTO jurisprudence, according to
which (1) the four requirements of Article 5.7 must be fulfilled in order to establish a valid
provisional measure, and (2) should the first two requirements not be fulfilled, there is no need to
analyse the other two, since resort to Article 5.7 ca nnot be justified if two of the requirements are not
met. Indeed, the nonfulfilment of just one of the requirements precludes the invocation of Article 5.7
of the SPS Agreement.
4.739 With respect to the first requirement, the scien tific evidence was not insufficient, since each
product had received at least two pos itive scientific opinions, firstly in favour of approval and finally
specifically rejecting the member States' attempt to introduce a "special safeguard". With respect to
the second requirement, the member States did not base their measures on the "available pertinent
information", since they disregarded the positive sci entific opinions of the scientific committees. The
evidence submitted by the European Communities in this case does not reflect these positive opinions,
either because it is non-scientific or because it pr e-dates the respective scientific opinion – which
rejected it. With regard to the third requirement, th e member States did not seek to obtain the further
information necessary for a more objective risk ass essment, because the evidence provided in this
case does not reflect the positive scientific opinions given by the scientific committees. With the
fourth requirement, as already mentioned, the memb er States did not review their measures: on the
one hand, Austria and Luxembourg established prohibitions which they did not even envisage lifting.
On the other, Germany and Italy formally establis hed "suspensions" but ne ver lifted or reviewed
them.
(iv) No invocation regarding the de facto morato rium or the "suspension of processing and
failure to consider specific applications of products of interest of Argentina"
4.740 Argentina recalls that the European Communiti es has invoked Article 5.7 only in relation to
the member State measures. Were the Panel to find that the de facto moratorium and the suspension

and failure to consider are inconsistent with Article 5.1 or Article 2.2, Article 5.7 would not apply as a
defence.
P. S
ECOND WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES
1. Horizontal issues
(a) Burden of proof
4.741 A correct allocation of the burden of proof is fundamental for this dispute. The parties
disagree on a number of factual and legal issues which are at the core of this dispute, but complaining
parties seek to ignore. They seek a Panel finding based on the assumption that the risks posed by all
the relevant GMOs are clear, and that the only r eason why they have not all been approved is the
"moratorium." Complaining parties do not engage in any meaningful product-by-product discussion.
That does not mean that the European Communities has the burden of proof. Complaining parties
must prove for each application that the absence of risk has been established and that no useful further
investigation into the risks is underway. The case- law on burden of proof is consistent: the party
invoking the existence of a certain situation bears the burden of proving it; to shift the burden, a prima
facie case must be established. The establishment of the prima facie case cannot be reduced to mere
assertion, without supporting evidence. The Panel must first verify if complaining parties have
established a prima facie case in relation to each of their claims, before ascertaining whether the
European Communities has refuted it.
(b) Risk assessment and the role of scientific opinions
(i) The meaning of "risk assessment" in the SPS Agreement
4.742 The term "risk assessment" in the SPS Agreement has to be understood in the broad sense of
"risk analysis" as defined by the Codex Alimentari us and other international instruments. Risk
assessment therefore encompasses three different as pects: (1) risk assessme nt in the narrow sense,
i.e. as a "scientifically based process"; (2) risk management; and (3) risk communication. This
conclusion follows from the definition of risk assessme nt given in paragraph 4 of Annex A. It also
follows from paragraphs 2 and 3 of Article 5 , which make it clear that in making an assessment of the
risks, Members must take into account not onl y scientific but also economic and regulatory
considerations. The list of factors to be taken into account is not exhaustive.
4.743 The United States and Canada seem to agree that at least some risk management
considerations must be taken into consideration in an approval proce dure. In particular, Canada takes
the position that management considerations may only apply with regard to risks that are identified
based on relevant scientific eviden ce. The European Communities disagrees. Particular risks can only
be assessed and potentially identified in the risk assessment process on the basis of the available
scientific information at the time of the assessment . Scientific knowledge may not be sufficient to
clearly identify the risk. Moreover, risks may become known or relevant at a later stage. In this way
the precautionary approach (or principle) becomes highly relevant. Prudent governments as risk
managers and regulators are entitled to develop and apply appropriate safeguards to protect citizens
and the environment. They are entitled to adopt ri sk management options, such as an appropriate
general surveillance scheme, which are able to de tect and identify any negative impact that was
unforeseen or unidentified in the initial process of risk assessment. This approach is entirely
consistent with international developments.

(ii) Risk assessment and the role of scientific opinions
4.744 Complaining parties generally seek to rely on the theory that the Eu ropean Communities is
bound to authorize GMOs for which European Co mmunities' scientific committees have issued
"favourable" scientific opinions. This position is flawed in a number of respects.
4.745 First
, scientific opinions are only part of the ri sk assessment in a narrow sense, i.e. the
scientifically based process of (a) hazard identif ication (b) hazard characterisation (c) exposure
assessment and (d) risk characterisation. On the other hand, risk management and risk
communication considerations are assessed by the regulator itself and not by those who deliver a
scientific opinion (in contrast with the usual practices in North America). A complete risk assessment,
within the meaning of the SPS Agreement, includes also these latter aspects.
4.746 Second, the scientific opinions by "EC committees" are not binding. There are several
scientific committees with different mandates and at di fferent levels in the European Communities. In
case of scientific disagreement, the opinions of th e European Communities' scientific committees do
not overrule other scientific opinions, such as those is sued by member States' scientific bodies. There
is no obligation in SPS law – or indeed in any WTO law – for a regulatory power to effectively
delegate to a single scientific committee only. This conclusion becomes particularly relevant in a
federal or quasi-federal regulatory context.
4.747 Third, scientific opinions are limited in scope and, therefore, often do not conclude the risk
assessment process, even in a narro w sense. The science on GMOs being in constant evolution, new
risk considerations sometimes arise spontaneously and change the scope of the risk assessment, as in
this case. The process of addressing risk/scientific issues, which are unresolved or new, may require
the authorities to go back for a further assessment by an independent scientific body that had issued an
earlier positive opinion, much later in the process of analysing a particular application.
(c) The SPS Agreement
(i) The scope of the SPS Agreement
4.748 The scope of the SPS Agreement is determined by Annex A.1, first paragraph. The list of risks
or matters subject to the SPS Agreement is exhaustive, as it is clear from the text of Annex A.1,
contrary to the more flexible approach taken with regard to the form of the measures subject to the
agreement (Annex A.1, second paragraph, contains the word "includes", which is absent from the first
paragraph).In determining the material scope of the SPS Agreement, it is necessary to rely on
internationally accepted definitions of the terms in A nnex A.1. On this issue, complaining parties are
inconsistent among themselves, and individual complain ing parties are internally inconsistent, as they
rely on the definitions in other international instrume nts only when it suits their case. In any event, it
is clear that the "common and ordinary" meani ng approach advocated, in some instances, by
complaining parties, to the exclusion of the inte rnational definitions, would not be sufficient. The
common language definitions of SPS terms are often so vague and broad as to deprive of any meaning
the categories and distinctions set out in Annex A. 1. For instance, the definition proposed by the
United States of the term "toxin" ("any substance which, when introduced into or absorbed by a living
organism, destroys life or injures health") is capable of encompassing anything, from a chemical
residue to a lead bullet.
4.749 There is a strong relationship between the SPS Agreement and the texts of specialised
international organisations and bo dies. Article 3 contains obligations on Members with regard to
international standards, guidelines or recommendati ons. Some of the key terms in Annex A.1 are

themselves international standards (the Codex de finition of contaminant is a "standard": Codex
Standard 193, rev 1, 1995). Furt hermore, Article 12(3) refers to the objective of securing from the
relevant international organisations the best available scientific and technical advice for the
administration of the SPS Agreement. This must include advice on the technical concepts that those
organisations have developed and that were adopted by the drafters of the SPS Agreement.
4.750 In their attempt to stretch the scope of the SPS Agreement, complaining parties pay also little
attention to the literal wording of Annex A.1, whic h carefully defines the sp ecific circumstances in
which the Agreement is to be applied. For instan ce, complaining parties continue with the careless
assumption that it would be sufficient for them to es tablish that a measure concerns a "toxin" (or an
"additive", or a "contaminant") for that measure to fall within the scope of the SPS Agreement. That is
wrong as a matter of law. Annex A.1(b) refers to toxins "in foods, beverages and feedstuffs". Toxic
characteristics of seeds or crops, or effects on non-targ et organisms, do not therefore fall within that
provision, when the GMO does not fall within the concep t of "food, beverage or feedstuff." Similarly,
as regards the issue of antibiotic resistance, compla ining parties disregard the fact that antibiotic
resistance may be developed through ways other th an the uptake of food or feed by humans or
animals, so this issue could in an y event not be apprehended solely under sub-paragraph (b) in so far
as human health is concerned. Furthermore, compla ining parties do not attempt to attribute a proper
meaning to the terms "disease-causing" or "di sease-carrying", ignoring the plain fact that the
development of antibiotic resistance cannot be said to be a "disease" "caused" or "carried" by a GMO.
4.751 A measure can only fall within Annex A.1 if it is applied to protect human, animal or plant
life or health. Therefore, the effects of th e relevant GMO on non-living components in the
environment, such as biogeochemistry, particular ly carbon and nitrogen recycling through changes in
soil decomposition of organic material, clearly fall outside the scope of the SPS Agreement. The same
comment may be made with respect to micro-organisms or micro-flora which do not affect human,
animal or plant life or health, but which are nevertheless part of the ecological equilibrium.
4.752 The negotiating history confirms that it was intended to have a precisely limited scope. Of
particular note are the discussions that took place on whether environmental risks should be covered.
Those that opposed this stressed that environmental risks were of a different nature and that rules
designed for SPS measures would not necessarily be a ppropriate for environmental risks. This view
ultimately prevailed, and consequently the SPS Agreement does not cover measures for the protection
of the environment as such (or based on consumer concerns, moral grounds etc.)
(ii) Mixed acts
4.753 How to deal with measures that prot ect against the risks defined in the SPS Agreement, but
that pursue also other legitimate objectives not covered by the SPS Agreement, is an important
threshold issue. Nothing obliges Me mbers to refrain from adopting single acts, incorporating two or
more measures regulated by more than one WTO Agreement or provision. When a WTO Member
adopts a single, indivisible act that pursues multip le legitimate objectives, some falling under the
SPS Agreement and some falling under other WTO Agreements , that Member cannot be directed to
withdraw or revise its measure unless it is found to be inconsistent with all relevant agreements.
4.754 In the case of a mixed act, the challenged act is not itself an SPS measure. It contains or
includes an SPS measure. But it also contains or includes a TBT measure. To find that the TBT
measure, because it is in the same act as an SPS measure, is itself transformed into an SPS measure,
would be an error of reasoning and of law. Article 1.5 of the TBT Agreement does not change this
conclusion. It is a jurisdictional conflict rule . The methods used to delimit the scopes of the
Agreements are different. So a "techni cal regulation" could fall within the SPS Agreement. In that

case, Article 1.5 means that such a measure falls to be considered only under the SPS Agreement. This
situation is different from the case in which a "technical regulation" pursues not only SPS objectives,
but also other types of legitimate objectives.
(iii) Article 2 and Article 5.7 of the SPS Agreement
4.755 Article 2.2 contains an express cross-referen ce to Article 5.7. Article 5.7 is thereby
incorporated by reference into the text of Article 2.2, which is entitled "Basic Rights and
Obligations.". Thus, read in the context of Article 2, the text in Article 5.7 sets out basic rights and
obligations, of equivalent status to the other basic rights and obligations set out in Article 2. The text
of Article 2.2 shows that the drafters saw Article 5.7 as excluding the application of the substantive
obligations in Article 2.2. The comma after the wo rd "evidence" means that the words that follow
exclude all the words up to the word "evidence." Th is is entirely logical. A concept of "necessity" is
already referred to in Article 2.1 and is in any ev ent built into the text of Article 5.7, because a
Member may only act on the basis of available pertin ent information, and only provisionally, in order
to allow sufficient time for sufficient scientific evidence to be collected.
4.756 The relationship between the text of Article 2.2 a nd the text of Article 5.7 is therefore one of
exclusion, not exception. Complaining parties disagree among themselves on this point, and their
arguments are confused and unclear. If it were true that there is sufficient scientific evidence, the
provisional measure would be incons istent with Article 5.7, not fall to be assessed under Article 2.2.
The exclusionary demarcation line between Articl es 2.2 and 5.7 is based on whether or not the
measure is provisional. The provisional nature of the measures must be motivated by the insufficiency
of the scientific evidence, but an Article 5.7 measure is still provisional.
4.757 Provisional measures continue to be subject to the requirements of Article 2.3. They may not
arbitrarily or unjustifiably discriminate between Members where identical or similar conditions
prevail, including between their own territory and that of other Members; and measures may not be
applied in a manner that would constitute a disguised restriction on international trade.
(iv) Article 5.7 and the rest of Article 5 of the SPS Agreement
4.758 Once the text of Article 5.7 is considered in th e appropriate context, its relationship with the
other provisions of Article 5 becomes clearer. The fact that Article 5.7 is positioned after Articles 5.1
to 5.6 (and not after Article 5.1) also confirms its nature as a special regime applying specifically to
provisional measures. Articles 5.5 and 5.6 would be difficult to apply if an acceptable level of risk
still has to be established on the basis of a more objective assessment of risks.
4.759 Provisional measures are still subject to a full set of controls under the SPS Agreement. They
must comply with the requirements of Article 5.7, as well as with Articles 2.1, 2.3 and 2.4. These
provisions contain rules and obligations that are analogous to those set out in Articles 5.1 to 5.6,
adapted appropriately to the provisional measures scen ario. Thus, Articles 5.1 to 5.6 are irrelevant:
provisional or temporary measures (whether the me mber State measures or the alleged temporary
"standstill or moratoria") fall to be considered under Ar ticle 5.7; and delays are to be considered in
accordance with Annex C. Even if Article 5.1 would be considered relevant, the words "as appropriate
to the circumstances" enshrine an important degree of flexibility, whether in relation to the member
State measures, or in relation to the alleged pr oduct specific delays. The obligation under Article 5.1
is only that measures be "based on" an assessment . This does not mean that the assessment itself
necessarily automatically dictates the terms of the legislative measure to be adopted.

4.760 Complaining parties accept that under the SPS Agreement it is permissible for an EC member
State to have a different level of protection compar ed to that applying el sewhere in the European
Communities. Complaining parties are wrong to assert that, in the context of the safeguard measures,
the member States are applying the same level of protection as at Community level. They are
applying a level of protection that reflects their ow n particular circumstances. In the context of
Articles 5.5 and 5.6, Members enjoy more flexibilit y in cases where they lack the elements to assess
the nature or the extent of a risk. A comparison w ith other situations is difficult if each situation
cannot be precisely defined or evaluated. In the context of Article 5.6, it is difficult to calibrate a
measure if the extent of the risks or the availability or effectiveness of protection measures is unclear.
In these circumstances, consistency with Articles 5.5 and 5.6 can only be considered taking into
account the degree of flexibility present in those provisions.
(v) Article 5.7 of the SPS Agreement
4.761 Complaining parties assert that there is no relationship between the acceptable level of risk –
or the analogous concept in the context of provisional measures – on the one hand, and the question of
whether or not relevant scientific evidence is insufficient on the other hand. The European
Communities does not agree. In the context of provis ional measures, a full risk assessment has yet to
be completed and the level of acceptable risk may ye t to be finally determined by the legislator.
However, the concept of sufficiency in Article 5.7 is relational, and must therefore refer to the matters
of concern to the legislator. Members may not n ecessarily react identically with regard to potential
risks and uncertainty. Depending on the specific ci rcumstances prevailing in each country, scientific
information may or may not be deemed sufficient to decide appropriate measures. A matter of
concern for one legislator may not be of equal concer n to other legislators because of climatic factors,
eating habits, social (environmental) values, etc. There is no magic moment at which the available
science become sufficient for all purposes. Rather, the actions of a legislator, whether definitive or
provisional, in response to the available science, are a function of what that legislator is concerned
about.
(vi) Article 2.3 of the SPS Agreement
4.762 Article 2.3 applies to measures, and is therefor e irrelevant to any consideration of alleged
delay. It refers to a situation in which identical or similar conditions prevail between Members, or
between the territory of the importing Member and th at of other Members. Complaining parties have
not even alleged that identical or similar conditi ons prevail between their own territories and the
territory of some other Member. Nor have they a lleged that the European Communities discriminates
between Members, including its own territory, in respect of its treatment of GMOs. The European
Communities deals with GMOs in an even-handed way, without discrimination. Article 2.3 also states
that measures should not be app lied in a manner which would constitu te a disguised restriction on
international trade. The present case concerns the ongoing discussions within the European
Communities about how to respond to the risks posed by GMOs, whatever their origin, any trade
effects being entirely incidental. This is a b asic right of the European Communities under the
SPS Agreement.
(d) The TBT Agreement
4.763 Complaining parties assert that the Panel can r esolve all the issues before it by reference only
to the SPS Agreement. Only Canada and Argentina have invoked, in the alternative, several provisions
of the TBT Agreement, but only in connection with the allege d product specific marketing delays and
the member State measures. There is no inconsistency with the TBT Agreement.

(i) The meaning of the term "technical regulation"
4.764 The member State measures are not "technical re gulations". The same applies to the alleged
product specific delays. It is impossible to unders tand how an alleged delay – that is, silence or
inaction – could lay down mandatory product char acteristics. The observations of the European
Communities in respect of Articles 2.1, 2.2, 2.9.1, 2.9.2 and 2.9.4 of the TBT Agreement, as regards
the member State measures, apply mutatis mutandis as regards the alleged product specific delays.
(ii) Article 2.1 of the TBT Agreement – the issue of likeness
4.765 Neither the member State measures nor the alleged product specific delays are technical
regulations. The Panel should reject the assertions made by Canada and by Argentina as regards the
issue of "likeness". Under Article 2.1 of the TBT Agreement, "likeness" is properly understood as
relating to products within the field of application of the technical regulation. Furthermore, GMOs are
not like products to conventional products.
(iii) Article 2.2 of the TBT Agreement
4.766 The general EC GMO legislation might be a techni cal regulation but is not before this Panel.
Complaining parties have not established that any actual application of the EC legislation – any
delays or member State safeguard measures – is mo re trade restrictive than necessary. Complaining
parties refer to the prohibition on marketing, pending authorization, but that is the very essence of the
GMO legislation – not an application of it. The provisional absence of a final decision cannot be
turned into an alleged measure.
4.767 There is no obligation to conduct a risk assessment under Article 2.2 of the TBT Agreement.
In any event, the European Commun ities is currently in the process of assessing the risks in order to
decide whether to authorize these products. The European Communities also contests the suggestion
that Article 2.2 includes an obligation according to which the legitimate objec tive must actually be
fulfilled. Whether or not the objective is actually fu lfilled in fact is irrelevant, provided that the
measure is capable of contributing to that objectiv e. Opinions issued by the European Communities'
scientific committees reflect questions posed at the time, and are themselves qualified. They may or
may not be sufficient for the Commission or the Coun cil, and may at the same time be insufficient for
the member States.
(iv) Article 5 of the TBT Agreement – The meaning of "conformity assessment procedure"
4.768 The European Communities does not agree with the assumption that the EC GMO legislation
constitutes a conformity assessment procedure within the meaning of Article 5 of the TBT Agreement.
A conformity assessment procedure does not exist wher e there is room for the exercise of discretion,
or the weighing of complex and to some extent conf licting considerations. It rather relates to the
situation in which precise criteria have already been laid down, and it is simply a question of verifying
whether or not a specific product meets those obj ective and precise criter ia (such as weight,
dimension, material composition, strength, electrical resistance, and so on).
4.769 In the light of the preceding observations, th e European Communities does not agree that
Canada and Argentina have demonstr ated the relevance of Articles 5.1.1, 5.1.2, 5.2.1 and 5.2.2 of the
TBT Agreement. Furthermore, there has been no "less favourable treatment" of GMO products,
within the meaning of Article 5.1.1. Nor there h as been any unnecessary obstacle to trade, within the
meaning of Article 5.1.2, as the risks to the envir onment have a character of irreversibility that makes
a stricter approach necessary than would be the case for reversible risks. Neither Canada nor

Argentina have discharged their burden of proving, w ith regard to the specific facts of each specific
product application, any moment at which the Euro pean Communities has not acted "as expeditiously
as possible", as required by Article 5.2.1. Argentina has made assertions concerning Article 5.2.2
which it has failed to substantiate with specific evidence.
(e) GATT 1994
4.770 If the SPS Agreement and the TBT Agreement are not applicable to the risks or "measures"
contested by complaining parties, their claims will fall to be considered under the GATT 1994. The
European Communities considers that Article XX of the GATT 1994 may in any event be relevant.
(f) WTO and other international agreements
4.771 The Panel must interpret the relevant rules of WTO law consistently with other rules of
international law relevant to th ese proceedings, in accordanve with US – Shrimp . The 1992
Convention on Biological Diversity and its 2000 Biosaf ety Protocol "are relevant to this case", and
that the provisions of inter alia the Codex Alimentarius Commission and other equivalent standards
are relevant to these proceedings as inter alia "international standards, guidelines and
recommendations" within the meaning of both the SPS Agreement and the TBT Agreement. None of
complaining parties disavow the approach taken in US – Shrimp. However, they are inconsistent as to
the consequences. On the relevance of internationa l instruments, they provide inconsistent answers
amongst themselves. Having proposed that no internati onal instruments are relevant, they rely on the
relevance of international conventions and texts if it suits them.
(g) Mootness
4.772 The alleged "general moratorium" has never ex isted. The present dispute has not become
moot: rather, it lacked material object ab initio. The same applies to product applications that were no
longer pending at the time of the establishment of the Panel. There can be no Community decisions on
those products, and this was true at the time of Panel establishment, consultations, and before.
4.773 Mootness is relevant for the product specific cl aims where product applications have been
withdrawn or decided after establishment of the Panel. Complaining parties urge that the Panel to rule
on measures that no longer exist, but do not explain why the Panel should not apply a legal principle –
mootness – that is recognized in jurisdicti ons around the world and commonly applied by
international tribunals, including the ICJ. The WTO is not an exceptional case impermeable to the
application of such a basic principle. The GA TT/WTO case-law invoked by complaining parties does
not support their claims. If the Panel decides to ma ke findings on measures that no longer exist, the
European Communities submits in the altern ative that the Panel should not make any
recommendations in respect of those measures.
2. Complaining parties' claims
(a)
Product-specific delays
4.774 Complaining parties claim that there is a susp ension of the approval system in respect of a
number of specific applications. These acts are said to constitute at the same time a violation of
certain provisions of the SPS Agreement and of its Article 8 and Anne x C, as well as of provisions of
the TBT Agreement and the GATT. They merely repeat their assertion that the alleged "general
moratorium" has impeded the operation of the Eur opean Communities' approval process. They make
generalised contentions, claiming that "x" number of years are "excessive" or "patently excessive".

They have failed to identify for each and every product-specific application the instances in which this
"failure to apply or suspension" has materialised. They ignore the facts.
(i) Factual issues
The individual product-specific applications/notifications

4.775 There is no specific analysis of each application – only a few specific arguments in relation to
a limited number of applications. Of these, several c oncern applications that have been withdrawn or,
as in the case of Bt11 and NK603, brought to a conclusion by way of approval. Claims concerning
those applications are not properly before the Panel: if the withdrawals or approvals took place before
the Panel was established, the Panel has no jurisdic tion; if they took place subsequently they have
become moot. The European Communities therefore limits its second written submission to the small
number of individual applications which remain out standing. For all those products in respect of
which no specific comments have been made, complaining parties must consider that all time spans in
the chronologies submitted by the Eu ropean Communities do not constitute delay or, if they do, that
they are justified.
4.776 An analysis of the procedural steps taken in relation to the pending product applications
shows that the few arguments put forward by complaining parties are either plainly mistaken or a
misrepresentation of the facts. So me of the issues complaining parties typically ignore include the
development of Stewardship programmes for post marketing guidance and monitoring (as
recommended by European Communities' scientific committees themselves), the development and
validation of detection methods, the update of applications in agreement with the applicant companies
(the so-called 'interim approach'), and even the applicant companies' delays in providing necessary
information. Complaining parties have therefor e deliberately chosen not to discuss any of the
scientific and technical issues that were raised and discussed during the approval procedures, and
which explain the alleged "delays". The European Communities has provided full details about the
pending product applications.
The time element

4.777 The specific facts of the specific cases demons trate that any generalisation is misplaced
because each application has its own sp ecificities. In particular, the analysis of the facts show clearly
that there are no "concerted acts and omissions that stall applications at key decision making stages in
the approval process regardless of the scientific ev idence demonstrating the safety of the product."
The time taken for each product-specific application is documented as being used in respect of the
following activities:
(a) To allow review by an organ of the Eu ropean Communities on the basis of the
requirements established by the EC legislation;
(b) To allow debate between the applicant, the member States (both as Competent
Authorities and in the Regulatory Committee), and the Commission on scientific
and/or technical issues;
(c) To address efforts to deal with risk management concerns (elaboration of monitoring
requirements, adequate agricultural practices, etc.) as well as risk communication
(labelling, etc.);

(d) To respond to delays voluntarily caused by the applicant and not attributable to the
European Communities (multiple notificati on; insufficient data; bad quality of the
data (e.g. molecular data); time to compile requested information or data etc.).
The scientific and technical nature of the reasons for the delays

4.778 The activities involved in the assessment of GMOs are scientifically and technically justified.
Therefore, should the Panel have any doubt on whet her the time which has elapsed for each product-
specific application was necessary and justified to a ddress scientific and technical issues, independent
scientific and technical advice must be sought. The parties dispute this factual issue.
(ii) Legal issues
Burden of proof
4.779 Complaining parties have not discharged their burden of proof. Their factual arguments are
generic (general suspension, general failure, ove rall time elapsed, stalled/delayed at member State
level, etc.), or just wrong (Commission's failure to submit proposal to Regulatory Committee,
imposition of interim approach, indefinitely suspende d, etc.). Assertion is no substitute for rigorous
presentation of facts. They also tend to standard ise their arguments and repeat them for several
product-specific applications. Whenever complaining pa rties attempt to look at individual facts, they
fail to indicate which period of time should be cons idered a delay and, in all cases, why the delay
would be considered unjustified in the specifics of each application.
4.780 In all cases, all three complaining parties fa il to address and comment on the numerous risk
assessment and risk management issues that were discussed and advanced in the specific proceedings.
All those issues should have been known to comp laining parties before the initiation of these
proceedings, through their contacts with applicant co mpanies. Complaining parties do not appear to
have available to them the information that would have enabled them to "exercise their judgement as
to whether action under these procedures would be fruitful" in accordance with Article 3.7 of the
DSU. The European Communities regrets the unw illingness of complaining parties to engage in
meaningful consultations prior to requesting the establishment of this Panel.
Applicable law
4.781 Events in each specific application procedure ma y originate with considerations within the
scope of different WTO agreements. The analysis to be applied to "mixed delays" is the same as that
to be applied to mixed acts. Action and inaction are two different sides of the same coin. The
European Communities therefore subm its that the Panel cannot lawfully reach a final conclusion on
the European Communities' behaviour, and make recommendations accordingly, on the basis of
Annex C only.
4.782 The European Communities has set out the concerns that have arisen in respect of various
product-specific applications together with the re levant WTO Agreement or Agreements that cover
them. In almost all cases, the GATT, the TBT Agreement and the SPS Agreement are all potentially
applicable by virtue of the regulatory concerns th at underlie the European Communities' procedures.
The superficially neat approach of complaining pa rties is inconsistent with the WTO Agreements.
First, and as explained above, the approval procedur e itself – which is not contested by complaining
parties – does not only address SPS concerns. Seco nd, disregarding the concerns actually addressed
in the specific application proce dures in effect ignores the provisions of Annex A.1. Complaining
parties' approach must therefore be dismissed.

The SPS Agreement

4.783 The SPS Agreement contains two types of provisions, those disciplining the development of
the sanitary or phytosanitary measures a nd those dealing with their application . Challenging the way
in which applications for authorization are dea lt with is a challenge against the application of a
sanitary or phytosanitary measure. Thus, among th e various provisions which complaining parties
allege to have been violated, only Article 8 together with Annex C can be applied to the facts of this
case. Articles 2.2, 2.3, 5.1, 5.5 and 5.6, on th e contrary, all contain obl igations concerning the
development of a sanitary or phytosanitary measure (i.e. the SPS measure itself).
4.784 The distinction between provisions on developm ent and on application of measures addresses
two different regulatory needs arising at two different points in time: the need to ensure the creation of
procedures which respect certain parameters and the need to ensure the management of these
procedures according to other parameters. This is c onfirmed by Article 8, which contains two distinct
legal provisions. In its first part, it submits "the operation of control, inspection and approval
procedures" to the provisions of Annex C. In the second part, it provides that the procedures
themselves must be in conformity with all other provisions of the SPS Agreement.
4.785 All parties agree that not every delay triggers a violation, and that both the "justification for"
and the "duration of" the delay are relevant to dete rmine whether the delay is "undue". That requires a
case-by-case assessment. In the case of appr oval procedures for novel products, each product
presents characteristics and specificities peculiar to it. These also vary according to the specific
habitat/environment in which the product is going to be produced and marketed, and according to the
level of protection that is sought. That a produc t may have been previously approved in other
jurisdictions is not necessarily relevant.
4.786 The time limits in the legislation setting up the approval procedure cannot be but "standard",
i.e. average, indicative. Members may not always abide by the standard processing periods, depending
on the specific circumstances of each case. That is why paragraph 1(b) of Annex C only requires
Members to publish the standard processing period or to communicate to the applicant the anticipated
processing period. The purpose of this provision is on e of transparency and is not linked in any way
to the concept of "undue" in pa ragraph 1(a). The European Comm unities' legislation contains an
indication of standard processing times but, at the same time, it has a built-in flexibility. Thus, any
period of time during which further information is awaited from the applicant, or during which the
scientific committee is analysing the dossier, is not taken into account.
4.787 In the absence of any serious analysis by comp laining parties, who simply try to reverse the
burden of proof, the European Communities would s uggest a possible classification of delays and
their justification, as follows:
(a) The delay is caused by risk considerations which do not fall within the scope of
Annex A
(b) The delay has been voluntarily accepted by the applicant
(c) The delay is caused by the entry into force of new legislation with stricter
requirements
(d) The delay is not attributable to a Member (e.g. caused by the applicant)

(e) The delay is necessary to en sure compliance with existing legislation and relevant
international standards
(f) The delay is caused by efforts to elaborate monitoring requirements, adequate
agricultural practices and similar efforts to manage SPS risks
4.788 In addition to these justifications, the European Communities submits that delays in approval
procedures can also be justified by (g) the analysis of scientific and technical issues, and (h) risk
communication matters such as labelling. In none of these cases is delay to be considered "undue".
The TBT Agreement

4.789 For a rebuttal of the claims related to the TBT Agreement, the European Communities refers
the Panel to the horizontal section above.
GATT 1994 – Articles III:4 and XX
4.790 If the Panel finds that any delay in a product-speci fic application is inconsistent with any of
the provisions invoked by complaining parties, th e European Communities' actions are nevertheless
justified under Article XX of the GATT 1994.
(b) The alleged "general suspension" or "general moratorium"
(i) Measures at issue
4.791 This Panel is being invited by complaining pa rties to identify the existence of a measure
which is alleged to be a "moratorium", and to decide the entire case on that basis. This is
notwithstanding complaining parties' evident inability to identify a single decision on the part of the
European Communities which reflects such a "morator ium". If the Panel is to assess the consistency
with WTO rules of this so-called "moratorium" – and if the European Communities is to bring its
actions into compliance with its WTO obligations – the Panel must first define with absolute precision
what the "moratorium" consists of and what the meas ure at issue is. A measure that is a "moratorium"
must therefore be shown to be a "plan or course of action" to suspend a procedure, or "a decision not
to decide." On the other hand, the "absence of a d ecision" is not the same thing as a "decision not to
decide." The facts which the Eur opean Communities has put before the Panel show that there has
been no such decision. There may be expressions of individual opinion associated with specific
persons, or views of individual member States. But the European Commun ities itself has not taken
any such decision.
4.792 First, even though the European Communities' legi slation was being revised in the period
1998 to 2001, the authorization procedures were never suspended to await it's entry into force. The
existing applications continued to be assessed on the basis of an "interim approach" which sought to
anticipate the new Community legislation, in pa rticular as regards certain risk management
requirements. Second , during the period in question the new legislation entered into force and the
above period of transition ended (i.e. in the case of Directive 2001/18 well before the establishment of
this Panel). While the application procedures, in some cases, may have suffered delays during the
transition period, they are now proceeding normally.
4.793 Complaining parties attempt to obtain a fact ual and legal ruling against the European
Communities based on their description of a factual s ituation that allegedly is the effect, result or
consequence of a presumed moratorium. That attempt seeks to replace legal and factual analysis with

mere assertion. Panels do not rule on "effects" w ithout establishing the existence of a measure for
which the WTO member is responsible. The questi on of what measure caused an observed effect
cannot be left open. Moreover, complaining parties reinvent the definitions and meaning of the terms
"moratorium" and "measure." The issue now is no l onger that of a suspension of the approval process,
but that of a "blockage at key stages in the pro cess", regardless of whether the product applications
have moved from one stage to the next. Complain ing parties present as a measure, i.e. as a plan or
course of action, the most diverse reactions of diffe rent players in relation to different applications,
and they conveniently leave out everything that does not fit that picture. Such reactions are part of an
internal decision-making process and as such do not have external legal effect. In so far as there is no
act or final outcome of the decision-making procedure, what could be attacked is a failure to act but,
in so far as the SPS Agreement is concerned, the only obligation in that respect is to act without undue
delay.
(ii) The issues the Panel would have to address if there were a measure
4.794 If the Panel takes the view that there is a me asure, it would have to consider the following
issues: (1) whether the measure existed when the Panel was established and if so, whether it still
exists; (2) to what extent that me asure comes within the scope of the SPS Agreement; (3) whether the
measure is inconsistent with Article 5.7, as the me asure would have to be considered to be of a
provisional nature applied for reasons of insufficiency of scientific evidence; (4) to the extent that the
measure does not fall under the SPS Agreement, whether it is a technical regulation falling under the
TBT Agreement or whether Article III:4 of the GATT 1994 would be applicable; and (5) possible
justification under Article XX of the GATT 1994.
(c) The EC member State safeguard measures
(i) Facts and legal argument before the Panel
4.795 To assist the United States, the European Comm unities gives the example of Bt-176. One of
the reasons for the Austrian measure is the issue of antibiotic resistance. Austri a's concern is that the
antibiotic resistance marker gene might be transferred to bacteria in the human gut, and that this might
reduce the effectiveness of antibiotics used in medicine. This issue falls , at least in part, outside the
SPS Agreement. Therefore, some of the reasons for the Austrian safeguard measure fall outside the
SPS Agreement and, in relation to these reasons, the Austrian safeguard measure cannot be considered
inconsistent with the SPS Agreement. The same analysis applies in relation to the other measures.
(ii) The concerns of the member States
4.796 The Panel asked the United States to explain its position in relation to the concerns cited by
the member States. The United St ates answered that question by re ference to what it alleges "the
member State measures cite" – which is different. The United States thereby changed the terms of
reference of the Panel's question, and thus failed to respond to the question actually posed. What is or
is not expressly referred to in the member State measures themselves is not the point. Those measures
are in some cases relatively succinct, as is ofte n the case with provisional measures. The United
States deliberately selects what it knows to be a narrow presentation of the issues, as part of its
general strategy to force as much as it possibly can into the scope of the SPS Agreement. A true
appreciation of the member State concerns emerge s from a fair and complete consideration of the
histories of each of these measures, and the procedural steps leading up to, and following, their
adoption. The European Communities has explained in detail to the Panel and complaining parties
the true scope of the concerns that resulted in these measures being adopted and maintained. The
European Communities has also explained in de tail which of these concerns fall within the

SPS Agreement, and which do not, and why. The United States has not responded to these
explanations, but attempts to change the underlying terms of reference. The assertions that the
complaining parties do make in respect of specific issues are manifestly erroneous.
Q. T
HIRD WRITTEN SUBMISSION OF THE UNITED STATES
1. Introduction
4.797 The European Communities has not even atte mpted to explain how the moratorium is
consistent with its SPS obligations. Rather, the European Communities' core defence remains that
despite the fact that the moratorium was widely and openly acknowledged by EC member States and
EC officials, no moratorium in fact ever existed. The European Communities attempts to support this
position through the submission of CDs containing documents related to the processing of
applications, and through brief narratives describing the processing of pending applications.
4.798 However, the mere fact that certain appli cations made some progress through the approval
process, or that some of the delays may not have been unjustified, most certainly does not disprove
the existence of the moratorium. The moratorium was a political-level decision not to allow any
product to reach the final stage of approval; it was entirely consistent with that decision for EC
regulators to allow certain applications to make some progress – short of final approval – through the
approval process.
4.799 Nonetheless, the United States notes that the a pplication histories submitted by the European
Communities do not support the European Communities' view that the moratorium never existed.
Rather, the chronologies provide numerous exampl es of how the moratorium operated to prevent
decisions being reached on the different product app lications and in different stages in the approval
process. In several cases, applications were comple tely ignored either at the member State or the
Commission level for years. In others, member States lodged baseless objections and requests for
information that unduly delayed various applications . The EC documents further show that the only
risk assessments for the products at issue were t hose conducted by the lead competent authority and
the European Communities' scientific committee, a nd that the results from those risk assessments
neither conflicted with each other nor otherwise justified failing to reach a decision on the products.
2. The second written submission of the Eu ropean Communities fails to raise any
meritorious arguments
(a) The European Communities' concept of "mootness" is not relevant to this dispute
4.800 The concept of "mootness" that the European Co mmunities has articulated is not of relevance
to this dispute. The Panel's terms of referen ce under the DSU are "[t]o examine ... the matter referred
to the DSB" in the request for the establishment of the Panel. In this case, those matters are the
general and product specific moratoria and the memb er State safeguard measures as they existed in
August 2003. The United States is not aware of, and the European Commun ities has not identified,
any panel that, absent an agreement of the parties, has declined to examine a measure that was in
force when its terms of reference were set. To the contrary, past GATT and WTO panels have
examined and made findings on measures even if they were discontinued during the panel's work. As
the panel wrote in the India – Autos dispute: "A WTO panel is generally competent to consider
measures in existence at the time of its establis hment. ... Panels in the past have examined
discontinued measures where there was no agreement of the parties to discontinue the proceedings."

4.801 The European Communities in its second written submission has two responses, both of
which are entirely without merit. First
, the European Communities argues that "Remarkably, the
complaining parties have made no attempt to explain why WTO Panels are prevented from applying a
legal principle that is recognized in jurisd ictions around the world and commonly applied by
international tribunals ... ." The European Comm unities makes no attempt at defining precisely what
"legal principle" of mootness the European Co mmunities claims that the WTO should adopt; the
European Communities fails to explain why the GA TT and WTO panels cited above have in fact
considered terminated measures, and the Europ ean Communities makes no attempt to explain how
such a principle would be consistent with the text of the DSU. In short, what is "remarkable" is that
the European Communities criticizes the complainants for relying on th e text of the DSU and on past
GATT and WTO practice.
4.802 Second, the European Communities tries to conf use the issue by addressing yet another
question: namely, whether a Panel issuing finding s on a terminated measure should also recommend
that the DSB request the defending Member bring its measure into conformity with WTO rules.
Plainly, under that same consistent GATT and WTO practice, panels do issue such recommendations.
Furthermore, Article 19.1 of the DSU specifically provides that "where a panel ... concludes that a
measure is inconsistent wi th a covered agreement, it shall recommend that the Member concerned
bring the measure into conformity with that agr eement." While the European Communities cites the
US – Certain EC Products dispute as an example to the contrary, that dispute in fact involved an
entirely different situation: the measure at issue in that dispute had ceased to exist before the date of
the request for establishment of the panel.
4.803 Moreover, this is not a case in which the measur e at issue has terminated. The United States
certainly does not agree that two token product ap provals – made only after substantial delays and
pursuant to Commission decisions after failure s by both the Regulatory Committee and Council to
take decisions – suffice to signal that the European Communities has begun to process other
outstanding applications without undue delay, as required by the European Communities' obligations
under the SPS Agreement.
4.804 It is particularly important for the United States, and for the WTO rules-based system as a
whole, that the Panel in this dispute comply w ith past practice and issue findings on the European
Communities' moratorium as of August 2003. A ll but two of the products caught up in the
moratorium remain unapproved. Biotech product appr ovals remain a controversial political issue in
the European Communities, and the recent expans ion of the European Communities from 15 to
25 member States has not simplified the situation. In addition, a number of EC member States believe
that yet additional legislation must be adopted be fore the granting of new biotech product approvals.
And, although the European Communities has now approved two corn varieties for import and
consumption, the European Communities has yet to approve under 2001/18 a single biotech product
for planting in the European Communities. Accordingly, if the Panel were to depart from the DSU
and past practice and apply the European Commun ities' concept of mootness, the possibility is
substantial that the European Communities – once freed from the pressure of this ongoing proceeding
– would halt all further approvals.
(b) The European Communities again fails to provi de any argument rebutting the widely known
fact that the European Communities has adopted a general moratorium
4.805 In its second written submission, the European Communities presents a number of arguments
why – despite the widespread acknowledgment by EC officials of the imposition of a general
moratorium – the Panel should nonetheless find that no moratorium ever existed. The European
Communities' arguments in fact lend further support to the existence of the moratorium.

