Document: WT/DS291/R WT/DS292/R WT/DS293/R Page 424 7.419 Canada argues that the approval procedures contained in Directive 2001/18 (and its predecessor Directive 90/220) and Regulation 258/97 are clearly "approval procedures" for the purposes of Annex C of the SPS Agreement.  It is clear that the approval legislation applicable to biotech products is a "law, regulation or requi rement".  Moreover, the approval procedures are imposed to "check and ensure" the fulfilment of  the requirements of the European Communities' approval legislation, namely that food and f ood ingredients do not "present a danger for the consumer" 546 or that the release into the environment of biotech products "will be safe for human
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

7.419 Canada argues that the approval procedures contained in Directive 2001/18 (and its
predecessor Directive 90/220) and Regulation 258/97 are clearly "approval procedures" for the
purposes of Annex C of the SPS Agreement. It is clear that the approval legislation applicable to
biotech products is a "law, regulation or requi rement". Moreover, the approval procedures are
imposed to "check and ensure" the fulfilment of the requirements of the European Communities'
approval legislation, namely that food and f ood ingredients do not "present a danger for the
consumer"
546 or that the release into the environment of biotech products "will be safe for human
health and the environment". 547 The approval procedures check and ensure that all of the relevant
information has been submitted and that the risk s associated with placing biotech products on the
market have been identified and assessed. Finall y, the European Communities' approval legislation
for biotech products is a "sanitary or phytosanitary" measure as defined in Annex A(1) of the
SPS Agreement.
7.420 Argentina argues that the EC legislation which establishes the procedure for the prior
approval of GMOs (Directive 90/ 220 and subsequently Directiv e 2001/18, and Regulation 258/97)
defines the procedures for the approval of biotech agricultural products of both domestic and foreign
origin. Argentina submits that this legislation cont ains provisions related to the system of control,
inspection and approval.
7.421 The European Communities states that to the extent that its approval system set up under the
relevant GMO legislation addresses risks coming under Annex A(1) of the SPS Agreement, it accepts
that that system is a "procedure to check and en sure the fulfilment of sanitary or phytosanitary
measures". The procedures sets forth in the relevant legislation are designed to ensure that adverse
effects on human health and the environment are avoide d. To the extent this is done by verifying and
assessing the risks coming under the SPS Agreement, those procedures can be said to be applied in
order "to check and ensure the fulfilment of sanitary or phytosanitary measures".
7.422 The Panel commences its analysis with the form el ement of the definition of the term "SPS
measures". The second paragraph of Annex A(1) indicates that SPS measures "include" all "laws,
decrees [and] regulations". In our view, the refere nce to "laws, decrees [and] regulations" should not
be taken to prescribe a particular legal form. Rath er, we consider that SPS measures may in principle
take many different legal forms.
7.423 We note that Directives 90/220 and 2001/18, as well as Regulation 258/97, are legislative acts
adopted by the European Council and the European Parliament.
548 As such, they are governmental
measures attributable to the European Communities. We also note that they are legally binding.
Directives 90/220 and 2001/18 are addressed to EC memb er States and are to be transposed by them
through legislative or administrative action. 549 Regulation 258/97 states, in fine, that it is binding in
its entirety and directly applicable in all EC me mber States. In the light of these elements, we
consider that, for the purposes of Annex A( 1), Directives 90/220 and 2001/18, as well as
Regulation 258/97, may be assimilated to measures adopted in the form of "laws" and, therefore, meet
the form element of the definition of the term "SPS measures".
7.424 Regarding the nature of SPS measures, we r ecall that the second paragraph of Annex A(1)
refers to a variety of "requirements and procedur es" which are quite different in nature. Among the
"procedures" specified in Annex A(1) are "testing, inspecting, certification and approval procedures".

546 Article 3 of Regulation 258/97.
547 Preambular paragraph 47 of Directive 2001/18.
548 Directive 90/220 was adopted by the Council only.
549 Articles 23 and 24 of Directive 90/220; Articles 34 and 38 of Directive 2001/18.

In the present case, the Parties have consistently referred to Directives 90/220 and 2001/18, as well as
Regulation 258/97, as setting out "EC approval proce dures" for biotech products. Annex A(1) does
not define the term "approval proced ures". However, Annex C to the SPS Agreement, which is
entitled "Control, Inspection and Approval Procedures" , contains a footnote which clarifies that
"[c]ontrol, inspection and approval procedures include, inter alia , procedures for sampling, testing
and certification".
550 Furthermore, the lead-in to Annex C(1) makes clear that Annex C(1) establishes
disciplines "with respect to any procedure to ch eck and ensure the fulfilment of sanitary or
phytosanitary measures". On the basis of these elements, the term "approval procedures" can be
understood as encompassing procedures applied to ch eck and ensure the fulfilment of one or more
substantive SPS requirements the satisfaction of whic h is a prerequisite for the approval to place a
product on the market.
7.425 As is apparent from our earlier description of the procedures set out in Directives 90/220 and
2001/18, GMOs may not be released into the e nvironment unless the consent of the competent
authority has been obtained. 551 Similarly, in the case of Regulation 258/97, foods containing or
consisting of GMOs may not be placed on the market unless an authorization decision has been
obtained.552 Thus, it is clear that Directives 90/220 and 2001/18 as well as Regulation 258/97 each
impose a pre-marketing approval requirement.
7.426 In the case of Directives 90/220 and 2001/18 the granting of marketing approval is
conditional on a demonstration to th e satisfaction of the competent authorities that the GMO to be
released into the environment does not pose a risk to human health or the environment. 553 We have
already determined that Directives 90/220 and 2001/18, as measures which are applied to avoid
adverse effects on human health and the environmen t which might arise from the deliberate release of
GMOs, meet the purpose element of the definition of the term "SPS measure". Therefore, we
consider that the requirement established by Dir ectives 90/220 and 2001/18 that GMOs released into
the environment not pose a risk to human health or the environment is a substantive requirement
imposed for the purposes mentioned in Annex A(1).
7.427 Regarding Regulation 258/97, we note that the gr anting of marketing approval is conditional,
inter alia, on a satisfactory demonstration that the novel food for which approval is sought not present
a danger for the consumer. 554 We have determined above that to the extent the Regulation is applied
for this purpose, it meets the purpose element of the definition of the term "SPS measure". Consistent
with this, we consider that the requirement estab lished by Regulation 258/97 that novel foods not
present a danger is a requirement imposed for a purpose mentioned in Annex A(1).
7.428 If, as we suggest, Directives 90/220 and 2001/18, as well as Regulation 258/97, contain
substantive SPS requirements the satisfaction of whic h is a prerequisite for the approval to place a
product on the market, the next question to be c onsidered is whether Directives 90/220 and 2001/18,
as well as Regulation 258/97, contain procedures to check and ensure the fulfilment of these
requirements. The answer is in the affirmative. 555 We have described in detail the procedures set out