4.806 First
, the European Communities defines a mora torium as existing where "the process of
decision-making is temporarily stopped." Th e European Communities then argues that no
moratorium existed, because some applicati ons continued to make some progress through the
European Communities' elaborate approval procedures. This is a straw-man argument, and simply
dispensed with. The United States has never claimed that all processing stopped; rather that the
European Communities adopted a deci sion to ensure that no product ever proceeded to the stage of
final approval.
4.807 Second, the European Communities relies on its adop tion of a so-called "interim approach,"
under which the Commission "sought to anticipate the new Community legislation." Upon
examination, however, the European Communities' reliance on the "interim approach" in fact supports
the existence of the moratorium.
4.808 On the one hand, the European Communities explai ns that: "The 'interim approach,' thus, is
not an act that was 'adopted' in any form, it is me rely a practice that was followed on the basis of a
political intent to try and achieve results in the approval procedures despite the transitional period of
legislative changes." On the other hand, the European Communities describes the interim approach as
follows: "On [12 July 2000], the Commission agreed on an 'interim approach' for relaunching the
authorizations of GMOs, entailing the anticipati on of the key provisions (labelling, traceability,
monitoring etc) of the forthcoming new environmen tal legislation. The new requirements would be
incorporated into the individual authorizations of GMOs granted under existing legislation." Taken
together, the European Communities is represen ting that under the interim approach, "new
requirements" would be incorporated into indivi dual applications; but that this decision was not
"adopted in any form" and was "merely a practice that was followed on the basis of a political intent."
4.809 The European Communities' own description of the "interim approach" confirms a
fundamental position of the United States: that th e European Communities, " on the basis of political
intent," made a decision to apply its biotech le gislation in a manner that differed substantially from
the text of the legislation. And, once it is understood, as the European Communities acknowledges,
that the European Communities would feel free to depart from its legislation by changing the approval
requirements, it is not at all hard to understand th at the European Communities might also decide to
delay its final decisions based on the same political considerations.
4.810 In addition, the European Communities states that the "interim approach" would involve
applying requirements of unenacted legislation. Those requirements, however, would not be finalized
for at least three years after the European Commun ities' purported adoption of an interim approach in
2000. Particularly in light of the European Communities' admittedly politically-based approval
system, it is not credible to believe that the Eu ropean Communities would decide to depart from the
face of its approval legislation by adopting new re quirements on an extra-legal basis, while at the
same time allowing products to move to final approval when the contents of those new requirements
were not yet decided upon. It is no mere coincide nce that the European Communities' first biotech
approval in over five years occurred in May 2004 – less than one month after entry into force of the
European Communities' new legislation.
4.811 Third, the European Communities now tries to explain away the numerous official
acknowledgments of the moratorium by claiming that "all these statements" refe r simply to the fact
that no biotech products reached final decision. To the contrary, the statements uniformly refer to the
"moratorium." And, as the European Communities itself informs the panel, a "moratorium" "may be
defined as 'a postponement or deliberate temporary suspension of some activity.'" The United States
submits that EC officials used the term "moratoriu m" because it precisely fits the situation: namely,

that the European Communities had decided not to allow any biotech product application to move to
final approval.
(c) The European Communities' theory of "mixed delays" is meritless
4.812 The European Communities' novel theory of "mix ed delays" is illogical and not supported by
the text of the SPS Agreement. The SPS Agreement provides that Members "shall ensure [that]
procedures to check and ensure the fulfilment of [SPS] measures ... are undertaken and completed
without undue delay." Nothing in the text of the SPS Agreement suggests, as the European
Communities contends, that a Member is excused from this obligation if the delay stems from a
consideration outside the scope of the SPS Agreement.
4.813 The European Communities has instead invented an entirely new approach to applying the
obligations of the WTO agreements. According to the European Communities' approach, as long as a
Member can show that its measure is not incons istent with a different obligation (in this case
obligations under the TBT Agreement), then that lack of inconsistency with one provision can excuse
the inconsistency with another provision. Appare ntly the European Communities would reverse the
usual rule of treaty interpretation that there is no conflict between two obligations if satisfying one of
them (for example the stricter one) would also satisfy the other. Instead, for the European
Communities, where two obligations apply, only the lesser
 of the obligations matters. Furthermore, in
this dispute the European Communities has not answered the question of how both the SPS and
TBT Agreements could apply to the same measure given the texts of Article 1.5 of the TBT Agreement
("The provisions of this Agreement do not apply to [SPS] measures as defined in Annex A of the
[SPS Agreement]") and Article 1.4 of the SPS Agreement ("Nothing in this Agreement shall affect the
rights of Members under the [ TBT Agreement] with respect to measures not within the scope of this
Agreement").
4.814 Moreover, the European Communities' argument, if taken to its logical conclusion, would
severely undermine the "undue delay" obligation in Annex C. For example, take a case in which a
WTO Member delayed an SPS approval procedure for years – for arbitrary reasons, or to protect a
domestic producer. Under the European Communitie s' suggested interpretation, the Member would
not be in violation of the SPS Agreement, because the delay did not arise from the evaluation of a risk
enumerated in the SPS Agreement. Surely, in such circumstances, the drafters of the SPS Agreement
did not intend to excuse a Member from its ob ligation under Annex C to undertake and complete
approval procedures without undue delay.
(d) The European Communities has no basis for its argument that the Panel should depart from
the definition of "risk assessment" set out in the Agreement
4.815 The European Communities spends considerable time addressing the definition of "risk
assessment" for purposes of analysis under the SPS Agreement. As an initial matter, the United States
notes that no issue in this dispute would appear to turn on the definition of "risk assessment." In
particular, the European Communities has not even attempted to identify any risk assessments that
might support the general moratorium, the product-specific moratoria, or the member States safeguard
measures. In any event, the definition of "risk assessment" is clearly set out in Annex A.4 of the
SPS Agreement, and that definition is dispositive. The European Communities' discussion of
alternative definitions of "risk assessment" is without merit, and should be disregarded.

(e) The European Communities continues not to pr esent a serious defence of its member State
measures
4.816 In its second written submission, the European Communities again fails to point to any
contrary risk assessments, nor does it attempt to explain how Article 5.7 applies in light of the full
scientific evaluations of these products by the Eu ropean Communities' own scientific committees.
The only new material in the EC's second written submission addressed to the member State measures
is an exhibit titled "Table summarising the position in relation to the member State measures, as set
out in the first written submission of the European Communities." The table, which purports to show
the various reasons why the member States adopt ed each safeguard measure, should be given no
weight by the Panel. It is not supported by any fo otnotes or any other references, and it appears to be
nothing more than an ex post facto attempt to justify those measures. Moreover, even if the new table
could be considered to have some evidentiary va lue, it does not begin to show how the safeguard
measures might be consistent with the SPS Agreement. For example, the table provides no citations to
any "available pertinent information" that might be u sed as part of an argument under Article 5.7, nor
does the table explain how scientific evidence might be sufficient when the European Communities
has issued affirmative risk assessments for each product.
3. The European Communities cannot explain away the gaps in its product chronologies
4.817 In its second written submission, the European Communities provides brief and conclusory
narratives concerning some, but not all, relevant bi otech product applications. Those narratives were
submitted prior to the European Communities' submissi on, at the Panel's request, of a more complete
set of product application documents , and thus do not refer to the more complete record currently
before the Panel. Moreover, the European Communities' narratives are in many cases misleading. An
examination of the actual documents in the applic ation histories confirm that many products were
subjected to undue delays in the form of lengthy periods of inactivity.
(a) EC Exhibit 69: Glufosinate tolerant and insect resistant (Bt-11) corn
4.818 The Scientific Committee on Plants (SCP) issu ed a favourable opinion on the application for
Bt-11 corn under Directive 90/220 on November 30, 2000. In the narrative in its second written
submission, the European Communities attempts to explain away a 2-year gap following the SCP
opinion by asserting that "the Scientific Committee recommended a monitoring plan, and the proposal
by the applicant remains unsettled." The actual doc uments, however, reveal that this assertion is
untrue. The opinion did not identify any missing information or other deficiency in the application.
(b) EC Exhibit 65: Bt cotton (531)
4.819 The application for Bt cotton (531) under Directive 90/220 suffered a 3-year period of
inactivity by EC regulators. The European Communiti es' justification of this gap is baseless. That
certain member States objected at the Regulat ory Committee does not justify the European
Communities' refusal to act on the application. Indeed, the European Communities' legislative
framework provides a specific avenue for further action where the Regulatory Committee is unable to
come to a decision: the Commission is to forward the application to the Council "without delay" for a
decision. Moreover, nothing in the record indicates that the applicant was ever requested to submit
additional information to address the member State objections, nor that the basis of these objections
was ever even notified to the applicant. Furthermor e, nothing in the record indicates why the member
States objected despite the SCP opinion that addressed the very issues covered in the objections. In
sum, nothing in the record indicates that the European Communities undertook any process
whatsoever to resolve the member State concerns.

4.820 The EC's second written submission also incorrectly states that the applicant "finally provided
... required additional information," which incorrectly implies that delays were due to outstanding data
requests. The applicant, however, was not responding to any request from the European
Communities, but, on its own initiative, provided a dditional information to the lead CA as, not
surprisingly, the state of scientific knowledge had advanced since the first written submission of the
application more than four years before.
(c) EC Exhibit 91: Roundup Ready corn (GA21)
4.821 The novel foods application for Roundup Ready corn (GA21) under Regulation was delayed
at the member State level for 10 months while the lead CA completed its risk assessment, and then
delayed for 17 months at the Community level before the SCF rendered its positive opinion in
February 2002. The European Communities charges that the 17 months it took for the SCF to render
its opinion was caused by the applicant. The trut h is reflected in the European Communities' own
chronology: The Commission asked the SCF for an opinion on 18 May 2000. Eleven months later

the SCF contacted the applicant for the first time, asking for additional information. Within less than
one month, the applicant provided an answer to all questions. The European Communities'
chronology provides no explanation, other than a cryptic notation about "lack of time," for the further
11 months it took for the SCF to issue an opinion on 27 February 2002.
4.822 After the SCF issued its positive opinion on 27 February 2002, the Commission failed to
forward a draft measure to the Regulatory Committee as is required to complete the approval process,
resulting in further delay that lasted until the new GM Food and Feed regulation was passed in
September 2003. Almost two months passed after the positive SCF opinion in February 2002 with no
activity at all on this application. The applicant then sent a letter on April 23, 2002 offering to narrow
the scope of the application in order to facilitate the European Communities' evaluation. Despite the
efforts of the applicant to remove any possible impediments, the Commission still failed to forward
the application to the Regulatory Committee. In stead, the Commission noted that although the next
step was to take a Community Decision, "[i]t is desirable that such a Decision would take into account
in an appropriate manner the legisl ative developments with respect to the authorization of GM food
and feed as well as the labelling of GM products." In other words, the European Communities simply
halted the processing of this application in an ticipation of possible upcoming changes to its
regulations.
(d) EC Exhibits 78 and 85: Roundup Ready corn (GA21)
4.823 The European Communities did not discuss the deliberate release applications for Roundup
Ready corn (GA21) under Directive 90/220 in its second written submission, based on the European
Communities' unilateral determination that the issu es regarding these applications were moot. In
response to the Panel's request for more comp lete information, the European Communities
subsequently produced a chronology and supportin g documentation for this and other withdrawn
applications. These documents confirm that these applications in fact suffered extensive, undue
delays. The European Communities delaying tactics also significantly delayed the parallel novel
foods application for Roundup Ready corn (GA21) under Regulation 257/98.
4.824 The first application for GA21 under Directiv e 90/220, submitted in the UK in 1997, was
delayed at the member State level for 7 months – from March to November 1999. The European
Communities' chronology gives the false impression that activity actually occurred on this application
after April 1999 by referencing an ACRE meeting on September 16, 1999. As the minutes to that
meeting show, however, GA21 was not on the agenda and was not discussed.

4.825 The second application for GA 21 under Directive 90/220 abruptly halted when it reached the
Commission level. The SCP rendered a favourable opinion on 22 September 2000. At this point,
however, all activity unexpectedly ceased at the Co mmission level. The Commission did not submit
the application to the Regulatory Committee for a decision, and there was no action or communication
by the Commission on this application for the next 3 years, up to the time the application was finally
withdrawn by the applicant on 15 September 2003.
(e) EC Exhibits 82 and 94: MaisGuard x Roundup Ready (MON810 x GA21) corn
4.826 MaisGuard x Roundup Ready maize is produ ced by conventionally hybridizing two
"parental" biotech products, MON810 and GA21. Progress on GA21 maize was a limiting step on
MON810 x GA21's progress in the regulatory process.
4.827 The deliberate release application for MON 810 x GA21 corn under Directive 90/220 was
submitted in August 1999, but never reached the Commi ssion level stage of review. The lead CA
requested further information on 30 November 1999, and the applicant responded in August 2001 to
all requests, except for a scientifically unjustified study on the nutritional composition of milk from
dairy cows fed this product. The applicant provid ed translated documents 5 months later in January
2002. Thereafter, for over 1½ years, until the application was withdrawn, the only activity by the lead
CA was a meeting held in April 2002.
4.828 The novel foods application for MON810 x GA 21 under Regulation 258/97 shares a similar
history. The application was submitted to the lead CA in February 2000. As noted above, the novel
foods application for the single trait parent GA21 under Regulation 258/97 stalled at the Commission
level. In its comments on the application for MON 810 x GA21, Italy stated that "examination of the
documentation relating to authorization should only be carried out after the marketing of GA21 has
been authorized." To date, the application for MON810 x GA21 is still pending.
(f) EC Exhibit 66: Roundup Ready cotton (RRC1445)
4.829 The European Communities susp ended the deliberate release application for Roundup Ready
cotton (RRC1445) under Directive 90/220 for nearly four years – from February 1999 until the new
legislation, 2001/18, took effect in January 2003. The European Communities' only defence of this 4-
year gap is its statement that "the Regulatory Co mmittee failed to reach a qualified majority because a
number of member States maintained objections." This observation fails to recognize that following
the Regulatory Committee vote, Directive 90/220 oblig ed the Commission to refer the application to
the Council for a decision "without delay," a step the Commission failed to take in this case. The EC's
second written submission also incorrectly implies th at the objections raised by member States had
not been adequately addressed in the SCP. In f act, the SCP assessed the safety of the product at issue
based on detailed scientific considerations. More over, none of the member States objecting at the
Regulatory Committee offered any competing risk assessments or scientific evidence for such
objections. Neither did the Commission nor the me mber States identify any specific inadequacies in
the SCP review. Finally, nothing in the reco rd indicates that the Co mmission communicated any
scientific concerns to the applicant, or that the Commission identifie d to the applicant any
shortcomings in the application.
(g) EC Exhibit 64: Roundup Ready fodder beet (A5/15)
4.830 The deliberate release application for Roundup Ready fodder beet (A5/15) has been in the EU
approval process for over 7 ½ years, having been subm itted to the lead CA in February 1997. The
SCP issued a positive opinion on June 23, 1998. The Regulatory Committee, however, did not meet

on this application for over a year and a ha lf and, even then, did not take a vote
. Four months later,
the Regulatory Committee met once again, on 9 March 2000, and once again, did not vote. After that,
the application remained in limbo and was never s ubmitted to either the Regulatory Committee or to
the Council. Over 4½ years after the SCP positive opinion and deadlock at the Commission level, the
applicant was forced to re-submit its a pplication under the new Directive 2001/18 on
16 January 2003.
4.831 The European Communities attempts in its second written submission to defend the
Commission's inaction by pointing to objections ra ised by member States. However, the SCP
considered the existing scientific evidence and th e information provided by the applicant to be
sufficient to address the objections voiced by the member States. In addition, the European
Communities' assertion that there were outstanding requests for information is not true. The applicant
had voluntarily provided additiona l information in an attempt to remove any possible remaining
obstacle to a Regulatory Committee vote. The actual reasons for the delay were stated in a January
2001 meeting with the applicant: "[h]aving the revised directive fully adopted will not be sufficient.
The re-start of the regulatory process will depend on the willingness of the Commission to do it. It is
commonly analysed that the Commission will not promote an Art 21 vote meeting, if there are no
indications that the member-states are supporting the process and/or expected to vote positively. ..."
(h) EC Exhibit 76 and 96: Roundup Ready corn (NK603)
4.832 The NK603 deliberate release application w as submitted in January 2000, and finally
approved – although provisionally to a GM food and feed approval – in July 2004. The Commission
approved the GM food and feed application for NK603 in October 2004. The processing of this
application was delayed by the moratorium, and its ultimate approval does not signal the end of the
moratorium.
4.833 The approval procedure did not progress "smoothly," as the European Communities contends.
For both the GM food and feed and the deliberate release applications, the Regulatory Committee was
unable to obtain a qualified majority vote. None of the documents provided by the European
Communities support the European Communities' clai m that those member States who abstained or
voted against the approval of the product in the Re gulatory Committee did so on the basis of "their
own risk assessments." Member States' objections and the applicant's answers to these were taken
into consideration by EFSA in delivering its pos itive opinions on NK603, and none of the member
States questioned the validity of EFSA's favourable opinions. The Council similarly failed to reach
qualified majority vote on the proposals. The fact that certain member States failed to cast their votes
in accordance with the European Communities' ow n scientific committee's conclusions shows that
member States continue to act based on political considerations.
(i) EC Exhibit 62: Oilseed rape (FALCON GS40/90)
4.834 The deliberate release application for oilseed rape (FALCON GS40/90) has been pending for
over 8½ years. It was first submitted on April 1, 1996, and the lead CA forwarded it to the
Commission on 25 October 1996. After member States objected during the review period, the SCP
formally expressed a positive opinion on July 14, 1998. The Regulatory Committee did not meet until
over a year later, on 29 October 1999, and, d espite the positive opinion, failed to vote on the
application. Four months later, on 9 March 2000, th e Regulatory Committee met again, and again
failed to vote on the application. Although the Eu ropean Communities' chronology states that the
failure to reach a vote was "due to further requ ests for information," the European Communities has
failed to provide any document that confirms that st atement. Instead, the record shows that the only
request for information that could possibly have been made at that meeting was a request from Italy,

and the applicant responded to Italy's questions by 30 November 2000. The Commission never
submitted a draft measure on the application to th e Regulatory Committee again, and the application
remained in this indeterminate state at the Commiss ion for almost 3 years. The applicant finally had
to submit an updated application under Directive 2001/18 on 16 January 2003.
(j) EC Exhibit 92: Bt-11 Sweet Corn
4.835 The novel food application for BT-11 Sweet corn was finally approved, under the GM Food
and Feed directive that entered in to force in April 2004, in May 2004. In its responses to the Panel's
questions posed on 3 June 2004, the European Co mmunities attempts to justify delays in the
processing of the BT-11 application by claiming that "[b]etween October and early December 2003
[after the SCF positive opinion], three new risks assess ment were issued by the member States, all of
which conflicted with the SCF opinion." The Euro pean Communities' contention is unsupported by
the record. No risk assessments were submitted during that time period.
4.836 The European Communities' incorrect assertion that competing risk assessments existed
should not divert attention away from the real cause of the delays. When the BT-11 application was
first evaluated at the Commission level in 2000, member States objected on the basis of the general
moratorium. For example, as recalled by Denmark's Agriculture and Fisheries Council, "[i]n August
2000, Denmark submitted an objection to the approva l of Bt11 maize in respect of the novel food
regulation with reference to the declaration a pproved by Denmark, France, Italy, Greece and
Luxembourg on the suspension of new GMO licences (t he moratorium declaration), which was made
at the Council meeting (environment) on 24-25 June 1999. The objection included a reference to the
fact that, pending the approval of a regulation that would guarantee the labelling and effective tracing
of GMOs and products derived from them, the mo ratorium countries would block any new licences
for the cultivation and marketing of GMOs."
4. Many member State requests for information were not based on legitimate scientific
concerns
4.837 The chronologies do not show – as the European Communities claims – legitimate scientific
grounds for each request for information, and for th e resulting delays, in the application histories.
Rather, many supposedly scientific questions are re quests that seek to force applicants prove the
complete absence of hypothetical risks, in disregard of the safety data provided in the application. A
pattern of deliberate delaying tactics is also illu strated by other types of scientifically baseless
objections or requests for information that would ha ve no relevance to an evaluation of the product's
safety.
(a) Member State objections do not illustrate scientific disagreement or uncertainty
4.838 The record shows that none of the various member States' objections and requests for
information qualify as competing risk assessments, " scientific disagreement" or "other scientific
opinions" that would call into question the positiv e risk assessments condu cted by the European
Communities' own scientific committees. None of th e objections made by the member States met the
SPS definition of risk assessments. The objections were vague and general; did not identify and
evaluate any specific risks posed; and were not su pported by any scientific evidence that provided a
basis for presuming a potential risk existed. Nor co uld the generic, vague statements in the member
State objections and requests for information be considered "conflicting scientific opinion" of any
weight that might counter the evidence presented in the product applications or in the risk assessments
conducted by the lead Competent Authority or EC-w ide scientific committees that demonstrated the
safety of the products.

(b) Various member State objections relate solely to inappropriate "theoretical risks"
4.839 As the Appellate Body stated in EC – Hormones, "[T]heoretical uncertainty is not the kind of
risk, which under Article 5.1, is to be assessed" unde r the Agreements. Yet the objections and related
requests for additional information raised by member States were often based on just such theoretical
risks, and this fixation on theoretical risks and th eir refutation is yet another manifestation of the
general moratorium. For example, France objected to the approval of Bt Cry 1F corn, stating
numerous times that additional animal studies were necessary "to prove the absence of risk," even
though the existing data [ e.g., acute protein toxicity studies; compositional analyses] showed that no
food safety risks could reasonably be anticipated. Ye t, such proof is unattainable. As the Appellate
Body explained, "[U]ncertainty [] always remain s since science can never pr ovide absolute certainty
that a substance will not ever have adverse health e ffects." It is not possible for a risk assessment to
evaluate every risk that a product might theoretically pose. It can, however, provide information that
allows decision makers to make reasoned judgmen ts about the risks it is reasonable to assume a
product may present, based on the product's characteristics. Accordingly, these member State
objections and requests for additional data are not the kind that could be used to justify a delay in an
approval procedure under Annex C of the SPS Agreement.
(i) Requests for chronic toxicity tests, when acute studies show no effects
4.840 For all of the products at issue in this dispute, the results of the acute toxicity tests and the
homology comparisons provide no indication for any concern and do not indicate the need for chronic
toxicity tests. For the most part, proteins that would be expected to be toxic to mammals should
express toxicity when tested at the high doses required in the acute oral test. None of the proteins at
issue in these applications are similar to proteins known to have longer-term effects in mammalian
species. In addition, the data submitted on all of the products at issue in this dispute indicate that the
inserted proteins are rapidly degraded in mammal ian gastric juices. These degradation products
become nutrients, and there is no evidence that they specifically bind to or accumulate in mammalian
tissues. Consequently, in the absence of any indication of concern in the acute toxicity tests, and in
the absence of a structural relationship between the pr otein and any toxins, allergens or other proteins
established to have longer-term toxicity, no fu rther testing would normally be considered
scientifically necessary to characterize any potential risks from the protein. Thus, requests for chronic
toxicity tests can only be interpreted as a demand to disprove a theoretical risk – that, for some
unknown reason, and contrary to all available data, the protein will be have differently than all other
proteins.
4.841 Unwarranted requests for chronic toxicity studies contributed to delays in the consideration of
the following applications: Roundup Ready Corn (Exhibits 76 and 96) and Roundup Ready (GA21)
Corn (Exhibit 91).
(ii) Request for multiple whole food studies
4.842 Another example of requests to disprove hypothetical risks involves whole food studies. As a
general matter, international consensus documents do not recommend the routine use of whole food
studies. Rather, these documents indicate that such studies are not generally necessary in the absence
of some indication for concern in the other data. No netheless, for all of the products at issue in this
dispute, at least one whole food study was submitted as part of the application. In every case, the
initial whole food study indicated no adverse effects. Based on the submitted safety data, as well as
the scientific knowledge accumulated from experien ce with these products, there is no reason to
believe that the results of the second – or in some cases third or fourth – whole food would differ in
any way relevant to the safety of the product.

4.843 Unwarranted requests for additional whole food studies contributed to delays in the
consideration of the following applications: Bt Cry 1F corn (1507) (Exhibits 74 and 75), Roundup
Ready Corn (GA21) (Exhibits 78 and 85); MaisGuard (MON810) x RoundupReady (GA21) (Exhibits
82 and 94), Roundup Ready corn (GA21) (Exhibit 91) , Bt-11 x Glufosinate Tolerant Sweet Corn
(Exhibit 92), and Roundup Ready Corn (Exhibit 96).
(iii) Insistence that safety of hybrid products be proven independent of the data on the parent
4.844 Another example of demands by the European Communities that applicants disprove merely
theoretical risks are repeated demands that separ ate assessments be conducted for each hybrid plant
produced through conventional breeding from a previous ly evaluated biotech product. In these cases,
member States requested additional evaluations without having a plausible scientific reason that the
risk profile of the hybrid plant would be altered by breeding such that the existing safety data on the
parents should be discounted. The products at issue were created by crossing (breeding) varieties of
the same species. Both varieties are themselves u sed in food, and therefore are extremely unlikely to
introduce traits that have not been in food before . In addition, plant lin es used for such crosses
generally have been subject to extensive backcrossi ng and field testing to ensure genetic stability.
Finally, because the plant lines are closely related to each other, crosses between them are no more
likely to be subject to unintended changes than conventional breeding between non-biotech plants.
4.845 A further consideration is that modern crop breeding relies on a knowledge base that has been
developed over the last 50 years through breeding programs. Hybrid seed typically goes through at
least 10 generations of breeding effort prior to the re lease of seed suitable for farmer cultivation. As a
result, modern cultivars of majo r commercial crops are predictabl e in almost all aspects of
performance (yield, disease resistance , maturity, etc.). The products at issue in this dispute use these
hybrids and also employ the same methods of seed production. Consequently, any significant
discrepancy that might theoretically arise from this cr oss would be expected to be detected in the field
tests. The request for data on each hybrid corn developed also ignores all of the information about the
safety of these plants that has been derived from the established processes in hybrid development, and
their history of use. Thus, the mere fact that a pr oduct is the result of cross-breeding is insufficient to
justify the need for additional studies to confirm the results of the existing data on the parents.
4.846 Unwarranted requests for additional studies of hy brid products contributed to delays in the
consideration of the following applications: Bt-1 1 Corn (Exhibits 69 and 92), Bt Cry 1F corn
(Exhibits 74 and 75), and Bt Cry 1ab x Roundup Ready Corn (Exhibits 82 and 94).
(iv) Vague requests for data on environmental effects
4.847 Another category of unwarranted information requests relate to the concerns expressed
regarding various vague, potential environmental ef fects, which, upon examination, amount to yet
additional requests to disprove wholly speculative ri sks. One primary example of these are concerns
about potential changes to biogeochemical processes. For a number of reasons, these are risks that,
based on what is generally known about the issue a nd the products, are so unlikely as to be purely
theoretical. The available information does not indicate that any of these bioengineered plants present
any potential for disrupting these cycles. The attrib utes of these products are such that there is no
general scientific reason to expect that they would cause such effects; for example, the modification is
not intended to function in a manner that affects these cycles. In addition, there is generally a
duplication of function between many microbial groups, such that even in the unlikely event that there
was a measurable effect on a particular group, it would have no effect on any global biogeochemical
process. Moreover, given the immense variation in levels of biogeochemical processes due to such
agricultural practices as cultivation, fertilization and no-till, it is difficult to envision that, absent a

truly massive change, any variati on in biogeochemical processes that could be linked to the biotech
plant could be determined to be significant. An y change of such a magnitude should have been
discerned as part of the field trials. Absent any indi cation of unusual activity in the field trials, there
is no reason to believe that positing such risks is anything more than mere speculation.
4.848 These types of vague and unwarranted requests for additional studies of environmental effects
contributed to delays in the consideration of the following applications: Bt–11 corn (Exhibit 69),
Bt Cry 1F corn (Exhibits 74 and 75), and Roundup Ready Corn (GA21) (Exhibits 78 and 85).
(v) Requests for studies on the composition of the food derived from the animal
4.849 A further example of requests related to unf ounded and theoretical risk are requests for
additional studies to provide confirmation that bi otech animal feeds do not alter the composition of
the food derived from animals consuming the feed . Where the compositional analyses demonstrate
that the nutritional makeup of the feed falls within the normal biological range of variation that has
been established for non-engineered, commercially av ailable feeds, there is no general scientific
reason to expect that any effects on milk or meat would occur. In addition, where it has been shown
that the introduced protein is rapidly degraded or excreted, like any other dietary proteins, there is no
scientific basis on which to speculate that these prot eins would accumulate in meat or milk. Where a
whole food study has been performed to confirm th e results of the compositional analysis, and the
study provides no indication of adverse effects or unexpected results, such concerns are wholly
speculative.
4.850 Unwarranted requests for studies of the products of animals that consumed biotech feed
contributed to delays in the consideration of the following applications: Bt (Mon810) x Roundup
Ready Corn (Exhibit 82) and Roundup Ready Corn (GA21) (Exhibit 91).
(vi) Objections wholly without scientific merit
4.851 In several instances, member St ates asked for other types of additional studies that would
yield information that would have no relevance in assessing the safety of the product at issue. These
include: Bt-11 Corn (Exhibit 69) – informati on on potential weediness of maize; Bt Cry 1F
(Exhibits 74 and 75) – Northern blot data on matu re kernels and proteomic analysis; Roundup Ready
Corn (Exhibit 76) – PCR analysis, additional alle rgenicity testing, protein conformation, and
proteomic analysis; Bt Corn-Cry 1F (Exhibits 74 and 75) – additional field trials.
R. T
HIRD WRITTEN SUBMISSION OF CANADA
1. Introduction
4.852 In this submission, Canada responds to argu ments and evidence advanced by the European
Communities in its Second Written Submission, as well as arguments and evidence put forward by the
European Communities in its earlier submissions to which Canada has not yet responded. Canada
also addresses specific elements of the documentatio n made available by the European Communities
that has not been specifically refe renced or discussed in the Europe an Communities' submissions. In
doing so, Canada stands by its original claims and arguments, and this submission should be
understood as an elaboration or clarification of those claims and arguments.
4.853 In what follows, Canada first addresses th e issues characterized by the European
Communities as "horizontal", systematically refutin g the European Communities' arguments relating
to risk assessment and the role or status of Community-level scientific opinions, as well as the

European Communities' interpretation of the relevant provisions of the SPS Agreement, the
TBT Agreement and the GATT 1994. Canada then turns to the European Communities' arguments
relating to Canada's claims and demonstrates, us ing the European Communities' own documents, why
Canada's claims are well founded in fact and law.
2. Horizontal issues
(a) Burden of proof
4.854 Canada largely agrees with the summary of th e case law set out in paragraphs 12-17 of the
EC's Second Written Submission. Contrary to the European Communities' assertions, however,
Canada has met its initial burden in respect of all its claims. The European Communities also
misapplies the jurisprudence to the case at hand. Specifically, the European Communities' assertions
regarding the need for the complaining party to demonstrate an absence of risk
 finds no basis in either
the text of the WTO Agreements or the related ju risprudence. Finally, the European Communities
claims that it has provided most of the eviden ce in this case. If the European Communities is
suggesting that Canada has failed to produce adequa te factual evidence to support its legal arguments,
the suggestion is utterly without merit.
(b) The European Communities' mischaracterization of Canada's arguments
4.855 In its Second Written Submission the Europ ean Communities repeatedly mischaracterizes
Canada's arguments. While Canada does its best to identify and correct all such mischaracterizations,
it encourages the Panel to verify for itself the a ccuracy of the European Communities' "restatements"
of Canada's arguments.
(c) Risk assessments and Community-level Scientific Committees
4.856 In what appears to be an effort to circumvent its obligations under the SPS Agreement, the
European Communities claims that the risk assessments for the biotech products subject to the
moratorium have not been completed yet. To support its argument, it: distorts the meaning of "risk
assessment" as used in the SPS Agreement; downplays the role of the opinions of Community-level
scientific committees; and, argues that the activities of the relevant regulatory committees should also
be considered a part of "risk assessment".
4.857 The European Communities' attempt to equate the term "risk assessment" as defined in the
SPS Agreement with "risk analysis" as defined by Codex Alimentarius relies on specious reasoning.
First, the European Communities fa ils to advance a cogent rationale under the principles of treaty
interpretation for relying on the Codex definition of "risk analysis". Second, the European
Communities' suggestion that only part of "risk assessment" as used in the SPS Agreement must be a
"scientifically based process" is at odds with th e definition of "risk assessment" in Annex A and the
requirements of Article 2.2 of the SPS Agreement. Third, the Codex defin ition of "risk analysis" is
only relevant – if at all – to risk assessments in relation to food safety. Fourth, the European
Communities' claim that, because the SPS Agreement includes labelling for food safety as an SPS
measure, "risk communication" is a part of "risk assessment", is as incoherent as it is illogical.
4.858 The European Communities seeks to downplay the opinions of its own Community-level
scientific committees by asserting that such opinion s do not "over-rule" other scientific opinions.
However, the European Communities fails to point out that the role of the Community-level scientific
committees is precisely to address scientific disagreement amongst EC member States and to review
the validity of objections raised by them. The Commission has consistently treated Community-level

scientific committee opinions as decisive and not as one opinion amongst many. Moreover, the
European Communities fails to point to or provide any other "scientific opinion", by an objecting EC
member State, that even approximates the rigour and thoroughness of the risk assessments conducted
by the Community-level scientific committees or, in many cases, the original competent authority.
4.859 Although Canada agrees that, in principle, the concept of "risk assessment" provided for in
the SPS Agreement involves both the identification and evaluation of risks and the evaluation of
options to manage risks so identified and evaluated, by no stretch of the imagination can the activities
of the European Communities' regulatory committees, or the EC member States, be considered as
"risk management" activities. There is simply no evidence that the activities of the regulatory
committees or the individual EC member States meet the standard set out in the SPS Agreement. The
only examples of such activities that could conceivabl y meet that standard are to be found in the work
of the Community-level scientific committees, including EFSA.
(d) Interpretive issues relating to the SPS Agreement
4.860 The European Communities' in terpretive approach to the SPS Agreement is a sweeping
assault on the obligations of that Agreement. The European Communities advances interpretations of
the scope and obligations of the SPS Agreement that are inconsistent with the ordinary meaning of the
text and undermine the Agreement's object and purpose.
(i) The definition of sanitary and phytosanitary measures
4.861 The European Communities distorts Canada's arguments in relation to the meaning of
"contaminants". In fact, Canada's arguments are co nsistent with Codex Standard 193. The European
Communities' arguments about Stan 193 are also wrong in principle. The European Communities'
assertion that "if the GMO is deliberately re-produced …in the full knowledge of the side effect, that
side effect can no longer be described as 'unintentio nal'" is also flawed. Moreover, the European
Communities' assertion that "'crop husbandry' does not cover laboratory work is at odds with the
ordinary meaning of the term "husbandry".
4.862 To the extent that the European Communities' approval procedures are applied to protect
against risks to human and animal health arising fro m toxins in food and feedstuffs, such procedures
are SPS measures as defined in Annex A(1)(b) of the SPS Agreement. The European Communities
suggests that the assessment of t oxicity of seeds and crops could be undertaken for reasons unrelated
to consumption by humans and animals, and that, by extension, such assessments of toxicity fall
outside the scope of the SPS Agreement. However, apart from effects on non-target organisms,
assessing for toxicity only makes sense if these produc ts are used for human or animal consumption.
This is reflected in the European Communities' le gislation. The assessment of effects on non-target
organisms, which typically involves the issue of toxicity, falls under either Annex A(1)(a) or (d).
4.863 The European Communities argues that that because allergens are neither "toxins" nor
"diseases", they do not fall within one of the risk s identified in Annex A(1)(b). However, the
European Communities' own food safety legislation re quires an assessment of potential allergenicity.
Moreover, international standards, guidelines a nd recommendations for the safety assessment of
biotech foods uniformly recognize the assessment of a llergenicity as an integral component of food
safety. In this light, it could not have been the intention of the drafters of the SPS Agreement to
exclude from the scope of the SPS Agreement such an important aspect of food safety as the
assessment of risks arising from allergens in food. Hence, for the purposes of the SPS Agreement,
allergens in food and feedstuffs can and should be considered "toxins".

4.864 The European Communities advances interpretations of animal and plant life and health that
are inconsistent with the ordinary meaning of these te rms in their context and in the light of the object
and purpose of the SPS Agreement. In particular, the European Communities claims that its
legislation constitutes measures to protect the "environment" and "biodiversity" and that because these
terms do not appear in the SPS Agreement, the approval regime, to the extent that it assesses risks to
the "environment" and "biodiversity", is not an SPS me asure. However, the types of risks relating to
the "biodiversity" and "environment" that are addre ssed under the legislation are those that ultimately
pertain to "animal or plant life or health." Moreover, the text of the SPS Agreement supports the
conclusion that SPS measures include measures applied to protect the environment. In addition, any
harm to biodiversity arising from the biotech products in issue amounts to harm to plant and animals,
as defined in the SPS Agreement. The European Communities' argument that risks to "biodiversity"
are not risks that fall within the scope of the SPS Agreement is at odds with the description of the
scope of the Pest Risk Analysis (PRA) set out in International Standard for Phytosanitary Measures
(ISPM) No. 11.
4.865 The European Communities argues for a narrow in terpretation of the term "pests". Both
premises of the European Communities' argument are without merit. First, the European
Communities suggests that a "pest" must be a living organism and cannot be simply modified DNA.
This is a straw-man argument. The focus of inqui ry in terms of pest characteristics is the plant
containing the transgene, not the modified DNA itself. Second, the European Communities'
suggestion that "pest" under the SPS Agreement is limited only to organisms that cause injury to
plants or plant products is inconsistent with the ordinary meaning of the term in its context.
4.866 The European Communities conflates concerns about the safety of biotech products with
concerns about the use of herbicides in order to claim that the approval procedures for biotech
products fall, at least in part, outside the SPS Agreement. This argument is without merit. The
approval procedure for one type of product (crop) cannot be transformed into a non-SPS measure by
linking the procedure to concerns related to the use of another type of product (herbicide).
(ii) Article 2 and Article 5.7 of the SPS Agreement
4.867 The European Communities' arguments re lating to Articles 2 and 5.7 of the SPS Agreement
are without merit. The European Communities seek s to juxtapose Articles 2.2 and 5.7 as separate but
equal provisions, both representing b asic rights and obligations. To lend credence to its arguments,
the European Communities tries to establish a parallelism with Articl es 3.1 and 3.3 and the Appellate
Body's remarks in EC – Hormones . The European Communities' inte rpretive approach is bereft of
logic, has no textual foundation and is untenable as a matter of treaty interpretation.
4.868 First, the European Communities tries to demons trate that Article 5.7, through incorporation
by cross-reference, is transformed into one of the "basic rights and obligations" of the SPS Agreement.
This argument is completely at odds with any reas onable approach to treaty interpretation. Second,
the European Communities se eks to rely on a comma to assert that the "necessity" and "scientific
principles" elements of Article 2.2 are excluded from applying to an Article 5.7 measure. However,
this argument would lead to the conclusion that Article 5.7 measures are not subject to any
proportionality requirements, a proposition that is at odds with the jurisprudence, the structure of the
SPS Agreement, and even the European Communities' own policy on the precautionary principle.
Third, despite the European Co mmunities' efforts to demonstrate that the relationship between
Articles 2.2 and 5.7 parallels that between Articles 3.1 and 3.3, the reasoning finds no support in the
text of the SPS Agreement or the existing jurisprudence. Fourth, the European Communities'
proposition that provisionality is the "demarcation line" for the applicability of Article 5.7 is destined
to fail for several reasons. The jurisprudence cited by the European Communities does not support its

proposition. Contrary to the European Communities' assertions, the complaining parties have never
conceded that the measures in question are, in fact, provisional. The European Communities'
observation that Article 2.3 continues to apply adds nothing to its arguments about the "demarcation
line". The European Communities' attempted bifu rcation between "provisional" and "definitive"
measures is nowhere reflected in the text of the SPS Agreement. The cumulative nature of the four
conditions set out in Article 5.7 does not suppor t the European Communities' argument. To the
contrary, the opening phrase of Article 5.7 supports Ca nada's argument that insufficiency of scientific
evidence is the threshold. Finall y, the European Communities contra dicts its earlier statements when
it claims it does not have the burden to demonstrate that the EC member State national measures are
provisional.
(iii) Article 5.7 and the rest of Article 5
4.869 In trying to demonstrate that Article 5.7 excludes the application of the rest of Article 5, the
European Communities mischaracterizes Canada's ar guments. The European Communities also fails
to explain convincingly why Articles 5.5 and 5.6 cannot apply to measures subject to Article 5.7. The
European Communities demonstrates a complete mi sunderstanding of the structure of Article 5,
misinterprets Articles 5.2 and 5.3, and misconstrues the role of the concept of "appropriate level of
protection". Finally, the European Communities' arguments with respect to the relevance of
Articles 5.5 and 5.6 contradict the European Comm unities' own policy statement on the application of
the precautionary principle.
(iv) Article 5.1
4.870 The European Communities asserts that Article 5.1 of the SPS Agreement does not apply to
the EC member State national measures , the moratorium, or the product-specific marketing bans.
This is not supported by either the facts or the juri sprudence. The European Communities fails to cite
any authority for the interpretive gloss that it seeks to impose on the phrase "as appropriate to the
circumstances". Furthermore, the European Comm unities' assertion that, "in relation to the alleged
product specific delays, there is no 'measure' within the meaning of Article 5.1" rings hollow in the
face of the indisputable existence of a measure, namely, the moratorium. Thus, the European
Communities' contention that the product-specific marketing bans are to be considered solely in
relation to the requirements of Annex C of the SPS Agreement is incorrect. Finally, the European
Communities relies on semantics in an effort to avoi d the clear obligation set out in Article 5.1, but
the fact remains that a rational relationship must exist between the selected measure and a risk
assessment.
 In the case of the moratorium, there is no risk assessment at all, and in the case of
individual product applications, no rational relationship exists between the product-specific marketing
bans and repeated risk assessments of the products in question.
(v) Article 5.5
4.871 The European Communities misrepresents Canada's position in stating that the "Complaining
parties accept that under the SPS Agreement it is permissible for a member State of the European
Communities to have a different level of protecti on compared to that applying elsewhere in the
European Communities". Canada has never stated this anywhere in its submissions. In any event, the
European Communities' argument is purely theore tical. The European Comm unities has asserted, but
not actually demonstrated, that the EC member States are imposing levels of protection that are
different from that of the EC legislation. It has also failed to indicate in any way what these allegedly
different levels of protection are and why they can be considered to be different from that reflected in
the EC legislation. To the contrary the eviden ce supports the conclusion that the member States
believe themselves to be applying the level of prot ection reflected in the EC legislation. More

generally, the European Communities' arguments with respect to the applicability of Article 5.5 are
simply not relevant in this particular situation.
(vi) Article 5.6
4.872 Nothing in the European Communities' argumen ts in its Second Written Submission counters
the prima facie case that Canada has already established.
(vii) Article 5.7
4.873 Canada has already demonstrated why Artic le 5.7 is not available to exempt the EC member
State national measures from the requirements of Article 2.2, and why, in any event, those measures
do not meet the requirements of Article 5.7. In contrast, the European Communities has not presented
any detailed, measure-by-measure f acts or arguments to demonstrate either that Article 5.7 applies so
as to exempt the measures from Article 2.2, or that the measures in question meet the requirements of
Article 5.7. The European Comm unities' efforts to convince the Pa nel that the measures in question
were taken in the face of great scientific uncertainty collapse in the face of th e fact that the European
Communities is not faced with competing risk ass essments of the stark contrast implied by the
European Communities – in fact, as the evidence demonstrates, th e European Communities is not
faced with competing risk assessments at all – re gardless of whether we are talking about pending
applications or the member State national measures.
(viii) Article 2.3
4.874 The application of the approval procedure is subject to Articles 2, 5 and Annex C of the
SPS Agreement. The European Communities' arguments ignore the case law on the relationship
between Articles 5.5 and 2.3.
(ix) Annex C(1)(a)
4.875 In essence, the European Communities denies the existence of a moratorium and argues that it
is justified in refraining from making a decisi on because scientific understanding may evolve and
unforeseen risks may arise in the future. To accept this argument would render illusory the protection
accorded by Annex C(1)(a). As a factual matter, apart from the fact that the moratorium is the
primary cause of the delays, there is no insufficiency of scientific evidence so as to justify the delay in
completing the approval procedures in question. While there may be circumstances in which a
precautionary approach in selection of the risk management measure is warranted, such circumstances
do not exist in this case and, in any event, a precau tionary approach cannot override the requirements
of Annex C.
4.876 The European Communities is really arguing that the product-specific marketing bans are
justified under Article 5.7. However, the Eur opean Communities has not claimed the protection of
Article 5.7, let alone demonstrated that its re quirements have been satisfied. The European
Communities appears to assume that Article 5.7 does not apply to the operation of inspection, control
and approval procedures. This assumption is inva lid. As Canada has already demonstrated, the
European Communities' measures are subject, not only to Annex C, but also the requirements of
Articles 2 and 5. If, as it now appears, the Eu ropean Communities is attempting to justify the
product-specific marketing bans on the basis of insufficiency of scientific evidence, the European
Communities must claim the protection of Article 5.7 and demonstrate that the product-specific
marketing bans meet the requirements of that provision. The European Communities has failed to do
so.

(e) The TBT Agreement
4.877 The European Communities conced es that the relevant EC legislation contains technical
regulations. The product-specific marketing bans arising from the moratorium are mis-applications of
that legislation. The "application" of technical regul ations is subject to both Article 2.1 and 2.2 of the
TBT Agreement.
4.878 The European Communities' argument that th e phrase "in respect of technical regulations"
limits the scope of Article 2.1 of the TBT Agreement to situations where the products in question are
both subject to technical regulations is untenable . There is nothing in those words to support the
narrow scope proposed by the Euro pean Communities. Nor is the Bi osafety Protocol relevant to a
determination of "likeness". The test of "lik eness" is fundamentally an examination of the
competitive relationships between the products in the market place. Even if it is possible, in principle,
for international legal instrument s to constitute evidence for or against "likeness", the Biosafety
Protocol does not provide any guidance in this respect.
4.879 The European Communities' assertion that only the European Communities' approvals
legislation for biotech products is capable of bein g a technical regulation is not correct. Canada has
showed that the member State national measures are also technical regulations. Furthermore, the
European Communities' contention that the "C omplainants have not established that any application
of the EC legislation … is more trade restri ctive than necessary" is without merit.
4.880 Canada is not contesting the European Commun ities' legislation as such. Rather, it is the
moratorium, which converts the legislation's conditi onal marketing ban into a permanent and
unconditional marketing ban, and the resulting misappli cation of the technical regulation, that Canada
is challenging. It is this misapplication of the t echnical regulation that Canada is challenging as being
more trade-restrictive than necessary, contrary to Article 2.2 of the TBT Agreement. Thus, the central
issue before the Panel is not whether the delays in the approval of specific applications are more
trade-restrictive than necessary, but whether denyin g the approval of specific product applications on
a systemic basis – essentially the misapplication of the EC legislation – is more trade-restrictive than
necessary.
4.881 The European Communities also claims that Article 2.2 does not require the measure in
question to "fulfil a legitimate objective". This ar gument finds no textual support in Article 2.2. On
the contrary, the language of Article 2.2 requires a direct causal relationship between the measure and
the achievement of the objective. The European Communities' interpretive approach would make it
virtually impossible to gauge the necessity of a given measure.
4.882 It is simply astounding that the European Commun ities, at this late stage in the proceedings,
still cannot inform the Panel what the EC member St ates' respective appropriate levels of protection
were, or how those levels of protection differ from that found in the European Communities'
legislation.
4.883 The European Communities asserts that "a c onformity assessment procedure does not exist
where there is room for the exercise of discretion, or the weighing of complex and to some extent
conflicting considerations." This argument is without merit. There is no language in the definition of
"conformity assessment procedure" to support the European Communities' characterization. The
definition includes a broad, and non-exhaustive, list of activities, many of which include the exercise
of discretion. It seems plain that if, as the European Communities conced es, these instruments are
technical regulations, then the approval proce dures laid down to ensure that the substantive
requirements set out therein are met must be conformity assessment procedures.

4.884 The European Communities argues that, because "release into the environment" has a
character of irreversibility, the delays in a pprovals do not violate Article 5.1.2 of the TBT Agreement.
However, the irreversibility of the negative impact of a given product is only one consideration to take
into account when determining whether the applicat ion of the conformity assessment procedure is
more strict than necessary.
4.885 Although the phrases "as expeditiously as possibl e" and "without undue delay" use different
words, their import is the same. Control, insp ection and approval procedures under Annex C of the
SPS Agreement and conformity assessment procedures under the TBT Agreement are intended to
achieve basically the same object. In terms of th eir ordinary meaning, the phrases mean essentially
the same thing. The European Communities has not advanced a different or competing interpretation
of these phrases. Canada has demonstrated that the product-specific marketing bans amount to
violations of Article 5.2.1 of the TBT Agreement.
 It is now for the European Communities to rebut
Canada's prima facie case. To date, it has failed to do so.
(f) Interpretive issues relating to GATT 1994
4.886 The European Communities makes several claims relating to Article XX of the GATT 1994.
None of these claims are supported by the facts, th e text of the WTO Agreements, the jurisprudence
or logic. The European Communities claims that Article XX of the GATT 1994 would be available to
justify a violation of one of the provisions of the TBT Agreement or the SPS Agreement. This claim is
completely untenable as a matter of treaty interp retation, and the European Communities offers no
cogent argument in support. In regard to GA TT 1994, the European Communities has not made out a
prima facie case for justifying any of the violations of Article III:4 and Article XI:1 (in the case of
Greece) of the GATT 1994 arising from the product-specific marketing bans or the member State
national bans. Clearly, it is the European Commun ities, as the party invoking Article XX, who bears
the initial burden of demonstrating that the requirements of Article XX have been met. Just as clearly,
the European Communities has failed to discharge this burden.
(g) "Mixed" acts
4.887 The European Communities has argued that de termining which agreement applies to the
measures in question is an important threshold issue. However, the European Communities'
bifurcation of the measures in dispute into SPS and non-SPS components is merely an attempt to
distract the Panel from focusing on the underlying issues in this case, that is whether the moratorium,
the product-specific marketing bans , the delay in processing biotech products, or the EC member
State national measures are justified in the circumstances. The European Communities' efforts to
characterize these measures as falling, in part, outside the scope of the SPS Agreement should be
rejected. However, even if one were to accept for the purposes of argument that the measures in
question involve the assessment of non-SPS risks, th e measures are not justifiable under either the
SPS Agreement or the TBT Agreement. Regardless of whether the meas ures in dispute are applied to
protect against exclusively SPS risks or a mix of SPS and non-SPS risks, the conclusion is the same –
the European Communities' own risk assessments have concluded that there is no justification for
these measures or the delay in processing biotech applications.
(h) "Mixed" delay
4.888 The European Communities argues that the reasons for the delay arise from the assessment of
risks that fall within the SPS Agreement and risks that fall outside of the SPS Agreement. Assuming
that the approval procedures can be split into differe nt components, the fact that the entirety of these
procedures may not be covered by the SPS Agreement does not mean that the entire measure falls out

of the scope of that Agreement. Measures taken for SPS reasons are subject to the SPS Agreement
regardless of whether or not the me asures are also be subject to the TBT Agreement or GATT 1994 .
Otherwise a WTO Member would be able to a void its obligation under Annex C(1)(a) by claiming
that the delay arose for non-SPS reasons. Where a procedure falls both under the SPS Agreement and
the TBT Agreement and a Member challenges delay in th at administrative procedure under both
Agreements, the assessment of whether Annex C(1)(a) of the SPS Agreement and Article 5.1.2 of the
TBT Agreement have been violated should be done in parallel. In this case, the measures in question
have given rise to violations under both Annex C(1)(a) and Article 5.1.2.
(i) Mootness
4.889 Whether a claim is moot depends on the partic ular circumstances of the discontinuation or
modification of the measure, viewed in light of the resolution of the overall dispute. The
jurisprudence of both the International Court of Ju stice (ICJ) and the WTO confirm this view. On
numerous occasions, GATT and WTO panels have exercised th eir discretion and have delivered
rulings on measures that had ceased to exist or had b een modified after the establishment of a panel.
Canada submits that the question of mootness is not relevant to Canada's claims related to the
moratorium because the moratorium has not ceased to exist and the product applications listed in
Canada's panel request remain unresolved. In addition, none of the EC member State national
measures listed in Canada's panel request have been withdrawn.
3. Canada's claims
(a) Moratorium
4.890 The European Communities denies the existence of the moratorium, asserts that it is not a
measure, argues, in the alternative, that it no longer ex ists, that it is of a "mixed" nature and, that it is
justified as a provisional measure under Article 5.7 of the SPS Agreement.
4.891 Essentially, the European Co mmunities argues that no moratorium exists, and that the
complaints arise from a series of coincidental dela ys. According to the European Communities, this
case should be viewed exclusively through the lens of Annex C of the SPS Agreement, and the sole
legal question is whether the delays in this pro cedure are "undue". While the complaining parties
have advanced claims under Annex C of the SPS Agreement, to characterize this dispute as merely
concerning procedural delays is to demonstrate a misunderstanding of its essence.
4.892 First, the evidence shows that the moratorium is more than a series of isolated procedural
delays. Second, the European Communities' argume nts rest on the faulty premise that the operation
of the approval procedures for biotech products is insulated from "political" decision-making. Third,
the European Communities attempts to deflect analysis of the hard questions about the necessity of
effectively suspending an approval system for six y ears in order to adopt legislative amendments and
whether this effective suspension is consistent w ith the European Communities' WTO obligations. In
this case, the suspension of the approval regime fo r biotech products, and the resulting delay in the
completion of those approval procedures, is not justified. Finally, the European Communities seeks to
blame the victim.
4.893 The European Communities argues that, because it is not "possible to identify with any
precision the precise acts and omissions" that constitute the moratorium, the moratorium cannot be a
measure for the purposes of the SPS Agreement. Evidently, the European Communities has not asked
its own officials what they mean t when they used the term " moratorium". In any event, the meaning
is abundantly clear from the context in which it was used.

4.894 The European Communities argues that the lim ited processing of some product applications
necessarily implies that there is no moratorium. This self-serving interpretation of " moratorium"
should be rejected. Canada has never argued that the moratorium has resulted in the complete
shutdown of all aspects of the approval procedures for biotech products. It is at critical junctures in
the approval procedure that the relevant EC body effectively has decided not to decide, thereby
putting off making decisions on product applications. It is the effective "decision not to decide" that
is the source of the moratorium.
4.895 The European Communities argues that if the Panel were to conclude that the moratorium is a
measure, it would have to determine to what extent the moratorium comes within the scope of the
SPS Agreement. The European Communities largely shifts the onus onto the Panel to develop the
European Communities' arguments in this regard. However, the European Communities has admitted
that the approval procedures for biotech products are, at least in part, SPS measures. Given that the
approval procedures are – at least in part – SPS m easures, the suspension of the completion of these
procedures on the purported basis that the procedures were not adequate to protect against the risks
assessed and managed under these procedures, should be considered an SPS measure. Consequently,
even on the European Communities' terms, the moratorium is, at least in part, an SPS measure.
4.896 The European Communities has failed to adva nce any detailed argument in response to
Canada's claims that the moratorium violates Articles 2.2, 2.3, 5.1, 5.5 and 5.6. Instead, the European
Communities asserts that only Article 8 and Annex C apply. This argument ignores the text of
Article 2.2 and the fact that SPS measures can be both procedural and substantive in nature. In
relation to the moratorium, the European Communities asserts vaguely that "the measure would have
to be considered to be of a provisional nature applied for reasons of insufficiency of scientific
evidence." In this regard, the European Communities appears to re ly on the Panel to divine the
European Communities' arguments.
(b) The product-specific marketing bans
(i) Oilseed Rape Ms1xRf1 and MsxRf2
4.897 As Canada explained in its Second Written S ubmission, the European Communities' assertion
that for all intents and purposes these products are a pproved is disingenuous. This is demonstrated by
the European Communities' own official documents . In its Second Written Submission, the European
Communities fails to advance any argument to refute Canada's claims regarding the product-specific
marketing bans in relation to these two products.
(ii) Oilseed Rape Ms8/Rf3
4.898 In paragraph 168 of its Sec ond Written Submission, the Euro pean Communities fails to
mention a number of significant facts, and actually provides evidence that supports Canada's original
contention that the product application was not put to a vote. Despite the existence of a positive SCP
opinion, despite a delay of 15 months between that opinion and the submission by the Commission of
a proposal for approving the product, and despite the re adiness of the applicant to meet the extralegal
requirements set out in the so-called "Common Po sition" on revisions to Directive 90/220 and to
submit additional information that met those re quirements, the Regulatory Committee never actually
voted on the product application.
4.899 In relation to paragraph 169, the European Comm unities fails to point out that the notifier's
attempts to comply with the "interim approach" were actually rebuffed by Belgium because of
concerns that accepting the applicant's effo rts would lead to the lifting of the moratorium. Even after

the Belgian scientific experts recommended approval of the revised post-marketing monitoring plan
and proposed agricultural guidelines for Ms8xRf3, th e Belgian government reiterated its position that
this was not to be interpreted as favouring the lifting of the moratorium. In short, there is no question
that the moratorium was being maintained and was having a direct and observable effect on the
processing of the application for Ms8xRf3.
4.900 The European Communities also fails to say that the submission of further information by the
notifier was necessary, not because of inadequacies relating to the existing legal requirements, but
because the application did not meet requirements that had yet to be defined, clarified or given legal
effect. Even Belgium recognized that it would be "improper government practice" to require
applicants to meet ever-changing requirements.
4.901 In paragraph 172, the European Communities' assertions concerning "significant new risk
information", specifically the UK Farm Scale Evaluation ("FSE") and the impact of the herbicide
regime associated with the Ms8xRf3 on farmland biodi versity, are specious for several reasons. First,
seed approval legislation is distinct from the pesticid e approval legislation. In no other instance are
the potential impacts on farmland biodiversity by the associated herbicide regime used as a
rationalization for not approving a seed. Second, the European Communities has selectively used
concerns about farmland biodiversity to block biotech crops while ignoring other issues that may have
an impact on farmland biodiversity. Third, and most startling, EC member States have actually
authorized the use of the herbicide formulation in question for general use as well as for specific use
on genetically modified herbicide-tolerant crops.
4.902 By conditioning biotech product approval on an a ssessment of risks ar ising from associated
pesticide use, Belgium side-steps the European Communities' own existing pesticide legislation and
imposes new barriers to the approval of herbicide- tolerant biotech products, barriers that are not
imposed in comparable situations involving herbicid e-tolerant non-biotech crops. This demonstrates
that Belgium's attempt to use concerns about herb icide use as a rationale for blocking the approval of
Ms8xRf3 is arbitrary and unjustified.
4.903 Regarding the FSE, it is important to be clear about its conclusions. The FSE clearly stated
that the potential impact on farmland biodiversity was not caused by the biotech product, per se, but
by the weed management regime used by the farmer. Belgium's refusal to recommend the approval of
Ms8xRf3 due to of the FSE is really because the he rbicide associated with the crop is too effective
 in
controlling weeds!
4.904 In addition, the UK authorities recognized that many other factors contribute to changes in
farmland biodiversity, from the presence of uncropped fi elds, margins or strips to the type of crop
cultivated. The Belgian Competent Authority appear s to ignore these conclusions and similar ones of
its own scientific experts and seizes upon only one fact or that could impact on farmland biodiversity,
the use of the herbicide, to the exclusion of all other factors. This is all the more surprising given that
one principal criterion for approval of plant protection products is their efficacy. The failure to place
the concerns about farmland biodiversity into a broa der context demonstrates that Belgium's actions
are arbitrary and unjustified.
4.905 The European Communities' assertion that th e use of non-selective herbicides, including
glufosinate-ammonium, creates unique or unacceptable e nvironmental risks is without merit. Several
EC member States have authorized the use of glufosinate-ammonium in accordance with the
requirements for plant protection products set out in Directive 91/414/EEC . Incredibly, the Belgian
pesticide regulatory authorities have already au thorized glufosinate-ammonium for use with
genetically modified herbicide tolerant oilseed rape, including Ms8xRf3. Thus, in an act of

extraordinary inconsistency, the Belgium comp etent authority under Directive 2001/18 refuses to
recommend the approval for cultivation of oilseed rape Ms8xRf3 on the basis of concerns relating to
the use of a herbicide that its own government agencies have already approved!
(iii) Oilseed Rape GT73
4.906 Now that the European Communities has pr ovided what appears to be complete
documentation, any remaining uncertainty about ti me line calculations can be removed. That
documentation shows that the Dutch Competent Aut hority required at least forty-two months to
conduct the initial assessment, instead of the ninety da ys set out in the legislation. The European
Communities' assertion that "this period of time wa s entirely dedicated to resolving scientific and
technical issues" disguises the fact that it took th e Competent Authority over three and one half years
to issue the initial assessment. It is not reasonable simp ly to attribute this to "resolving scientific and
technical issues". The "slippage in the timetable" caused by the issue of confidentiality should not be
attributed to the applicant where the "slippage " arises from an applicant seeking to ensure the
fulfilment of the European Commun ities' obligations, both under the SPS Agreement and domestic
law, relating to the protection of legitimate commercial interests.
4.907 The movement of the application from the Neth erlands to the Community-level in January
2003 does not negate the existence of the moratorium. To the contrary, the continued excessive
delays arising with each procedural step support a finding that the moratorium continues to be
maintained. As to the objections lodged by EC member States, Annex II to this submission
demonstrates that the objections were without scientific merit. The European Communities'
assertions misrepresent or gloss over a number of salie nt facts, including the failure by the European
Communities to respect its own time limits, the apparent disregard by the EC member States for
EFSA's opinion at the Regulatory Committee stage, a nd the failure of Germany to act in a manner
consistent with its own previous statements w ith respect to the conditions necessary to lift the
moratorium. In short, the repeated, unjustified delays created by the EC member States demonstrate
beyond question that the European Communities has violated its obligations under Annex C of the
SPS Agreement or, alternatively, Article 5 of the TBT Agreement, as well as providing clear and
compelling evidence that a moratorium on the approval of biotech products has been put in place and
continues to exist.
(c) The EC member State national measures
4.908 The European Communities' asser ts that the complaining parties have not engaged on the
facts; in fact, it is the European Communities that has been remarkably reticent in examining the facts
and scientific evidence relating to the EC member State national measures . This is reflected in the
limited space allotted in the European Communities' submissions to an examination of the facts and
science surrounding these measures. The table appended to the European Communities' second
written submission is completely unsupported by any arguments or references to specific exhibits.
Most of the facts and science relating to these measures comes from the complaining parties.
4.909 Nowhere in its submissions does the Europ ean Communities disclose that it has already
requested the EC member States to lift their bans, nor does it put into evidence any of its
correspondence with those member States in this regard, even t hough new evidence shows that the
Commission favours a repeal of the bans.
4.910
The European Communities also re peats its assertion that "[a]ll the Complainants originally
stated that member State measures are provisional m easures". This assertion is as incorrect now as it
was when it was first made. To the contrary, Cana da has noted that, despite the requirements of the

European Communities' own legislation, and despite the numerous and uncontradicted risk
assessments declaring these products to be safe, the bans have been maintained, thus belying the
notion that these measures are of a temporary nature.
4.911 France's decision to extend its bans until Octobe r 2006 was not taken in an informational
vacuum. On 13 February 2004, the French governme nt received expert scientific advice from its own
scientists that importing and marketing oilseed rape seeds derived from Topas 19/2 for processing and
animal feed purposes hold no greater risks than im porting and marketing conventionally bred oilseed
rape seeds. Despite this advice, France exte nded its ban on oilseed rape seeds derived from
Topas 19/2 until October 2006, when the original authorization for this product expires.
4.912 In regard to the cultivation of oilseed rape th at has been genetically modified for herbicide
tolerance, the French scientific e xperts found no direct risks to the environment. Any concerns were
limited to potential indirect environmental and ag ronomic management issues arising from the use of
the herbicide. As Canada has already demonstr ated, however, any concerns held by France with
respect to oilseed rape seeds derived from Ms1xRf1 because of the indirect impacts associated with
the herbicide glufosinate-ammonium are belied by the fact that France has already authorized the
herbicide in question for uses relevant to biotech oilseed rape cultivation, including total weed
elimination.
4.913 Regarding the European Communities reference to "different levels of protection sought by
different legislators", Canada notes that the Europe an Communities has yet to actually identify these
allegedly different levels of protection or the speci fic products to which they apply, and has yet to
identify the specific "legislators" to which it is referring. To assert, as the European Communities
does, the national bans are justified on the simple grounds that some mysterious legislator somewhere
has in mind an unspecified level of protection, one th at is allegedly higher than that intended to be
achieved by the Community legislation, is to ma ke a mockery of the rigorous requirements found in
the SPS Agreement with respect to basing SPS measures on scientific evidence and a risk assessment.
S. T
HIRD WRITTEN SUBMISSION OF ARGENTINA
1. Introduction
4.914 Argentina's further comments concern, in pa rticular, the information submitted by the
European Communities on 30 September 2004 (last set of 5 CD ROMs). In addition, having reserved
its rights to develop arguments related to the TBT Agreement, Argentina would like to put forward
certain comments in this regard as well.
4.915 Argentina wishes to reaffirm that the informa tion provided by the European Communities did
not match the positive scientific opinions already is sued by the European Communities' scientific
committees, which favoured approval of the stalle d agricultural biotech products. Moreover, this
additional information tends to confirm the information submitted by the European Communities at an
earlier stage of this process, in the sense that the European Communities has prevented the
applications for agricultural biotech products from reaching final approval, despite the positive
scientific opinions. As if this were not enough, the European Communitie s has itself explicitly
acknowledged that this additional in formation is not relevant to the case. In this respect, Argentina
would like to focus on the European Communities' acknowledgement that the relevant information
has already been provided. However, taking into co nsideration the relevant information submitted by
the European Communities, Argentina would reply to the additional documentation submitted by the
European Communities as follows.

2. Arguments
(a) The de facto moratorium
(i) The existence of a de facto moratorium
4.916 Although the European Communities has repeatedly acknowledged the existence of a de facto
moratorium, it also insists on distorting this fact by referring to issues such as the alleged need for a
precise definition of a de facto moratorium or the alleged need for specific identification of acts or
omissions within the European Communities or th e need for a "plan or course of action" or a
"decision not to decide".
The "Inter-Service Consultation" phase

4.917 Argentina affirms again that the European Communities has admitted the existence of a
de facto moratorium. Apart from the declarations and statements made by EC officials, we have
demonstrated that the scientific evidence supporting approval of the agricultural biotech products has
not been deferred or postponed for mere procedural reasons. From the information on the CD ROMs,
it is evident that the European Communities and/or its member States tried to refute or ignore the
positive scientific opinions of its Scientific Committees, in order to stall the approval or marketing of
agricultural biotech products.
4.918 As we have shown, there are relevant stages w ithin the proceedings, with no legal basis in the
approval procedures but with political relevance for stalling the procedure and demonstrate that the
European Communities was treating agricultural biotech products "in baskets".
4.919 The "Inter-Service Consultation phase" effectiv ely prevented all the applications – with
positive scientific opinions in 1998 – from moving forward : within the Regulatory Committee draft
stage, and beginning on 4 September 1998 for all th ese products, the applications for Falcon GS40
Oilseed rape, MS8xRF3 Oilseed rape, and A5/15 Fodde r beet were stalled. Only Bt 531 cotton and
RRC 1445 cotton (of particular interest to Argentin a) were able to reach the Regulatory Committee
voting stage in that year. In respect of these two products, this phase took place twice in September
1998 and May 1999 after there was a lack of a qualified majority vote in February 1999.
4.920 In conclusion, these applications for approva l of agricultural biotech products had the
following in common: all of them were submitted under Directive 90/220, all of them received a
positive scientific opinion within the European Comm unities before 2000, and a ll of them underwent
an additional stage that was not in cluded in the European Communities' approval legislation, namely,
the "Inter-Service Consultation" phase, which is cap able of stalling the procedure and reveals the
de facto moratorium.
4.921 These applications were put to the vote in the Regulatory Committee, where the positive
scientific opinions were ignored by those EC member States who voted negatively without any
scientific evidence that could override the positive opinions. It is evident that in 1998-1999 the
European Communities was revealing its intention not to have any further agricultural biotech
products approved. This was confirmed by the "C ommon Position" and the declarations of several
member States, which revealed the position towards agricultural biotech products within the European
Communities.

The "Common Position" and the declaration by various member States

4.922 In 1998 the approvals and rejec tions of applications stopped because the EC legislation was
considered inappropriate. In June 1999 the EU Council of Environmental Ministers drew up a
document called the "Common Position" for the reform of Directive 90/220. This document stated
there would be no approvals until there was new legi slation. The Declaration by Denmark, Greece,
France, Italy and Luxembourg stated their intentio n of not allowing more biotech approvals. This
position was reiterated in July 2000 during an info rmal Environment Council meeting in Paris. In
Argentina's view, the "Common Position" reveal s the European Communities' intention not to
approve any more agricultural biotech products.
Regarding the "Interim approach"
4.923 The European Communities' consideration of a ch ange in the legislation created uncertainty
about the approvals. As a consequence, several applicants offered to fulfil the requirements contained
in the "Common Position", since they had no other choice. Afterwards, in July 2000, the Commission
proposed the so-called "Interim approach". This came after a long period of time without approvals
and was the result of the applicants' concerns – not of any initiative by the European Communities, as
the European Communities asserts.
4.924 Under the "Interim approach" there were neither approvals nor rejections. Moreover, the entry
into force of Directive 2001/18 brought the "Interim approach" stage to a close.
4.925 Argentina recalls again what it has previously asserted with regard to what the European
Communities calls "progress" in the approval pro ceedings. This has actually entailed neither
approvals nor rejections of app lications. The "Interim approach" became just another expression of
the de facto moratorium.
Further applications receive positive scientific opinions before the entry into force of
Directive 2001/18
4.926 While all the applications with a positive sci entific opinion dated 1998 were stalled, new
applications were in position to be approved thanks to the positive opinion of the Scientific
Committees: both Phoe6/Ac Oilseed rape and Bt11 maize received a positive opinion on
30 November 2000 and were to be resubmitted under Directive 2001/18. Both applications were
stalled for two years. The same can be argued w ith reference to the potato, though within a shorter
time-frame, since the positive scientific opinion was issued in July 2002.
4.927 In February 2001, six member States reaffirm ed their commitment to suspending approvals,
on the grounds that the new procedures were inadequate.
4.928 By the end of October 2001, the majority of member States essentially agreed that the
moratorium should not be lifted until the full tr aceability and labelling provisions had entered into
force. At an informal meeting of the Environmen t Council, eight member States effectively rejected
the Commission's plan to consider new authorizatio ns, by demanding that the new regulations be in
force first. In December 2001, Belgium declared once again that the de facto moratorium would have
to be maintained until there was proper legislation on traceability and labelling.
4.929 Consequently, the European Communities was cl early announcing its intention to maintain
the de facto moratorium, even if Directive 2001/18 was to enter into force. This refutes the European

Communities' allegation that any delays should have ended with the entry into force of
Directive 2001/18.
4.930 Since 2000 new applications under Direc tive 90/220 received positive scientific opinions
before Directive 2001/18 came in force (October 200 2). These applications did not go through any
"Inter-Service Consultation" phase (except NK603 maize at a late stage), but they were stalled, some
before reaching the Regulatory Committee stage, some within that stage due to the negative vote of
certain member States which ignored the positive scien tific opinions. In any case, these applications
were stalled until Directive 2001/18 came in force and had them all resubmitted with new
requirements.
4.931 Additionally, some products received positive scientific opinions under Regulation 258/97,
starting a little earlier (September 1999). These products, it will be recalled, did not go through any
"Inter-Service Consultation" phase, but were also stalled, both before reaching the Regulatory
Committee stage and within that stage.
4.932 In this connection, Argentina cites the situation of GA21 maize: Maize GA 21 C/GB/97/M3/2
(withdrawn in July 2001 due to the decision to discontinue the application, on 21-03-2001) and
C/ES/98/01 received a positive scientific opinion from the SCP under Directive 90/220 in September
2000. The application did not reach the Regulator y Committee stage and had to be resubmitted in
January 2003 under Directive 2001/18. It was finally withdrawn in September 2003.
4.933 As demonstrated, further applications recei ved positive scientific opinions, favouring their
approval, but were stalled within their procedures and some had to be withdrawn.
(ii) Conclusion
4.934 In Argentina's opinion, this element of intent, of deliberate action, which – through the
"Common Position", the Declaration of Denmark, Greece, France, Italy and Luxembourg, and the
additional "Inter-Service Consultati on" phases – is reflected in the approval proceedings, shows that
the de facto moratorium constitutes a measure and that it is not the mere outcome of a situation that
has existed since 1998. From 1998 on there were no more approvals of agricultural biotech products
because the European Communities de cided that there should be no mo re approvals of agricultural
biotech products . This intention within the European Co mmunities was expressed, made effective,
and reiterated over time by several member States.
4.935 After considering the European Communities' r easons for the absence of approvals of new
agricultural biotech products between 1998 and the present – insufficiency of Directive 90/220 and
the need for replacement by Directive 2001/18, th e need for further legislation on traceability,
labelling, monitoring, liability, coex istence, etc. – Argentina conclud es that they do not release the
European Communities from its WTO obligations. None of these reasons should prevent the approval
of agricultural biotech products that have recei ved a positive scientific opinion within the European
Communities.
4.936 The European Communities referre d to the need for even newer legislation on traceability,
labelling, monitoring, liability and coexistence. None of this new legislation deals with risk
assessment – which the positive scientific opinions by the Scientific Committees do address – so the
European Communities cannot disregard the risk assessment undertaken and suspend all approvals
without infringing the SPS Agreement.

4.937 Argentina not only maintains that the de facto moratorium is a current existing measure – and
it certainly was at the time that the terms of refe rence of this Panel were established – but also
reiterates that the WTO Agreement is meant to deal with de facto measures as well, including any
actions or omissions of WTO Members. Otherw ise, WTO Members could circumvent their WTO
obligations by merely issuing informal measures, which have not been set forth in positive legislation.
(b) The "suspension of processing and failure to c onsider individual applications for specific
products of particular interest to Argentina"
(i) General comments
4.938 Having received the final information from the European Communities relating to the
products of interest of Argentina, we realize that the European Communities has not refuted the
information, but rather confirmed Argentina's a llegations and, consequently, does not overturn the
positive scientific opinions from the EC Scientific Committees. Starting from the positive scientific
opinions issued by the European Communities itself, and given the resulting non-approval due to the
European Communities' deliberate
 actions aimed at having no agricultural biotech products approved,
we once more state that this claim goes far bey ond a mere question of delay – as the European
Communities would have us believe.
4.939 As Argentina has stated before, since the de facto moratorium affects all applications, these
relevant additional stages also apply to the products of interest of Argentina, namely, Bt-531 cotton,
RRC 1445 cotton, NK 603 maize, GA 21 maize and Soy Lines A2704-12 and A5547-127. In this
respect, Argentina reaffirms its arguments contained in its Written Rebuttal.
(ii) Specific products
4.940 In this section, Argentina will refer to the information provided by the European
Communities on the last five CD ROMs on 30-09-2004. However, it is useful to recall that the
"suspension and failure to consider" has been argued by Argentina starting from when the
applications submitted under Directive 90/220 and under Regulation 258/97 were stalled.
4.941 Argentina will once again go through the appli cations relating to the agricultural biotech
products of interest, analysing the documents provided by the European Communities, and
demonstrating once again that the additional in formation does not overturn the positive scientific
opinions of the EC Scientific Committees. In fact, all the information demonstrates that the European
Communities and/or some of its member States put forward arguments or concerns of a non-scientific
nature.
Bt 531 cotton

The proceedings were stalled
4.942 As regards the relevant stages identified by Argentina in its Rebuttal, the additional
information submitted by the European Communiti es confirms that the approval proceedings for
Bt 531 cotton under Directive 90/220 (and later Directive 2001/18) were stalled.
Comments on the information provided on the CD ROMs
4.943 Regarding the specific documents submitted by the European Communities relating to Bt 531
cotton under Directive 90/220 and Directive 2001/18, Argentina affirms its position that the positive

scientific opinion by the Scientific Committee on Plants
 dated 14 July 1998 is the relevant document
to be taken into account. The following does not refu te this SCP opinion: the launching of the "Inter-
Service Consultation" on the draft Commission De cision (4 September 1998); is non-scientific in
nature and did not refute the positive scientific opi nion; the launching of the vote in the Regulatory
Committee (26 November 1998); the Danish request to extend the deadline for a vote to review
additional information (30 November 1998); the letter by the Commissie Genetische Modificatie (NL)
(3 December 1998); the COM note to the effect that the deadline for voting had been extended
(4 December 1998); the Belgian request to postpone the vote (10-12-1998); the UK request to
postpone the vote (21 December 1998); the note to th e effect that the deadline had been extended
(23 December 1998); the Opinion of the Commission du Génie Biomoléculaire (13 January 1999); the
note on the lack of a qualified majority (22 February 1999); the launching of the "Inter-Service
Consultation" phase (7 May 1999); the letter ( 25 July 2001) (as well as the translations
(18 February2002)). The European Communities w as unable to invoke any scientific evidence
capable of refuting the positive scientific opinion dated 14 July 1998.
4.944 Any EC concerns regarding furt her information on certain issues had been properly answered
as of February 2002
, but the process remained stalled thanks to the "Inter-Service Consultation" phase
that had been in force since May 1999 and c ontinued until Directive 2001/18 came into force in
October 2002, requiring all applica tions to be updated at member State level. For these reasons,
Argentina does not accept the European Communities' allegation that it was due to the applicant that
the approval procedure did not proceed. From the Regulatory Committee voting stage and the "Inter-
Service Consultation" phase the approval procedur e for Bt 531 cotton was stalled because of the
European Communities, not because of any action or omission on the part of the applicant.
4.945 Additionally, we observe that although it came into force in October 2003, Directive 2001/18
was published in the Official Journal in April 2001. Since the applicant had to submit information
under the new legislation, Argentina cannot accept th e European Communities' statement concerning
"29 months" to fulfil the requirements.
4.946 Argentina will now turn to the last documen ts at member State level. The following
documents does not refute the SCP opinion of July 1998: the letter from the lead CA (1 August 2003);
and the NCB letter (2 October 2003).
4.947 In Argentina's opinion, it has been proved that the application for Bt 531 cotton had to pass
through several procedural stages not included in the European Communities' legislation, and that
reveals a clear intention within the European Co mmunities not to allow the final approval of this
agricultural biotech product.
RRC 1445 cotton
The proceedings were stalled
4.948 As to the relevant stages identified by Argen tina in its Rebuttal, the additional information
submitted by the European Communities has confir med that the approval proceedings for RRC 1445
cotton under Directive 90/220 (and later Directive 2001/18) were stalled.
Comments on the information provided on the CD ROMs
4.949 Regarding the specific documents submitted by the European Communities relating to RRC
1445 cotton under Directive 90/220 and Directive 2001/ 18, Argentina reaffirms its position that the
positive scientific opinion by the Scientific Committ ee on Plants dated 14 July 1998 is the relevant

document to be taken into account. The following does not refute the SCP opinion: the launching of
the "Inter-Service Consultation" on the draft Commission Decision (4 September 1998); the launching
of the vote in the Reg. Comm. (26 November 1998) ; Denmark's request for an extension of the
deadline for a vote to review additional informa tion received by Monsanto (30 November 1998); the
letter from the Commissie Genetische Modificatie (3 December 1998); the COM note extending the
deadline for the vote (4 December 1998); th e Belgian request to postpone the vote
(10 December 1998); the statement by Austria (13 December 1998); the UK request to postpone the
vote and discuss further information recently submitted (21 December 1998); the COM note
extending deadline (23 December 1998); the Opinion of the Commission du Génie Biomoléculaire
(13 January 1999); the COM note concerning a further extension of the deadline for a vote at the
request of the lead CA – 26 January 1999 – was pr ocedural in nature and did not rebut the positive
scientific opinion of July 1998; the UK response to the European Communities (10 February 1999);
the note on the lack of a qualified majority (22 Fe bruary 1999); the launching of the "Inter-Service
Consultation" phase on the draft Council Decision (7 May 1999).
4.950 In the light of the above and according to th e European Communities' information, from the
launching of the "Inter-Service Consulta tion" phase in May 1999 to the update under
Directive 2001/18 in January 2003, the applicant received no request for further information or
clarification, so the European Communities ca nnot even suggest that the process was ongoing.
Additionally, the European Communities was unabl e to invoke any scientific evidence capable of
refuting the positive scientific opinion dated 14 July 1998.
4.951 Argentina will now refer to the last docum ents at member State level: the following
documents do not refute the positive scientific opinion of July 1998: the letter from the lead CA
(1 August 2003); the NCB letter (2 October 2003).
NK 603 maize

The proceeding was stalled
4.952 As previously stated, the applications for NK 603 maize were initiated in 2000 under
Directive 90/220 (later Directive 2001/18), and in 2001 under Regulation 258/97. In both
proceedings, the application received a positive scientific opinion in N ovember 2003. Although
NK 603 maize was finally approved after the initiati on of this WTO proceeding, this should not
impair the ability of the Panel to deliver a finding on the claim relating to this specific product.
Comments on the information provided on the CD ROMs
4.953 The NK 603 maize application under Directive 90/220 was originally submitted in August
2000 and later had to be resubmitted under Directive 2001/18. In this connection, Argentina will refer
to information provided by the European Communities on the CD ROMs. NK 603 maize received a
positive scientific opinion from EFSA dated 25 November 2003, which is the relevant document to be
taken into account. The following does not refute the EFSA opinion: the documents and stages prio
r
to the positive scientific opinion (25 Novemb er 2003); the launching of the "Inter-Service
Consultation" on the draft Commission Decision (8 December 2003); the lack of a qualified majority
in the Regulatory Committee (18 February 2004) – does not reflect the positive scientific opinion and
is rather procedural in nature; it demonstrates th at some member States continue to vote negatively
despite the scientific evidence; the transmission of the proposal to the Council (26 March 2004); the
position of Denmark (4 June 2004).