550 Footnote 7 of the SPS Agreement.
551 Articles 6, 10, 11 and 13 and preambular paragraphs 17, 18 and 20 of Directive 90/220; Articles 4,
6, 13, 15 and 19, and preambular paragraphs 28 and 47 of Directive 2001/18.
552 Articles 3, 4, 6 and 7 and preambular paragraph 2 of Regulation 258/97. We note that the exception
of the simplified procedure provided for in Article 5 of Regulation 258/97.
553 Articles 4, 11 and 13, as well as preambular paragraph 21 of Directive 90/220; Articles 4, 13 and 15,
as well as preambular paragraph 47 of Directive 2001/18.
554 Article 3(1) of Regulation 258/97.
555 See Articles 11-13 and 21 of Directive 90/220; Articles 13-22 and 30 of Directive 2001/18;
Articles 3, 4-7 and 11-13 of Regulation 258/97.

in Directives 90/220 and 2001/18, as well as Regulat ion 258/97. These procedures serve the purpose
of checking and ensuring the fulfilment of the relevant substantive SPS requirements.
7.429 The foregoing considerations lead us to the vi ew that the procedures set out in Directives
90/220 and 2001/18, as well as Regulation 258/97, ar e procedures applied to check and ensure the
fulfilment of one or more substantive SPS requirement s the satisfaction of which is a prerequisite for
the approval to place a product on the market. We have said earlier that such procedures can be
considered as "approval procedures" within the meaning of Annex A(1) and C(1).
7.430 Since we have found that Directives 90/220 and 2001/18, as well as Regulation 258/97 (to the
extent it seeks to prevent novel foods from being a danger for the consume r), constitute "approval
procedures" within the meaning of Annex A(1), it fo llows that they meet the nature element of the
definition of the term "SPS measure".
7.431 In the light of the above, we conclude that Directives 90/220 and 2001/18, as well as
Regulation 258/97 (to the extent it seeks to pr event novel foods from being a danger for the
consumer), qualify as SPS measures within the meaning of Annex A(1) as far as their form and nature
are concerned.
(i) Conclusion on whether the EC approval procedures are "SPS measures"
7.432 We have now considered Directives 90/220 and 2001/18, as well as Regulation 258/97, in
terms of their purpose, their form and their nature. In relation to each of these issues, we have found
that they satisfy the definition of the term "SPS meas ure" set out in Annex A(1). In the light of this,
we come to the conclusion that Directives 90/220 and 2001/18, as well as Regulation 258/97 (to the
extent it seeks to prevent novel foods from be ing a danger for the consumer), constitute
"SPS measures" within the meaning of Annex A(1).
7.433 At this juncture, we could go on and address whether any of the three EC approval procedures
at issue in this dispute embodies more than one SPS measure. However, neither the Complaining
Parties nor the European Communities have argued that to the extent any of the EC approval
procedures falls to be assessed under the SPS Agreement, it should be deemed to constitute more than
one SPS measure. Indeed, in their submissions to th e Panel, the Parties treated Directives 90/220 and
2001/18 as well as Regulation 258/97 as constituting one SPS measure each. Also, in this case, our
disposition of the Complaining Parties' claims under the SPS Agreement (and, where appropriate, any
implementing action to be taken in view of our dis position of particular claims) is not affected by
whether we treat any of the EC approval procedures as constituting a single SPS measure or as
embodying more than one SPS measure. Taking account of these elements, like the Parties, we will
treat each of the EC approval procedures as constituting one single SPS measure.
(d) Whether the EC approval procedures may affect international trade
7.434 Article 1.1 of the SPS Agreement provides, inter alia, that the SPS Agreement "applies to all
[SPS] measures which may, directly or indirectly, affect international trade". Thus, for an SPS
measure to be subject to the disciplines of the SPS Agreement, it must be capable of affecting
international trade. Accordingly, we now turn to consider, as an additional and separate matter,
whether Directives 90/220 and 2001/18 as well as Regulation 258/97 may affect international trade.
7.435
 In our view, it is not necessary to demonstrate that an SPS measure has an actual effect on
trade. Article 1.1 merely requires that an SPS measure "may, directly or indirectly, affect
international trade". Bearing this in mind, we first recall our earlier determination that