4.954 Regarding the specific documents submitted by the European Communities relating to
NK 603 maize under Regulation 258/97 (originally submitted under this Regulation in April 2001), a
positive scientific opinion was received from EFSA, dated 25 November 2003 wh ich is the relevant
document to be taken into account. The draft decision presented to the Regulatory Committee (no
qualified majority) – 30 April 2004 – was procedural in nature.
GA 21 maize

The proceeding was stalled
4.955 Although the application for GA 21 maize was withdrawn in September 2003 under the a
Directive 90/220 (later Directive 2001/18), Argentina c onsiders this withdrawal to be evidence of a
de facto moratorium proceeding and of the "suspension and failure to consider". The application
made no progress in the proceedings and was withdrawn.
Comments on the information provided on the CD ROMs
4.956 Concerning the specific documents submitted by the European Communities relating to
GA 21 maize under Directive 90/220 and Directive 2001/ 18, Argentina reaffirms its position that the
positive scientific opinion by the Scientific Co mmittee on Plants dated 22 September 2000 is the
relevant document to be taken into account.
4.957 The positive opinion dated 22 September 2000 was followed by: the letter (19 January 2001);
the Spanish letter (21 March 2001); the letter (decis ion to discontinue UK notification) (21 March
2001); the undertakings to fulfil the requireme nts of Directive 2001/18 (21 September 2001); the
updates and commitments (18 March 2002); the new SNIF and updated risk assessment
(15 January 2003). These documents are either of a non-scientific nature or are specifically refuted by
the scientific arguments submitted by Argentina. The application was finally withdrawn (15
September 2003).
(c) "Undue delay"
4.958 With respect to "undue delay", after analysin g the information and chronologies submitted by
the European Communities, Argentina affirms and de monstrates that the delays that occurred during
the proceedings were not on the part of the appli cants, but on the part of the European Communities
and/or its member States. We do not accept the European Communities' allegation in this respect.
4.959 Concerning Bt 531 cotton, there were no delays on the part of the applicant following the
issuance of the positive scientific opinion (July 19 98). The alleged objections in the Regulatory
Committee were scientifically contested by Argent ina, inasmuch as they do not match the positive
opinion of the Scientific Committee. Additionally, we do not accept the delay of 29 months plus
7 months attributed to the applicant either, sin ce, as previously stated, there are no EC documents
specifically requesting information that might suggest delay on the part of the applicant. As to the
European Communities' assertion regarding the need to have the monitoring plan completed, the
monitoring plan was originally presented in December 1996 with the applicant's first notification, and
that this monitoring plan received a positive scientific opinion in July 1998. Thus, we cannot accept a
vague and general assertion that the monitoring plan was incomplete.
4.960 In connection with the Eur opean Communities' statements concerning RRC 1445 cotton, we
consider them to be irrelevant as well. The outcome of the written procedure in the Regulatory

Committee that the European Communities mentions has already been scientifically addressed by
Argentina.
4.961 As regards the monitoring plan to be comp leted, Argentina agrees with the European
Communities that this monitoring plan was request ed under Directive 2001/18. For the same reason,
we also stress that this plan was presented by th e applicant on January 2003, and that the European
Communities' requests for additional information were made in August and October.
4.962 With reference to the case of NK 603 maize under Directive 90/220 and Directive 2001/18, as
well as under Regulation 258/97, Argentina reiterates that these two proceedings were started in
August 2000 and April 2001 respectively, and that there had been no further progress as of
August 2003. For the above-mentioned reasons, Arge ntina considers that the specific agricultural
biotech products of particular interest were affect ed by "undue delay" in their approval procedures
following their submission to the European Communities.
(d) TBT Agreement
4.963 As stated at the outset of this Supplementary Rebuttal, Argentina would like to elaborate
further on its alternative arguments relating to the TBT Agreement.
(i) Technical regulation
Article 2.1 of the TBT Agreement

4.964 The European Communities has not explaine d in any detail the supposedly proper
interpretation to be given to the words "in respect of technical regulations" contained in Article 2.1 of
the TBT Agreement. However, it can be inferred that the European Communities considers this phrase
to refer to less favourable treatment within the limited scope of a single regulation, without explaining
the reasons why.
4.965 However, there is no basis for consideri ng that likeness should properly be understood
"as relating to products within the field of application of the technical regulation", as the European
Communities asserts. If this were the case, it woul d be very easy for Members to circumvent their
WTO obligations. Moreover, the only practical result of such an interpretation would be that simply
by applying different legislation to products that are actually "like" a Member could avoid scrutiny
under WTO rules and, thus, engage in "less favourable treatment" without any legal consequences.
4.966 Argentina considers that Article 2.1 of the TBT Agreement basically develops obligations
similar to those of Article III.4 of the GATT 1994. Thus, the phrase "in respect of technical
regulations" simply reflects the difference in scope between Article 2.1 of the TBT Agreement and
Article III.4 of the GATT 1994, which applies the sa me disciplines but to a much broader range of
measures.
Article 2.2 of the TBT Agreement
4.967 With reference to this part of the European Communities' rebuttal, Argentina would first like
to point out that it has challenged, in the alternativ e, the application of the EC legislation under the
TBT Agreement. In this respect, as Argentina has made clear throughout its presentations in these
proceedings, the European Communities' legislation per se has not been challenged, only the
application of that legislation.

4.968 The European Communities affirms that "… the prohibition on marketing, pending
authorization is the very essence of the GMO legisl ation – not an application of it …". Contrary to
this assertion by the European Communities, Ar gentina considers that the "very essence of the
GMO legislation" is not "the prohibition on marketing pending authorization" but assessing the
suitability of products in order to approve or reject them for release into the environment or for
consumption as food or feed.
4.969 It should also be pointed out that the concept of "application" includes not only the act of
approval (or rejection) but also the failure to approve (or reject), as in the case before the Panel.
4.970 The European Communities also repeats its recu rrent allegation that what the complaining
parties are actually claiming is a delay that is mo re restrictive than necessary. Argentina has already
made its claim clear enough in this regard. Argentin a wonders whether it is possible to consider that,
for example, in the cases of Bt 531 cotton and RRC 1445 cotton, the passage of six years after a
positive assessment by the competent scientific committee with no approval or rejection can somehow
be regarded as "the provisional absence of a final deci sion". Argentina considers the answer to this is
obviously no.
4.971 Moreover, WTO Members are being adversely affected by this EC infringement of Article 2.2
of the TBT Agreement, since according to that Article " Members shall ensure that technical
regulations are not … applied with … the effect of creating unnecessary obstacles to international
trade … ". It seems reasonable to infer that, although the article refers to the way in which Members
apply technical regulations, it also refers to non-co mpliance of those regulations (in the present case,
the European Communities' approval system).
4.972 The European Communities also asserts that there is no obligation to conduct a risk
assessment under Article 2.2 of the TBT Agreement. However, probably as a second thought,
immediately after this assertion the European Co mmunities makes clear that "In any event, the
European Communities is currently in the process of assessing the risk s in order to authorize these
products". It seems that the European Communities is acting in this way 'just in case', which to some
extent reveals the inconsistency of its own arguments.
4.973 The European Communities' argument has no b asis in the text of Article 2.2 of the
TBT Agreement because this article establishes that " … In assessing such risk, relevant elements of
consideration are, inter alia: available scientific and technical information … ".
4.974 The European Communities is therefore bound to make an 'assessment' because Article 2.2 of
the TBT Agreement refers to this obligation. Moreover, in assessing such risk, 'available scientific and
technical information' constitutes 'relevant elements ' of consideration. These "relevant elements" of
consideration are the positive scientific opinions of the European Communities' scientific committees.
The European Communities also ch allenges the assessment of its own Scientific Committees by
asserting that "The European Communities fundamentally disagrees that it has been demonstrated that
there is no risk associated with the relevant products " although, three paragraphs earlier it asserts that
"EC GMO legislation is not a matter before this Pa nel". The Scientific Committees being so relevant
to the European Communities' approval legislation, it is difficult to see how they can be challenged
without challenging the relevant legislation.
4.975
 Moreover, the European Communities does not explain why it is wrong to break the provision
down into three components. The European Communities' assertion that "whether or not the objective
is actually fulfilled in fact is irrelevant provided that the measure contributes or is capable of
contributing to that objective", is not explained either.

4.976 However, in Argentina's view, the phrase "t echnical regulations shall not be more
trade-restrictive than necessary to fulfil a legitimate objective, taking account of the risks non-
fulfilment would create" in Article 2.2 of the TBT Agreement must be considered to entail a meaning.
If the objective is not achieved, the application of the respective technical regulation becomes
inconsistent with that article.
4.977 It must be pointed out that the European Communities is definitely "avoiding risk assessment"
since it has not taken the positive scientific opinion s into account, and is "making decisions not based
on a risk assessment", for similar reasons.
4.978 The European Communities' assertion to the effect that "Those opinions (EC Scientific
Committee opinions) may or may not be sufficient for the Commission or the Council, and may at the
same time be insufficient for the member States" on ly reveals the lack of a basis for the European
Communities' arguments since there is no scientific evidence that might jeopardize the opinions of
those Committees.
4.979 Finally, the European Communities al leges that "Article 2.2 of the TBT Agreement does not
even use the precise words 'risk assessment'". However, as that article is worded " In assessing such
risks", it is difficult to see how a Member can 'assess a risk' other than by carrying out an assessment
of it (the risk). It is important to note that this article stipulates that " … In assessing such risks,
relevant elements of consideration are, inter alia: available scientific and technical information … ".
4.980 However, as already explained, the European Communities has insisted and confirmed that it
"is currently in the process of assessing the risks in order to decide whether to authorize these
products". What would be the reason for undertaki ng such an assessment if there was absolutely no
obligation to do so under Article 2.2 of the TBT Agreement?
(ii) Conformity assessment procedure
Article 5.1.1 of the TBT Agreement

4.981 It has been shown that the application of the European Communities' legislation is
inconsistent with this provision since agricultural biotech products receive less favourable treatment
than non-biotech products.
Article 5.1.2 of the TBT Agreement
4.982 The European Communities only refers to "rel ease into the environment" and does not
explain the situation of products which have r eceived positive opinions from the EC Scientific
Committees to the effect that they do not entail any risks for the environment. In other words, the
European Communities simply denies any inconsistency with this article on its part.
Article 5.2.1 of the TBT Agreement
4.983 The European Communities simply refers to th e meaning of "as expeditiously as possible",
and asserts that Argentina has not proved incons istency in the context of the specific product
applications. The paragraph affirming that the co mplaining parties have not proved it sounds strange
since there have been no approvals or rejections at all since 1998. Nor has there been any scientific
evidence to refute the opinions of the EC Scien tific Committees. Moreover, Argentina has awarded
an argument elsewhere and the European Communities has not developed a competing argument.

T. T
HIRD WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES
1. Introduction
4.984 The European Communities welcomes the course th at the Panel has followed in this dispute
after the Second Written Submissions. Rightly, the pr oceedings have come to focus on certain delays
that are alleged to have occurred in individual pr oduct applications; and on the question whether such
delays were justified.
4.985 At the same time, it has become clearer what the dispute is not about: The dispute is not
about a general moratorium, but a bout individual delays. Furtherm ore, neither the Panel nor the
experts consulted in this dispute are required to decide whether genetically modified organisms
(GMOs) per se present a risk or not. Nor are they required to decide whether specific GMOs should or
should not be authorized in the European Communiti es: those decisions will in any event have to be
made by the authorities of the European Commun ities on the basis of the relevant legislation,
whatever the outcome of this dispute may be. Rather, the experts have the important, but more
limited, task to assist the Panel in understanding the scientific background of a number of requests for
additional information or objections that have caused delays in the processing of individual product
applications.
4.986 The Complaining parties have come to reali ze that they can only prove their case if they
demonstrate instances of 'undue delay' for each indi vidual product application. In their Second
Written Submissions they had still relied almost excl usively on the existence of an ominous 'general
moratorium'. Manifestly, the assertion of such a mo ratorium (whatever the exact definition of such a
non-measure may be) was to serve one main purpose, namely to relieve the complaining parties of
their burden of proof with respect to specific probl ems that the complaining parties allege to have
occurred during various product applications. To th e extent they have at all addressed individual
product applications their allegations are sketchy or manifestly unfounded. Supposedly it is with this
third written submission that the complaining parti es now intend to finally address the issue of delay
in a proper way.
4.987 The European Communities put all relevant facts 'on the table' in its First Written Submission.
Since the complaining parties have not so far co me back to the facts and the legal arguments
presented by the European Communities, there is litt le that the European Communities can add to its
previous Submissions at this stage. In light of the course the proceedings have taken, however, the
European Communities would like to take the oppor tunity to address a few key issues it considers
pertinent at this stage of the proceedings.
4.988 First, it would like to point out that the complaining parties have not met the onus of proving
their case. The European Communities then wishes to draw the Panel's attention to the role of panels
and expert advice under the DSU with a view to assisting the Panel in making its factual findings.
Finally, the European Communities will sketch certai n implications that the principle of procedural
fairness has on the Panel's selection of potential questi ons to experts in the complaining parties' third
written submissions.
2. The burden of proof
4.989 As the European Communities explained in detail in its Second Written Submission83, it is for
the complaining parties to establish a prima facie case. The failure of the complaining parties to

83 Paras. 10 et seq.; paras. 248 et seq.

address each and every delay in its Second Written Subm ission is particularly regrettable in view of
the fact that the European Communities presented detailed chronologies and additional documentation
since the very beginning of this procedure. Docu ments subsequently made available by the European
Communities merely serve to support the facts known to the Panel, without adding any substantive
new facts. On the basis of this information, the European Communities has entirely refuted the
complaining parties' original contention that the pr ocedures have been "stalled". It has demonstrated
that all notifications have been continuously pro cessed and that, to the extent that delays have
occurred, these delays occurred for legitimate reasons.
4.990 Since the European Communities h as, thus, refuted the contentio n that procedures have been
"stalled", it is for the complaining parties to present a prima facie case of undue delay with respect to
each individual product application. The complaini ng parties have not taken this opportunity in their
Second Written Submissions.
4.991 Instead of presenting detailed facts and arguments which would warrant the conclusion that
'undue delays' occurred, the complaining parties' discussion of individual product applications is
mostly reduced to a particular legal argument, which runs like a red thread through their Submissions:
that the European Communities is under a WTO obligation to authorize a product application, once an
advisory scientific committee has issued a 'favourable' scientific opinion. The European Communities
has demonstrated that this legal argument is simplistic and erroneous as a matter of law.
84 In any
event, a legal argument – persuasive or not – is never a substitute for a rigorous presentation of the
facts that are necessary for the Panel to reach its conclusions.
4.992 The failure on the part of the complaining parties to present a prima facie case with regard to
each individual product application cannot be 'compe nsated' by reference to additional information
that may be contained in expert opinions. The Panel must not make the case for the complaining
parties. In Japan – Agricultural Products II, the Appellate Body confirmed this fundamental rule of
evidence valid also in WTO proceedings:
"Article 13 of the DSU and Article 11.2 of the SPS Agreement suggest that panels
have a significant investigative authority. However, this authority cannot be used by
a panel to rule in favour of a compla ining party which has not established a prima
facie case of inconsistency based on specific legal claims asserted by it. A panel is
entitled to seek information and advice from experts and from any other relevant
source it chooses, pursuant to Article 13 of the DSU and, in an SPS case, Article 11.2
of the SPS Agreement, to help it to understand and evaluate the evidence submitted
and the arguments made by the parties, but not to make the case for a complaining
party."
85
4.993 Hence, the Panel can only base its findings on expert advice to the extent that complaining
parties have asserted all such facts necessary to subs tantiate their claims. The Appellate Body in
Japan – Agricultural Products II overruled the panel on the ground that it based itself on information
not expressly asserted by the complaining party:
"In the present case, the Panel was correct to seek information and advice from
experts to help it to understand and evaluate the evidence submitted and the

84 The procedure requires the regulator (other than the scientific body) to take account of various non-
SPS concerns and the Community legislation which sets this procedure is not at issue in this case. See second
written submission of the European Communities, paras. 27 et seq.
85 Appellate Body Report, Japan – Agricultural Products II, para. 129.

arguments made by the United States and Japan with regard to the alleged violation
of Article 5.6. The Panel erred, however, when it used that expert information and
advice as the basis for a finding of inconsistency with Article 5.6, since the United
States did not establish a prima facie case of inconsistency with Article 5.6 based on
claims relating to the 'determination of sorption levels'".
86
4.994 The European Communities welcomes the fact that the Panel took the opportunity to seek
extensive background information and technical advi ce from experts. At the same time, it invites the
Panel to be mindful of the fact that such expert a dvice does not alter the burden of proof. It is entirely
on the complaining parties to present a prima facie case of inconsistency with WTO law; and to refute
any such evidence presented by the European Communities to the contrary.
3. The role of the Panel
4.995 The present dispute has arrived at a very delicate junction. The Panel has used its right
pursuant to Article 13 of the DSU and Article 11.2 of the SPS Agreement to consult several experts on
certain aspects of GMOs. The Panel has sought expert advice both with a view to receiving general
background information and to clarifying specific qu estions of science regarding individual product
applications. As a result, the Panel will need to evaluate extensive scientif ic evidence to reach its
finding. To assist the Panel in this task, the European Communities wishes to draw the Panel's
attention to the particular role of panels and experts under the DSU.
4.996 The role of panels in WTO dispute settlement is set by Article 11 of the DSU. It provides that
a panel must make an "objective assessment" of the f acts. Consequently, the standard of review to be
applied by panels is neither 'total deference' to a factual determination by a Member's authority nor a
de novo review of such a determination, allowing the pa nel complete freedom to come to a different
view than the competent authority.87 As the Appellate Body noted, a panel is not tasked to "substitute
[its] own conclusions for those of the competent authorities."88
4.997 A distinguished, former chairman of the Appe llate Body wrote on this issue: "the panel
should accord a considerable degree of discretion to national authorities in the determination and
assessment of facts." In particular, a panel cannot "displace the national authority" by rejecting
findings made by such an authority on the grounds that it considers other findings more warranted.
Finally, a panel is bound to "respect the parameters of the national authority's own investigation."
89
4.998 In US – Cotton Yarn, the Appellate Body had the occasion to further elaborate on and clarify
the line that is to be drawn between perm issible "objective assessment" and prohibited "de novo
review":
"In our view, a panel reviewing the due diligence exercised by a Member […] has to
put itself in the place of that Member at the time it makes its determination.
Consequently, a panel must not consider evidence which did not exist at that point in
time. A Member cannot, of course, be faulte d for not having taken into account what
it could not have known when making its dete rmination. If a panel were to examine
such evidence, the panel would, in effect, be conducting a de novo review and it

86 Appellate Body Report, Japan – Agricultural Products II, para. 130.
87 Appellate Body Report, EC – Hormones, para. 117.
88 Appellate Body Report, US – Lamb, para. 106.
89 C.-D. Ehlermann, N. Lockhart, "S tandard of Review in WTO Law", 7 Journal of International
Economic Law (2004) 491, at 502.

would be doing so without having had the benefit of the views of the interested
parties. The panel would be assessing the due diligence of a Member in reaching its
conclusions and making its projections with the benefit of hindsight and would, in
effect, be reinvestigating the market situ ation and substituting its own judgement for
that of the Member. In our view, this woul d be inconsistent with the standard of a
panel's review under Article 11 of the DSU."
90
4.999 The Appellate Body's ruling in US – Cotton Yarn is of perfect relevance for delimitating the
panel's standard of review in the present case. The obligation "to put itself in the place of that
Member at the time it makes its determination" has several consequences for the present Panel. Thus,
the Panel must look at the state of scientific inform ation and data existing at the time of the measure
in question (in this case, the allege d "delay") rather than, from an ex post perspective, at the current
state of scientific knowledge. 91 On this basis, all answers by the experts to questions which relate to
specific products as well as to those that aim at giving the Panel a sc ientific background to the dispute
need to take into account this décalage in time between the current scientific knowledge and the
scientific knowledge at the time of the alleged "delay".
4.1000 Moreover, the requirement of an "objective assess ment of the facts" largely depends on the
concrete question at issue and th e provisions of WTO law on which a claim is based. As the same
distinguished commentator put it, "[c]ertainly, pane ls perform an 'objective assessment'; but the scope
and intensity of the panel's assessment is not the same for every issue, in every dispute." 92 For the
SPS Agreement, the Appellate Body stated in EC – Hormones:
"The standard of review appropriately applicable in proceedings under the
SPS Agreement, of course, must reflect the balance established in that Agreement
between the jurisdictional competences c onceded by the Memb ers to the WTO and
the jurisdictional competences retained by the Members for themselves. To adopt a
standard of review not clearly rooted in the text of the SPS Agreement itself may well
amount to changing that finely drawn balan ce; and neither a panel not the Appellate
Body is authorized to do that."93
4.1001 Hence, in the present case, the Panel must ta ke account of the carefully struck balance
between jurisdictional competence of the WTO and th e sovereignty of its Members as reflected in the
relevant covered agreement. This balance, in turn , is expressed differently in different provisions of
the covered agreement. In the case of the SPS Agreement, an Article 5.2 claim may warrant a
relatively strict review of the examination unde rtaken by a Member's competent authority. By
contrast, the more general wording of Article 1(a) of Annex C of the SPS Agreement ("without undue
delay") indicates a more deferential standard of review.
4.1002 The latter provision is central to the present dispute. The "fine balance" drawn by the
SPS Agreement is reflected in the notion of "undue delay". When considering the issue of "undue
delay", the Panel is not required (or permitted) to engage in a de novo review of individual product
applications. Rather, the Panel merely needs to l ook at the applications to satisfy itself that such
delays that may have occurred were based on a reasona ble justification. In other words, the Panel is

90 Appellate Body Report, US – Cotton Yarn, para. 78 (emphasis original).
91 See also C.-D. Ehlermann, N. Lockhart, cited above, at 502: "This constraint influences the temporal
scope of the panel's factual review. To remain in the 'place' of the nationa l authority, the panel is not entitled to
examine new facts that were not, or could not, have been included in the national authority's investigation."
92 C.-D. Ehlermann, N. Lockhart, cited above, at 496.
93 Appellate Body Report, EC – Hormones, para. 115.

not asked to determine whether a prudent government, in the abstract, should have behaved or not in a
certain manner thus causing delay. It merely needs to find whether, in the concrete case and in light
of the factual information and the legal arguments before the relevant authorities, that behaviour
which in the end caused a delay could justifiably have been adopted.
4.1003 In this context, the European Communities notes that some questions to the experts
94 could be
interpreted as coming close to a (prohibited) de novo review of product applications. For example, in
the General Questions section, the Panel repeatedly asked whether "[o]n the basis of the information
before the Panel, [ there is] any scientific evidence to support th e hypothesis that" certain risks may
ensue from GMOs. The European Communities does not dispute the right of the Panel to request
such background information that it considers useful for its understanding of the current scientific
debate on GMOs. However, when making its find ings, the Panel must be mindful of the proper
standard of review. In line with the Appellate Body holding in US – Cotton Yarn, the relevant point
in time is the time of the adoption of the measure alleged to be WTO inconsistent. For example, to
decide whether a request for information was justifie d, it will be necessary to inquire in the state of
scientific knowledge or uncertainty at the time the information was requested.95
4. The function of expert advice
4.1004 The proceedings have moved to the stage of e xpert consultation. In deciding to consult
experts pursuant to Article 13 of the DSU and Article 11.2 of the SPS Agreement, the Panel has
acknowledged the importance of certain scientific questions for resolving the present dispute.
4.1005 The European Communities notes that many of the questions invite the experts to respond "on
the basis of the information before the Panel" or "given the information before the Panel". 96 As the
European Communities has previously noted, the e xperts should also be requested to provide the
Panel with other information of which they may be aware even if it is not "before the Panel". The
European Communities, therefore, welcomes the fact that the Panel has invited the experts to do this
in its letters to the experts.
4.1006 As the European Communiti es has previously argued 97, it is not open to the Panel to ignore
the various scientific positions (in addition to the views expressed by the European Communities' own
scientific Committees) that have evolved on risk assessment and risk mana gement issues in the
international scientific community. To understand th e background of this dispute, the Panel must be
aware of the various risks that were debated in the scientific world during the relevant period of time.
The "General Questions" to the experts demonstrate that the Panel shares this view.
4.1007 Moreover, scientific expertise is essential to assi st the Panel in determining whether certain
delays that may have occurred were "undue". In this context, the Panel may need to decide whether,
for example, the time needed to develop a monito ring plan was excessive, whether certain concerns
by the Belgian Biosafety Council were legitimate and reasonable in light of a field study, or whether
at the time of a delay, there was a degree of scien tific uncertainty about a particular issue. The Panel
has understood this second function of expert advice by asking several detailed questions regarding
individual product applications.

94 Questions to Experts of 12 October 2004.
95 The European Communities previously expressed this concern in its comments of 24 September
2004 on the draft questions to experts, cf. Explanation Nr. 2 regarding draft Question 1.
96 See for example point 7 of Annex D to the letter of 23 September.
97 Final Position of the European Communities on the Need to Seek Scientific or Technical Expert
Advice, 21 July 2004; Letter of 27 July 2004 to the Chairman of the Panel.

4.1008 By contrast, neither the Panel nor the experts consulted in this dispute are called upon to
decide whether GMOs per se present a risk or not. Expert advice under the DSU and the
SPS Agreement does not have the purpose of resolving scientif ic controversies. Rather, expert advice
is provided for assisting the Panel in its limited t ask of making findings in the dispute between the
parties.
4.1009 It is implicit in the function of expert advice to "assist" the Panel that the power to make legal
findings, as such, remains a prerogative of the Panel. Pursuant to Article 13.2 of the DSU, expert
opinions serve to clarify "a factual issue concerni ng a scientific or other technical matter". Experts
enable panels to fully understand any scientific and technical facts of a case. By contrast, expert
opinions do not relieve the Panel of its duty to make an independent legal assessment of those facts.
4.1010 A final point on the role of expertise in the present dispute seems pertinent to the European
Communities. Expert advice on GMOs is limited to clarifying certain questions relating to scientific
risks (i.e. risk assessment in the narrow sense).
98 By contrast, expert advice cannot offer the Panel
much indication as to whether certain conduct was reasonably justified from a risk management or
risk communication perspective. Just as scientif ic opinions do not conclude the risk assessment
process99, scientific expert advice in WTO proceedings does not conclude the Panel's assessment
whether certain measures could reasonably and justifiably be undertaken. Instead, the Panel will need
to reconstruct a process of complex interaction with multiple actors – risk assessment bodies, risk
managers or regulators – to evaluate the WTO c onsistency of the European Communities' actions.
Expert advice can only assist the Panel in fulfilling pa rt of this task. The ultimate, overall assessment
remains the prerogative and the duty of the Panel.
5. Procedural fairness and the admission of additional questions
4.1011 The principle of procedural fairness requires that each party be able to comment on factual
assertions and legal arguments put forward by the opposing party. As the flip side of the same coin,
the principle of procedural fairness equally requ ires that each party present factual evidence as early
as possible. This side of the principle is reflected in Appendix 3 to the DSU, which requires a party to
present the facts of the case in its first written submi ssion. Each party can, thus, legitimately expect
the opposing party to prepare its submissions in accordance with the principles of sound
administration of justice.
4.1012 The European Communities notes that the Panel, in its timetable circulated on 28 October
2004, afforded the parties an opportunity to suggest a dditional questions for the experts at this already
exceptional third round of submissions. The comp laining parties had extensive opportunity to
comment and to suggest questions during the consu ltation on the draft questions in September.
Indeed, the complaining parties, at the time, insi sted on obtaining more time in order to review
allegedly new information submitted by the European Communities.
4.1013 To the extent that the complaining parties, fo r reasons of strategy or negligence, failed to
previously comment on the European Communiti es' Submissions and to propose the relevant
questions, the European Communities respectfully requests that the Panel refrain from considering
such questions now.100

98 Second written submission of the European Communities, paras. 21 et seq.
99 Second written submission of the European Communities, para. 31.
100 It may not be entirely coincidental that the complaining parties asked the Panel for an opportunity to
submit third written submissions on 10 August 2004, i.e. right after the Panel's decision to consult experts.

4.1014 Such a selective approach would be in line with the Panel's previous practice in this dispute.
The Panel has been very selective, even restrictiv e, in choosing from the parties' proposals such
questions that would be addressed to the experts, rejecting a number of questions proposed by the
European Communities. In exercising its discreti on with regard to the selection of questions, the
Panel has the opportunity to take into considerati on the fundamental principles of procedural fairness
outlined above.
4.1015 The European Communities reserves its right to suggest additional questions concerning any
new facts and arguments presented in the complaining parties' third written submissions. For the rest,
the European Communities considers it a question of procedural fairness not to re-address, in the
disguise of questions to experts, any "old" issues th at have already been on the table since its First
Written Submission.
4.1016 The principle of procedural fairness raises anot her issue in this context. According to the
timetable, the European Communities will be provide d the opportunity to comment on any questions
suggested by the complaining parties on 17 Nove mber. The European Communities notes that it will
have merely four working days to comment on a pot entially, large number of scientific questions. In
view of the extensive time available to the comp laining parties to prepare such questions, the
European Communities doubts whether four days will offer sufficient time to study the questions in
the appropriate detail and to provide well-founde d comments. The European Communities, thus,
respectfully invites the Panel to reconsider its timetable in this respect.
U. S
ECOND ORAL STATEMENT OF THE UNITED STATES ON THE MEETING WITH EXPERTS AND
ADDITIONAL SCIENTIFIC EVIDENCE
1. Introduction
4.1017 As the United States has repeatedly explained, the central issue in this case is that the
European Communities adopted a moratorium on bi otech approvals. Under that moratorium, the
European Communities allowed some products to make some progress through the lengthy European
Communities' approval procedures, but allowed no product to reach the point of final decision.
4.1018 The central, dispositive legal issues in this dispute – whether the European Communities
adopted a moratorium, and whether that moratorium is consistent with the WTO Agreement – do not
turn on any scientific issues. However, the United States does believe that the answers to certain
scientific questions provide further confirmation of the fact that the European Communities adopted a
moratorium. In particular, when an application is delayed until an applicant responds to a scientific
question that is not required as a matter of science fo r completion of a risk assessment, the application
has been unduly delayed. Moreover, this evidence mu st then be added to all of the other evidence
confirming the existence of the moratorium.
4.1019 In its third written submission, the United States provided over 20 examples where the
questions by member States and EC regulators were not required for assessing risks. Time constraints
do not allow us to address each of those examples, but – as the United States addressed in its
comments on the experts' responses – the expert s' comments confirm that questions were not
scientifically justified. In addition, in their t estimony last week, the experts did not alter their
conclusions on these issues. In short, the scientific issues, and the consultations with the experts, has
further confirmed the existence of the moratori um and undue delay in the processing of biotech
applications.

2. Evaluating whether particular questions were scientifically justified
4.1020 As the United States has repeatedly explained, th e resolution of this dispute does not turn on
an examination of each and every member State obj ection. However, in the event the Panel makes
findings on the member State objections examined by the scientists, the United States has three
general comments on the issue of whether or not par ticular member State questions were required for
assessing the risk of a product, and on how the Pa nel should evaluate the experts' views on this
subject.
4.1021 First
, as a matter of legal interpretation of the SPS Agreement, certain objection must be
considered as resulting in "undue delay" under Annex C. In particular, where a member fails to make
a decision on a product until the applicant answers a question that is so vague and general as to be
unanswerable must be considered "undue delay." An example of such an unanswerable question
would be "does the product have any adverse impact on any aspect of the environment," where the
regulator does not specify what impacts are of concern and what impacts would be considered
adverse. In essence, such a question means that th e regulator is putting an impossible burden on the
applicant to prove the negative – in this example, to prove that there are no adverse impacts on any
aspect of the environment. That burden is compounded by the fact that the regulator gives the
applicant no guidance. Such types of questions nece ssarily result in endless delay, which in turn must
be considered "undue." Otherwise, a WTO Memb er could block all product approvals, indefinitely,
by posing such vague and general questions. The views of the scie ntific experts may, however, be
helpful in determining whether or not a question is so vague and indeterminate as to be unanswerable.
4.1022 Second
, in deciding whether a question contributes to undue delay, or was legitimately posed
to assist in assessing risks, the entire factual context of this dispute must be considered. In particular,
in examining the objections, the fact that EC political-level officials and member States had
announced a moratorium must always be kept in mind. In fact, unnecessary information requests
often came from the same memb er States which had announced the moratorium. The United States
submits that the Panel is entitled to employ its co mmon-sense understanding of the entire situation in
examining the facts of this case. Indeed, viewing all facts in context is simply part of making "an
objective assessment of the matter before it," as provided under Article 11 of the DSU.
4.1023 Third,
 and relatedly, the fact that an expert is of the view that there was a plausible scientific
rationale for a question does not necessarily inform the Panel that the member State asking the
question shared that rationale. In many cases, the objection did not specify why additional
information was needed, and the experts were left to speculate on the reasoning behind a question.
Where the record provides no specific rationale for th e question, the experts and the Panel are left to
speculate. The experts, and very properly so, we re not instructed to examine the member State
objections in light of the entire factual context. In contrast, however, we submit that the Panel's
objective assessment of the facts should take account of the European Communities' many
announcements that it had imposed a moratorium on biotech approvals.
3. The European Communities' comments on the experts' responses
4.1024 I will now turn to the European Communities' comments on the experts' responses. Those
comments, although impressive in length, have very l ittle, if any, relevance to dispositive legal issues.
Three sections of the European Co mmunities' comments appear to be addressed to the moratorium
and undue delay.
4.1025 Part V of the European Communities' comme nts addresses the experts' responses to the
Panel's product specific questions. Time constr aints do not allow us to present views on each and

every member State objection that the Panel has considered up to now in this dispute. However, I will
make the following general points.
4.1026 Where one or more expert responded that a par ticular member State request for information
was needed for a risk assessment of the products, the Eur opean Communities, understandably,
supports those views. However, even if the Eur opean Communities and the experts' characterization
of such member State objections are accurate, the f act that some objections by EC regulators were not
unwarranted is still consistent with the existence of the moratorium. The complaining parties have
never claimed that each and every member St ate objection or request for information was
unwarranted or resulted in undue delay.
4.1027 Where one or more expert responded that a par ticular member State request for information
was not
 needed for the assessment of risks, the European Communiti es, understandably, takes issue
with those views. And, I would like to point out th at the experts believed that a substantial number of
different types of questions, when considered in lig ht of the totality of information available, were
unnecessary for conducting a safety assessment. Those types included:
• questions related to the safety of the an tibiotic resistance marker genes in these
products;

• requests for additional molecular characterization data;

• requests for quantitative, event specific detection methods;

• requests for detailed information on environmental effects when the application
sought approval only for import and processing, and not for planting;

• vague and open-ended requests for information on environmental effects;

• requests for chronic toxicity studies;

• requests for additional whole-food studies; and

• requests for studies on the composition of food produced from animals that consumed
biotech feed.

4.1028 At the experts' session, the European Commun ities directly challenged the experts on these
issues. In the view of the United States, the expe rts were persuasive in defending their positions.
Should the Panel decide it needs to make findings on those member State objections, based on all the
evidence and explanation the United States has provi ded in its own submissions, the United States
supports the views of the experts with regard to scientifically unjustified questions. Findings that
such objections were not justified amount to "undue delay" under Annex C of the SPS Agreement, and
such findings serve as further confirmation of the existence of the moratorium.
4.1029 Parts III and IV of the European Communities' comments on the expert responses address
"general and methodological issues" and the Panel' s general questions. The theme of these comments
are "complexity," "scientific uncertainty," and "evolving science". Th e European Communities'
elaboration on these themes is wildly overstated, which I will turn to shortly. But regardless of their
accuracy or inaccuracy – the discussion of such broad themes has little or no ro le in the resolution of
this case. To the extent such themes inform the ev aluation of particular member State objections, the

experts and parties have incorporated those themes in their comments on the particular objections.
And, to the extent those themes do not relate to individual member State objections, they touch on no
issue in this case.
4.1030 The European Communities' general comments a ppear to be aimed toward the development
of an argument that the moratorium falls within article 5.7 of the SPS Agreement. The European
Communities' general discussion of themes such as "uncertainty," however, does not help the
European Communities in the development of any ar gument under Article 5.7. In fact, Japan – the
responding party in the Japan – Apples – similarly relied on a general theme of uncertainty, and the
Appellate Body firmly rejected it:
"The application of Article 5.7 is trigge red not by the existence of scientific
uncertainty, but rather by the insufficiency of scientific evidence. The text of
Article 5.7 is clear: it refers to 'cases where relevant scientific evidence is
insufficient', not to 'scientific uncertainty'. The two concepts are not interchangeable.
Therefore, we are unable to endorse Japan's approach of interpreting Article 5.7
through the prism of 'scientific uncertainty'".
101
The Panel should do the same here with respect to the European Communities' suggestion.
4.1031 As I noted, the European Communities' discussion of uncertainties and risks associated with
biotech products is wildly overstated. The Unite d States addressed this matter comprehensively in
Section II.A of its second written submission. I won' t repeat that discussion he re, except to note that
the European Communities' contentions are inconsis tent with its own public statements regarding
biotech products. For example, the EC Scientific Steering Committee stated that "published review of
data do not indicate the GM crops presently in cu ltivation pose any more risks for humans, animals,
and the environment than do their conventional counterparts."
4.1032 In addition, the experts' responses do not s upport the European Communities' presentation on
risks and uncertainties of biotech products. Regard ing the potential for these products to present any
human health effects, the advice from the experts – both in their written testimony, and during the
discussions last week--identified no scientific issues that could justify the European Communities'
inability to determine whether the products met its level of protection. Rather, the advice confirmed
that the totality of the information presented wa s generally sufficient to allow the European
Communities to evaluate any potential adverse human hea lth effects, even if in the abstract a scientist
might have preferred more detailed molecular char acterization, or more precise information on a
particular point.
4.1033 Furthermore, while the experts believed that issues relating to the evaluation of environmental
effects were frequently more complex than those fo r food safety, the experts also presented various
ways to analyse and resolve the issues the Eur opean Communities raised. For example, on issues
relating to potential effects on non-target organi sms, one expert confirmed that although the
evaluation of potential effects on non-target organisms can be challenging because it is not possible to
study all of the various species, systems, and bi ogeochemical cycles, several different methodologies
to do so are available. The expert (Dr. A ndow) mentioned two appro aches, one using general
environmental indicator species and the other focusing on those non-target organisms that would be
expected to be exposed in the agricultural envir onment where the crops would be grown. The fact
that these methods have been available since 1999 calls into question the European Communities'
post-hoc justifications.