Directives 90/220 and 2001/18 as well as Regulation 258/97 set out procedures which are applied to
check and ensure the fulfilment of a substan tive SPS requirement the satisfaction of which is
necessary to obtain approval to place a product on the market. It is uncontested that Directives 90/220
and 2001/18 as well as Regulation 258/97 apply to GMOs and foods containing or consisting of
GMOs which are produced outside the European Co mmunities and hence would be imported into the
European Communities upon approval. Finally, we note that the procedures in question may
themselves have a direct or indirect effect on international trade, e.g., because their completion takes
time, or because they impose information and documentation requirements on applicants.
7.436 For these reasons, we conclude that Directives 90/220 and 2001/18 as well as
Regulation 258/97 (to the extent it seeks to pr event novel foods from being a danger for the
consumer) are SPS measures which may, directly or i ndirectly, affect international trade within the
meaning of Article 1.1 of the SPS Agreement and, as such, are subject to the provisions of the
SPS Agreement.
7.437 With this conclusion in mind, we now proceed to examine the first measure challenged by the
Complaining Parties, the alleged general EC moratorium on approvals.
D. G
ENERAL EC MORATORIUM
1. Measure at issue
7.438 The Panel begins its examination of the first me asure at issue in this dispute – the alleged
general EC moratorium – by setting out the Complain ing Parties' descriptions of that measure as well
as the European Communities' response thereto.
7.439 The United States asserts in its panel request that since October 1998, the European
Communities has applied a moratorium on the appr oval of biotech products. Pursuant to the
moratorium, the European Communities has suspended consideration of applications for, or granting
of, approval of biotech products under the EC a pproval system. In particular, the European
Communities has blocked in the approval process under the relevant EC legislation all applications
for placing biotech products on the market, and has not considered any application for final approval.
Thus, as described, the measure at issue is the suspension by the European Communities of
consideration of applications for, or granting of, approval of biotech products.556
7.440 The United States subsequently added in its subm issions that it is not claiming that each and
every application stopped all progress beginning in 1998. 557 To the contrary, the moratorium was a
decision by the European Communities not to move products to a final decision in the approval
process. Thus, certain progress in the process, short of final decision, is not inconsistent with a
moratorium on final approvals.
7.441 Canada asserts in its panel request that since October 1998, the European Communities has
maintained a moratorium on the approval of biotech products. The European Communities
effectively has suspended the consideration of app lications for approval of biotech products, and the
granting of approvals for those products, under the re levant EC approvals processes. Accordingly, as
described, the measure at issue is the general suspension by the European Communities of its own

556 See the US request for the establishment of a panel. WT/DS291/23, paras. 1 and 3.

processes for the consideration of applications fo r, and of the granting of, approval of biotech
products.
558
7.442 Canada subsequently added in its submissions that the moratorium maintained by the
European Communities did not involve the complete shutdown of the approval process, at every
stage.559 While the processing of certain applications was completely suspended, some progress was
made in relation to other appli cations. Moreover, throughout the existence of the moratorium, the
Commission continued to refer applications to th e various scientific comm ittees for their opinion.
However, it is at the critical decision-making junctur es, or key stages, of the approval procedure that
applications were blocked.
7.443 Argentina asserts in its panel request that the European Communities has applied a de facto
moratorium on the approval of agricultural bi otechnology products since October 1998. This de facto
moratorium has led to the suspension of considerati on of, and failure to consid er, various applications
for approval of biotech products as well as to undue de lays in finalizing the processing of applications
for the approval of such products under the relevant EC legislation. Thus, the measure at issue is the
suspension by the European Communities of consid eration of, and failure to consider, various
applications for approval of biotech products.560
7.444 Argentina subsequently added in its submissions that it is not arguing that there was a total
lack of movement through the successive stages of the approval process. 561 Rather, Argentina argues
that since 1998, any such movement has failed to l ead to approval due to deliberate blockage or
stalling at key stages of the approval process.
7.445 The European Communities suggests that the Complaining Parties' allegation that it
suspended consideration of applica tions only at key stages in the approval process is at odds with the
concept and definition of a moratorium. 562 The European Communities further suggests that the
Complaining Parties are not challenging a measure, but an alleged practice – an alleged repeated
pattern of suspending consideration of individual applications.
7.446 The European Communities argues th at an examination of the applications identified by the
Complaining Parties shows that there has never been a "general suspension" of approvals, and that the
individual applications have not been stalled at any moment. The evaluation process has continued
through the past years, with the EC and member States authorities taking into account the changing
legislative and regulatory framework as well as the evolving scientific debate in the treating of the
pending applications. The European Communities notes that many applications had to be re-
submitted under Directive 2001/18 by January 2003 , and that many applications have been
withdrawn, usually for purely commercial reasons.
7.447 The European Communities observes that all pe nding applications have been subject to
requests for additional information, often related to insufficient data having been provided in the
dossier to allow for a proper risk assessment. So me requests, however, especially with regard to
monitoring and traceability issues, were made in anticipation of the new legislation to be adopted, and
were based on voluntary commitments from the a pplicants. The European Communities maintains

558 See Canada's request for the establishment of a panel. WT/DS292/17, paras. 1 and 5.
559 Canada's first written submission, para. 2.
560 See Argentina's request for the establishment of a panel. WT/DS293/17, paras. 2 and 5.
561 Argentina's first written submission, paras. 198 et seq.

that since the entry into force of Directive 2001/18 individual applications haves been moving
smoothly through the different steps of the relevant EC approval procedures.
7.448 The Panel notes that the Complaining Parties use slightly different language to describe the
measure at issue. Yet none of the Complaining Pa rties ever suggested that they were challenging
different measures. Indeed, the Complaining Parties' submissions all refer to the measure in question
as the "moratorium". The Panel therefore proceed s on the basis that the Complaining Parties are
contesting one and the same measure – the alleged moratorium on the approval of biotech products.
7.449 According to the Complaining Parties, the alle ged moratorium was in effect between October
1998 and 29 August 2003, which is th e date this Panel and its terms of reference were established. It
is important to point out in this respect that the Complaining Parties are not of the opinion that the
alleged moratorium was lifted after August 2003. To the contrary, in the Complaining Parties' view,
the alleged moratorium was still in effect in Fe bruary 2005, when the Panel's second and last
substantive meeting with the Parties was held.
7.450 The Complaining Parties sometimes refer to th e measure at issue in this Section as the
"general moratorium" or the "across-the-board moratori um". This reflects the fact that this particular
measure is alleged to have been applied to all ap plications for approval of biotech products which
were pending during the relevant ti me period (October 1998 to August 2003).
563 It is well to recall in
this context that the Complaining Parties are also challenging certain product-specific measures, i.e.,
measures which are alleged to apply only to individual biotech products.
7.451 The Complaining Parties did not identify a formal EC legislative or administrative act giving
effect to the moratorium allegedly imposed by th e European Communities. However, it is not the
Complaining Parties' argument that the European Communities adopted a formal, de jure moratorium
on approvals during the relevant time period. Acco rding to the Complaining Parties, the moratorium
on approvals adopted and applied by the European Communities during the relevant time period was
an effective, de facto, moratorium.564
7.452 In describing the measure at issu e in their panel requests, all three Complaining Parties refer,
inter alia , to a "suspension by the European Communiti es of the consideration of applications for
approval of biotech products". This could be understood as meaning that the European Communities
suspended the processing of all applications, a nd that all approval procedures were brought to a
complete standstill. In their submissions to the Pa nel, the Complaining Parties point out, however,
that they are not alleging that the European Comm unities suspended all consid eration of applications,
at all stages of the approval process. What th ey are alleging is that the European Communities
effectively suspended consideration of applications at certain critical stages with a view to preventing
the final approval of these applications. This allega tion is not inconsistent with the reference in the
panel requests to a "suspension by the European Co mmunities of the consideration of applications for
approval of biotech products". In the Panel's vi ew, the Complaining Parties' submissions do not
allege the existence of a measure which is different from that described in the panel requests. They
rather provide further clarification of the descriptions contained in the panel requests.

563 US first written submission, para. 34; US second written submission, paras. 34-35 and 52; Canada's
first oral statement, para. 38; Canada's second written submission, para. 1; Canada's third written submission,
Argentina's third written submission, paras. 53 and 59.
564 US first written submission, para 3; Canada's first oral statement, para. 37; Argentina's first written
submission, para. 52.

7.453 The European Communities suggests that the Complaining Parties' allegation that it
suspended consideration of applica tions only at key stages in the approval process is at odds with the
concept and definition of a moratorium.
565 The Panel is not convinced by this argument. In their
panel requests, the Complaining Parties do not alle ge the existence of a moratorium on the processing
of applications for approval. They allege th e existence of a moratorium on the approval of
applications. A moratorium on approvals does not necessarily im ply a suspension of approval
procedures at every stage in the approval process. As noted by the Complaining Parties, it is
consistent with the notion of an approvals morato rium that individual applications are allowed to
make some progress in the approval process, provided that no application is allowed to obtain final
approval.
7.454 The European Communities further suggests that the Complaining Parties are not challenging
a measure, but an alleged practice – an alleged repeated pattern of suspending consideration of
individual applications. The United States responds that this is not the case. It points out that it is
challenging the alleged moratorium, and not the pattern of non-decisions that resulted from the
moratorium. The United States notes that it does not contend that the moratorium itself constitutes a
mere practice. Rather, the United States argues that the moratorium is a measure. According to the
United States, the absence of approvals is the result of a definitive, albeit unpublished, act – a
conscious, political-level decision by the European Communities not to allow any application to reach
the stage of final approval.566
7.455 The Panel does not understand Cana da and Argentina to conceive of the alleged moratorium
differently from the United States. Indeed, Canada contends that the European Communities decided
to stop authorizing new biotech products, regard less of the actual risks involved for individual
products.567 In Canada's view, there was an effective "political" decision on the part of the European
Communities not to approve applications. Canada c onsiders that it is this effective "decision not to
decide", or in other words, the effective decision not to complete any approval procedures, that is the
source of the alleged moratorium.568 Argentina also submits that the de facto moratorium is the result
of a decision. 569 Argentina asserts that since 1998 there have been no approvals of biotech products
because the European Communities decided that there should be no new approvals. 570 It is true that
Argentina stated that the alleged moratorium has been applied and maintained as a practice in the
European Communities.571 However, Argentina also stated that the de facto moratorium is a measure.
Moreover, Argentina used the word "practice" after noting that th e alleged moratorium had been
imposed de facto and was not set forth in any piece of legislation. 572 As the Panel understands it,
Argentina's reference to a practice was intended to distinguish between, on the one hand, measures the
existence of which is self-evident because they take the form of laws or regulations and, on the other
hand, measures the existence of which is rev ealed by an observable pattern of conduct, e.g., by
repeated and systematic actions and omissions.
7.456 In conclusion, the Panel considers that th e measure which is being challenged by the
Complaining Parties is the alleged EC moratorium on the approval of biotech products. The essential

566 US first oral statement, para. 42; US seco nd written submission, para. 45; US third written
submission, paras. 5 and 17.
567 Canada's third written submission, para. 124.
568 Ibid., paras. 202, 203 and 214; Canada's replies to Panel question Nos. 172 and 179.
569 Argentina's third written submission, para. 50; Argentina's second oral statement, p. 5.
570 Ibid., paras. 17, 50 and 153; Argentina's second written submission, paras. 49 and 129.
571 Argentina's first written submission, para. 34.
572 Ibid.