101 Appellate Body Report, Japan – Apples, para. 184.

4. Advice from IO's on definitions
4.1034 The European Communities asserts that their in terpretations are "effectively confirmed" by
various organizations' advice. However, the Eu ropean Communities provides little or no explanation
for its conclusion. In some cases, the Europ ean Communities has selectively relied on the advice
provided, generally failing to acknowledge the advice regarding how such terms are typically
construed and applied. For example, although the European Communities relies on the IPPC's
definition of a pest, they do not address the fact that ISPM 11, which was also cited by the IPPC,
directly contradicts many of the arguments presented in its first written submission.
4.1035 For other terms, the European Communities relies on artificial, and largely irrelevant,
distinctions to support its claim. For example, the European Communities ar gues that the definition
suggested for the term "additive" confirms that the GMO itself
 is not an additive. This argument is
entirely beside the point. Whether the plant itsel f is an "additive" – a point the United States has
never contested – in no way resolves the question of whether the genetic insert or construct in the
product is properly considered as an "additive" within the meaning of the SPS Agreement.
Applesauce that contains food colouring is not itsel f considered to be a food additive, but it is
indisputable that the food colouring contained in the applesauce falls within the definition of an
additive in food. And any measure applied to pr otect human health from risks arising from the food
colouring in the applesauce would accordingly be considered an SPS measure.
4.1036 The European Communities raises this same argument with respect to "contaminants,"
"toxin," and "disease." Whether the organizations' a dvice confirms that the biotech products are not
themselves contaminants or toxins, is utterly irrele vant to whether either the genetic inserts or the
substances produced by the inserts are contaminan ts or toxins. Nor would advice that biotech
products are not "diseases" resolve whether measur es taken to address any risks that might be
presented by the antibiotic marker genes could prope rly be characterized as a measure taken to
address "risks arising from ... disease-causing organisms."
5. Experts' advice and safeguard measures
4.1037 Our discussion of the experts' advice on the safeguard measures is mostly a legal one, so we
will present our views on that in our opening statement on legal issues.
V. SECOND ORAL STATEMENT OF CANADA ON THE MEETING WITH EXPERTS AND ADDITIONAL
SCIENTIFIC EVIDENCE
1. Comments on the meeting with experts
(a) Introduction
4.1038 Canada has only a few comments to make concerning the discussion with the experts on
17 and 18 February 2005. Due to time constraint s, Canada will not address in detail the European
Communities' voluminous Comments on the Scientific and Technical Advice to the Panel. However,
we would like to note that the European Commun ities' Comments express many of their own views
on the Panel's Questions. Many of the European Co mmunities' assertions appear to rely on scientific
evidence dating back many years that was not previous ly in the record. If this information is or was
truly relevant, it is indeed unfortunate that it was not put before the EC Scientific Committees
assessing the safety of these products, referred to in the European Communities' Second Written
Submission, or indeed, included in its remarkably slim Supplementary Rebuttal Submission.

4.1039 As a result, our comments now will focus on last week's discussion with the experts.
4.1040 As a preliminary point though, I would like to make the observation that the European
Communities, throughout this proceeding, has attempted to remove biotechnology from the context of
modern agriculture in order to exaggerate risks a nd scientific uncertainty. Canada, on the other hand,
has sought to put biotechnology squarely back into its proper context.
(b) Herbicide Tolerant Crops
4.1041 Drs. Snow, Squire and Andow agreed that, in principle, the ecological effects of herbicide
tolerant cropping are similar regardless of whethe r the HT crop was developed through transgenesis
or mutagenesis. So apparently apples are in fact apples after all and not pears. All experts agreed that
the potential ecological and agronomic effects depend ed on the type of herbicide to which the crop
was tolerant and not the crop itself.
4.1042 Dr. Snow explained that the key issue is whethe r the herbicide is used to control weeds in
general, but where this is not the case (for example, as with glufosinate-ammonium) then the possible
negative effects associated with a loss of the benefit of that herbicide should be minimal. In other
words, volunteers and weeds tolerant to glufosin ate-ammonium could be controlled using the same
methods used to control conventional oilseed rape – that is to say, a different herbicide or tillage.
4.1043 Dr. Andow agreed, pointing out that glyphosate-tolerant plants present a different type of
problem because of the wide use of glyphosate gene rally and the fact that it is one of the safer
herbicides on the market. There is obviously a concern about loss of use of that particular herbicide.
Dr. Andow confirmed Dr. Snow's advice that ther e are weeds resistant to imidazolinone, and that
there are no reported weeds resistant to glufos inate-ammonium. So, any problems with the
development of weed resistance to glufosinate- ammonium HT crops woul d be no different, and
perhaps even less, than resistance to the imi-HT crops.
4.1044 Dr. Snow indicated that she thought there was a problem in Canada with the control of
multiple herbicide resistant weeds, but didn't have up-to-date information on this. Considering that
over 80 per cent of oilseed rape grow n in Canada is HT, it would be folly to expect that there are
absolutely no problems. However, all published evidence indicates that HT oilseed rape can be
controlled using the same methods as controlling or dinary oilseed rape. The Hall article (Exhibit
EC-37), Senior article (Exhibit CDA-194) and the Bright Study (Exhibit CDA-188) all support this
conclusion. To describe this as "an extremely difficult problem to manage" is yet another unwarranted
exaggeration by the European Communities.
4.1045 Several experts indicated that gene flow amongs t oilseed rape is a concern in the European
Communities. However, the experts distinguished between the genuine environmental and agronomic
concerns and those related to labe lling thresholds and co-existence. Dr. Snow indicated that she
would not classify the mere presence of a transgene as a problem unless it had adverse biological
consequences. Drs. Squire and Snow stated that if the herbicide to which th e crops were tolerant was
not used for weed control, then no problems should be expected. Now this is entirely consistent with
the SCP opinions regarding risks associated with Ms1/Rf1 and Ms8/Rf3 dating as far back as to 1998.
4.1046 As the experts pointed out, gene flow also gi ves rise to concerns related to so-called "co-
existence". But, as the Commission itself has stated and I quote"[i]t is important to make a clear
distinction between the economic aspects of co-e xistence and the environmental and health aspects
dealt with under Directive 2001/18". (Here I refer you to Exhibit CDA-165.) Now the experts make
this distinction. The European Communities does not. The purely economic aspects of co-existence

arise because of the European Communities' self-i mposed arbitrary thresholds for labelling and
traceability. The European Communities has attempted to disguise these concerns as environmental
harm. Now the experts have unmaske d this disguise and confirmed that herbicide tolerant crops that
do not cause injury to plant and plant products or environmental hazards, where the herbicide to
which the crop is tolerant is not used extensively to control weeds.
(c) Seed Spillage
4.1047 In relation to seed spillage, Dr. Squire cites three studies concerning the in-land transport of
recently harvested seeds from the farm to a proc essing facility. He states that spillage occurs
frequently along motorways and fields, but that the seed s eventually die out. He also confirms that
seed spillage is a small pollen source compared to th e crops themselves. He also agreed with the
EFSA opinion regarding the potential for seed spillage a nd the necessity of a monitoring plan. This is
the EFSA opinion in relation to GT73.
4.1048 Dr. Andow in his written opinion agrees that environmental harm from seed spillage is
negligible if not nil. He states at paragraph 62.01 that and I quote "it would require escape during
importation and/or processing and several years of multiplication at levels similar to the multiplication
during oilseed rape production and the growing of these large quantities on a landscape". He
concludes that even if such a scen ario were possible "there would be many, many possible ways to
manage this risk".
4.1049 Both Drs. Squire and Snow confirm that the r eal issue is not environmental harm but perhaps
a concern about meeting thresholds for labelling.
(d) Molecular Characterization
4.1050 Dr. Healy puts molecular characterization into its proper context. Although important, it is
but one tool used in conducting a safety assessment. Dr. Snape, during the expert hearing, reversed
his written advice in relation to oilseed rape Ms8/Rf3, indicating that the information provided by the
notifier on molecular characterization was comprehensive and of a high standard and that no more

information was necessary to do the safety assessment.
4.1051 In the light of the modification of his original advice, Canada submits that Dr. Snape's written
opinion should be given little weight, if any. Dr. Healy's compelling, well-organized advice should be
accepted by this Panel without qualification. Dr. Healy confirmed that one needs to examine the
totality of information in order to conduct the safet y assessment. Dr. Healy also confirmed that it is
possible to conduct a safety assessment without a comprehensive molecular characterization.
Although a full molecular characterization of produ cts developed through mutagenesis may not be
possible, nonetheless a safety assessment would be possible. Dr. Healy also indicated that although it
is possible to conduct a complete molecular character ization for biotech crops, it is not always clear
how to interpret this data, given natural variations in plants.
(e) Biogeochemical Cycles
4.1052 Dr. Snow responded to this question very concisely. She has not heard of a problem with
biotech crops affecting biogeochemical processes. She confirmed that the differences in impact on
biogeochemical cycles as between biotech and non-biotech crops would not be significant.
4.1053 Every form of agriculture has the potential to affect biogeochemical processes. As
Dr. Andow has indicated, there are literally hun dreds of these processes occurring in the soil.

Tellingly, the European Communities appears to show little concern for this issu e in relation to other
agricultural practices.
(f) Pest Status
4.1054 Dr. Snow confirmed that the assessment of pest status under ISPM No. 11 is related to
whether the weed is more difficult to control, not the economic harm to farmers arising from
thresholds established for marketing purposes.
(g) Scale-up Effects
4.1055 Scale-up effects was a recurring theme in the experts' advice. Dr. Andow confirmed that
changes brought about by biotech crops would be subtle at most if at all. He indicated that any subtle
changes could cause a more serious impact if the scal e and rapidity of use increased dramatically.
This is an inherent risk in any form of monoc ulture, and as the experts stated, these issues are not
limited only to biotech crops. In addition, Dr. Andow stated that any effects from scaling up, can be
managed through the adaptation of agronomic practice.
4.1056 Dr. Squire stated that the impacts of current agricultural practices on biodiversity have not
been asked before in relation to any other form of agriculture. He said that it is legitimate to ask these
questions, but he acknowledged that it would be impossible to gain a better understanding of these
impacts without large scale cultivation.
4.1057 Dr. Squire was clear – he said "it's incumbent on us to scrutinize other practices like we do for
GMHT. We need consistency – it's not consistent right now."
4.1058 That Mr. Chair is part of the central theme of Canada's case.
(h) Differences in Risks
4.1059 I will now make a few brief comments on muta genesis and other methods of introducing
genetic variation into plants such as radiati on and chemically-induced mutagenesis; somaclonal
variation; and even conventional selective breeding. Drs. Andow, Healy, Snape and Nutti all agreed
that all methods of introducing genetic variation ha ve potential to produce unexpected or unintended
effects. The likelihood of changes to the genome varies with the method of genetic modification.
This has been discussed in the recent report of th e National Academies on the safety of genetically
engineered foods. The report placed different methods on a continuum, with selection breeding from
within a homogeneous population having the least likelihood of causing unintended changes and
mutagenesis techniques the most likelihood. Sign ificantly, the various recombinant DNA techniques
fell at different points between these extremes.
(i) Conclusion
4.1060 Under present time constraints, we have not been able to address every issue discussed last
week. However, we would be happy to answer any questions the Panel may have.
2. Comments on additional evidence submitted by other parties
4.1061 At the meeting with the experts on 17-18 Februa ry 2005, the Panel sought the parties' views
on the status of certain documents referenced by the European Communities in its comments on the

experts' replies, but not submitted by the European Communities as exhibits within the deadline set by
the Panel.
4.1062 Canada recalls that on 14 February 2005, the European Communities submitted a list of the
documents cited to by the European Communities in its comments on the experts' replies, and a
CD-ROM that supposedly contained all of the docu ments on the list. The list included approximately
360 separate documents. Canada also notes that the European Communities' submission of these
documents was already some two weeks late.
4.1063 In reviewing the documents on the CD-ROM, it b ecame evident that in at least one case (an
article by M.J. Crawley, et al.) the document i ndicated on the European Communities' list is not the
same as the document on the CD-ROM. Canada has been unable to determine whether there are more
"substitutions" of this nature.
4.1064 More importantly, the CD-ROM received by Cana da actually contains less than half of the
documents found on the European Communities' list. In fact, Canada estimates that approximately
170 documents found on the European Communities' list are neither on the CD-ROM, nor among the
exhibits already filed by any of the parties.
4.1065 In Canada's view, with the exception of offi cial WTO documents, documents that have not
been submitted by the parties as exhibits are not part of the record. Furthermore, no weight should be
given to factual assertions or arguments that purpor t to derive their authority from such documents.
There are a number of good reasons that support this view.
4.1066 I refer you to paragraph 12 of the Panel's Work ing Procedures in this regard. Paragraph 12
reflects standard DSU practice. Its purpose is two -fold. It enables the panel to make an objective
assessment of the facts of the case, in accordance with Article 11 of the DSU. It also ensures that the
parties have available to them and can consider in a timely manner all of the evidence upon which an
opposing party relies.
4.1067 If it were the case that a party could simply refer to evidence in its submissions but not
provide that evidence to the Panel and the other pa rties, opposing parties would be forced to track
down that evidence in order to be able to protect their rights. This would impose an extraordinary
burden on all parties – including, or perhaps partic ularly, on developing country parties – and would
encourage the proliferation of improper litigation t echniques. It would also severely hamper the
functioning of panels, and likely have a significant negative effect on the ability of the Secretariat to
assist panels in their work.
4.1068 Furthermore, in disputes such as this one, wher e the Panel has sought scientific expert advice,
and the documents in question are extremely technical in nature, it is important for the experts to have
full access to all documents on which the parties seek to rely. This is necessary in order to afford the
experts an adequate opportunity to prepare for the m eeting with the parties, and to assist the Panel as
effectively as possible.
4.1069 In short, this is a basic issue of both procedural fairness and efficiency.
4.1070 The question arises whether, at this very la te stage in the pro ceedings, the European
Communities should nevertheless be given a last opport unity to submit these documents. In Canada's
view, to allow the European Communities to benefit from its own repeated failure to meet the Panel's
deadlines would threaten the integrity of th e Working Procedures and render Paragraph 12
meaningless. The European Communities has had ample opportunity to submit these documents.

There can be no good reason why the European Communities was unable to produce on a timely basis
documents that would have had to be in its posse ssion in order for the European Communities to be
able to rely on them when preparing its comments.
4.1071 In addition to plainly being at odds with th e Working Procedures, allowing the European
Communities to submit these documents at this late stage in the proceedings would significantly
undermine the objective of the meeting with the e xperts and the second meeting of the parties.
Moreover, both meetings involve considerable co mmitments of time and resources by the other
parties, the Panel and the experts. Allowing th e European Communities to submit these documents
now would require the Panel to delay the proceedings further in order to allow the other parties and
the experts an adequate opportunity to review and comment on the alleged significance of the
documents in question, and then to afford the pa rties an opportunity to comment on whatever further
replies are submitted by the experts.
4.1072 On a final note, as Canada has observed prev iously in these proceedings, the European
Communities' pattern of failing to respond in a timel y manner to the Panel's instructions is troubling.
To reward the European Communities for its own re peated failures by allowi ng it to file the missing
documents at this stage is to impose the consequences of those failures on the Panel, the other parties,
and the experts.
W. SECOND ORAL STATEMENT OF ARGENTINA ON THE MEETING WITH EXPERTS AND
ADDITIONAL SCIENTIFIC EVIDENCE
1. Comments on the expert meeting (17-18 February)
4.1073 We respectfully remind the Panel that we did not request this technical advice to be necessary
for this case. Argentina considers that this WTO case is of a legal nature, rather than of a scientific
one. Nevertheless, after the meetings on 17 and 18 February 2005, we consider the following issues to
be relevant for the present case:
(a) Mere information vs. scientific evidence
(i) The relevance of scientific evidence
4.1074 In the current dispute, the European Communiti es has made every effort to submit more and
more information, whether it was relevant or not. This led to a hard work that only confirmed that our
initially submitted scientific evidence remained unrefuted.
4.1075 Argentina recalls the Panel's Follow-up Question 4 102, related to the distinction between what
regulators "need to know" vs. what is "nice to know ", as Dr. Snow had correctly pointed out in her
responses.103 When answering this Follow-up Question 4, Dr. Squire correctly asserted that:
"If we get what we need to know, we are there."104

102 Follow-up Question 4 from the Panel to Experts, dated 17 February 2005, referring to "General
questions", "Safeguard measures" and "Comparison of biotech products to other type of products" ( "Dr. Snow
commented that it is not always clear where to make the distinction between what regulators «need to know» vs.
what is «nice to know». (…)" ).
103 Dr. Allison Snow "Responses to Scientific Questio ns from the Panel", "B. Scientific uncertainty
during 1998-2003", second paragraph; 5 January 2005.
104 Response by Dr. Squire to Follow-up Question 4 from the Panel, on Friday, 18 February 2005.

4.1076 This statement confirms the importance of identifying the necessary scientific evidence in
order to make a decision. In this respect, we be lieve the point has been made that not any kind of
additional scientific information is capable of refuting solid scientific evidence. We submitted
scientific evidence, while the European Communities submitted a huge amount of information
, but
not evidence capable of matching the evidence submitted by Argentina.
(ii) Scientific evidence and hypothetical statements
4.1077 We appreciate the fact that Dr. Andow clarif ied his initially ambiguous answers, during the
meetings of experts. Specifically, we appreciate the clarifications referred to his use of hypothetical
statements.105 We believe that the clarification proved to be very useful in order to make our points
that there is actually no scientific evidence that can justify the European Communities' measures
towards agricultural biotech products since October 1998.
4.1078 In this sense, Argentina highlig hts the important answer by Dr . Andow in the sense that he
certainly agrees106 with the following statement made by Argentina:
"The absence of information does not imply the presence of effects".107
4.1079 We believe that the European Communities has had more than enough scientific evidence at
hand in order to take a valid sanitary or phytosan itary measure and approve the agricultural biotech
products, but instead the European Communities has tried to ignore this evidence in this WTO case
with a huge amount of information, collected through several publications and extracted from
opinions, supposed to refute solid evidence with "uncertainties".
4.1080 As the experts pointed out, there will always be a degree of new scientific findings that will
complete or refine the previous knowledge. But th is gap of knowledge cannot be used as an excuse
for ignoring scientific evidence and applying a sanitary or phytosanitary measure without any
supporting scientific evidence. As examples, Ar gentina welcomes that, during the meetings of
experts, two important matters ha ve been finally clarified for us all, disregarding the European
Communities' arguments. With regard to horizontal gene transfer , we thank the clarification made by
Dr. Squire, which confirmed Argentina's point. 108 Being so, we cannot accept the European
Communities' assertion 109 as a valid scientific statement. With regard to the impact of agricultural

105 When answering the Questions from Argentina referring to "General questions", "Safeguard
measures" and "Comparison of biotech products to other type of products" on Thursday 17 February, Dr.
Andow explained that, when making his responses to the Questions from the Panel, he had taken the task "not to
weigh the evidence, but to say whether it existed".
106 Dr. Andow answered to this statement by Argentina submitted in Question 13 (advanced as question
10, referring to "General questions", "Safeguard measures" and "Comparison of biotech products to other type
of products"), with the words: "Certainly. I agree."
107 Response by Dr. Andow to Question 13 from Argentina (advanced as question 10, referring to
"General questions", "Safeguard measures" and "Comparison of biotech products to other type of products"), in
connection with Dr. Andow's paragraph 07.06 in his Response to Questions by the Panel.
108 Question 32 from Argentina to Dr. Squire, dated 18 February 2005, referring to "Product Specific
Questions". In his response, Dr. Squire stated: "The issue of unlikely refers to the frequency… considering
frequency, it is extremely low, time-dependant… whethe r evolution or agricultural practice is uncertain… There
are studies in place… I am not qualified… In general, I agree with the tone of this question."
109 See Comments by the European Communities on the Scientific and Technical Advice to the Panel,
28 January 2005, paragraph 95, in which the European Communities refers to "circumstantial evidence… during
evolution and confirms the likelihood of the scenario." Besides, the European Communities immediately says
"However, in terms of risk analysis, the risk has not been properly quantified and is probably very low."

practice
, the known impact of agricultural biotech produc ts is marginal. In this sense, Argentina
highlights the fact that even the European Communities had to finally admit this.110
(iii) The excuse of waiting for more information to appear
4.1081 It has been made clear that there is no sense in neither approving nor rejecting the approval of
agricultural biotech products, just because the European Communities claims that it is waiting for new
information to appear, for new technologies to deve lop, or for new methods and techniques to be
discovered, when there is solid scientific evidence at hand.
4.1082 Argentina has carefully read the informati on submitted by the European Communities, and
has found no matching evidence that could refute the positive scientific opinions by the European
Communities' scientific committees. The alleged "uncer tainties" or "hypothetical risks" do not refute
the scientific evidence, and thus cannot justify wh at the European Communities did towards its WTO
obligations.
(iv) The twisted view of the biotechnology – Relevance of science
4.1083 Argentina welcomes the appropriate clarifications by the experts in their responses and during
the meetings, for example the use of the concept "contamination". The malicious use of terms has
distorted the view in which these products are c onsidered and the way in which they should be
treated. Particularly, we would appreciate if the European Communities would restrain itself from
using concepts like, "cancer" 111, "may induce dramatic unintended changes" 112, "infestation … to
cause contamination"113, among others.
4.1084 The experts' conclusion is contrary to Europ ean Communities' assumption that all agricultural
biotech products should be treated as a whole, regardless from the "case- by-case" analysis which
Argentina firmly believes should be strictly applie d for deciding upon approvals or rejections of
agricultural biotech products. The European Commun ities has continuously invoked this approach as
well, but it actually does not apply it since Oct ober 1998. Even at these later stages of this WTO
proceeding, the European Commun ities states that agricultural biot ech products deserve to be
considered as a whole.114
4.1085 In this sense, we quote Dr. Snow:
"… Furthermore, it is not logical to group all GM crops into a single category and
conclude that they are either inhere ntly safe or inherently dangerous ( see

110 Comments by the European Communities on the Scientific and Technical Advice to the Panel,
28 January 2005, paragraph 238.
111 Ibid.
112 Comments by the European Communities on the Scientific and Technical Advice to the Panel,
28 January 2005, paragraph 55.
113 Comments by the European Communities on the Scientific and Technical Advice to the Panel,
28 January 2005, paragraph 191.
114 Comments by the European Communities on the Scientific and Technical Advice to the Panel,
28 January 2005, paragraph 45, last sentence, in which the European Communities refers to the products in
general (not "case-by-case"), regarding possible effects on human health.

Question 103 below). It is important to evaluate new GM crops on a case-by-case
basis in each country where the crop will be grown, …"
115
(b) Agricultural biotech products and "non-biotech" products
4.1086 Considering the food safety assessment , it has been proved that agricultural biotech products
with a positive scientific opinion by the EC Scie ntific Committees have shown no differences with
their "non-biotech" counterparts. Dr. Nutti has been ve ry clear in this matter and has always remained
within her field of expertise and referring to the Codex guidelines. We also recall the point made
clear on Friday 18 February, regarding the feed safety, in the sense that the given products -crops-
proven to be safe for humans, are expected to be safe for animals as well.
4.1087 Considering the no lesser important environmental issue , Argentina had the three experts on
this matter to confront their opinions116, and the result was that they agreed in two decisive statements.
Both Dr. Snow 117 and Dr. Andow 118 agreed with the following statement by Dr. Squire, when
referring to whether "contamination" risk is greater than for non-GM varieties:
"… there is no reason to suppose that biotech crops confer different degrees of
impurity compared with crops produced from, say, induced mutagenesis."119
4.1088 Additionally, both Dr. Squire 120 and Dr. Andow 121 did agree with the fo llowing statement of
Dr. Snow, when referring to whether any of the biotech products at issue in this dispute poses a
substantially greater risk as regards the dir ect or indirect consequences of unintentional
"contamination":
"Another way to answer this question is to focus on the characteristics of biotech
crops -their phenotypes- rather than the me re presence of transgenes. This is more
appropriate if the goal is to avoid direct or indirect harms to human, plant or animal
health, or the environment. (…)"
122
4.1089 Argentina observes as well that Dr. Andow agr eed with two important statements by Dr.
Snow, used by the Panel to put Follow-up Questions 6 and 7 to the experts:
4.1090 On one hand, Dr. Andow did agree when he was asked:

115 Dr. Allison Snow "Responses to Scientific Qu estions from the Panel", "A. Which environmental
concerns about GM crops are really «science-based»", second paragraph; 5 January 2005.
116 Questions from Argentina to Experts, dated 17 February 2005, referring to "Comparison of biotech
products to other type of products".
117 When asked to clarify by Dr. Snow, Dr. Squire stated "A lot of crops have impurities; some can be
ignored, some can be managed." Consequently, Dr. Snow answered: "Being so, I agree, because it is related to
gene flow, and that is common to GMOs and to non-GMOs."
118 After the answer of Dr. Snow, Dr. Andow replied: "If it refers to gene flow, I agree. It will depend
on the goal, on the impurity management."
119 Dr. Squire "Measures affecting the approval and marketing of biotech products", "Notes on
ecological and environmental standards", Issue 3, response to the Panel's Question 103.
120 Dr. Squire answered: "In the context of this question, I agr ee. In Europe, maybe the presence is not
wanted, although there is no effect."
121 Dr. Andow responded: "I agree."
122 Dr. Allison Snow "Responses to Scientific Qu estions from the Panel", "Comparable novel non-
biotech products (such as plant products produced by selective breeding, cross-breeding and induced
mutagenesis), answer 103, second paragraph; 5 January 2005.

"Dr. Snow indicated that the process of inserting genes can have unintended
consequences such as abnormal growth or development, but it is unlikely that these
effects will be ecologically significant in commercially-produced biotech crops or
that they would be more risky than the t ypes of side-effects that arise routinely from
conventional breeding".
123
4.1091 On the other hand, he did also agree when asked:
"Dr. Snow stated that there is no reason to expect different effects on the genetic
diversity of wild relatives to arise from th e gene flow from biotech as compared to
non-biotech crops."124
4.1092 This said, we consider that it has been conf irmed by the experts that agricultural biotech
products with a positive scientific opinion by the EC Scientific Committees do not require a different
treatment from the "non-biotech" products, as rega rds the food and feed safety issue and from the
environmental point of view.
2. Comments on "additional scientific evidence"
4.1093 Argentina believes that there is no more ev idence needed to be submitted in these
proceedings, particularly after the outcome of the e xpert meeting. Putting it in a different way, the
scientific evidence submitted by Argentina – the EC Scientific Committees positive opinions – was
not matched by the mere information presented by the European Communities.
X. SECOND ORAL STATEMENT OF THE EUROPEAN COMMUNITIES ON THE MEETING WITH
EXPERTS AND ADDITIONAL SCIENTIFIC EVIDENCE
1. Comments on the meeting with experts
4.1094 We had the benefit of hearing directly from th e six independent scientific experts appointed
by the Panel. The dominant themes that emerge from the experts' advice cannot be ignored by the
Panel. We heard that the underlying scientific issues are complex and difficult – two words which
were used repeatedly over the two days. We were told that the level of scientific understanding is
evolving and that knowledge today is very different from ten years ago, and that five years ago the
debate could not even have been held. We were told that each product has to be treated on its own
merits. We were told that there are no established international standards to determine levels of
ecological safety. We were told that each environment is unique and that you cannot simply transfer
experience from one region, such as might be found in the United States, to another, such as might be
found in the European Communities. And we were told that comparing GM products with non-GM
products was like comparing apples and pears.
4.1095 The complaining parties would have the Panel i gnore all of that. They would have the Panel
decide against the plain facts and the views of th e scientific experts. They would have the Panel
decide that the EU should have simply applied the American or Canadian or Argentine experience to
its own very different geographic and biological reality ; and that even in the face of the insufficiency

123 Follow-up Question 6 from the Panel to Experts, dated 17 February 2005, referring to "General
questions", "Safeguard measures" and "Comparison of biotech products to other type of products". Dr. Andow
answered: "I would agree."
124 Follow-up Question 7 from the Panel to Experts, dated 17 February 2005, referring to "General
questions", "Safeguard measures" and "Comparison of biotech products to other type of products". Dr. Andow
answered: "I would agree. There is no sense in «biotech vs. non-biotech»."

of the science none of the delays or the measures adopted were justified. The complaining parties
would even have the Panel decide that there is no difference between "apples and pears". We submit
that this would bring the WTO system and the DS U to a place it was never intended to be. It was
surely not the function of the WTO to be used to allow one country (or group of countries) to impose
their own system of values and their own attitude to risk and biosafety on another country or group
countries.
4.1096 When Dr. Squire wished the Panel "good luck", he undoubtedly had in mind, from his
perspective as a scientist, the monumental task of sorting out definitively the complex, evolving,
divergent and contradictory views on the scientific issues. In reality, of course, this Panel's legal task
is far more limited than that. And to that end, the scientific advice will eventually have to be placed in
its proper legal context.
4.1097 The European Communities believes that th e legal rules determine the relevance and
significance of the scientific advice. The complaining parties, on the other hand, right from the start of
this case, have made several erroneous legal assumptions – not least the claim that the European
Communities adopted in 1998 and then maintained th ereafter a definitive and general decision not to
approve any GM products in Europe. This false assumption has seriously distorted the complaining
parties' presentation and appreciation of the science.
4.1098 The scientific experts' advice was generally untainted by the legal context in which it was
given. That gives it a special value. It was indeed striking to listen to the closing views of the experts.
Taken together, and placed in the pr oper legal context, in our view, those statements clearly support
the legal position of the European Communities in th is case. They plainly entitle a WTO member to
proceed with prudence and caution in its decision-making processes.
4.1099 In particular, the European Communities inv ites the Panel to take careful note of the
remarkably high degree of consensus among all the expe rts to the effect that the science of GMOs is
highly complex, continuously evolving, and still c ontains many open questions and uncertainties. On
that basis alone, it cannot be right for the Panel to follow the simplistic and reductionist "one size fits
all" approach of the complaining parties. We heard was that there is a basis for concern and prudence.
4.1100 The European Communities would like to briefly re call the tenor of some of the advice. Time
and again the experts came back to the differences between food safety and environmental protection.
Dr. Andow repeatedly stressed that there is a world of difference between these two subjects.
Traditional food is generally assumed to be safe for consumption – so GM risk assessment for food
safety, whilst still methodologically controversial, can generally start on the basis of comparison. This
is simply not true of the environmental risk as sessment. Consequently, the complaining parties'
central assumption – that there are reliable compar ators for environmental purposes – is not supported
by the advice. At this time the science is not su fficiently well known. There are many respects in
which the overall effect of GM products on the en vironment – whether negative, neutral or positive –
was in 1998 and remains still today uncertain. This was eloquently illustrated by Dr. Andow's
description of the far reaching consequences of what he referred to as the "European" earthworm's
invasion of the forests of North America; juxtaposed to the beneficial effects of earthworms on soil
structure in European agro-ecosystems.
4.1101 Another very striking closing remark ma de by Dr. Andow – which has been a leitmotif of all
the expert advice – is the novelty, evolution and rate of change of scientific knowledge on highly
complex issues, such as the environmental impact of changes due to the introduction of new
agricultural technologies. GM products, Dr. Andow obser ved, have, to some extent, been swept up in

such developments. This case concerns many issues at the frontiers of science, in which the situation
is dynamic and rapidly evolving. Legislators are entitled to be prudent.
4.1102 Dr. Andow also reminded us that, in this incr easingly complex and evolving situation, it is
legitimate (and even necessary), for assessors and legi slators to take into account the way in which
different issues are connected. He referred to herbic ide resistant GM crops. In this respect, it may be
true that one thing is the assessment of the GM pr oduct, and another thing is the assessment, done in
isolation from the GM crop, of the herbicide used. Howe ver, it is now clear that it is legitimate – from
a scientific point of view – to take the view that there are cross-cutting issues between the approval of
an HTGM crop and the approval of the corresponding herbicide. Most notably, the use of the
herbicide may affect the composition of the food or feed resulting from th e HTGM crop as compared
with its non-GM equivalent. Furthermore, Dr. Andow also reminded us that th e newness of some of
the herbicide tolerant traits, intr oduced into several crops in an agricultural environment where these
herbicides are already present for other purposes, cert ainly had raised legitimate scientific questions
and concerns for a decision maker. With a growing awareness of such issues comes a growing
awareness of the implications of the lack of reliable comparators as regards environmental effects, and
a growing awareness of the need to obtain information that is as complete as possible for conducting a
full assessment. Time and again the experts advised that prudence and caution were justified.
4.1103 With regard to resistance, Dr. Andow also r ecalled that, over the last 50 years or so,
knowledge about resistance problems had developed pr ogressively. First with respect to insecticides;
then with respect to fungicides; and more recently with respect to herbicides. For years entomologists
were telling the world, with the introduction of each new insecticide, that there was no way that insect
resistance problems would develop. And each time resistant insects would nevertheless emerge. So
eventually, during the 1980s, scientists understandably stopped making such predictions. There is now
a much greater awareness that it is possible that su ch problems could arise with a similar or greater
impact, in the light of the level of expression of to lerance in GM plants, in the context of herbicide
resistance. And glyphosate is an area of particular concern because of the way in which it is already
used in the Europe, which reflects the particular agricultural structures in different regions. And Mr.
Chairman, Members of the Panel, I would like to add that Glufosinate, although currently of more
limited use in Europe, is nevertheless widely used as a main weed killer in orchards and vineyards,
close to oilseed rape transport routes and close to major crop fields in Europe. Contrary to Canada's
assertion, these are matters of significant and legitimate concern.
4.1104 Dr. Healy confirmed the need for a case-by-case approach. She urged that there be a careful
assessment of all the available information. She emphasised that the quality and the quantity of the
information were important for the risk assessment. She confirmed that missing information – that is,
insufficient science – could legitimately give rise to safety concerns, and that generally the more data
one has, the better the safety assessment can be. Sh e indicated her view that, in a number of the
applications she looked at when formulating her ad vice, not all the expected information was present
or of sufficient quality.
4.1105 Dr Healy also echoed Dr. Andow's comments a bout rapidly changing science. She confirmed
that scientific knowledge about molecular character isation techniques has developed extensively over
the past decade, particularly as regards the sequenc ing of the insertion and of the flanking regions.
She observed that there has been a rapid evolution in detection methods, and th at this accelerated in
the late 1990s, with significant implications on th e question of specificity in identifying the GMO.
Her observations lend support to one of the European Communities' basic legal points: at the frontiers
of science, assessors and legislators are entitled to be prudent.

4.1106 Dr. Snow rather memorably noted that learning about the concerns and issues relevant for the
agro-ecosystem in the European Communities was like learning about another planet. She indicated
that she had appreciated this process, and that, by placing herself in the shoes of the European
Communities, she had come to understand that many of the concerns and requests for information
were, indeed, valid. Picking-up on the closing remarks of Dr. Andow, and foreshadowing those of
Dr. Squire, Dr. Snow indicated a shared concern a bout mischaracterised comparisons with regard to
possible changes in agricultural practices, and thei r environmental implications. She also confirmed
her view that many of the issues remained open as regards co-existence and traceability.
4.1107 Dr. Squire underlined how much has been learnt over the last 5 or 6 years on the scientific
and technical aspects of European agro-ecosystems; he observed that the current debate could not
even have been conducted a few years ago; and he expressed satisfaction that the relevant issues were
now being more fully aired.
4.1108 Dr. Squire also drew the attention of the Pane l to the fact that the concerns that were
expressed in Europe and the research that had been done in response to them were now reflected in
the international consensus reflected in the Co dex standards. Accordingly, even though these
standards did not exist at the time the European Communities was making many of its requests for
further information these requests were compatible with what was later reflected in the standards. Dr.
Nutti also confirmed that the Codex process started around 1999-2000 and it to ok four years to adopt
the standard. So in fact, what the complaini ng parties would perhaps qualify as unnecessary requests,
or inaction, has turned out to be the basis for intern ational consensus, and if we have the international
standards that we have today is in part thanks to the efforts made by EC authorities to know more.
4.1109 Dr Squire also reminded us that, as regard s the environment, we are discussing potential
impacts that, whilst not immediately catastrophic or large, did concern small changes that could
certainly be significant and that incrementally, over time, could lead to very significant impacts. In the
case of co-existence, he expressed the view that even very small changes could have dramatic effects
for farmers' livelihoods.
4.1110 Earlier, Dr. Squire had recalled that, in some pa rts of Europe, and in contrast to the Americas,
a very large proportion of land is in agricultural u se, so that, in those areas, the "environment" is
essentially constituted by agro-ecosystems. Conseque ntly, in these regions of Europe, agricultural
management, environmental, conserva tion and biodiversity issues are inseparable. In this situation, it
is perfectly reasonable that the authorities consider that one cannot afford to obliterate a species just
because it does not appear to be immediately economica lly useful. That is because, in complex ways,
such species contribute to sustaining the environment that, in turn, supports us. The European
Communities shares this view. It does not support the contention of Canada that the purpose of
agriculture is to reduce biodiversity, or the apparent view of the United States that the conservation of
biodiversity must be limited to specific geographical areas. By contrast, the European geographic and
environmental context is materially different, so that one of the objectives of agriculture is the
sustainable management of biodiversity. Unlike Canada, the European Communities does not ask the
Panel to consider these matters "with respect to the whole world" (as Dr. Snow remarked) – but rather
with respect to the specific characteristics of the receiving environment that European decision-
makers are charged with protecting.
4.1111 Dr. Snape's comments throughout the experts' meeting often recalled the basic truth that one
cannot compare "apples and pears". He made abundantly clear his view that it is perfectly acceptable
from a scientific point of view for assessors and legi slators to take into acc ount the basic differences
between GM and non-GM products. He confir med the need for an extensive molecular
characterisation in order to ensure sufficient knowledg e for a proper risk assessment – that is, in order

to identify potential hazards – and in order to be able to assess the potential impact of the GM
product.
4.1112 The European Communities has already comment ed on certain differences in approach
between Drs. Snape and Healy. But the meeting w ith the experts served to clarify that, in fact,
Drs. Snape and Healy agree on many issues. For instance, both of them confirmed that sophisticated
methods of molecular characterisation were availabl e by 1995. Moreover, Dr. Snape has written, and
Dr. Healy explained orally last Friday, that they were surprised by the poor quality of the data
submitted by applicants as regards molecular char acterisation (with one exception). The European
Communities considers that risk assessors are not re quired to operate on the basis of assumptions or
guesses. They are entitled to seek complementary da ta. If the technology to produce such data was
available at that time – as has been confirmed – and it was therefore practicable for companies to
provide the data, why shouldn't the EC authorities ask for it? Why should risk assessors rely on
second-best, potentially inaccurate, alternatives to carry out their work?
4.1113 Finally, with regard to food safety, Dr. Nu tti accepted the general proposition that, at least
where international guidelines, such as the Codex, le ft certain matters open for interpretation, there
could be different but equally valid scientific views about how best to proceed, or about the amount of
data requested. Where there are no establishe d international standards – as in the case of
environmental assessment and protection and notw ithstanding the recent adoption of the Biosafety
Protocol, which will hopefully lead to the emergence of such standards – Dr. Nutti's point becomes
even more valid. Dr. Nutti also clearly admitted th at there is a lack of international guidance as
regards feed safety assessments – a matter in respect of which, in any event, Dr. Nutti made it very
clear that she had not offered any advice to the Pa nel – and that the issue was therefore much more
open than in the case of food safety.
4.1114 Perhaps we should step back and try to achieve some kind of overall perspective on the expert
advice. In this respect, the European Communities would like to recall that the complaining parties
launched this case on the basis that the science wa s sufficiently complete and that the science
mandates, as the only possible approach, the immediat e approval of all the relevant products by the
European Communities. The complaining parties' vi ew was that this Panel did not even need any
advice from independent experts. Plainly, in the light of what the experts have now advised, the
complaining parties' position is untenable. The sci entific advice justifies the Communities' prudence
and caution. It confirms the need to consider each product on its own merits. It confirms that the
European Communities was and is justified in ta king the time necessary to obtain the appropriate
information – information that the applicants had simp ly failed to provide – and to consider all of the
concerns legitimately raised by scientists, legislator s and stakeholders. After the closing statements
from the experts, there can be no doubt that the complaining parties' assumptions – and the legal
assertions based on those assumptions – have been demonstrated to be wrong.
2. Comments on additional evidence submitted by other parties
4.1115 The European Communities has some difficulties in understanding the Panel's approach to the
submission of "additional scientific and technical evidence" and/or "comments". The Panel's
invitation to comment, today, on additional eviden ce submitted by the other parties, for us, is a
welcome opportunity to clarify a number of issues.
4.1116 First, the European Communities notes the Panel' s and Canada's apparent understanding that
"evidence" is solely constituted of scientific papers or other forms of documented scientific expertise
(such as the experts' advice) and that comments on such evidence do not constitute "evidence". It
notes that the United States has accordingly not submitted any scientific evidence at all.