elements characterizing the alleged EC moratorium, which the Complaining Parties say was in effect
between October 1998 and the date of establishment of this Panel ( i.e., 29 August 2003), are the
following:
(a) It was not adopted through a formal EC rule- or decision-making process, but it
nonetheless constitutes a measure attributable to the European Communities.
(b) It was applicable to all applications fo r approval of biotech products which were
pending or newly submitted during the relevant time period.
(c) It involved the effective suspension by th e European Communities of final approval
decisions with regard to the applications mentioned in the preceding sub-paragraph.
2. Existence of a general moratorium on approvals
7.457 The European Communities argues that there is no moratorium and no suspension that the
Panel could rule on because there has been neither a moratorium nor a suspension of the approval
process since October 1998. The European Comm unities acknowledges that no applications were
approved between October 1998 and August 2003
573, and that some applications suffered important
delays. But the European Communities submits that the absence of approvals and the delays were the
result of prudent and responsible actions and not of a "decision not to decide".
7.458 The European Communities asserts that it has ne ver adopted any formal or informal act of
any kind to impose a moratorium on approvals. It also notes that the Complaining Parties were
unable to identify a single decision attributable to the European Communities which imposed such a
moratorium. It is therefore the contention of th e European Communities that the measure described
by the Complaining Parties did not and does not exist.
7.459 The Panel notes that the European Communities cont ests, not just certain aspects of the
alleged general moratorium, but its very existence. It is therefore necessary to examine in detail
whether the evidence supports the Complaining Pa rties' assertion that between October 1998 and
August 2003 the European Communities applied a general de facto moratorium on the approval of
biotech products.
7.460 The Panel will begin its examination by consid ering how, in the Complaining Parties' view,
the European Communities allegedly suspended ap provals and whether the European Communities
could suspend approvals in this manner. Next, the Panel will determine whether there are any
grounds for believing that the European Communities or one of its entities (the member States, the
Commission, the Council, etc.) intended to suspend approvals. Then, the Panel will analyse whether
the European Communities actually su spended approvals during the releva nt time period. As part of
this analysis, the Panel will in a first step dete rmine whether any biotech products were approved
during the relevant period. In a subsequent step , the Panel will review a substantial number of EC
documents and statements by EC and member State officials which were submitted by the
Complaining Parties and which they say acknowle dge and confirm the existence of a general
moratorium during the relevant time period. Finall y, the Panel will review the facts and history of
individual applications for the approval of biotech products. The Complaining Parties argue that these
application histories support and confirm their ot her allegations, while th e European Communities
submits that the histories rebut the Complaining Parties' allegations.

573 The European Communities notes, however, that a num ber of biotech food products were placed on
the market during the period in question. See infra, para. 7.497.

(a) Alleged manner of suspending approvals
7.461 As noted above, the Complaining Parties alle ge that the European Communities suspended
consideration of applications at certain critical stages of the EC approval process with a view to
preventing the final approval of applications. Th is leaves open the question of which are relevant
stages in the approval process and of which EC entities (member States, Commission, Regulatory
Committee, Council, etc.) contributed to the suspen sion of approvals and how. Therefore, the Panel
will now describe how, according to the Complain ing Parties, the European Communities allegedly
suspended approvals and examines whether it was po ssible for the European Communities to suspend
approvals in this manner.
7.462 The United States' main contention in this respect is that at a certain point certain EC
member States decided that they were not going to vote for new approvals of biotech products in the
relevant Regulatory Committee or in the Council. The United States recalls that under the European
Communities' rules of qualified majority voti ng in the Regulatory Committee or the Council, a
minority of member States can block EC action. Blocking minorities in the Regulatory Committee or
the Council may be overridden by a simple majority vote in the Commission. But, according to the
United States, the record shows that the Commissi on decided not to do so. The Commission did not
submit draft measures to the appropriate Regulatory Committee or to the Council. The United States
further argues that if one of the member States th at is unwilling to grant marketing approvals was the
original recipient of an application, then that single member State could block an application all by
itself. The same single member State could also block a product approval by refusing to complete the
process, that is to say, by not allowing the produc t to be placed on the market once it has been
approved at Community level by Commission decision.
7.463 Canada asserts that the European Communities has suspended the approval of applications
through one or more of the following acts and omissions. First, at EC member State level, the
competent authorities of certain EC member States have failed to ensure that the approval procedures
are completed without undue delay. Secondly, at Community level, certain member States have
routinely objected to favourable assessments by the competent authority of another member State.
Thirdly, where an application is supported by favo urable risk assessments, the Commission has in
some cases failed to submit a draft measure to the relevant Regulatory Committee. Fourthly, certain
member States have blocked the adoption of draf t measures by the Regulatory Committee, regardless
of the scientific merits of the application in question. Fifthly, where there has been an impasse at the
Regulatory Committee, the Commission has failed to break the impasse by referring the matter to the
Council. Lastly, when a product has been approved by Comm ission decision, the competent authority
of the responsible member State has failed to allow that product to be marketed.
7.464 Argentina submits that the European Communities has prevented the approval of biotech
products since 1998 through various actions and omissions. First, failure by the lead CA to complete
the relevant approval proce dures without undue delay. Secondly, failure by the Commission to
present draft measures to the Regulatory Committee fo r approval of products that have received a
favourable opinion from th e scientific committees. Thirdly, systematic opposition by EC member
States to approval when a draft is submitted, with no scientific grounds for opposing the
Commission's draft measure. Fourthly, failure by the Commission to refer a proposal to the Council
when the Regulatory Committee issues no opinion.
7.465 The European Communities notes that the kinds of "acts and omissions" referred to by the
Complaining Parties are part of an internal EC decision-making process and do not have external legal
effect. Only the definitive outcome of the decisi on-making procedure has legal effect. The European

Communities deduces from this that the "acts and om issions" referred to by the Complaining Parties
are not reviewable as measures in their own right.
7.466 The Panel notes that, according to the Complaining Parties, there were two EC entities with
responsibilities in the EC approval process which through their actions and/or omissions prevented the
final approval of applications during the time peri od in question (October 1998 to August 2003). The
two entities are EC member States and the Commission. The issue the Panel must consider, therefore,
is whether it was possible for these two entities to prev ent or delay approvals of biotech products in
the manner alleged by the Complaining Parties.
7.467 The Panel first turns to consider the member States' ability to prevent or delay approvals
through their actions and/or omissions. Based on its understanding of the relevant EC approval
procedures, the Panel agrees with the Complaining Parties that during the relevant time period EC
member States could prevent or delay approvals of biotech products in the following ways:
574
(a) The member State acting as the lead CA could delay the completion and circulation
of its initial assessment.
(b) Other member States could object to the placing on the market of a biotech product
following a favourable assessment by the lead CA.
(c) A group of member States that constituted a blocking minority could prevent the
relevant Regulatory Committee and the C ouncil from reaching the qualified majority
necessary to adopt draft measures proposing the approval of applications.
(d) The member State acting as the lead CA in the context of an approval procedure
conducted under Directives 90/220 or 2001/18 c ould refuse to give its consent to the
placement on the market of a biotech product after the Commission had approved an
application.
575
7.468 The Panel now turns to consider the Commission' s ability to prevent or delay approvals. In
this case as well, the Panel agrees with the Complain ing Parties that during the relevant time period
the Commission could prevent or delay approvals of biotech products in the following ways:576
(a) The Commission could delay the submission of a draft measure to the appropriate
Regulatory Committee, or it could fail to convene the Regulatory Committee for a
vote on a draft measure which has been submitted.
(b) The Commission could delay the submission of a draft measure to the Council where
the Regulatory Committee was unable to r each the qualified majority necessary to
deliver an opinion.
7.469 It is clear that in two of the above-mentione d scenarios involving member State action, such
action would not be sufficient, in itself, to prevent the final approval of an application. One scenario

574 We stress that we are focusing here on whether the member States had the ability to prevent or delay
approvals of biotech products, and not whether it would have been legal under EC law for them to do so.
575 As explained above, under Regulation 258/97 applications for which a decision has to be taken at
Community level are approved by the Commission with direct and immediate effect. No subsequent consent at
member State level is required.
576 Here as well, we stress that we are focusing on whether the Commission had the ability to prevent or
delay approvals of biotech products, and not whether it would have been legal under EC law for it to do so.

is that of one or more member States objecti ng to the placing on the market of a biotech product
following a favourable assessment by the lead CA. Such member State objections alone could not
prevent the final approval of an application because when such objections are raised, it is incumbent
on the Commission to submit a draft measure to the Regulatory Committee for its opinion. The other
scenario is that of a group of member States preventing the Regulatory Committee and/or the Council
from adopting a draft measure proposing the approval of an application. The vote in the Regulatory
Committee and/or the Council could not prevent th e application from moving towards final approval
because in such cases, it would be incumbent on th e Commission to submit a draft measure to the
Council and, if the Council were to fail to reach a qualified majority in favour or against the draft
measure, to adopt the draft measure submitted to the Council. However, in both of these scenarios,
the Commission could prevent the final approval of an application by not submitting draft measures to
the Regulatory Committee or the Council.
7.470 The European Communities alleges that also in the scenario where the lead CA, in the context
of an approval procedure conducted under Directives 90/220 or 2001/18, refuses to give its consent to
the placement on the market of a biotech product, member State action would not be sufficient, in
itself, to prevent the final approval of an appli cation. The European Communities submits that in
cases where a biotech product has been approved by Commission decision, the applicant would be
entitled under EC law to place the product on the market even if the lead CA has not yet taken the
necessary steps to allow that product to be market ed. According to the Eu ropean Communities, the
applicant could invoke before national courts the obligation imposed on the lead CA by the
aforementioned Commission decision. This is an issu e to which the Panel will revert later, when it
discusses the approval procedures concerning MS1/RF 1 oilseed rape (EC-89) and MS1/RF2 oilseed
rape. At this point, it is sufficient to note that ev en if the applicant could ultimately prevail before a
national court, the lead CA could effectively prev ent the product from being marketed until there was
an enforceable court ruling.
7.471 Regarding the European Communities' argument that actions and/or omissions by member
States or the Commission in the context of EC ap proval procedures are not reviewable measures in
their own right, the Panel need only note its unde rstanding that the Complaining Parties are not
challenging these actions and/or omissions per se . The Complaining Parties are challenging the
alleged moratorium on approvals. The actions or omissions of member States and the Commission
are, however, directly relevant to the Complaining Parties' challenge as they are claimed to constitute
the manner in which the European Communities gave effect to the alleged moratorium.
(b) Intention to suspend approvals
7.472 In the above analysis, it has been considered whether individual EC member States, a group
of EC member States, and/or the Commission could prevent the final approval of applications during
the time period in question (October 1998 to August 2003). The Panel was able to agree with the
Complaining Parties' main contention in this regard.
7.473 The issue to which the Panel now turns is wh ether there are any grounds for believing that
any member State and/or the Commission intended to prevent the final approval of applications
during the time period in question.
(i) EC member States
7.474 With regard to the member States, the Complaining Parties provided to the Panel a formal
declaration made by five member States (Denmark , Greece, France, Italy and Luxembourg) in June
1999. The declaration was made in the context of the meeting of the Council of 24/25 June 1999 at

which a political agreement – a common positi on – was reached on the proposal to amend
Directive 90/220. The declaration reads as follows:
577
Declaration by the Danish, Greek, Fren ch, Italian and Luxembourg delegations
concerning the suspension of new GMO authorizations
The Governments of the following Member States (Denmark, Greece, France, Italy
and Luxembourg), in exercising the powers vested in them regarding the growing and
placing on the market of genetically modified organisms (GMOs),
given the need to put in place a tighter, more transparent framework, in particular for
risk assessment, having regard to the speci fics of European ecosystems, monitoring
and labelling,
given the need to restore public and market confidence,
point to the importance of the Commission submitting without delay full draft rules
ensuring labelling and traceability of GMOs and GMO-derived products and state
that, pending the adoption of such rul es, in accordance w ith preventive and
precautionary principles, they will take steps to have any new authorizations for
growing and placing on the market suspended.
7.475 According to the Complaining Parties, the key element of the above-quoted declaration is
the statement that:
"[I]n exercising the powers vested in them regarding the growing and placing on the
market of genetically modified organisms [ …] they [the five member States in
question] will take steps to have any ne w authorizations for growing and placing on
the market suspended."
7.476 In the Complaining Parties' view, this passage demonstrates that the five member States at
issue decided that they would block the approval process. The Complaining Parties argue that the
"steps" the five member States said they would ta ke include using their votes in the relevant
Regulatory Committee or the Council so as to block the adoption of draft measures approving
applications. It has been pointed out in this regard that, taken as a group, the five member States in
question have enough votes in the Regulatory Co mmittee and the Council to form a blocking
minority.
7.477 In response to a question from the Panel, the European Communities stated that declarations
to Council minutes, such as the above-quoted June 1999 declaration by five member States, have no
legal significance or effect in the European Commu nities, as confirmed by the jurisprudence of the
European Court of Justice.
578 The European Communities submits that its member States are fully
aware of this position, but have recourse to such declarations for political purposes – to send a
message to other institutions, to the public or to satisfy a political need.