4.1117 The European Communities subm itted evidence within the above meaning in its 31 January
submission as well as in its 10 February submis sion and referred to a c onsiderable number of
scientific papers. Which leads to the second point.
4.1118 The issue arises as to when evid ence within the above meaning can be considered to have
been submitted to the Panel. The European Communities notes that the Panel reserved further
discussion on this issue for the second meeting. As the European Communities has explained (in its
letter of 14 February as well as at the expert meeting) , it takes the view that where scientific expertise
is publicly available, a reference to the source is enough for the purposes of submitting that evidence
to the Panel. Where, on the other hand, such ev idence is not publicly available, a copy of the
expertise needs to be submitted to the Panel. Based on this understanding, the European Communities
has submitted copies of all papers that are not yet published and has provided references to all other
published papers it has relied on in its comments. In order, however, to facilitate the Panel's work it
has sent, on 14 February, a CD containing copies of pa pers referred to in its 31 January and in its
10 February submission. The European Commun ities notes that Argentina has not submitted any
copies of the scientific papers it has referred to in its submissions.
4.1119 Third, it is not entirely clear to the Europ ean Communities whether there is a difference
between comments on additional evidence on th e one hand, and comments on comments (on
additional evidence) on the other. In a previous version of the timetable of these proceedings, the
latter notion had featured, but terminology has changed since then. What complicates issues further is
that we have been invited to comment on additiona l evidence as provided by the other parties today,
but will have another opportunity to do so again some time after the hearing.
4.1120 The European Communities does of course ha ve comments on the complaining parties'
contentions. They were contained in our 10 Februa ry submission, which we annex to the first oral
statement at the second meeting of the Panel with the Parties. The complaining parties have had them
since 10 February, and the Panel will also have read them before rejecting them.
Y. S
ECOND ORAL STATEMENT OF THE UNITED STATES ON THE EUROPEAN COMMUNITIES'
SECOND AND THIRD SUBMISSIONS
1. Introduction
4.1121 Since the first substantive meeting, hundreds of pages have been written and many, many
hours have been expended by all involved. But in terms of the development of the dispositive legal
issues, the complaining parties' case has only been further confirmed and remarkably little else has
changed. In particular, the central defence of the European Communities – despite the overwhelming
evidence to the contrary – remains that the European Communities did not impose a moratorium. The
European Communities still has not even attempted to rebut the complaining parties' arguments
showing that the moratorium is inconsistent with the SPS Agreement. And likewise, the European
Communities has still not attempted to explain how its member State safeguard measures could be
consistent with the SPS Agreement.
2. Developments since the first substantive meeting
4.1122 The European Communities' submissions have provided additional confirmation of the
complaining parties' case – even though the compla ining parties' first written submissions were more
than sufficient and no additional confirmation wa s required. The confirmation has followed a
consistent pattern: the European Communities h as repeatedly submitted information supposedly in
support of its positions, but each time the European Co mmunities' information is both consistent with

the existence of a moratorium, and indeed prov ide further support for the complaining parties'
contentions that the European Communities has adopted a moratorium and has failed to process
applications without "undue delay."
4.1123 The first US written submission provided overwhelming evidence that the European
Communities adopted and maintained a moratorium under both its deliberate release and novel food
directives. EC officials and bodies from across th e range of EC institutions – the Commission, the
Council, the Parliament, and member States – have acknowledged the existence of the moratorium.
Although no further confirmation is needed, the Un ited States is providing one further official
acknowledgment of the moratorium. The Unite d States does so only because the European
Communities in this dispute has claimed ignorance of the moratorium, and has asked the complaining
parties to explain it. The exhibit, from a French Government website, asks and answer the question,
"What is the de facto moratorium on GMOs?" The United States suggests that if the European
Communities wants a definition of the moratorium, the European Communities should refer to this
exhibit, which describes the moratorium, at least in the view of the Government of France.
4.1124 The first US written submission went on to explai n that the moratorium was inconsistent with
various provisions of the SPS Agreement: Articles 2.2, 2.3, 5.1, 5.5, 7, and 8 and Annexes B and C.
Among other things, the United States explained that many of the product applications caught up in
the moratorium had received positive risk asse ssments from the European Communities' own
scientific committees. But then those applications failed to make further progress when the
applications reached a political level – in partic ular, when the European Communities refused to
submit the applications to a vote by member States in the European Communities' regulatory
committee.
4.1125 The European Communities in its first writte n submission attempted to rebut the US prima
facie case by arguing that any and all delays were the result of legitimate scientific questions, and by
relying on certain exhibits to its first written submission. Those exhibits contained chronologies of
the approval process for a number of products, alon g with only a small selection of the underlying
documents cited in the chronologies.
4.1126 As the United States explained at the first s ubstantive meeting, the European Communities'
chronologies were perfectly consistent with the ex istence of a moratorium. The chronologies showed
some questions from regulators and some responses, and some progress, but at the end of the day no
decisions were made. Moreover, certain chronol ogies contained lengthy, unjustified gaps – of over
two years – for which no explanation other than the European Communities' adoption of a
moratorium were plausible.
4.1127 Also at the first meeting, the European Commun ities represented to the Panel that each of the
member State objections and questions resulted from conflicting risk assessment s, and thus that all
delays were warranted to address outstanding scientif ic issues. When the Panel asked the European
Communities to point out those risk assessments in the exhibits provided with the European
Communities' first written submission, the Europ ean Communities explained that such documents
were held by the member States. In othe r words, the European Communities had made
representations to the Panel about a set of doc uments even though – according to the European
Communities – the Commission did not even have ac cess to those documents and would need to
request them from member States.
4.1128 By late June, the European Communities provi ded additional documents from the dossiers,
although the dossiers were still far from complete. In its second written submission, the United States
explained that the partial product dossiers provided by the European Communities did not, as the

European Communities had asserted, contain comp eting risk assessments. And, the documents
provided yet further confirmation – though none w as needed – that the European Communities had
subjected applications to "undue delay" and had ad opted a moratorium. The United States identified
additional application histories – particularly tho se nearing the final stage of the decision-making
process – that exhibited lengthy, unwarranted de lays, unrelated to any requests for additional
information. In addition, a number of product histories contained specific statements from member
States acknowledging the existence of the moratorium. In each case, the me mber States wrote that
regardless of any scientific issues regarding the pa rticular application at issue, the member State
asking for more information was not going to vo te for approval, unless and until the European
Communities had adopted new forms of legislation.
4.1129 In August, the Panel requested that the Eu ropean Communities complete the application
histories that the European Communities had relied upon for its defence. As a result, an amended set
of application histories was made available to th e complaining parties and the Panel by the end of
September.
4.1130 As pointed out in the third US written subm ission, once again the European Communities'
additional documentation did not include the comp eting risk assessments claimed by the European
Communities, and the documentation was fully consis tent with the existence of a moratorium. And
once again, upon examination, the documentation provided further evidence – although none was
needed – of "undue delay" and the existence of the moratorium. The United States showed
13 examples of how underlying documents in the product chronologies confirmed the existence of
unwarranted delays in processing applications. The third written submission of the United States also
provided over 20 examples where the questions by EC regulators were not required for assessing
risks.
4.1131 The process of consultation with experts followe d. The experts' written and oral responses
were consistent with the US views, and the e xperts noted many types of questions which were
scientifically unjustified.
4.1132 In sum, the documents submitted by the Eur opean Communities and th e comments from the
experts are entirely consistent with a political-l evel moratorium under which applications were
allowed to make some progress but were never allo wed to reach a final decision. Moreover, the
documents illustrate many instances of unwarranted delays in the form either of inactivity by the
European Communities or member State officials, or in the form of unjustified requests for additional
information.
3. Burden of proof
4.1133 Throughout this proceeding, the European Communities has placed great emphasis on the
issue of the burden of proof – for example, the European Communities' third written submission is
devoted largely to this topic. This dispute, how ever, presents no difficult or unusual issues regarding
burdens of proof.
4.1134 The European Communities argues that the United States has not met its burden of presenting
a prima facie case because the first written submission of th e United States did not address "each and
every delay" in the processing of each product covere d in the US panel request. This argument is
baseless. The contention of the United States and th e other complaining party is that the European
Communities adopted a moratorium that ne ver allowed products to reach final
 approval. The United
States does not contend, as the European Commun ities' argument implies, that the European
Communities suspended all processing of applications, nor does the United States contend that each

and every one of the European Communities' delays were unwarranted. Thus, nothing in the theory of
the US case requires an examination of each and every delay for each and every product.
4.1135 The European Communities also asserts that the European Co mmunities, as opposed to the
complaining parties, has provided most of the evidence in this dispute. This contention is untrue: the
complaining parties have provided extensive eviden ce. For example, the first written submission of
the United States included over 100 exhibits, includi ng positive risk assessments by EC scientific
bodies, numerous statements by EC officials ac knowledging the moratorium on biotech approvals,
and copies of the relevant EC laws and member State safeguard measures. What the European
Communities really objects to is that the Eur opean Communities, as opposed to the complaining
parties, provided the documents in the product appli cation histories. The United States, however, did
not need the application histories to prove its prima facie case. It was the European Communities
itself that chose to rely on the application histories in the European Communities' attempt to rebut that
prima facie case. Having chosen to rely on the pr oduct application histories, the European
Communities cannot complain when the complaining pa rties insist that this information must be
complete, and that the European Communities not be permitted to rely on excerpts of information
presented by the European Communities out of context for purposes of this dispute.
4. Member State safeguards
4.1136 With regard to the member State safeguard me asures, the United States has explained that, in
each case, the European Communities' own sci entific committees had reached positive risk
assessments, and had examined and rejected
 the reasons put forth by the member States for adopting
the measures. Accordingly, these measures also we re not "based on scientific principles" and were
"maintained without sufficient scientific evidence," in violation of Article 2.2. The measures also
were not "based on" a risk assessment, in violation of Article 5.1. Although the European
Communities has since vaguely implied that the measu res fall within the scope of Article 5.7, this
provision cannot apply to the member State safe guard measures. The Eu ropean Communities itself
has completed positive risk assessments: therefor e the scientific evidence cannot be considered
"insufficient."
4.1137 The European Communities continues not to provi de a serious defence of the member State
safeguard measures. Since the first substantive meeting, the only new development regarding the
safeguard measures is that the Panel posed some que stions to experts on the safeguards, and certain
experts responded to those questions.
4.1138 With regard to food safety, the expert specia lizing in food safety found no validity to any of
the rationales put forward by the member States. With regard to environmental effects, experts
specializing in environmental issues wrote that cer tain member States in certain instances may have
had scientific concerns that were not adequately addressed in the European Communities' positive risk
assessments. These views of the experts on e nvironmental issues, however, have very little
significance for the resolution of this dispute, and certainly cannot suffice to bring the safeguard
measures within the scope of Article 5.7.
4.1139 As the European Communities itsel f has stressed in its third written submission, the role of
the experts is to provide views on scientific questio ns posed by the Panel; it is not the role of the
experts to make the case for a disputing party. But the European Commun ities has never explained
how Article 5.7 might apply to any of the member State safeguard measures. In particular, the
European Communities has not descr ibed (1) why the member State believed that the relevant
scientific evidence was insufficient to assess a risk, or even the specific risk that was of concern to the
member State, (2) what available pertinent info rmation might serve as the basis for the safeguard

measure, (3) whether the member State sought to obtain additional information necessary for an
objective assessment of the risk; and (4) whether th e member State reviewed the measure within a
reasonable period of time.
4.1140 The experts provided scientific opinions on some of the elements that might be relevant to an
analysis under Article 5.7 of the SPS Agreement, but those statements do not come close to a full
analysis under Article 5.7. Moreover, even if th e European Communities were to tried to build an
Article 5.7 argument from the responses of the experts, the European Communities could not do so.
4.1141 First, the safeguard measures are product bans, preventing cultivation, import and processing,
and the use of the products as food. The expert s' responses, however, entirely support the scientific
findings of the European Communities' scientific co mmittees with respect to food safety. In addition,
the experts' scientific concerns addressed cultivatio n, not import and processing . Thus, the experts'
responses cannot serve as the basis for an argument that the safeguard measures fall under Article 5.7.
4.1142 Second, the experts' responses cannot assist th e European Communities in meeting the third
and fourth requirements of Article 5.7. In pa rticular, Article 5.7 requires Members adopting a
provisional measure to seek to obtain additional info rmation necessary for an objective assessment of
the risk; and to review the measure within a reas onable period of time. There is no basis for finding
that the member States adopting the safeguard measures sought the additional information necessary
for an objective assessment. As the Appellate Body confirmed in the Japan – Agricultural
Products II, where a Member fails to seek additional in formation as required under Article 5.7, the
measure cannot fall within the scope of the Article 5.7 analysis.
4.1143 Third, even where the experts sp eak of risks associated with cultiv ation, the experts were left
to speculate on the actual reason the member Stat e had for adopting the measure. The experts'
speculations of the rationales of the member Stat es cannot stand in the place of actual assertions by
the European Communities concerning any purported scientific basis for its member State measures.
4.1144 Fourth, and finally, in the event the Panel would engage in further analysis of environmental
issues under Article 5.7, the United States notes that the same experts who disagreed with the risk
assessments of the SCP also generally found that eith er (1) science has advanced since the date of the
imposition of the measures so that a risk assessment is now possible, and (2) that management
measures are available and that there would no longer be a scientific basis for a total ban on planting.
In addition, the experts noted that in some cases st udies could have been started as early as 1998 to
address the member States' concern. Those opinions of the experts are summarized in Part II.C of the
US comments on the experts' responses.
5. Mootness
4.1145 At the first substantive meeting, the European Communities argued that this dispute is moot
because the European Communities had approved a single product – a sweet corn for food use – under
the Food and Feed directive. As the United States explained it its second and third written
submissions, the concept of mootness is inconsiste nt with the text of the DSU and longstanding
GATT and WTO practice. The measure to be examined in this case is the moratorium at the time of
Panel establishment, which is Augus t 2003. Nonetheless, the United States would like to point out
recent developments illustrating that the moratorium is still very much alive. To be clear, whether or
not the moratorium is maintained after August 2003 is not a legal issue before the Panel. But the
current status of the European Communities' morato rium should be of consid erable relevance to an
understanding of the European Communities' motivations, and to an objective assessment of the facts.

4.1146 The United States refers the Panel to US Exhibit 148, which is an article describing the latest
state of play in the political manoeuverings that lie at the heart of the moratorium. The excerpt
illustrates and supports the following points.
4.1147 First, even nearly a year after the April 2004 entry into force of the new tracing and labelling
and GM food and feed directives, the European Co mmunities must still fight a political battle to reach
a decision on any biotech product. This undermines the European Communities' contentions that
products were delayed because of the need for the new directives to enter into force.
4.1148 Second, the application described in the article (GA21) is for food use. The product received
a positive opinion from the Scientific Committee on Food three years ago, and yet the European
Communities still fails to submit it to a vote of the member States in the Regulatory Committee.
Since the approval is for food use, none of the environmental issues discussed at length by the
European Communities in its most re cent comments are relevant to the application. Yet, the political
battle remains.
4.1149 Third, the European Communities continues to ba n a large range of products for reasons that
are openly political – openly, that is, except in the m eetings in this dispute. This is why it is so
important to the complaining parties, and indeed for the rules-based trading system itself, for the
Panel to find that the European Communities' moratorium is not consistent with WTO rules.
Z. S
ECOND ORAL STATEMENT OF CANADA ON THE EUROPEAN COMMUNITIES' SECOND AND
THIRD SUBMISSIONS
1. Introduction
4.1150 In these proceedings, the European Commun ities has consistently tried to remove
biotechnology from the context of modern agriculture to exaggerate risks and scientific uncertainty.
In contrast, Canada has sought to put biotechnology squarely back into its proper context. The
European Communities’ suggestion that its appro ach to biotechnology reflects a more prudent and
profound concern for the environment is starkly refu ted by Dr. Squire’s testimony regarding general
agricultural practices in the European Communitie s. Not only has the European Communities been
“slow to learn”, it has applied whatever knowledge it has learned in an arbitrary and scientifically
unjustified fashion. This case is really about the arbitrary and unjustified distinctions that the
European Communities has drawn between produ cts developed through rDNA technology and
products developed through the use of chemical mutagens or radiation.
2. Overview of the dispute
4.1151 Canada's principal arguments run as follows:
• The European Communiti es has maintained a moratorium on the approval of new
agricultural biotech products since October 1998.

• The moratorium has effectively stalled indefinite ly all product applications in the
system, giving rise to de facto product specific marketing bans.

• A number of EC member States have put in place national bans on biotech products
that had been approved by the European Co mmunities prior to the institution of the
moratorium. The member States that are maintaining these national bans are the
same Member States that have expressed support for the moratorium.

4.1152 Canada has shown that these are distinct measures, that they are subject to the WTO
Agreement, and that they are inconsistent with the SPS Agreement. The scientific advice given to the
Panel by the experts reinforces the case that Canada has established.
4.1153 To this date, the European Communities has de nied even the existence of the moratorium . It
largely bases its defence on what it calls scientific complexity and uncertainty. It purports, on one
hand, to rely on the advice of the experts in this regard. Where the experts do not agree with the
European Communities’ general theme, the Europ ean Communities seeks to discredit the experts in
question, ignore their advice, and/or answer the Panel’s questions itself based on what the European
Communities implies is the advice of better experts. None of this has any merit.
4.1154 The European Communities argues that ther e are qualitative differences in the risks
associated with biotech products as compared to th eir novel non-biotech counterparts. The evidence
of the European Commission’s own Directorate-General for Research demonstrates that this premise
is flawed. It is also inconsistent with the re peated conclusions of the EC scientific committees and
EFSA.
3. Arguments and evidence relating to the moratorium and the product-specific bans
(a) The moratorium
4.1155 In what follows, Canada responds to the Eur opean Communities' most recent arguments in
relation to Articles 5.1, 2.2, 5.7 and 5.5. Canada has already demonstrated the ways in which the
European Communities has given effect to the moratorium since 1998, and that the moratorium is a
SPS measure for the purposes of the SPS Agreement.
(i) The European Communities has failed to ba se its moratorium on a risk assessment in
violation of Article 5.1
4.1156 Article 5.1 requires WTO Members to base thei r measures on a risk assessment. The risk
assessment must meet the requirements of Annex A( 4) and there must be "a rational relationship
between the measure and the risk assessment". The moratorium does not meet either requirement.
4.1157 The European Communities claims that Dir ective 90/220 was inadequate for assessing the
environmental risks posed by biotech products, requ iring amendments to that legislation. The
European Communities claims that it adopted an "interim approach" while the new legislation was
being developed. However, the evidence shows that the EC member States were not interested in
making decisions on product applications under this approach. Furthermore, the evidence shows that
the true reason for amending Directive 90/220 was to streamline the approval procedure, including a
need to harmonize risk assessment criteria. A d esire for harmonization doe s not constitute a risk
assessment for the purposes of Article 5.1.
4.1158 The European Communities also asserts that an absence of appropriate risk management
measures in its legislation prevented it from fina lizing risk assessments. However, these risk
management measures were not related to identifi ed risks. This fundamentally undermines the
European Communities' assertion that it assesses risk s and applies risk management measures on a
case-by-case basis. Therefore the European Communities cannot credibly argue that the need for such
measures is "based on" a scientific risk assessment.

4.1159 In trying to rationalize the moratorium under Regulation 258/97, the European Communities
points to hypothetical unanticipated chronic effects on human health. In essence, the European
Communities asserts that the new requirements for labelling, traceability and detection methods are
necessary so that long-term chronic effects of biotec h products could be appropriately studied. The
European Communities claims that the absence of evidence of acute toxicity is not proof of an
absence of long-term chronic effects. This applies to almost any novel food and reflects the European
Communities' attempt to divorce biotechnology from it s proper context. The argument that long-term
chronic effects need to be studied for all biot ech foods, as a class, also suggests the European
Communities is not assessing risks on a case-by-case basi s. In any event, the European Communities
fails to put forth any evidence, much l ess a risk assessment, to suggest that a moratorium was
necessary until such measures were put in place. This is because no scientific justification exists.
4.1160 The SPS Agreement does not permit a WTO Member to suspend existing SPS approval
procedures, thereby effectively banning products wi th pending applications, simply because it wants
to update its legislation. A suspension may be wa rranted in some circumstances, for example, where
credible scientific evidence demonstrates actual risks to human health or the environment. That is not
the case here. The legislative chang es, for the most part, were related to hypothetical adverse effects
or to facilitate the removal of a product from the ma rketplace in the unlikely ev ent of a hypothetical
risk arising.
(ii) The European Communities may not rely on scien tific uncertainty to justify the moratorium
under Article 5.7
4.1161 The European Communities attempts to rationalize the moratorium and the resulting delays in
processing individual applications on the basis of sci entific uncertainty, claiming that the scientific
evidence was insufficient to complete risk assessments and a dopt appropriate risk management
measures. If this is so, the European Communities must demonstrate that the moratorium falls within
the scope of Article 5.7 and that it meets all of th e requirements of that provision. The European
Communities fails to do so; instead it suggests that it is for the Panel to develop the European
Communities' arguments. As a matter of law, this is not sufficient to discharge the European
Communities' burden.
4.1162 In any event, the moratorium does not meet the requirements of Article 5.7. The European
Communities has not established that the "relevant sci entific evidence is insufficient" to complete a
risk assessment. "Sufficiency" requires the exis tence of an "adequate relationship between two
elements". These two elements are the scientific evidence and the obligation to base SPS measures on
a risk assessment. Thus, the question is whether th e relevant scientific evidence is sufficient for a
Member to base its SPS measures on a risk assessment. If the evidence is sufficient, then Article 5.7
may not be used as a defence.
4.1163 The European Communities cannot credibly claim that relevant scientific evidence regarding
biotech products is insufficient to permit the eval uation of the likelihood of entry, establishment or
spread of a pest, or the evaluation of the potential for adverse effects on human or animal health from
consuming biotech products. Prior to the moratorium, the European Communities considered the
scientific information regarding biotech products to be sufficient to permit such an evaluation.
Indeed, the European Communities approved several such products, all of which remain on the EC
market. Community-level scientific committees have repeatedly performed risk assessments (and
have found no evidence of risk), demonstrating conclusively that there is sufficient scientific evidence
to permit the European Communities to perform a risk assessment.

4.1164 Much of the "scientific uncertainty" raised by the European Communities is really the
"uncertainty that theoretically always remains since science can never provide absolute certainty that
a given substance will not ever have adverse [] ef fects". The European Communities states that, "an
absence of scientific evidence does not constitute evidence of an absen ce of impacts or risks." This
may be true if a reasonable effort is not
 made to conduct studies to detect plausible hazards and
evaluate the risks these hazards might pose. This is obviously not the case here. A considerable
amount of research on potential risks has been carried out. The European Communities is in effect
seeking "absolute certainty" and then suggesting th at the absence of absolu te certainty makes it
impossible for this Panel to do its work. It seeks to equate the lack of absolute certainty with
insufficient scientific evidence, ev en though the Appellate Body has ma de it clear that these concepts
are not interchangeable.
4.1165 The question here is whether relevant scientif ic evidence is sufficient to perform a risk
assessment, not whether, at the margins, some scientif ic uncertainty remains. In determining whether
relevant scientific evidence is sufficient one must have regard for the context. The European
Communities attempts throughout its submissions to shift the focus away from the large quantity of
high quality scientific information available, to th e margins of scientific uncertainty. This strips
biotech products of the context within which they have been developed and are to be employed, and
downplays the vast experience within the Europ ean Communities and around the world with plant
breeding technology, food safety assessment, and th e management of herbicide and pesticide
resistance, amongst other things.
4.1166 A large body of research on transgenic plants has been carried out by university and
government laboratories investigating aspects of rDNA technology, and a considerable part of that
research has been undertaken in th e European Communities. All of this forms part of the abundance
of high quality scientific evidence concerning the risks or potential risks posed by the products in
question in this dispute. Dr. Squire indicated th at biotech products have been subjected to an
"unprecedented" degree of regulatory scrutiny. As compared to their conventional counterparts,
considerably more information is known at the mole cular level about the currently available biotech
products. Consequently, the European Communities cannot credibly claim that relevant scientific
evidence was or is insufficient then to justify th e suspension of the approval procedures for biotech
products. Accordingly, Article 5.7 cannot be invoked to justify the moratorium.
4.1167 Similarly, the European Communities cannot cred ibly claim that relevant scientific evidence
was insufficient to perform a risk assessment in relation to sp ecific product applications. The
determination of whether relevant scientific eviden ce was sufficient to undertake and complete a risk
assessment is linked to the issue of "undue dela y" under Annex C1(a). Article 5.7 informs the
determination of "undue delay" under Annex C(1)(a).
4.1168 Given the moratorium and its demonstrated impact on the processing of applications, the
European Communities must demonstrate in each case that "relevant scientific evidence is
insufficient" to complete the risk assessment in that case. This requires a determination of
"sufficiency". In other words, what information is "need to know" and what information is "nice to
know". As indicated by the experts, many of the requests for additional info rmation by EC member
States were not necessary to ensure the validity of th e risk assessments that had been performed. So,
the absence of "nice to know" information cannot ju stify a claim of insufficiency of scientific
evidence.
4.1169 Some of the EC member State questions have been based on a presumption that the product
necessarily will be cultivated on a large scale. Th e European Communities as serts that, because the
agro-environmental impacts from large-scale cultivation cannot be predicted with absolute certainty, a

failure to approve the product is justified. However, there is no a priori reason why cultivation cannot
be introduced on a smaller and progressive scal e. A gradual introduction of a product, with
appropriate monitoring plans and agricultural guide lines, has already been demonstrated to be a
feasible option in the European Communities.
4.1170 In determining whether relevant scientific eviden ce is sufficient, it is important to consider
the totality of the information submitted in support of an application. This approach is endorsed by
Drs. Healy and Nutti and has been adopted by th e Community-level scientific committees. In the
light of the large quantity of reliable scientific ev idence developed over the years, in part by the
European Communities itself, and the fact that the European Communities' own independent
scientific committees have been ab le to complete risk assessment s, any claim by the European
Communities that "relevant scientific evidence is in sufficient" is without merit. The European
Communities has failed to meet the first requireme nt of Article 5.7. As the requirements under
Article 5.7 are cumulative, and the European Communities has not and cannot meet the first
requirement, it is not necessary to address the other elements of Article 5.7.
4.1171 For these reasons, the European Communities cannot successfully invoke Article 5.7 to
excuse its failure to meet the obligations under Article 5.1 or Article 2.2 of the SPS Agreement.
(iii) The European Communities' application of its appropriate level of protection for biotech
products results in discrimination or a disguised restriction on international trade, contrary
to Article 5.5 of the SPS Agreement
4.1172 It is apparent from its most recent arguments that the European Communities is seeking a
level of protection for biotech products that approximates "absolute safety". The European
Communities has raised almost every imaginable hypot hetical risk, often relying on scientific reports
that have been widely dismisse d. Despite rigorous risk assessments and no evidence of harm, the
European Communities strenuously maintains that risk management measures are necessary.
4.1173 Despite the broad international consensus that biotech products should be contrasted on a
comparative basis with their conventional counterpa rts, the European Communities' approach is to
assess biotech products in a vacuum. The European Communities ignores the demonstrated benefits
associated with these crops and the well-establishe d risks to human health and the environment
arising from the existing practices that some of these crops can help improve. By doing so, the
European Communities seriously undermines its clai m to be acting on a precautionary basis in order
to protect the environment.
4.1174 The European Communities' level of protection for biotech products should be contrasted
with the level adopted for novel crops developed thro ugh other forms of genetic modification, such as
radiation and chemically-induced mutagenesis; so maclonal variation; and even conventional selective
breeding. As confirmed by the experts, biotech and non-biotech methods of genetic modification do
not differ inherently with respect to the types of ri sks to human health or the environment that they
pose.
4.1175 All methods of introducing genetic variati on have potential to produce unexpected and
unintended effects. The experts agreed with this . The likelihood of changes to the genome varies
with the method of genetic modification. This has been discussed in the recent report of the National
Academies on the safety of genetically engineered foods. The report placed different methods on a
continuum, with selection breeding from within a homogeneous population having the least likelihood
of causing unintended changes and mutagenesis tec hniques the most likelihood. Significantly, the
various recombinant DNA techniques fell at different points between these extremes.

4.1176 Unintended effects do not necessarily imply hazar d. The potential for hazard arises from the
product, rather than the method of production. It is interesting to note that the most striking
unintended effects on human health from food produ ction have resulted from conventional breeding
(e.g. potatoes with high levels of glyco-alkaloid). The method used in developing the product does
not alter the nature of the risks.
4.1177 Despite the fact that all forms of plant gene tic modification have the potential to produce
unintended adverse effects, the European Communities has not imposed a moratorium on products
from other forms of plant breeding. Indeed, a lthough plants produced via conventional breeding
methods are routinely evaluated for changes in productivity, reproductive efficiency, reactions to
disease and quality characteristics, they are not assessed for safety.
4.1178 One of the most striking examples of the Eu ropean Communities' selective concern about
risks is the difference in its treatment of herbicide tolerant (HT) oilseed rape crops developed through
mutagenesis and recombinant DNA technology. The e xperts agreed that HT crops, regardless of the
method of production, posed similar risks. Th e European Communities' entire discussion in its
comments on the experts' advice about the risks posed by HT crops applies equally to biotech and
mutagenic crops. However, despite the fact that the likelihood of unanticipated changes to the
genome are at least as likely with mutagenesis as with transgenesis, the European Communities does
not require a comprehensive risk assessment for HT crops developed through mutagenesis. For
mutagenic crops, unlike their biotech counterparts, there appears to be little concern with the
environmental or health effects. The panoply of regulatory requirements imposed on biotech products
is completely absent in the case of mutagenic crops. Above all, there is no moratorium.
4.1179 Given the similarity of risks and the othe r factors set out in Canada's First Written
Submission, these differences in appropriate levels of protection are arbitrary and unjustified and give
rise to discrimination or a disguised restriction on inte rnational trade in violation of Article 5.5 of the
SPS Agreement.
(b) Product-specific marketing bans
(i) Oilseed rape GT73
4.1180 Keeping in mind that the oil produced from GT 73 oilseed rape has already been approved for
human consumption, Dr. Nutti's conclusions concer ning the impact on human health were entirely
consistent with the Dutch Competent Authority and the EFSA opinions. In terms of animal feed, the
European Communities has failed to cast doubt on the EFSA 2004 opinion concerning the safety of
GT73 for use as feed. The European Communities' alleged concern about th e pesticide residues and
related metabolites was dismissed by Dr. Nutti.
4.1181 In terms of environmental relea se, the alleged concern cited by EC member States appears to
be related to the potential of seed spillage. Th e experts dismissed this concern as not being
scientifically justifiable, and the studies cited by Dr. Squire are of limited applicability, given that in-
land transportation of imported seeds is unlikely. In any event, if seed spillage occurs around
docklands and processing facilities, these weeds can be easily controlled. Dr. Squire also agreed with
the EFSA opinion that the monitoring plan proposed by the notifier was acceptable given the factors
set out in the EFSA opinion. Thus, the demands for more onerous monitoring are entirely unjustified.
4.1182 Because the product-specific ban for GT73 is not supported by a risk assessment, the
European Communities is violating Articles 5.1 a nd 2.2. Moreover, a delay of seven years in
approving this product is, by any reasonable standard , "undue" and therefore violates Annex C(1)(a).

Furthermore, by imposing the ban on GT73, con tinuously making unjustifie d demands for additional
information and seeking to impose onerous and unne cessary monitoring requirements, the European
Communities is violating Article 5.5. The main beneficiaries are European oilseed rape producers
selling their products to European Communities' crushing facilities.
(ii) Oilseed rape Ms8xRf3
4.1183 In terms of molecular characterization, Dr. Healy confirmed that the requests for additional
molecular characterization were not necessary to co mplete the safety assessment. Dr. Snape agreed
with both Dr. Healy and, importantly, with the February 2002 opinion of the Belgian Biosafety
Council. The experts also confirmed that the like lihood that Ms8xRf3 would establish or spread as a
weed in the absence of the application of gl ufosinate-ammonium was no different than for
conventional varieties of oilseed rape, and that th e techniques in place to control conventional oilseed
rape volunteers or weeds can be applied with equal effectiveness to Ms8xRf3.
4.1184 In assessing the legitimacy of the Belgians' re quest for additional information on farmland
biodiversity, food web integrity, etc., the Panel s hould bear in mind the full context in which the
request was made, as well as the advice provided by Drs. Snow and Squire.
4.1185 Although the experts indicated that, technically speaking, the Belgian request was justified,
when placed in context, the request should be seen as an attempt to frustrate the approval procedure.
The effects of herbicide use can be managed, and herbicide-tolerant crops provide additional
flexibility in terms of weed control.
4.1186 The product-specific ban for Ms8xRf3 is not "ra tionally connected" to the risks identified in
the risk assessment, contrary to Article 5.1 and by implication Article 2.2. Moreover, a delay of nine
years in approving this product is by any reasonable standard, "undue" in viola tion of Annex C(1)(a).
In terms of Article 5.5, by imposing this ba n, continuously requesting unnecessary information and
seeking to impose onerous monitoring requirements and agricultural practices, the European
Communities is violating Article 5.5.
(c) National bans
4.1187 Canada stands by its previous legal ar guments, which are suppor ted by considerable
documentary evidence, and which demonstrate that the EC member State national bans are SPS
measures, and that they are subject to, and inconsiste nt with, Articles 5.1, 5.5, 5.6, 2.2 and 2.3 of the
SPS Agreement. In contrast, the European Communities has yet to develop a fully coherent legal and
factual argument for each of the measures that would refute Canada's initial prima facie case.
4.1188 Canada has a few additional comments in the light of the advice of the scientific experts and
the European Communities' written comments on those re plies. In brief, the experts' advice largely
reinforces Canada's arguments that the national bans are not supported by sufficient scientific
evidence or a risk assessment, contrary to Articles 2.2 and 5.1 of the SPS Agreement. Furthermore,
the expert advice supports the proposition that Article 5.7, even if it may have been applicable to these
measures at the time they were adopted, did not appl y by the time this Panel was established, and that
it does not apply today.
4.1189
 Oilseed rape Topas 19/2 was approved by the European Communities for import and
processing in April 1998. It has been banned by France and Greece. The experts agreed that no
scientific rationale exists for these measures given that the product was only approved for import and
processing. Although Dr. Andow suggested that Fr ance could have justified its measure in 1998 –

albeit on grounds other than those actually cited by France – he concluded that France and Greece
would have had sufficient data could have made a decision no later than 2001. The European
Communities, in its comments on the experts' replie s, misrepresents the essen tial question that must
be answered. Indeed, France's own scientific expert s did not consider herbicide-tolerant oilseed rape
– when imported for processing purposes – to give ri se to any more risks than conventional oilseed
rape.
4.1190 The experts also agree that the "scientific evidence and other information" provided by France
does not meet the definition of a risk assessment as set out in either the SPS Agreement or the IPPC.
Although Dr. Andow suggests that the documentati on does fall within Annex III of the Biosafety
Protocol, in Canada's view, Annex III does not constitu te an international standard for the purposes of
the SPS Agreement, and is therefore not relevant to a de termination whether the materials submitted
by France meet the requirements of the SPS Agreement.
4.1191 Finally, based on the draft decision it has tabl ed in the Regulatory Committee, the European
Commission shares the view that there is no scienti fic justification for maintaining a prohibition on
the import and processing of oilseed rape Topas 19/2. The conclusion is inescap able that the French
prohibition and the Greek import prohibition on Top as 19/2 is being maintained without sufficient
scientific evidence, contrary to Article 2.2 of the SPS Agreement, is not based on a risk assessment,
contrary to Article 5.1 of the SPS Agreement, and cannot be justified on the basis of Article 5.7
because sufficient scientific evidence exists to complete such a risk assessment.
4.1192 In relation to maize T25, according to Dr. A ndow the emergence of weed resistance was the
only plausible concern raised by Austria. Even th en, it is not clear from the evidence that Austria was
truly concerned about this potential risk. In any ev ent, the reality, as the Eu ropean Communities must
recognize, is that glufosinate ammonium has been remarkably successful in terms of preventing the
emergence of resistance, and herbicide resistance management strategies were well developed by the
late 1990s.
4.1193 T25 has undergone an exhaustive scientific scr utiny. In each and every instance, the
European Communities' own scientific experts ca me to the same conclusion. The European
Communities' evidence cannot be considered an adequa te basis to find that Austria's ban was or is
consistent with either Articles 2.2 or 5.1, or jus tifiable under Article 5.7. Were it otherwise, the
disciplines found in these provisions would be rendered largely meaningless.
4.1194 Finally, with T25 as with other products, the European Commission has tabled a draft
decision asking Austria to repeal the ban prohib ition on maize T25. Evidently, the Commission
shares Canada view that there is no scientific evidence to justify the maintaining the measure.
4.1195 Regarding the Italian ban on maize MON809, MON810, Bt11 and T25, Canada seeks
clarification from the European Commu nities with respect to the ban's current legal status. There is
some evidence that the measure is no longer in effect, but this evid ence is not conclusive. Canada
therefore seeks confirmation from the European Communities (with supporting documentation) that
the Italian measure has been repealed or has otherwise been rendered null and void.
4.1196 Assuming that the measure remains in effect , the absence of evidence to support a national
ban in this case is, if anything, even more pronoun ced as compared to the other product specific bans.
Dr. Nutti was the only expert who addressed the Panel's questions with respect to Italy's national ban.
For each of these maize varieties, she concluded that Italy had sufficient scientific evidence available
to it to complete the risk assessments, and that the information provided to the European Commission
by Italy in support of its measure "did not s upport a temporary prohibition" of MON810, MON809,