577 Declaration by the Danish, Greek, French, Italian and Luxembourg delegations concerning the
suspension of new GMO authorizations, 2194 th Council Meeting - Environment-, Luxembourg, 24/25 June
1999. Exhibits US-76 and 77; Exhibit CDA-3; Exhibit ARG-12.
578 The European Communities refers to case C-375/98, Ministério Público and Fazenda Pública v
Epson Europe BV, [2000] ECR I-4243, para. 26.

7.478 The Panel considers that the June 1999 declaration by Denmark, Greece, France, Italy and
Luxembourg (hereafter the "Group of Five") clear ly reveals an intention on the part of the
Governments of the Group of Five countries to do wh at is within their power to prevent the approval
of further applications, pending the adoption of EC rules ensuring "labelling and traceability of GMOs
and GMO-derived products". The phrase "state that [… ] they will take steps" necessarily implies
such an intention.
7.479 It is important to note, however, that the June 1999 declaration amounts to more than a
statement of intent. It does more than tentativ ely pronounce how the Group of Five countries intend
to exercise their powers. The declaration definitively announces how the Group of Five countries will
exercise their powers. Indeed, the Group of Five coun tries in their declaration do not "state that [...]
they [intend] to take steps" to prevent the approval of further applications. Rather, they "state that [...]
they will take steps" (emphasis added) to do so. In the Panel's view, it may be inferred from this
language that each of the Group of Five countri es made a decision on how it would exercise its
powers.
7.480 The European Communities pointed out that decl arations like the June 1999 declaration have
no legal effect under EC law. The text of the Ju ne 1999 declaration does not suggest otherwise.
There is no indication that the declaration was inte nded to impose obligations on the Governments of
the Group of Five countries vis-à-vis other member States or the Commission. The European
Communities appears to infer from the circumstance that the 1999 declaration itself is not legally
binding that it might not reflect the real intentions of the Governments of the Group of Five countries
and that it may have been made merely for the sak e of expediency, "to satisfy a political need".
However, a panel must not lightly cast doubt on th e good faith underlying governmental declarations
and on the veracity of these declarations. In the instant case, the precise, legal-style drafting of the
1999 declaration demonstrates that it is not a casual statement, but a carefully considered one. What
is more, the 1999 declaration is a formal, on-th e-record declaration made on behalf of the
Governments of the Group of Five countries and reflecting their official position. In these
circumstances, and in the absence of evidence to the contrary, it may be presumed that the 1999
declaration by the Governments of the Group of Five countries accurately expresses their true
intentions.
579

579 With respect to DS292 we note that Canada has introduced evidence which suggests that the Group
of Five declaration was reiterated over time. First, evidence submitted by Canada suggests that the declaration
was reiterated at the formal adoption of the Common Position on 9 December 1999. Exhibit CDA-32, p. 5.
Secondly, Canada refers to a statement by the Group of Five countries plus Austria of 15 February 2001 which
also reaffirmed the intention expresse d in the June 1999 declaration. The statement accompanied the adoption
by the Council of the definitive legislative act embodyin g the revised Directive 90/220, following the European
Parliament's second reading under the co-decision pr ocedure. The Council decided to make the statement
public. It reads in full:

"Statement by the Danish, Greek, French, Italian, Austrian and Luxembourg Delegations

Having regard to the principle of prevention and precaution, the delegations of the following Member
States: Denmark, Greece, France, Italy, Austria and Luxembourg

• reaffirm the need to introduce a more rigoro us, transparent and comprehensive framework
concerning risk assessment and risk management (taking account of the specific characteristics of
European eco-systems), monitoring, traceability a nd labelling of GMOs and to generally restore
the confidence of the public and of operators;

7.481 Another element which needs to be noted in respect of the 1999 declaration is the fact that it
is a joint declaration. More particularly, what is of interest is the composition of the Group of Five
countries. During the time period in question (October 1998 to August 2003), the member States
making up the Group of Five countries had enough vot es in the appropriate Regulatory Committee or
the Council to prevent these bodies from achieving the qualified majority that is necessary to adopt a
draft measure proposing the approval of an application.
580 In other words, the Group of Five countries

• note that the amended provisions of Directive 90/220/EEC significantly but only partially
improve the existing arrangements and emphasise the essential improvements made concerning
transparency, public access to in formation, regional biological monitoring of the countryside,
gradual elimination of antibiotic resistance markers, legal certainty and ratification of the
Carthagena Protocol;
• ask the Commission to follow up its commitment concerning the early submission of
comprehensive legislative proposals on GMO tr aceability and labelling, environmental liability
and ratification of the Carthagena Protocal.

Accordingly, the above delegations

• reaffirm their intention, when exercising the power s conferred upon them, of ensuring that the
new authorizations for cultivating and marketing GMOs are suspended pending the adoption of
effective provisions concerning a complete traceability of GMOs that guarantees reliable
labelling of all GMO products;
• call on the Commission to make rapid progress towards the establishment of a system of
environmental liability to supplement the regulatory framework n ecessary for development in the
field of biotechnologies, as in other environmental fields." (Exhibit CDA-114; emphasis added).