Bt11 or T25. In its comments on Dr. Nutti's repli es in relation to the Italian national ban, the
European Communities offers scant scientific eviden ce in its efforts to discredit or contradict her
opinion. It also gets some of the f acts wrong. For instance, it confuses the bla gene, which confers
antibiotic resistance to ampicillin, with the nptII gene. Furthermore, the nptII gene is not present in
the final construct and, in any event, it has a 13-year history of safe use in food and feed.
4.1197 In short, as with the other EC member State national measures, the advice of the experts, and
all other available scientific evidence strongly supports Canada's arguments that the Italian measure is
not based on a risk assessment, contrary to Articles 5.1 and 2.2 of the SPS Agreement. Furthermore, it
seems clear that sufficient scientific evidence exists to complete a risk assessment, and that Article 5.7
therefore is inapplicable.
4. Other issues
4.1198 Canada turns briefly to the European Communitie s' arguments with respect to standard of
review and the definitions provided by international organizations (IOs).
4.1199 In regard to the standard of review, the Eu ropean Communities makes two assertions, neither
of which has any merit. First, the European Communities argues that the Panel should limit its
examination of the scientific evidence and data to th at existing at the time of the measure was put in
place. Second, the European Communities argues that the Panel should take a deferential approach in
its assessment as to whether the Eu ropean Communities has violated Article 1(a) of Annex C. For
each argument, the European Communities misrep resents the proper role of the Panel by
misconstruing and misapplying the language of Article 11 of the DSU and the relevant jurisprudence.
4.1200 First, regarding the temporal issue, the European Communities' reliance on US – Cotton Yarn
is misplaced; the standard of review in safeguard cases is different from the standard of review in SPS
cases. To limit the inquiry to the "state of scientif ic information and data existing at the time the
measure" arose would not enable the Panel to dete rmine whether the measure was justifiable at the
time the Panel was established, contrary to the object and purpose of the SPS Agreement, and
inconsistent with the requirement in Article 11 of the DSU. The reference in Article 2.2 to the
"maintenance" of an SPS measure would lose all meaning, contrary to the principle of effective treaty
interpretation.
4.1201 Second, the European Communities' attempt to cr eate a distinction in the application of the
standard of review as between Ar ticle 5.2 and Annex C1(a) is not supported by the jurisprudence.
The Panel should review the European Communitie s' measures based on how a reasonably diligent
government would and should
 have behaved in view of the fact ual information at its disposal. A
deferential approach to the interpretation and application of Annex C1(a) would not be consistent with
the jurisprudence. In any event, there is no doubt that the European Communities has failed to meet
its procedural obligation under Article 1(a) of Annex C. Accepting that 6.5 years amounts to a
justifiable delay would render A nnex C(1)(a) meaningless; this w ould be inconsistent with the
principle of effective treaty interpretation.
4.1202 In regard to the definitions provided by the IOs, the European Communities asserts that the
definitions support the European Communities' case. Canada disagrees. On their face, the definitions
found in the materials provided by the IOs do not support the European Communities' assertions as to
the meanings of the terms in question. Despite the European Communities' contentions that a GMO
cannot, a priori, be considered as toxins, contaminants, allergens, pests, disease-causing or disease-
carrying organisms, definitions of these terms, or elements of them can all be found in documents that
expressly address biotechnological issues. If the Eu ropean Communities' assertions were correct,

there would be little rationale for these terms to appear in glossaries and international standards
documents pertaining specifically to biotechnology.
4.1203 Furthermore, and in any event, the definitions provided by the IOs are not dispositive of what
the enumerated terms mean in the context of either the SPS Agreement or the TBT Agreement. This is
particularly true of those enumerated terms that appear in these agreements. Terms such as these must
be interpreted in accordance with the customary rules of treaty interpretation, as expressed in
Articles 31 and 32 of the Vienna Convention on the Law of Treaties.
AA. S
ECOND ORAL STATEMENT OF ARGENTINA ON THE EUROPEAN COMMUNITIES' SECOND AND
THIRD SUBMISSIONS
1. The de facto moratorium measure
(a) The measure addressed in these proceedings
4.1204 Referring to the de facto moratorium, which is the lack of any approvals or rejections of any
new agricultural biotech product since 1998, the European Communities has failed to approve a single
application until 2004. Faced with this lack of approvals or rejections, the European Communities has
limited itself to deny the existence of the de facto moratorium or, alternatively, to assert that if such a
measure exists it would not be challengeable unde r WTO Agreements. Argentina has demonstrated
throughout these proceedings that both assertions have no basis.
4.1205 The existence of the de facto moratorium has been recognized by high EC officials with
jurisdiction over the matter addressed in this disput e in a number of opportunities, and this evidence
was put before the Panel. Hence, Argentina will not repeat references to this striking evidence.
4.1206 The de facto moratorium consists in a persistent conduct of the European Communities that
reflects a practice. This pattern of conduct is a compound of acts and omissions that have as effect the
stalling of all applications in the European Communities' approval system. The de facto moratorium
operates at the crucial stages of the procedures unde r EC regulations. Although some applications
have moved within the approval procedures, this movement in no case has resulted in approval or
rejection. This fact lies at the heart of the concept of the de facto moratorium.
4.1207 The European Communities' assertion about the impossibility of challenging the de facto
moratorium under WTO Agreements was rebutted by Argentina in these proceedings. Argentina's
arguments are supported by GATT/WTO jurisprudence and they were explained in its First Written
Submission.
4.1208 Argentina would like to stress that if we were to follow a narrow definition of "measure", it
would result in allowing WTO Members to circumvent legal scrutiny of their measures simply by not
putting them in a piece of legislation. Moreover, it would also devoid WTO law of its meaning.
4.1209 The first of these consequences (circumvention of legal scrutiny) was already referred to in
Argentina's First Written Submission, and even po inted out by third parties in these proceedings.
However, Argentina would like to refer to the second of these consequences (to devoid WTO law of
its meaning).
4.1210 According to Argentina's point of view, from the GATT/WTO jurisprudence arises quite
clearly that one central feature of WTO system is to ensure that Panels and the Appellate Body are
able of scrutinizing all measures regardless the way by which WTO Members may have put them in

place. A narrow definition of "measure" would lead not only to foster the lack of transparency by the
WTO Members but also to deprive panels and the Appellate Body from analysing any measure which
infringes the covered Agreements. Jurisprudence was clear in interpreting GATT/WTO law in a broad
sense, in order to assure that compliance with WT O law would not be circumvented simply because
of the form in which a measure is imposed. Argen tina deems that in the present dispute the European
Communities should not use its own lack of transparency to avoid legal scrutiny of the de facto
moratorium.
(b) Inconsistency of the de facto moratorium with Article 5.1 of the SPS Agreement
4.1211 The European Communities' legislation establis hes that the assessment of biotech products
must be on a "case-by-case" basis. However, th e European Communities has imposed, without any
scientific evidence, an across the board measure to all biotech products in the European Communities'
approval system. Since this measure lacks of an y basis on scientific evidence, it infringes basic
obligations contained in the SPS Agreement. Besides, this de facto moratorium undermines the
European Communities' assertion that it has been assessing the risks on a "case-by-case" basis.
(c) The European Communiti es cannot justify the de facto moratorium under Article 5.7 of
SPS Agreement
4.1212 Argentina considers that the European Comm unities has had sufficient relevant scientific
information at hand, namely the positive opinions issu ed by its Scientific Committees. These positive
opinions constitute sufficient scientif ic evidence in terms of Articles 2.2 and 5.1 and have not been
refuted either by the European Communities or by the experts appointed to assist the Panel.
(d) The de facto moratorium infringes Article 5.5 of SPS Agreement
4.1213 The experts have ratified that the treatme nt given by the European Communities to
agricultural biotech products compar ed with "non-biotech" products is inconsistent with Article 5.5.
This is because it was demonstrated that agricultura l biotech products entail similar risks than those
arising from "non-biotech" products.
2. The "suspension and failure to consider" is not based on scientific evidence, and
therefore violates WTO obligations
4.1214 Regarding Bt 531 cotton
, we believe that the EC's alleged scientific arguments remain refuted
as the evidence submitted by Argen tina has not been contested by other relevant scientific evidence.
As regards the meetings on 17-18 February, the issue affecting Bt 531 cotton has been analysed in a
broader scope, and from the responses from the experts the European Communities cannot invoke any
valid or relevant scientific evidence which could refute the positive scientific evidence arising from
the opinion of the EC Scientific Committee from July 1998.
4.1215 Regarding RRC 1445 cotton
, Argentina considers that the meetings from 17-18 February did
clarify the questions, and confirmed our argument in the sense that there is no scientific evidence
within the information submitted by the European Communities that could refute the positive opinion
by the EC Scientific Committee dated July 1998 which favored the approval of RRC 1445 cotton.
We particularly mention the clarification made by Dr. Squire referred to the alleged possibility of
horizontal gene transfer, confirming Argentina's point.
4.1216 With regard to NK-603 maize, Argentina is pleased that it has been properly addressed by the
experts. We agree with Dr. Andow, when he asser ted that there were no reasons to dismiss the

positive opinion from the European Communities' sci entific committees in the way the European
Communities tried to do in these proceedings. As regards the meetings on 17-18 February, the
original extent and value of the positive opinions by the European Communities' scientific committees
have been clearly established, esp ecially when Dr. Nutti specifically addressed an issue contained in
the positive assessment and which the European Communities tried to turn into an hypothetical
question. Additionally, we also appreciate that the experts did recognize that monitoring is not needed
when the product is intended to be only for import and not for cultivation.
4.1217 With regard to GA 21 maize
, the application was withdrawn in September 2003, and
Argentina states that this withdrawal precisely demonstrates the effect of the de facto moratorium and
the "suspension or failure to consider". GA 21 ma ize did receive a positive scientific assessment both
under Directive 90/220 and under Regulation 258/97. The European Communities did ignore for
years this scientific evidence favouring approval, until the applications were withdrawn.
4.1218 Summing up, Argentina respectfully requests the Panel to find that the "suspension and
failure to consider applications of products of partic ular interest of Argentina" are inconsistent with
the European Communities' WTO obligations.
3. The "undue delay"
4.1219 Article 8 of SPS Agreement establishes two different obligatio ns: the first one refers to the
commitment to comply with Annex C, and the seco nd one establishes the obligation to ensure that
"their procedures are not inconsistent with the pr ovisions of this Agreement". Given the fact that
Argentina has demonstrated that Article 5.1 h as been infringed, the delay in the approval of
agricultural biotech products of interest to Argen tina is not justified, as it is not based on scientific
evidence. Therefore, there is no reason that justif ies the delay. This is without prejudice of the
particular infringement to paragraph a), b), c) and e) of Annex C.1 of SPS Agreement.
4. The member State bans are not based on sci entific evidence, and therefore violate the
SPS Agreement
4.1220 The specific products affected by the measures applied by Germany, Austria, Italy and
Luxembourg had prior approval by the European Communities, based on scientific opinions issued by
the European Communities' own Scientific Committees. These member State bans have ignored this
scientific evidence and maintain restrictions on th e entry of these products into their territories.
Furthermore, some of these countries have attempted to seek protection under safeguard procedures to
try to justify their measures, which has resulted in new scientific opinions issued by European
Communities' scientific committees. These new opinions refuted the grounds for the state measures.
4.1221 The foregoing, as well as the experts' responses, demonstrate the lack of scientific evidence
supporting the measures currently maintained by tho se member states, and confirm the arbitrary and
unjustified distinction made with respect to the a ffected products. For this reason, as in the foregoing
sections, we request that the Panel confirms the inconsistency with the SPS Agreement.
BB. SECOND ORAL STATEMENT OF THE EUROPEAN COMMUNITIES ON THE COMPLAINING
PARTIES' SECOND AND THIRD SUBMISSIONS
1. Delays
4.1222 The central issue in this case is delay. The European Communiti es has resisted the
complaining parties' attempts to present the issue of delay in an oversimplified manner, both on the

factual and the legal level. On facts
, the European Communities has de monstrated that applications
have not been put on hold since 1998, as the compla ining parties initially claimed. It has presented
detailed chronologies that show in all cases valid reasons to delay procedures, while requests for
further information were pending. Scrutiny of indi vidual delays has shown that in the overwhelming
majority of cases there were valid reasons at the origin of these delays. On law , the European
Communities has resisted the complaining parties' atte mpts to translate these individual delays into a
measure which they call "moratorium". The complaining parties' presentation of their "moratorium"
has gradually changed from the description of a ban, to that of a stalling of all procedures to that of
individual delays arising out of the greater scheme, which is the alleged "m oratorium". We are now
in the grotesque situation that the complaining par ties see proof of the existence of the moratorium
even in individual delays which they themselves ac knowledge to be warranted. The Panel has rightly
focused on assessing individual delays.
(a) Burden of proof
4.1223 As regards the individual delays, it is clear that the complaining parties' initial prima facie
claim that all procedures have been stalled ha s been extensively rebu tted by the European
Communities through the individual product historie s presented in its submissions as well as in the
chronologies submitted. It is for the complaining parties to rebut this evidence by putting forward
arguments and evidence as to why the reasons for delays are unjustified, with the consequence of
making the delay undue.
(b) Delays identified as "undue" by the complaining parties
4.1224 Falcon GS40/90, EC 62
: The United States was the only complaining party to include it in its
terms of reference. The only argument raised is that the Commission refused or failed to submit a
draft measure to the Regulatory Committee. The European Communities has already addressed this.
As for the points addressed by the Panel's questio ns, the United States say that the experts were
confirming its claims. The European Communities fa ils to see which claims. In its comments on the
experts' replies, the United States refers back to sections of its supplementary rebuttal where no
mention is in fact made of Falcon.
4.1225 MS8xRF3, EC 63 : Similarly to Falcon GS40/90, the United States, has only challenged the
interim approach (and the fact that the Regulator y Committee was not consulted) as "undue delay".
The European Communities has already addressed these issues. Canada, on the contrary, has analysed
at some length the process. It has repeated the ar guments on the failure to vote, that the European
Communities addressed. It has agreed with some st eps taken, such as an agreed code of good
agricultural practices and a monitoring plan. It has identified a number of requests for information that
it considered problematic. On these, the Panel has asked the views of the experts, whose advice has
yielded a host of divergent views showing that th ese issues are far from settled. For instance, on the
request for further molecular characterisation, the views of Dr. Healy and Dr. Snape diverge
substantially. The European Communities views on th e rationale for these requests is in its comments
on Scientific Advice and it stands by those views, considering that such requests were justified.
4.1226 The Canadian contention that the Belgian A dvisory Council "approved" Ms8xRf3 for import
and processing is wrong. National bodies only provide "opinions"; "approval" or not occur at
Community level. The product is, in fact, currently under evaluation by EFSA for all uses. Canada's
assertion that one objection by Belgium to approval for cultivation is "that coexistence rules are not
yet in force" is misleading. One of this authority' s main concern was about gene transfer, both in wild
relatives and in neighbouring fields. Canada also alle ges that "Belgium rejects the 'interim approach'",
"rebuffing" the notifier attempts to comply. Again, Canada's selective quotations are misleading. A

careful reading of the relevant minutes (EC-63) make s clear that the authority debated about whether
the application should be supplemented. The conc lusion was, however, positive and the application
indeed proceeded. Canada also raises that Belgium has authorized glufosinate for GM crops. As can
be seen, that authorization is for a different use (seed production only) for a different event
(MS1xRF2).Hence the European Communities fails to see the relevance of this fact for this
authorization.
4.1227 Roundup Ready
 Fodder beet A5/15, EC-64 : A5/15 is only within the terms of reference of
the United States. Its claims are all generic and re fer to issues such as the Commission refusal/failure
to submit a draft measure and the application of the "interim approach". The European Communities
has already addressed these. The Panel has addressed a number of points through the scientific
experts, and their advice on these has been rather supportive of further requests by the CAs. Thus,
Dr. Andow has concurred with the Dutch request for a theoretical safety assessment, the Dutch and
UK requests for additional data on molecular characteri sation, and the Italian request for transfer and
recombination of genes in natural conditions, as bei ng relevant for an environmental risk assessment
and not previously addressed.
4.1228 Bt Cotton (531), EC 65 : Both Argentina and the United States have included 531 in their
terms of reference. Their claims are that the Re gulatory Committee failed to vote and the interservice
consultation amounts to the moratorium. Th e European Communiti es has addressed these,
highlighting that the Regulatory Committee faile d to reach a vote because of Member States'
objections related to issues such as ARMG, non-targ et effects and the monitoring plan. Argentina
does not come back to it but just skims thr ough and dismisses some documents without proper
analysis, and limiting its rebuttal to saying that a monitoring plan had already been submitted and
positively assessed. The United States spends some time on this, but provides no argument to counter
the validity of the concerns, and only says that all information had been provided. The Panel has not
reverted to its experts on the scientific justifica tion of these concerns and the European Communities
maintains that they were legitimate and scientifi cally sound, not previously addressed. As for the
remark that the applicant was not requested to s ubmit specific data, requests by other CAs or by the
Community's committees for additional information is automatically transmitted to the applicant. This
being an automatic procedure, no trace is kept of such transmission.
4.1229 Roundup Ready Cotton (RRC1445), EC 66
: As for 531, Argentina and the United States do
not identify specific delay and limit the claims – yet again – to issues such as the Regulatory
Committee failure to vote and the interservice consul tation. In its Supplementary Rebuttal the United
States dismisses the scientific concerns highlighted by the European Communities as "missing the
point" of an undue delay of four years. However, the Panel's experts have considered that the
objections concerning the adequacy of the monitoring plan are scientifically justifiable.
4.1230 Amylogene starch potato, EC 67: The United States was the only one to include it in its terms
of reference. The only argument raised is that the Commission refused or failed to submit a draft
measure. The European Communities has already addressed this issue, highlighting also the concerns
expressed by the SCP on this product. The European Communities notes that three out of four Panel's
experts that provided an opinion on these concerns warranted their scientific validity.
4.1231 Oilseed rape Liberator, EC 68
: Yet another product include d only within the terms of
reference of the United States, for which it has not put forward claims apart from the usual allegation
that the Commission refused to submit a draft m easure. Once again, the European Communities has
addressed this issue. It explained that this application was subject to a number of objections related to
issues such as molecular characterisation, compositional analysis and long term environmental effects.
The European Communities also highlighted current issues raised by the lead CA on molecular

characterisation and post marketing monitoring pl an. The Panel has not considered necessary to
assess whether these concerns were scientifically justified or not. The European Communities
therefore maintains that these were legitimate and scientifically sound concerns.
4.1232 Maize Bt 11, EC 69
: The United States has raised a number of claims here. Apart from the
Commission's alleged failure to submit a draft measure, the United States has also alleged a two years
and a half delay after the SCP's opinion. The European Communities has dealt with both claims,
highlighting that the applicant has still to subm it the surveillance plan requested in 2000. The
argument that such plan is only to be applied after commercialisation is beside the point. If it is true
that it will only be applied after commercialisatio n, it nonetheless needs to be submitted before
authorization, with all information necessary to be properly assessed. As with regard to the US claims
that concerns on compositional analysis, biogeochemistry, ecological effects, weediness, are
unfounded and already addressed, the European Comm unities contests this. The Panel has not asked
to assess whether these concerns are scientifically justified or not. The European Communities,
therefore, sustains that these were legitimate and scientifically sound concerns.
4.1233 Oilseed rape GT73, EC 70
: On GT73, the United States claims that the Member States
opposed it on the basis of the need for legisla tion on traceability, labelling and coexistence. Canada
appears to identify an overall delay of forty-tw o months, plus a number of "unreasonable or [ ]
unjustified questions or objections". The European Communities stands by the arguments it has put
forward and notes that some concerns arisen in th is application (molecular characterisation, feeding
studies, monitoring plan) have been taken up in the Pa nel's questions to the experts, which have given
a rather positive assessment of th ese concerns. For the others, th e European Communities maintains
its position that these were either legitimate a nd scientifically sound concerns or regulatory
requirements outside the scope of this dispute (traceability and labelling).
4.1234 Bt corn Cry1F (1507), EC 74
: The United States identifies here four requests for additional
information which it claims are not justified and cause undue delay. The European Communities
notes that none of these have been raised for a nother application for the same product (EC 75). The
United States claims that, apart that Member States blocked it, they opposed the application for the
need for legislation on traceability, labelling and co existence. The Europ ean Communities has dealt
with these claims, highlighting a number of issues identified both by the lead CAs and by other
Member States with regard to molecular characteri sation, allergenicity and toxicity, environmental
effects, monitoring effects, sampling and detecti on methods. The United States claims that some of
these concerns (whole food studies, safety assessment, non-target organisms, protein analysis) are
unfounded. Some of these have been taken up to the experts, which gave a rather positive assessment.
For the others, the European Communities maintain s that these were either legitimate and sound
concerns or regulatory requirements outside the scope of this dispute (traceability and labelling).
4.1235 Nk 603, C/ES/00/01, EC 76
: The United States raises issues which, in its view, support an
undue delay. The United States claims that the a pplication remained at Member State level for
25 months. Acknowledging several requests for informa tion, the United States dwells on the fact that
12 were spent by the CA to assess the information re ceived. The US' idea that a CA is to immediately
digest and process information which the applicant h as taken 13 months to gather, is somewhat naive.
The United States refers to delays occurring at the Community procedure. The European
Communities points out that the procedure is set out in the legislation which the complaining parties
have not attacked. The United States refers to two requests for information it considered to be invalid,
causing in their opinion undue delays. One is an Au strian request for data and studies on subchronic,
mutagenic, reproductive and ecotoxic effects. This has not been addressed by the Panel's experts.
The European Communities disagrees that that request was "unfounded and unreasonable." The
European Communities notes that Austria's requ est was broader, covering central issues

(compositional analysis, molecular characterisation), th e scientific validity of which the United States
has not contested. The other request is from Spai n, to use PCR to screen for putative random
insertions of fragments and possible transcription. This was covered by the Panel's Question 38, but
no expert replied. The European Communities re fers to its comments on the experts replies and
which explain why this request was scientifically valid.
4.1236 Roundup Ready Corn GA (21) EC 78 and 85
: The United States admonishes certain delays at
the Member State level conveniently omitting that ther e were numerous requests for information. All
the requests identified by the United States have be en covered in the Panel's Questions 40 & 40bis.
These have been extensively discu ssed by the experts and the European Communities refers to
paras. 476ff of its own comments on the experts repli es, in which it explains that these requests were
scientifically reasonable.
4.1237 MaisGuard x Roundup Ready (MON810 x GA 21), EC 82: The United States identifies some
delays that occurred at Member State level. These can be explained: one of the parents of this hybrid,
GA 21, had not been assessed yet and the CA w as awaiting the assessment. Whether a safety
assessment for a hybrid can be put on hold while the assessment of the parental lines is awaited was
not discussed by the experts. However, it w ould seem obvious that the hybrid cannot be assessed
conclusively as long as one of its parental events' assessment is still open.
4.1238 GA 21, Food Use, EC 91
: The United States raises some arguments for "undue delay" in this
application. The European Communities has alread y replied to most of them, and notes that the
United States seems to be raising a scientific issu e, which has not been addressed by the experts,
about a comment by the Greek CA concerning toxic ity tests of the whole product, and not only the
protein. It is merely an observation from Greece that no such data exist, but not a suggestion or
request to perform the tests. The European Communities fails to see how that observation could
caused delay whatsoever. It would seem that the United States has singled out this comment on an
arbitrary basis.
4.1239 Bt Sweet Corn, EC 92
: The United States and the Eur opean Communities disagree on the
nature of comments and objections made. However, i rregardless of whether one would call them risk
assessments or not, they were based on valid and reasonable scientific reasons, a fact which the
United States does not contest. The United States addresses some requests for information on
compositional analysis and substan tial equivalence. These requests are not covered by the Panel's
questions and the European Communities disagrees with the United States on the scientific validity of
these requests.
4.1240 MaisGuard (MON810) x RoundupReady (GA 21), EC 94
: The United States raises two
issues on EC 94. One is a delay due to the uncom pleted assessment of GA 21, one of the parental
lines. As discussed for EC 82 (release into the e nvironment, same hybrid), this question was not
discussed by the experts, and the comment on the n ecessity of hybrid's parental assessment still
applies. The second issue is a request for a whole food study in mice. This was addressed by the
Panel's Question 44 and discussed by the experts. The European Communities refers to its comments
on the experts' replies at paras. 555ff. It ma intains that such studies were necessary to assess
unintended effects caused by possible additional DN A fragments, and that the request was made on
valid grounds. Therefore, the delay caused by it cannot be considered "undue."
4.1241 Roundup Ready corn NK 603, Food Use, EC 96 : The United States takes issue with certain
procedural delays that occurred at Community leve l, which are due to the way the procedure is set
out. The European Communities has already comme nted on this on previous applications. The
United States also challenges certain requests for in formation as invalid. These have been covered by

the Panel's Questions 53 and 54. The European Co mmunities refers to its comments on the experts'
replies at paras. 615ff, in which it explains why these requests were scientifically valid.
(c) Assessment of delays under the different claims made by the complaining parties
4.1242 Annex C 1(a) of the SPS Agreement
. As regard the individual product claims made, on a
possible violation of Annex C 1(a), first , to the extent the products for which the complaining parties
have alleged "undue delays" ar e withdrawn or have been authorized since, the claim is sans objet. In
this respect we refer to our comments later on mootness. Second , a delay is not undue if and to the
extent it has occurred for a number of reasons, of which at least one is clearly valid. This is very clear
from the text, which states: "Members shall ensure w ith respect to any procedure to check and ensure
the fulfilment of sanitary or phytosanitary measu res, that: (a) such procedures are undertaken and
completed without undue delay". It is not any cause of delay that is prohibited but undue delay in the
undertaking and completion of procedures . If the procedure cannot be completed for some reason
other than the factor under consideration, ther e is no violation of this provision. Third , nobody
contests at this stage that the scientific knowledge on possible harm ful effects of GMOs is still
insufficient. The experts have painted the picture of a rapidly evolving, in parts highly controversial
scientific debate and it is against this background that they – without always agreeing- have confirmed
the justification for, but sometimes also criticised certain requests for additional information. It is
against this background that Canada and the United States are proposing to apply the requirements of
Article 5.7 of the SPS Agreement when assessing what is undue and what not. However, Article 5.7,
just like Article 5.1, does not apply to a failure to act. The European Communities agrees that the
precautionary principle is to be taken into account when assessing "undueness" in paragraph 1(c) of
Annex C. As the Appellate Body has made clear in EC – Hormones: "there is no need to assume that
Article 5.7 exhausts the relevance of a precautionary principle". Fourth, there has been considerable
debate on "mixed delays," i.e. delays relatin g to concerns that cannot be assessed under the
SPS Agreement but need to be assessed under another ag reement. Notwithstanding the European
Communities' position on the scope of the SPS Agreement, the complaining parties' argument that:
"Nothing in the text of the SPS Agreement suggests, as the European Communities contends, that a
Member is excused from this obligation if the dela y stems from a consideration outside the scope of
the SPS Agreement." misses the true point: if a non-SPS con cern is legitimately delaying completion
of a mixed SPS/non-SPS approval procedure, then that procedure is not "unduly delayed" within the
meaning of the SPS Agreement. If WTO Members are allowed to have approval procedures covering
SPS and non-SPS concerns (and no-one has said they cannot), it cannot be that WTO Members are
obliged to approve products which come within the scope of the SPS Agreement when there are non-
SPS concerns outstanding. In any event, all concer ns reflected in requests for additional information
were scientifically valid and reasonable.
4.1243 Delays and "de facto moratorium". The Panel's experts ha ve confirmed most concerns raised
by CA as valid. Where they have not done so, the experts have acknowledged that the authorities'
cautious approach was certainly valid or legitim ate in the context of the complex and difficult
scientific issues raised at the time. Faced with this, the United States abandons logical reasoning and
now invites to "put this all back in context, a nd to use common sense", but the reality is that the
examination of individual measures is logical ly inconsistent with the existence of an a priori
moratorium. The complaining parties started off this case thinking that they could attack in WTO
dispute settlement the fact that GMOs are what th e United States has called "a controversial political
issue in the EC". However, public opposition and political perceptions are not regulated by the WTO
Agreement and are not the proper subject of dispute se ttlement. Nor of course is the voting behaviour
or the "intransigence" of any individual political actor. If they were, panels would be constantly
discussing the internal workings of WTO Members. On the contrary, it is necessary to identify a
measure within the meaning of the DSU and demons trate that that measure is contrary to a WTO

obligation. The reality is that the European Communities has adopted legislation to regulate GM
products (legislation that is not itself the subj ect of these proceedings) and has examined the
applications that it has received.
2. Mootness
4.1244 The Panel is competent to consider those me asures which were in effect in August 2003,
including the Member State safeguard measures. Bu t a measure can only be in effect in August 2003
in respect of a product application that remains " live". For those products which had been withdrawn
by that date a measure can no longer be considered to be in effect. The United States appears to
accept that proposition.
4.1245 The same principle must apply where a measure ceases to be in effect after the Panel has been
constituted, for example because the product has been withdrawn or has been approved. In such
circumstances the application is sans objet. It is not the European Communities' position that in such
circumstances the Panel is bound
 not to consider the measure. Cons istent with international practise,
including that of the International Court of Jus tice, there is no longer any utility in considering a
measure which ceases to be in effect because there does not exist, in respect of that measure, a dispute
between the Parties. In such circumstances courts d ecline to proceed to consider such measures. The
reason relates to the absence of any remedy which can be ordered. That is particularly pertinent in the
context of the WTO DSU: how is a member to implement a Panel recommendation in respect of a
measure which is no longer in effect?
V. ARGUMENTS OF THE THIRD PARTIES
5.1 The arguments of the third parties, Australia, Chile, China, New Zealand and Norway are set
out in their written and oral submissions to the Panel and in their answers to questions. The third
parties' arguments as presented in their submissions are summarized in this section.
125
A. THIRD PARTY ORAL STATEMENT OF AUSTRALIA
1. Introduction
5.2 As a third party to this dispute, Australia welcomes this opportunity to present its views to the
Panel.
5.3 The Panel has an important and challenging task in front of it. The first written submissions
of the principal parties have raised a wide range of complex factual, scientific and legal issues, which
may, or may not, be pertinent to the Panel's resolution of the dispute. The issues raised include:
• the nature of risks associated with biotech products and relevant approaches to risk
assessment;

• the legal characterisation of the contested measures;

• whether these measures are subject to the WTO covered agreements, and if so, which
provisions are applicable;

125 The summaries of the third parties' argume nts below are based on th e executive summaries
submitted by the third parties where the third parties made available such summaries to the Panel.

• whether the European Communities has act ed inconsistently with any of the
applicable WTO provisions; and

• the relevance, if any, to the Panel's de liberations of the European Communities'
extensive references to the Biosafety Protocol and to the concept of precaution as
reflected in legal texts other than the WTO covered agreements.

5.4 These issues clearly have a systemic dimension as well.
5.5 Given the facts and circumstances of this dispute and the obvious care and attention taken by
the complaining parties in framing their legal claims and arguments narrowly, Australia is of the view
that the Panel should adopt a measured appro ach and limit its rulings and recommendations
accordingly. Australia notes that the Panel has cons iderable discretion to exercise 'judicial economy'
in making an objective assessment of the matter before it, and in making its recommendations and
ruling.
126
5.6 Whatever approach is adopted by the Panel in making its objective assessment, Australia has
a substantial interest in the matter before the Panel, particularly in relation to the interpretation and
application of the cited provisions of the covered ag reement, and in any consideration by the Panel of
any legal claims and arguments regarding the relationship between the WTO Agreement and any
other international laws or standards that may be considered relevant.
5.7 Given these interests, which we would expect ar e shared by other third parties, Australia
would expect the Panel to provide all third parti es with the fullest possible opportunity to express
views on any specific issue of law or legal interpretati on considered by the Panel to be relevant to the
resolution of the dispute.
5.8 Accordingly, Australia requests the Panel to ensure that all third parties are given an
opportunity to respond in writing to all relevant wr itten questions presented to the parties following
this meeting, as well as to any relevant subsequent written questions that might be raised at a later
stage in the proceedings.
2. Australian interests
5.9 I would like to expand on the issues of interest to Australia.
5.10 Australia has a strong interest in any assess ment by the Panel of the applicability and
interpretation of the provisions of the SPS Agreement raised by the parties (Articles 1, 2, 5, 7, 8 and
10, and Annexes B and C). Areas of particular interest to Australia, should the Panel consider these to
be of any relevance to the resolution of the dispute, are the scope of the SPS Agreement and its
applicability to the contested measures, and the relatio nship of Article 5.7 with other provisions of the
SPS Agreement or with any other relevant agreements.
5.11 Australia also has a strong interest in any assessment by the Panel of the applicability and
interpretation of the provisions of the TBT Agreement (Articles 2, 5 and 12) and of the GATT 1994
(Articles III and XI) which have been raised by the pa rties. Areas of particular interest to Australia,
should the Panel consider these to be of any releva nce to the resolution of the dispute, include the
scope and application of the TBT Agreement in general, and of the term "like products" under the
relevant TBT and GATT provisions in relation to biotech products.

126 Appellate Body Report, US – Wool Shirts and Blouses, page 18.

5.12 Finally, in relation to the European Commun ities' extensive references to the Biosafety
Protocol and to the concept of precaution as reflected in non-WTO legal texts, in Australia's view the
matter before the Panel can be resolved solely by reference to the WTO covered agreements. Given
the facts of this dispute, there is no need for th e Panel to consider the applicability of such non-WTO
legal texts. Of particular relevance is the fact that none of the three complaining parties are parties to
the Biosafety Protocol.
5.13 However, should the Panel consider the Biosafety Protocol or non-WTO reflections of the
concept of precaution to be of any relevance to the resolution of the dispute, Australia has a strong
interest in ensuring that its views on these issues be taken into account.
3. Third party participation rights
5.14 I want to conclude by registering clearly with the Panel Australia's expectation that all third
parties will be provided with the fullest possible opportunity to express views on specific issues of
law or legal interpretation considered by the Panel to be relevant to the resolution of the dispute. As
noted earlier, Australia expects this view is shared by other third parties.
5.15 Article 10 of the DSU requires the Panel to ensure that the interests of third parties are fully
taken into account during the Panel process. At this point in the process, an extraordinarily wide
range of factual, scientific and lega l issues have been raised. It is also apparent that the fundamental
nature of the dispute and legal claims is vigorous ly contested; this is most clearly indicated in
paragraph 11 of the European Communities' first written submission which purports to reserve the
right to provide a "a full refutation of the Complainants first written submission" for its second written
submission. Given this situation, it is simply not possible for third parties to determine which of these
issues will be the subject of an objective assessment by the Panel, and it would be unproductive for
third parties to present views on the full range of issues on a completely speculative basis.
5.16 Against this background, Australia has theref ore not presented any substantive views on the
wide range of factual, scientific and legal issues ra ised by the principal parties. Instead, we have
sought to identify issues on which Australia wishes to present its views, in the event those issues are
considered by the Panel to be relevant to the resolu tion of the dispute. As indicated earlier, given the
circumstances in this dispute, the most appropria te approach for the Panel to take into account
Australian and other third party interests under the c overed agreements is to provide third parties the
fullest possible opportunity to provide responses to any written questions presented to the parties
following this meeting, as well as to any subsequent qu estions that might be raised at a later stage in
the proceedings. This approach is within the Panel's discretion and is fully consistent with relevant
DSU provisions, such as Articles 10 and 13.
127)
B. THIRD PARTY ORAL STATEMENT OF CHILE
5.17 Chile is grateful for the opportunity to express its views in this dispute. We are motivated by
a genuine interest in the discussion of this subject matter in respect of which my country, like many
other developing countries, is currently developi ng a national policy. We also have a systemic
interest in the proper interpretation and applica tion of the provisions of the WTO agreements, in
particular the SPS Agreement, the TBT Agreement, and the GATT 1994.
5.18 The purpose of this statement is to provide the Panel with certain items of information
regarding the objectives of a biotech policy in a c ountry like Chile. We recognize that the work of

127 Appellate Body Report, US – FSC (Article 21.5 – EC), para. 243.

this Panel is determined by its terms of reference, and specifically, by the legal provisions which
Argentina, Canada, and the United States consider to have been violated by the measures adopted by
the European Communities. Howeve r, we cannot simply disregard the possible implications of a
ruling like the one that has been requested for the developing countries that are currently drawing up
their policies and legislation in that area.
5.19 The development of a biotech policy is seen by Chile as a way of main taining and enhancing
the competitiveness of certain economic sectors that rely on scientific and technological innovation,
such as the agricultural, forestry and aquaculture sectors. Indeed, modern biotechnology would help
to improve competitiveness by fostering the protect ion and preservation of genetic material while at
the same time paving the way to involvement in areas such as biomedicine.
5.20 All of this calls for an appropriate regulatory framework, one that would consolidate the role
of public institutions with legal authority in the bi otech area. At the same time, there is a need for
coordination among these agencies and proper cons ultation with civil society, for adequate
entrepreneurial institutions, and for scientific and technological capabilities and the capacity to train
human resources.
5.21 For all of these reasons, Chile is highly interested in the systemic implications of the WTO
consistency of product approval me asures within the European Union. In particular, we are
concerned by the failure to approve the release of biotech products since 1998, in spite of the
existence of Community legislation in that r espect (Directive 90/220, replaced by 2001/18).
Likewise, we are concerned by the bans on the re lease of biotech products in certain EC member
States that would appear to be inconsistent with Co mmunity legislation. Finally, we are interested in
the relationship between the failure to approve th e applications for entry with the new Community
legislation on traceability and labelling of biotech products.
5.22 Mr Chairman, let me turn to the two unsolicite d submissions received by the Panel from third
parties that are not party to this dispute.
5.23 I begin by stressing that there is no provision under the DSU that enables panels to accept
unsolicited and unwanted information. The Appellate Body has ruled on this issue in the past, but that
does not constitute a precedent. On the contrary , most WTO Members expressed their opposition to
this kind of submission at a special meeting of the General Council at the end of 2000. On that
occasion, participants reaffirmed the intergovern mental nature of the Organization on which the
participation of Members rests, particularly unde r the DSU. Chile and the other Members represent a
national stance which, as a rule, has been develope d taking account of all of the sectors and interests
involved. Chile cannot negotiate – or seek the settlement of a dispute – with each one of these
interests separately. Nor can the other Members ne gotiate with the Chilean actors separately. We
assume that the national position of a Member is re flected in its submissions, arguments and defence,
and that these do not represent the vision of certain sectors only.
5.24 Secondly, the rights and obligations of Members can only be modified by consensus
following a formal negotiation process such as the one that has been conducted since the Doha
Ministerial Declaration, in which, once again, th e opinion of the majority of Members was that the
participation of non-governmental third parties in WTO disputes should be rejected.
5.25 Thirdly, the developing countries already suffer from serious limitations during the dispute
settlement process: for example, it is not easy for them to meet deadlines, or to deal with the
formalities and other procedures, not to mention th e growing complexity of the subjects submitted to

the mechanism and of the arguments of the disputin g parties. Having to examine and reply to the
questions raised in third-party submissions further increases the already considerable burden.
5.26 Finally, we understand that the Panel has cons ulted with the Parties on the possibility of
requesting an expert opinion on certain issues raised in this dispute, in accordance with Article 13 of
the DSU. Regardless of whatever position the dis puting parties may have concerning the wisdom or
appropriateness of such an expert opinion, we think that this is the only path to follow.
5.27 Chile respectfully requests the Panel to take these views into consideration when deciding on
the issue raised by Argentina, Canada and the United States.
C. T
HIRD PARTY WRITTEN SUBMISSION OF CHINA
1. Introduction
5.28 Although this dispute raise a host of issues that are important to the operation of the
SPS Agreement, TBT Agreement and GATT 1994, the application of Article 5.7 of the SPS Agreement
and the likeness of biotech products and non-biotech products under Article III: 4 of the GATT 1994
call for close attention and analysis by the Panel.
2. China's view on Article 5.7 of the SPS Agreement
5.29 China believes that "insufficient scientific evid ence" referred in Article 5.7 does not imply
that Article 5.7 can be invoked without risk assessm ent, but merely that su ch an assessment can be
made on the basis of factors, which would not fu lfil the Article 5.2 risk assessment requirements.
Thus, the application of Article 5.7 will depend not only upon the natu re of the risk, but also the
nature of the risk assessment. In order to prove "relevant scientific informat ion is insufficient" the
following two criteria must be met:
(1) There is a risk assessment for the subject goods; and
(2) Available pertinent information falls s hort to complete the examination of the
risk factors listed in Article 5.2 of the SPS Agreement.
5.30 In EC – Hormones , the Appellate Body states that risk factors listed in Article 5.2 are not
exclusive.
128 In this case, traceability could be a risk fact or to be considered under Article 5.2 of the
SPS Agreement. Before European Communities passed its Regulation 1830/2003, the available
pertinent information could be insufficient to ex amine traceability of biotech products. Only after
European Communities passed its regulation on traceability and labelling a more objective assessment
of risk can be completed.
5.31 Article 5.7 requires the measure to be adopt ed "on the basis of available pertinent
information". In China's view, "available pertin ent information" includes not only scientific
information, but also all information having logical relevance to this matter. The words "including" in
Article 5.7 indicates that information "from the re levant international organizations" and "from SPS
measures applied by other members" is not exhausti ve in nature. Thus, in this case, the panel may
consider background of so-called product-specifi c delay and the EC member State safeguard
measures as a whole to determine whether European Communities or the EC member State adopted it
on the basis of available pertinent information.

128 See Appellate Body Report, EC – Hormones, para. 187.

5.32 In Japan – Agricultural Products II, the Appellate Body stated that the additional information
sought must be germane to conducting a more objective risk assessment.
129 China believes that such
additional information may not be narrowly interpreted as scientific information only. In this case, the
European Communities' legislation process on biotech products could be consid ered as one aspect of
the information collection.
5.33 The Appellate Body in Japan – Agricultural Products II , stated that "what constitutes a
'reasonable period of time' has to be established on a case-by-case basis and depends on the specific
circumstances of each case, including the difficulty of obtaining th e additional information necessary
for the review and the characteristics of the provisional SPS measure".130
5.34 China is of the opinion that "reasonable period of time" depends on the capability of a WTO
Member to obtain additional information. For instance, to obtain the same information to conducting a
more objective risk assessment, a developing country with less research ability is more likely to take
longer period of time than developed countries. In this case, GMO technology is at the frontiers of
science, and each WTO Member, including European Communities, may not have capability to obtain
additional information to conduct a more objective risk assessment at current stage. Thus, in order to
obtain such additional information, longer period of time may be considered reasonable.
3. Biotech products and non-biotech products are not "like products" under Article III: 4
of the GATT 1994
5.35 China is of the opinion that biotech products are not like products of non-biotech products. In
EC – Asbestos , the Appellate Body identified four gene ral criteria in analysing "likeness" under
Article III:4: (1) the properties, nature and qualit y of the products; (2) the end-uses of the products;
(3) consumers' tastes and habits; and (4) the tariff classification of the products. 131 And none of them
alone is determinative, all of the evidence, taken as a whole, must be weighted.132
5.36 First, when the panel considers the physical a nd natural similarity of biotech products and
non-biotech products, the anti-natural character of bi otech products must be given more weight in
evaluation. "Genetically Modified Organism (GMO)" is defined as an organism, with the exception of
human beings, in which the genetic material has been altered in a way that does not occur naturally by
mating and/or natural recombination .133 (emphasis added) Even the term "biotech products" is use
instead of GMO, the panel shall bear in mind thr ough its analysis that biotech product does not occur
naturally by mating and/or natural recombination.
5.37 Second, in EC – Asbestos , the Appellate Body noted that: "Although we agree that it is
certainly relevant that products ha ve similar end-uses for a 'small num ber of … applications', or even
for a 'given utilization', we think that a panel must also examine the other, different end-uses for
products".134 (emphasis original) There are some unique characters for biotech products intertwined
with its end-use, such as insect -resistance, pesticide-tolerance. Those differences should not be
ignored by this panel, on the contrary, this panel shall give more weight on the unique character of
biotech products.

129 See Appellate Body Report, Japan – Agricultural Products II, para. 92.
130 See Appellate Body Report, Japan – Agricultural Products II, para. 93.
131 See Appellate Body Report, EC – Asbestos, para. 101.
132 See Appellate Body Report, EC – Asbestos, para. 103.
133 See Article 2 of Directive 2001/18.
134 See Appellate Body Report, EC – Asbestos, para. 119.

5.38 Third, the consumers' tastes and preferences in Europe, which are unfavourable towards
biotech products, shall be taken into consideration by this panel to conclude biotech products are not
like products of non-biotech products.
5.39 Finally, because commercial applications of biotechnology came into being in 1990s, it is
understandable that there is no distinction under ta riff classification between biotech products and
non-biotech products. However, the labelling requirements set forth in new legislations, such as
Regulation 1830/2003, show a tendency to separ ate biotech products from non-biotech products.
Therefore, no differences under tariff classification between biotech and non-biotech products shall be
given little practical weight.
5.40 In sum, China believes that the factual evidence relating to each of the four criteria makes it
clear that biotech products and non-biotech products must not be considered to be "like products".
D. T
HIRD PARTY ORAL STATEMENT OF CHINA
5.41 Mr. Chairman and members of the Panel, on beha lf of China, I would like to thank you for
providing the opportunity to present our views. Today, I will focus on two key issues in this dispute.
The first issue is the requirement to invoke Article 5.7 of the SPS Agreement; the second issue is the
"likeness" of biotech products and non-biotech products.
5.42 Article 5.7 permits Members to adopt provisi onal SPS measures where relevant scientific
evidence is insufficient. China be lieves that "insufficient scientific evidence" referred in Article 5.7
does not imply that Article 5.7 can be invoked with out risk assessment. In or der to prove "relevant
scientific information is insufficient" two criteria mu st be met: (1) There is a risk assessment for the
subject goods; and (2) available pertinent information falls short to complete the examination of the
risk factors listed in Article 5.2 of the SPS Agreement.
5.43 Article 5.2 lists seven risk factors that shall be considered. In EC – Hormones, the Appellate
Body states that risk factors listed in Article 5.2 ar e not exclusive. In this case, traceability could be a
risk factor to be considered under Article 5.2 of the SPS Agreement. Before the European
Communities passed its Regulation 1830/2003 , the available pertinent information could be
insufficient to examine traceability of biotech products.
5.44 Pursuant to the second sentence of Article 5.7, a provisional measure may not be maintained
unless the Member which adopted the measure seeks to obtain additional information necessary for a
more objective assessment of risk. China believes that such additional information may not be
narrowly interpreted as scientific information onl y. In this case, the European Communities'
legislation process on biotech prod ucts could be considered as one aspect of the information
collection.
5.45 Article 5.7 requires the Member to review the SPS measure within a reasonable period of
time. The Appellate Body in Japan – Agricultural Products II stated that "what constitutes a
'reasonable period of time' has to be established on a case-by-case basis and depends on the specific
circumstances of each case, including the difficulty of obtaining th e additional information necessary
for the review and the characteristics of the provisional SPS measure".
5.46 China believes that "reasonable period of time" depends on the capability of a WTO Member
to obtain additional information. For instance, to obtain the same information to conducting a more
objective risk assessment, a developing country with less research capability is more likely to take
longer period of time than developed countries. In this case, GMO technology is at the frontiers of

science, and each WTO Member, including European Communities, may not have capability to obtain
additional information to conduct a more objective risk assessment at current stage. Thus, in order to
obtain such additional information, longer period of time may be considered reasonable.
5.47 As regard to Article III:4, China is of the opi nion that biotech products are not like products
of non-biotech products. In EC – Asbestos, the Appellate Body identified four general criteria in
analysing "likeness" under Article III:4: (1) the proper ties, nature and quality of the products; (2) the
end-uses of the products; (3) consumers' tastes an d habits; and (4) the tariff classification of the
products. And none of them alone is determinative, all of the evidence, taken as a whole, must be
weighted.
5.48 First, when the Panel considers the properties, nature and quality of the products, the anti-
natural character of biotech products must be given more weight in evaluation. "Genetically Modified
Organism (GMO)" is defined as an organism, w ith the exception of human beings, in which the
genetic material has been altered in a way that does not occur naturally by mating and/or natural
recombination. (emphasis added) Even the term "biotech products" is use instead of GMO, the panel
shall bear in mind through its analysis that biot ech product does not occur naturally by mating and/or
natural recombination.
5.49 Second, in EC – Asbestos, the Appellate Body noted that: "Although we agree that it is
certainly relevant that products ha ve similar end-uses for a 'small num ber of ... applications', or even
for a 'given utilization', we think that a panel must also examine the other, different end-uses for
products. There are some unique characters for biotech products intertwined with its end-use, such as
insect-resistance, pesticide-tolerance. Those differe nces should not be ignored by this panel, on the
contrary, this panel shall give more weight on the unique character of biotech products.
5.50 Third, the consumers' tastes and preferences in Europe, which are unfavourable towards
biotech products, shall be taken into consideration by this panel to conclude biotech products are not
like products of non-biotech products.
5.51 Finally, because commercial applications of biotechnology came into being in 1990s, it is
understandable that there is no distinction under ta riff classification between biotech products and
non-biotech products. However, the labelling requirements set forth in new legislations, such as
Regulation 1830/2003, show a tendency to separate biotech products from non-biotech products.
Therefore, no differences under tariff classification between biotech and non-biotech products shall be
given little practical weight.
5.52 Mr. Chairman and members of the Panel, China believes that the factual evidence relating to
each of the four criteria makes it clear that biot ech products and non-biotech products must not be
considered "like products".
E. T
HIRD PARTY WRITTEN SUBMISSION OF NEW ZEALAND
1. Introduction
5.53 The Panel in this dispute is asked to dete rmine whether certain measures adopted by the
European Communities affecting the appr oval and marketing of biotech products 135 meet the
requirements of the SPS Agreement. New Zealand is one of many WTO Members that has exercised

135 New Zealand uses this term throughout the submission in the same sense as it is used by Canada.
See first written submission of Canada, para. 27.

its right under the SPS Agreement to adopt measures to regulate the entry and release of new
organisms, including genetically modified orga nisms, necessary for protection from any adverse
effects of those organisms. The SPS Agreement guarantees to WTO Members the right to take
measures for the protection of human, animal and plant life or health.
136 The complaining parties in
this dispute do not contest that right.137
5.54 However, sanitary and phytosanitary measures adopted by WTO Members are subject to the
disciplines set out in the SPS Agreement.138 Those disciplines seek to en sure that such measures do
not restrict trade unnecessarily. At issue in this dispute is whether the European Communities has
complied with those disciplines.
5.55 As both a significant producer and exporter of agricultural products, New Zealand has a
strong interest in ensuring that the delicate balance of rights and obligations set out in the WTO
Agreements, especially the SPS Agreement, is maintained.
5.56 This dispute raises a number of specific i ssues regarding the interpretation of the
SPS Agreement upon which New Zealand will comment. This submission will first argue that the
European Communities' moratorium a nd its product-specific marketing bans
139 are "measures" within
the meaning of the SPS Agreement and thus are subject to scrutiny for compliance with the disciplines
of the SPS Agreement. Second, this submission will discu ss the procedural requirements that
Members must comply with in adopting sanitary and phytosanitary measures, particularly under
Articles 7 and 8 of the SPS Agreement. And third this submission will comment on issues relating to
the right of Members to adopt measures in accordance with the SPS Agreement and to determine their
appropriate level of protection from risks to human, animal or plant life or health under the
SPS Agreement.
5.57 Insofar as the European Communities' product-speci fic marketing bans may not be subject to
the provisions of the SPS Agreement, the TBT Agreement would apply as argued in the alternative by
Canada and Argentina. New Zealand has c hosen not to address arguments concerning the
TBT Agreement in this submission, but reserves the right to do so in the Third Party Session of the
Panel.
5.58 Given the limited time that New Zealand has ha d to consider the first written submission of
the European Communities
140, New Zealand reserves the right to make any further comment on it
during the Third Party Session of the Panel. New Zealand will not comment on the European
Communities' presentation in Part II of the European Communities' submission ("Factual Part"),
including the European Communities' presentation of aspects of New Zealand's legislation or policy
which are not in issue in this dispute.141

136 Article 2.1.
137 First written submission of the United States, para. 68; first written submission of Argentina,
para. 195.
138 Article 2.1.
139 New Zealand uses the terms "moratorium" and "product-specific marketing bans" in the same sense
as they are used by Canada. See first written submission of Canada, para. 1. New Zealand will not address issues
relating to the national measures adopted by particular EC member States.
140 First written submission of the European Communities.
141 This should not be read, however, as endorsi ng the EC representation of any aspect of New
Zealand's policy or legislation.

2. Legal arguments
(a) The moratorium and product-specific marketi ng bans are "measures" for the purposes of the
SPS Agreement
5.59 Annex A paragraph 1 of the SPS Agreement defines what are "sanitary or phytosanitary
measures" and are therefore subject to the provisions of the SPS Agreement. What distinguishes
sanitary and phytosanitary measures from other meas ures that affect international trade is their
purpose, that is, they seek to provide protection from certain sanitary and phytosanitary risks.
5.60 Sanitary or phytosanitary measures include, inter alia, measures applied to protect plant life
from risks arising from the entry, establishment or sp read of pests, and measures applied to protect
human or animal life or health from risks ar ising from contaminants, toxins or disease-causing
organisms in foods, beverages or feedstuffs . The evidence of the complaining parties
142 shows that
the European Communities' regulatory approvals processes have been adopt ed by the European
Communities for the purpose of providing protection from one or more of these risks. Both the
moratorium and the product-specific marketing ba ns are thus sanitary or phytosanitary measures
within the meaning of the SPS Agreement.
5.61 An illustrative list of the types of sanitary an d phytosanitary measures that a member might
adopt is also provided in paragraph 1 of Annex A of the SPS Agreement. It is clear that this list is not
exhaustive and that a measure of a type not listed, but which is adopted for one of the purposes listed,
would still be a sanitary and phytosanitary m easure falling within th e jurisdiction of the
SPS Agreement.
5.62 WTO jurisprudence has clarified that the te rm "measure" in the context of the WTO
Agreements has a broad content. Accordingly it captures not just acts, but also omissions; 143 and not
just legally binding or mandatory acts or policies, but non-mandatory measures. 144 The reason for
interpreting the term "measure" as having such a br oad content is clear. Primarily, it means that
actions of a Member that affect trade, whether fo rmal or informal, are comprehensively subject to
scrutiny for consistency with their WTO obligatio ns. A broad interpretation of "measure" is also
specifically consistent with the object and purpose of the SPS Agreement. The SPS Agreement
imposes disciplines on WTO Members' use of sanitary and phytosanitary measures in order to avoid
unnecessarily restricting trade. A narrow interpreta tion of "measure" would allow WTO Members to
circumvent their WTO obligations simply by resortin g to less direct means than transparent, formally
adopted laws or procedures.
5.63 As acknowledged by the complaining parties, the existence of the European Communities'
moratorium and product-specific marketing bans has to be inferred from the actions and statements of
the European Communities. Th at is because the European Co mmunities has issued no written
document, regulation or legislative provision estab lishing either the moratorium or the marketing
bans. In the present dispute a narrow interpretation of the term "measures" would allow the European
Communities to avoid scrutiny of its actions that impact on trade in biotech products because the
Panel could look no further than the legislated a pprovals process that the European Communities has
in place. New Zealand submits that such an inte rpretation and approach must be rejected. The
SPS Agreement and WTO jurisprudence provides sufficient basis for the Panel in this dispute to

142 First written submission of Argentina, paras. 36 -63; first written submission of the United States,
paras. 74-80; and first written submission of Canada, paras. 160-174.
143 Appellate Body Report, US – Corrosion-Resistant Steel Sunset Review, para. 81.
144 Panel Report, Japan – Agricultural Products II, para. 8.111.

consider the European Communities' moratorium and product-specific marketing bans to be
"measures" and therefore must submit them to scrutiny for compliance with the European
Communities' WTO obligations under the SPS Agreement.
(b) Procedural requirements of the SPS Agreement
(i) Failure to "publish promptly"
5.64 The need for transparency in the adoption and application of sanitary and phytosanitary
measures is an important aspect of the protections provided by the SPS Agreement against
undisguised restrictions on trade. Under Article 7 Members are required to meet the requirements for
transparency set out in Annex B, including the re quirement in paragraph 1 to "publish promptly" all
sanitary or phytosanitary regulations that they adopt.
5.65 Applying Appellate Body jurisprudence regarding the interpretation of the term "sanitary or
phytosanitary regulations"
145, it is clear that the European Communities' moratorium and product-
specific marketing bans are subject to the require ment that they be "published promptly". As
presented by the complaining parties, the European Communities has failed to publish the existence of
either the moratorium or the bans, and thus has also failed to do so "promptly" as required.
(ii) Undue delay
5.66 Under Article 8 of the SPS Agreement WTO Members must observe the provisions of
Annex C in the operation of their approval proce dures associated with sanitary and phytosanitary
measures, including the requirement in paragraph 1(a) of Annex C that approval procedures are
"undertaken and completed without undue delay". In their submissions the complaining parties
discuss the meaning of the term "undue delay" and conc lude that in the context of paragraph 1(a) of
Annex C it refers to "the 'unjus tifiable' and 'excessive' 'hindrance' in undertaking or completing an
approval procedure."146 As the European Communities acknowledges147, both the reason for the delay
and its duration are relevant considerations in determining whether the delay is undue.
5.67 Thus whether there has been "undue delay" with in the meaning of paragraph 1(a) must be
determined on a case by case basis. In New Zealan d's view there must be a strong presumption that
"undue delay" has occurred where a Member has in fact suspended the operation of the approval
procedures provided for in its own legislation wit hout providing any justification in terms of the
SPS Agreement for doing so. Accordingly in the present dispute the European Communities has acted
with "undue delay" in undertaking or completing its approval procedures for biotech products.
(c) Substantive requirements of the SPS Agreement
5.68 The SPS Agreement imposes substantive, as well as procedural, disciplines on the use of
sanitary and phytosanitary measures. Article 2. 1 gives Members the right to establish measures,
including for biotech products, that are necessary fo r the protection of human, animal or plant life or
health and that are not inconsistent with the provisions of the SPS Agreement. Article 2.2 sets out the
basic requirement that such measures must be based on scientific principles and may not be
maintained without sufficient scientific evidence.

145 Appellate Body Report, Japan – Agricultural Products II, para. 105.
146 First written submission of the United States, para. 89; first written submission of Canada,
147 First written submission of the European Communities, para. 479.

5.69 Successive Panels and the Appellate Body have now provided considerable guidance on the
interpretation of provisions of the SPS Agreement that are relevant to this dispute. In considering the
arguments before it the Panel should apply that gui dance in order to ensure that the balance is
maintained between a Member's right to adopt san itary and phytosanitary measures on the one hand,
and its obligation not to unnecessarily restrict trade on the other.
5.70 This balance is evident in the provisions of the Agreement relating to a Member's
determination of its appropr iate level of sanitary or phytosanitary protection. Annex A, paragraph 5,
of the SPS Agreement defines the "appropriate level of sanitary or phytosanitary protection" as that
"deemed appropriate by the Member establishing a … measure". However, Members may not adopt
measures that are more trade restri ctive than necessary to achieve their desired level of protection,
taking into account technical and economic feasibility. The SPS Agreement also provides guidance as
to when a measure could be considered to be mo re trade restrictive than necessary, namely where
another significantly less trade restrictive measure is technically or economically feasible that would
achieve the same level of protection.
148
5.71 It is not necessary in this case to examine in great detail the level of protection afforded by the
European Communities' legislated approvals process es. The legislative fra mework adopted by the
European Communities must be taken to represent at least the level of protection deemed appropriate
by the European Communities to ma nage risks arising from biotech products. If the measure actually
applied is more trade restri ctive than that, then the SPS Agreement, and basic logic, supports the
conclusion that the measure applied is more trade restrictive than necessary to achieve the level of
protection deemed appropriate. The European Communities' moratorium and product-specific
marketing bans are measures that are clearly more tr ade restrictive than necessary to meet the level of
protection that the European Communities itself has de emed to be appropriate in respect of biotech
products. Accordingly, the moratorium and product -specific marketing bans are measures that are
more trade restrictive than necessary for the protec tion of human, animal or plant life or health and
thus are inconsistent with the provisions of the SPS Agreement.
F. THIRD PARTY ORAL STATEMENT OF NEW ZEALAND
5.72 Mr Chairman, Members of the Panel, New Zealand's views on the issues of concern in this
dispute are set out in our Third Party Submission of 24 May 2004. In our statement today we briefly
summarise those views.
5.73 As outlined in our submission, New Zealand has joined this dispute because of our systemic
interests and our desire to ensure that the delicate balance of rights and obligations set out in the WTO
Agreements, especially the SPS Agreement, is maintained.
5.74 The SPS Agreement guarantees to WTO Members the right to take measures for the
protection of human, animal and plant life or h ealth, including measures to regulate the import and
marketing of biotech products. That right is not contested in this dispute.
5.75 However WTO Members that adopt SPS measures must comply with the disciplines of the
SPS Agreement that are designed to ensure that SPS me asures do not restrict trade unnecessarily.
These disciplines include provisions requiring transpar ency in the adoption and application of such
measures as well as provisions imposing substantive requirements that such measures must be based
on scientific principles and not maintained without sufficient scientific evidence.

148 Footnote 3, Article 5.6.

5.76 The "measure" at issue in this dispute is not the European Communities' legislated approvals
process, but the actions taken by the European Communities that have in fact impacted on the
approval and marketing of biotech products. These actions have been describ ed by the complaining
parties as a general moratorium on approval of biotech products, or product-specific moratoria or
marketing bans. It is well established that the term "measure" in the WTO context is broad in content
and thus a Panel may look beyond the formal laws and regulations of a Member to assess overall the
nature and impact of a Member's actions on trade. Accordingly in New Zealand's view the Panel
should find that these actions – the moratorium a nd product-specific bans – are "measures" adopted
by the European Communities that affect trade in biotech products and are thus subject to scrutiny
with the European Communities' WTO obligations.
5.77 The complaining parties have also demonstrat ed that the European Communities' measures
are SPS measures within the meaning of the SPS Agreement. New Zealand's Written Submission
highlighted three ways in which the complaining parties have demonstrated that the European
Communities' moratorium on biotech products and its product-specific marketing bans failed to
comply with the European Communities' obligations under the SPS Agreement.
5.78 The European Communities' measu res fail to meet the clear procedural requirements of the
SPS Agreement that SPS measures must first be "published promptly" and second that approvals
processes that Members adopt must be undertak en and completed without "undue delay". These
procedural requirements operate to provide protecti on against such measures being used to restrict
trade unnecessarily. The European Communities' failure to publish the moratorium or the bans is
clear.
5.79 In respect of whether there has been "undue delay" in the application of the European
Communities' approvals processes, there must be a strong presumption that a delay is "undue" where
a Member has in fact suspended the operation of its legislated approvals process without providing
any justification in terms of the SPS Agreement for doing so.
5.80 The European Communities also failed to m eet the substantive requirement of the
SPS Agreement not to adopt measures that are more trad e restrictive than necessary to achieve their
desired level of protection. The legislative frame work adopted by the Eur opean Communities for the
approval and marketing of biotech products must be taken to represent at least the level of protection
deemed appropriate by the European Communities to manage risks arising from biotech products.
The European Communities' moratorium and product-sp ecific marketing bans – more trade restrictive
than the European Communities' le gislative framework – are therefor e clearly more trade restrictive
than necessary to achieve the European Communities' appropriate level of protection.
5.81 In conclusion, for the reasons set out in Ne w Zealand's written submission, the Panel should
find that the European Communities' moratorium and product-specific marketing bans fail to meet the
requirements of the SPS Agreement .
G. T
HIRD PARTY WRITTEN SUBMISSION OF NORWAY
1. Introduction
5.82 While recognizing the many potential benefits from GM products, Norway underlines that
GMOs have been used for a relatively short tim e and that important effects on health and the
environment remain not fully understood. The a pproval of GMOs and GM products raise several
complex issues of a scientific and factual nature. The process of risk assessment is therefore

particularly time-consuming. A prudent approach to GMOs in WTO members' regulatory frameworks
is therefore warranted.
5.83 Norway restricts its third party submission to certain legal issues concerning Bt. 176
149,
MS1xRF1150, and Topas 19/2. 151 These are three out of totally seven GMOs in relation to which
national EC member State measures are contested.
2. Factual background, with emphasis on con sequences of use of antibiotic resistance
marker genes (ARMGs)
(a) Overview
5.84 GMOs are one of the results of modern biotechnol ogy. They are created by a particular set of
techniques which are used to genetically modify (or "g enetically engineer") organisms. In short, they
require a change of genetic material within an organism through genetic recombinant nucleic acid
techniques. This is explained in more detail in chapter 2.1 of Norway's first written submission.
5.85 Contrary to what has been claimed, there is no "proven safety record" 152 with regard to
GMOs. National and international re gulatory developments demonstrate that GMOs are not a mere
continuation of traditional breeding. This is sh own in Chapter 2.3 of Norway's first written
submission. GMOs should therefore not be treated as equivalent to non-GM products. Little is known
about long-term effects of foods from transgenic crops. Moreover, little scientific agreement exists
regarding their environmental impacts. New scientif ic evidence concerning environmental and health
impacts is constantly emerging.
5.86 Among the possible environmental effects outlined by scientists are the spreading of genes
through hybridisation between GM plants and closely related domesticated or wild species, population
growth, spreading and invasion of GM plants in to natural ecosystems, increased competition from
GM plants or their hybrids with natural species , the spreading of genes through horizontal gene
transfer from plants to microorganisms in the enviro nment, development of herbicide resistant weeds,
development of insects resistant to insecticides, effects on non-target organisms and secondary
environmental effects as a consequence of changed agriculture practises e.g. new use of insecticides,
herbicides, fertiliser's etc. 153

149 Subject to safeguard in Austria, Luxembourg and Germany.
150 Subject to safeguard in France.
151 Subject to safeguard in France and Greece.
152 As stated in the first written submission of the United States, ref. heading preceding paragraph 27.
153 Keeler K.H. 1985 (Exhibit NOR-77); Crawley, M.J., 1988. Meeti ng report: COGENE/SCOPE at
Lake Como. Special combined issue: Trends Biotechnology & Trends Ecology, Evol 3. 2-3 (Exhibit NOR-78);
Ellestrand N.C. 1988. Special combined issue: Trends Biotechnology & Trends Ecology, Evol 3. 30-32 (Exhibit
NOR-79); Tidje J.M (and 6 others) 1989. Ecology. Vol 70, No 2 (Exhibit NOR-80); Williamson M. 1989.
Special combined issue: Trends Biotechnology & Trends Ecology, Evol 3. 32-35 (Exhibit NOR-81); McNally
R. 1994. The Ecologist, Vol 24, No. 6 Nov/Dec, 207-212 (Exhibit NOR-82); Doyle J.D, Stotzky G, McClung G,
Hendricks C.1995. Advances in Applied Microbiology, Vol. 40, 237-287 (Exhibit NOR-83); The Royal Society
of Canada. 2001. Elements of Precaution: Recommendations for the regulation of food biotechnology in
Canada. An expert panel report on the future of food biotechnology prepared by the Royal Society of Canada at
the request of Health Canada, Canadian Food Inspection Agency and Environment Canada
(ISBN-0-920064-71-x) (Exhibit NOR-22); Snow A.A. et al., 2004; "Genetically engineered organisms and the
environment: Current status and recommendations" ESA position paper (Exhibit NOR-4).

5.87 Some of these hypothesises have been debated in the scientific literature and many of them
have been verified by research in some species and environments. A conse quence may be population
decrease or extinction of species in natural ecosystem s, or different type of problems for agriculture.
Whether these types of effects will occur is difficult to predict a priori, and will depend on the species
and genetic modification in question, the receiving e nvironment or the farming and agro-ecosystem in
use.
5.88 Among the scientific concerns that have been raised in connection with public and animal
health are insufficient studies on putative effects of GM nucleic acids or food/feed on potential animal
or human consumers, whether the transgene DNA sequences given in the notifications are the same as
the insert sequences found in the GM plants, pe rsistence and uptake of DNA and proteins from
mammalian GIT (gastro intestinal tractus), transgen ic or altered host cell pr oteins and production of
chemicals and pharmaceuticals in plants. Some of the concerns will also be relevant for environmental
risk assessments of GMOs due to the fact that the processes can take place in the environment.
5.89 These possible effects and concerns are explained in more detail in chapter 2.2 of Norway's
first written submission.
5.90 A prime concern is the potential spreading of genes through horizontal gene transfer from
plants to micro-organisms in the environment, particularly in respect of antibiotic resistance marker
genes (ARMGs)
5.91 As described in Chapter 2.4 and documented by risk assessments, these effects were the main
reason for prohibiting the three GMOs in Norway.
5.92 Horizontal gene transfer is unknown. This me ans that intentional genetic modification of for
example plants could lead to unintentional gene tic modification of other organisms. Today no
scientists deny the occurrence of horizontal gene transfer, and different mechanisms have been
described for the process. An increasing amount of ge nes and traits in different species that most
probably have been spread through horizontal gene transfer, have been reported. The consequences of
such unintentional genetic modifications on human health and the environment, including possible
long-term effects, are not well known.
5.93 ARMGs are used as a selection tool during the process of modification. In most cases they
remain within the plant as an intact genetic trait.
154 Resistance towards antib iotics is an increasing
problem in therapeutic human and veterinary medicine . Most likely, this is a result of unwise use and
spread of antibiotics in general. Two uncertainties exist: Firstly: When GM plants are digested, what
possible increased spread of antibio tic resistance genes may occur through horizontal gene transfer to
organisms in the environment and in the human a nd animal digestical tract? Secondly: What
consequences may this have with regard to resi stance development of pathogenic bacteria in the
future?
5.94 Norway has explained the risks associated w ith Bt 176, MS1xRF1 and Topas 19/2 which led
to their prohibition in Norway. The essence is described below:

154 Droege M. et al., 1998 (Exhibit NOR-105); Nielsen K. M. et al., 2000 (Exhibit NOR-106), 2003
(Exhibit NOR-76).

(a) Maize Line Bt 176
Concerns are here related to risks associated with a possible horizontal transfer of the
amp gene for resistance to the antibiotic am picillin contained in the product, as well
as with ecological effects of th e insect toxin encoded by the cryIA (b) genes. A
transfer of the amp gene to pathogenic bacteria in such a way that the gene is
successfully incorporated and expressed would be highly undesirable. This is because
it might impede clinical treatment. As is documented in the attached risk assessment,
studies indicate that there is a risk for horizontal transfer of the amp gene.
(b) Oilseed rape line MS1 x RF1
Concerns are here related to the risks associat ed with a possible horizontal transfer of
the nptII gene for resistance to the antibioti cs neomycin and canamycin contained in
the product, as well as with the consequen ces of gene flow from the genetically
modified oilseed rape to wild plants and crops. Transfer of this gene to pathogenic
bacteria could contribute to worsening th e problem of development of antibiotic
resistance. When the risks of this particul ar genetically modified oilseed rape were
assessed, some results indicated a risk of horizontal transfer of the nptII gene. As with
Bt 176, further studies were needed. A further concern was documented in the
above-mentioned risk assessment. This wa s related to hybridisation between
genetically modified oilseed rape and several wild and domesticated plant species in
Norway. Introgression of the gene conferring gluphosinate-tolerance into cross-
compatible species could lead to the devel opment of gluphosinate-resistant weeds. In
addition, hybridisation with other crop plan ts could have undesirable effects. These
may include future agricultural problems connected to weed management.
(c) Oilseed rape line Topas 19/2
It contains the npt II gene encoding resistance to the antibiotics kanamycin and
neomycin. The assessments and comments w ith regard to ARMGs in oilseed rape
MS1xRF1 above are also applicable to oilseed rape line Topas 19/2.
3. Legal discussion
(a) Overview
5.95 Norway submits that risks related to ARMGs are not covered by the SPS Agreement, or by
Article 2 of the TBT Agreement. The applicable WTO Agreement is thus the GATT. The member
State measures are not in breach of Article III: 4 of the GATT 1994, and are at any rate justified under
Article XX of the GATT 1994.
5.96 If the Panel nevertheless were to consider that such bans should be addressed under the
SPS Agreement, Norway argues in the alternative that the national EC member States bans conform to
Article 5.7 under the SPS Agreement.
(b) The SPS Agreement is not applicable to measures against ARMGs
5.97 The definitions in Annex A point 1 are quite precise. The application of the SPS Agreement
will depend on the purpose of each particular measure , and more specifically which risks the measure
is intended to protect against. If a particular objective is not covered by the SPS Agreement, a decision

which invokes this particular risk shall not be assessed under SPS, but rather under the
TBT Agreement or the GATT 1994. Should the Panel decide that only one objective falls under the
SPS, the remaining part of the decision must be assessed under the other Agreements.
5.98 The protection from risks arising from GMOs or GM products, is not mentioned per se in the
wording of Annex A. Whether a measure falls unde r Annex A, point 1 will therefore be decided by
the objective(s) of a measure in relation to the concrete risk(s).
5.99 The concern with ARMGs is that the antibiotic resistant trait in the GM crop or product DNA
might be transferred to bacteria, particularly in th e digestive tract of humans or animals. This might
have negative impact on clinical and veterinary medicine, which relies heavily on antibiotics (and
therefore on the absence of resist ance to antibiotics). As explai ned by the European Communities
155,
plant DNA is in itself not an organism. Even if it were, it would however not be the plant DNA that
caused the disease. The disease would have to ari se from other sources. Therefore, plant DNA is not
covered by the definitions set out in Annex A point 1. Accordingly, the SPS Agreement is not
applicable.
(c) Alternative argument in respect of Article 5.7 of the SPS Agreement
5.100 Should the Panel, nevertheless, decide to assess member States' national measures regarding
any of the three GMOs under the SPS Agreement, Norway will argue, in the alternative, that the
measures against the risks of ARMGs fully conform with the SPS Agreement, in particular Article 5.7
thereof.
5.101 The European Communities has convincingly s hown that the national measures of member
States – if they are to be assessed under the SPS Agreement – are "provisionally adopted". 156 This
follows inter alia from the legal basis in internal EC law. We refer to the European Communities' first
written submission for further details. 157 Since these member States' measures are provisional, any
evaluation of the conformity of the bans with the SPS Agreement must be made under Article 5.7 and
not under Article 5.1.
5.102 Norway argues that the four cumulative requireme nts set out in Article 5.7 are satisfied and
accordingly that there is legal basis for adoptin g and maintaining the pr ovisional phytosanitary
measures.
5.103 Firstly, Norway argues that we are faced with a situation where "relevant scientific evidence
is insufficient". Biotechnology is s till in its infancy. Many of the scientific findings are inconclusive
or ambiguous. GMOs are exceedingly complex to analyse. It may take years before one may find
reliable evidence, which allows to conclude as to their possible harmful impact on health and/or the
environment.
5.104 Secondly, the measures in question were adopted "on the basis of available pertinent
information". The EC member States could collect information from open sources and they could
depend on risk-assessments delivered by other member States due to internal transparency
mechanisms within the EU. They could also de pend on the Norwegian risk-assessment due to the
same kind of mechanisms within the European Economic Area. On the whole, there exists a

155 Ibid, paras. 431-432.
156 At least Canada does not seem to contest that these are provisional measures, see first written
submission of Canada, para. 379.
157 First written submission of the European Communities, para. 589.

presumption that sufficient information was at hand for the EC member states to identify the risks
posed by GMOs.
5.105 Thirdly and fourthly, the Europ ean Communities fulfils the requirement of seeking "to obtain
the additional information necessary for a more obj ective assessment of risk and will review the
measure within a reasonable period of time". In orde r to gain better insight a considerable amount of
research is continuously carried out world-wide. An expert panel recently established under the
European Food Safety Authority has recently assessed ARMGs, and a working group within the
European Communities is currently considering th e use of ARMGs in GMOs. In conclusion, the
requirements under SPS Article 5.7 are thus met in relation to the three GMOs.
(d) The TBT Agreement is not applicable to measures against ARMGs.
5.106 Canada and Argentina argue that to the extent that the SPS Agreement is not applicable, the
member State national measures could be reviewed under various subparagraphs of Article 2 to the
TBT Agreement.
158 In Norway's view the arguments of Ca nada and Argentina do not correctly reflect
the content of Article 2.2. The reason is that EC member State national measures are not "technical
regulations" within the meaning of the TBT Agreement.159 They do not contain general descriptions of
a normative nature applicable to an undeter mined number of producers. In the case in EC – Asbestos,
the Appellate Body inter alia held that since the national measure "lays down "characteristics" for all
products that might contain asbestos" 160 (underlining added), the measure was covered by Article 2.2
of the TBT Agreement. In our dispute, however, the national measures do not apply to all GMOs or
even all GMOs coding for antibiotic resistance. Rather, each measure contains a single ban on one
particular GMO. Each measure is addressed to one specific manufacturer or right holder and creates
legal rights and obligations only upon this addressee. Therefore, they fall outside the scope of
Article 2 of the TBT Agreement.
(e) The GATT 1994
5.107 Canada and Argentina claim that [some] of the member State national measures violate
Article III: 4 of the GATT 1994.
161 These allegations are unfounded.
5.108 In order for a violation of Article III: 4 to o ccur, several conditions have to be fulfilled. A
main requirement is that imported products are treated less favourably than domestic products. In this
dispute, the national origin of the manufacturers is not a relevant issue. As shown throughout this
submission, quite different concerns have led to th ese national measures. Indeed, most of the GMOs
subject to member State national measures have in fact been notified by co mpanies incorporated in
the European Communities and belong to such companies. 162 Thus, the national measures do not
distinguish on the basis of nationality. Moreover, there is no evidence that the national measures are
in particular addressed at the imported GMOs. This is also the case with the Greek national measure,
which according to its intended legal effects applies erga omnes.
5.109 Moreover, in order to be caught by Article III: 4 of the GATT 1994, the complaining parties
must show that these GMOs are "like" products. Several factors will contribute to deciding whether

158 First written submission of Canada, paras. 473- 505; and First written submission of Argentina,
paras. 547-592.
159 First written submission of the European Communities, para. 642.
160 Appellate Body Report, EC – Asbestos, para. 75.
161 First written submission of Canada, para. 444; and first written submission of Argentina, paras. 338.
162 See first written submission of the European Communities, paras. 632-633.

these are "like" products or not. As demonstrated in Chapter 2.3, most WTO members distinguish
between GMOs and its conventional counterparts as regards regulatory regimes. This is because
GMOs in fact may have different effects on he alth and environment than their conventional
counterparts. Also, as shown in Chapters 2.4.2. 2 and 2.4.3.2, international organisations are
increasingly viewing products containing GMOs with genes coding for antibiotic resistance as distinct
from conventional products. Also, the growing requi rement for labelling of GMOs, which come as a
respond to consumer demands, indicate that GMOs should not be treated as "like" products.
5.110 In conclusion, the member State measures in re lation to the three GMOs are not in breach of
Article III: 4 of the GATT 1994.
5.111 Even if there should be a breach, other Articles of the GATT 1994, Article XX of the GATT
1994, in particular sub-paragraph (b), provide a defence with respect to the three GMOs discussed
here.
4. Concluding remarks
5.112 Norway respectfully requests the Panel to take the facts and arguments presented above fully
into consideration when making its findings and recommendations.
H. T
HIRD PARTY ORAL STATEMENT OF NORWAY
1. Introduction
5.113 Norway has in its written submission addressed th e risks associated with three particular
GMOs: Bt 176163, MS1xRF1164, and Topas 19/2.165 These are three out of seven GMOs in relation to
which national EC member State measures are contes ted in the present case. Norway's focus on these
three GMOs today is due to the fact that they contain antibiotic resistance marker genes (ARMGs).
This is also the main reason why their marketing is prohibited in Norway.
5.114 In my oral intervention I will focus on two issues of legal interpretation. Firstly , I will argue
that the SPS Agreement is not applicable to risks arising from ARMGs. And secondly I will show that
these national measures are not infringing the GATT 1994. In respect of the scientific evidence
relating to GMOs in general, as well as our other legal arguments, I refer to our written submission.
2. Application of the SPS Agreement
5.115 The complaining parties argue in the first instance that the member State national measures
fall under the SPS Agreement. This argument is based on a simplification on how the SPS Agreement
is to be understood. Only national meas ures that have certain specified objectives and which address
certain specified risks are covered by the SPS Agreement.
5.116 It is clear from Annex A of the SPS Agreement that the "risks" covered must "arise" or be
caused by the risk factors mentioned in point 1. Measures against other risks, no matter how serious
their consequences may be, are not covered by the SPS Agreement, but may be covered by the
TBT Agreement or the GATT 1994.

163 Subject to the safeguards in Austria, Luxembourg and Germany.
164 Subject to the safeguard in France.
165 Subject to the safeguards in France and Greece.

5.117 In respect to the risks posed by GMOs with ARMGs – as is the case with the 3 above-
mentioned GMOs – the specific concern is that anti biotic resistance genes might be transferred to
bacteria, particularly in the digestive tract of huma ns and animals (so-called " horizontal transfer"). If
this should happen, the treatment of infections by certain antibiotics – ampicillin, kanamycin and
neomycin – could be impeded both in human and ve terinary medicine, because of resistance acquired
by bacteria to these antibiotics.
5.118 According to Annex A point 1 litra b), an SPS measure is inter alia a measure whose purpose
is to protect human or animal life or health fro m disease-causing organisms in foods, beverages or
feedstuffs. Although the protection against ARMGs is a clear human and animal health concern,
these risks do not fall under Annex A point 1. Firstly, the inserted DNA which contains the antibiotic
resistance gene, is not an organism in itself. Secondly, the gene is not disease-causing, but may
merely prevent the treatment of diseases caused by ordinary bacterial infections. Therefore, the
SPS Agreement is not applicable to the national bans insofar as their object is to protect against the
risks of antibiotic resistance.
3. Application of the GATT 1994 – Article III:4
5.119 Canada and Argentina have presen ted arguments alleging that the national EC member States
bans infringe Article III:4 of the GATT 1994. As far as Article III:4 of the GATT 1994 is concerned,
we have in our written submission argued that impor ted products are not treated less favourably than
domestic products. The GMOs in question are prohibited, irrespective of their country of production.
5.120 Furthermore, Norway argues in its written submission that GMO-products are not "like"
products, and we refer to our written submission for mo re details. Let me just point to para 105,
which refers to the Codex decision of July 200 3, whose guidelines now treat antibiotic resistance
marker genes in food production, differently from foods which do not contain such genes. I would
also point to the many national legislations that have enacted separate approval procedures for GMOs.
This clearly demonstrates that most WTO Members consider GMOs to be something different from
the original non-modified organisms. In conclusion Article III:4 is not infringed.
4. Application of the GATT 1994 – Article XX
5.121 If the Panel, nevertheless, were to conclude th at Article III: 4 or Article XI: l of the GATT
1994 – in the case of Greece – have been violated , it must assess whether the national EC member
States measures can be justified under Article XX. The burden of proof in
this respect rests upon the
European Communities.
5.122 Norway would like to note that in respect of the three GMOs with ARMGs, the policy
pursued by the European Communities and its memb er States with regard to GMOs would seem to
fall directly under Article XX of the GATT 1994, s ub-paragraph (b) as measures to protect "human,
animal or plant life or health". The risks that th ese GMOs pose, have been explained in detail in the
Norwegian written submission and the documents annexed thereto.
5.123 Limiting myself to comment briefly upon the requirement of "necessity" in sub-paragraph (b),
it is difficult to see that there could be reasonable – and less trade distorting – alternative measures
available, in order to fulfil the established policy objective of avoiding antibiotic resistance. Labelling
for instance, would clearly not achieve the declared health objectives. I should also note that no
alternative measures seem to have been suggested by any of the complaining parties.