We note that Argentina also refers to Exhibit CDA-114. Finally, evidence submitted by Canada
suggests that the Group of Five countries plus Austri a reaffirmed their previous declarations at the final
adoption of the revised Directive 90/220 on 12 March 2001. Exhibit CDA-31, p. 1. Argentina also refers to
Exhibit CDA-31, p.1.
580 Article 21 of Directive 90/220 provides that Regulatory Committee opinions "shall be delivered by
the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to
adopt on a proposal from the Commission". It further pr ovides that in those cases where a measure cannot be
adopted after the Regulatory Committee stage and the matter goes before the Council, " [t]he Council shall act
by a qualified majority". Article 148(2) of the Treaty Establishing the European Community as Amended by
Subsequent Treaties provides in relevant part (emphasis added):
"Where the Council is required to act by a qualif ied majority, the votes of its members shall be
weighted as follows:

 Belgium 5
Denmark 3
 Germany 10
 Greece 5
 S p a i n 8
 F r a n c e 1 0
 Ireland 3
 Italy 10
 Luxembourg 2
 Netherlands 5
 A u s t r i a 4
 P o r t u g a l 5
 Finland 3
 S w e d e n 4
 United Kingdom 10

constituted a "blocking minority" at the level of decisions by the Regulatory Committee and the
Council. It should be recalled in this context that the 1999 declaration states that the Governments of
the Group of Five countries "will take steps to have any new authorizations for growing and placing
on the market suspended". One of the steps open to the Governments of the Group of Five countries
was to act as a "blocking minority" in the releva nt Regulatory Committee or Council. Thus, to the
extent that the 1999 joint declaration by the Grou p of Five countries was perceived as announcing or
confirming the formation of a credible "blocking minority", it sent an important signal to other
member States and the Commission. It would have signalled that if the Group of Five countries were
to act in accordance with their declaration, app lications could henceforth be approved only at
Community level
581 and only if the Commission was willing (i) to submit draft measures to the
Regulatory Committee and the Council and (ii) to override a "blocking minority" by adopting the
proposed measures.
7.482 Before proceeding further, we also need to address the substance of the declaration by the
Group of Five countries. To begin with, we reca ll that in their declaration, the Group of Five
countries pointed to the importance of the Commi ssion "submitting without delay full draft rules
ensuring labelling and traceability of GMOs and GMO- derived products" and stated that "pending the
adoption of such rules, they would take steps to have any new authorizations for growing and placing
on the market suspended". This suggests that upon adoption of such rules, the Group of Five
countries might no longer use the powers confer red upon them so as to prevent the approval of
applications.
582 It is therefore important to be clear about the rules the Group of Five countries
wanted to see adopted, all the more so as subse quent to the June 1999 declaration the European
Communities adopted two legislative acts which specified labelling and traceability requirements.
7.483 In March 2001, the European Communities adopted the amended Directive 90/220 as
Directive 2001/18. Directive 2001/18 laid down la belling requirements in Article 21 and certain
traceability and monitoring requirements in Article 4(6) (and Annex IV) and in Article 20 (and
Annex VII). In September 2003, i.e., shortly after this Panel was established, the European
Communities adopted Regulation 1 830/2003 "concerning the traceability and labelling of genetically
modified organisms and the traceability of food and feed products produced from genetically
modified organisms and amending Directive 2001/18/EC". For the reasons set out below, the Panel is
of the view that the rules which the Group of Fi ve countries wanted to see adopted are the rules
adopted in September 2003 as Regulation 1830/20 03, and not those adopted in March 2001 as
Directive 2001/18.583

For their adoption, acts of the Council shall require at least:
62 votes in favour where this Treaty requires them to be adopted on a proposal from the commission."
Since the total number of votes is 86, the 30 votes of the Group of Five co untries (Denmark, Greece,
France, Italy and Luxembourg) are sufficient to prevent the required qualified majority of 62 votes from being
achieved.

581 It could be expected that in any case where a l ead CA that was not part of the Group of Five
countries made a favourable assessment at member State level, one or more of the Governments of the Group of
Five countries would take the "step" of objecting to the product being placed on the market in order to force a
decision at Community level where the Group of Five countries could take the further "step" of acting as a
"blocking minority".
582 It should be noted that in the context of the EC legislative process, the adoption of rules by the
European Parliament and the Council is a stage that is different from the proposal for such rules by the
Commission and the entry into force of such rules.
583 As we explain further below, we think it is plausible that the new EC rules which the Group of Five
countries wanted to see adopted also include the rules adopted in September 2003 as Regulation 1829/2003.

7.484 First, the June 1999 declaration by the Group of Five countries calls on the Commission to
submit a proposal for rules ensuring labelling and traceability. By June 1999, the Commission had
already submitted a proposal for an amendment of Directive 90/220.
584 In contrast, the Commission
did not submit a proposal for what was to become Regulation 1830/2003 until 2001. 585 Secondly, the
June 1999 declaration calls for rules "ensur ing labelling and traceability of GMOs and GMO-derived
products" (emphasis added). Neither Directive 90/220 nor Directive 2001/18 applied to GMO-
derived products.586 In contrast, Regulation 1830/2003 applies to such products. 587 Lastly, mention
should be made of a June 1999 formal declaration by seven member States (Austria 588, Belgium589,
Finland, Germany, Netherlands, Spain and Sweden ). Like the Group of Five declaration, the
declaration in question was made in the context of the meeting of the Council of 24/25 June 1999 at
which a political agreement was reached on the propo sal to amend Directive 90/220. The declaration
by the seven member States (hereafter the "Group of Seven") is reproduced in relevant part below:590
"Declaration by the Austrian, Belgian, Finnish, German, Netherlands, Spanish and
Swedish delegations
Being aware of the increasing public concer n about the potential risks to health and
environment linked to the release and the placing on the market of GMOs, the above-
mentioned delegations
– stress the need to implement a more transparent and strict framework
concerning critical issues such as ri sk assessment taking into account the
specificity of European ecosystems, monitoring and labelling as well as the
need to restore the trust of public opinion and of the market;
– reaffirm their intention to work for a rapid finalisation of the legislative
process concerning the proposal for an amendment of Directive 90/220/EEC
and invite the European Parliament to join the Council and the Commission
in their intention so that the legislative process can be rapidly finalised.
Against this background the Governments of these Member States, having regard to
the precautionary principle set out in Article 174(2) of the Treaty, intend:

That Regulation lays down additional labelling requirements for genetically modified food and feed. See infra,
para. 7.1039.
584 The proposal was published on 4 May 1998. Preamble to Directive 2001/18; Exhibit US-71.
585 The proposal was published on 30 October 2001. Preamble to Regulation 1830/2003.
586 Article 2(4) of Directive 90/220; Article 2(7) of Directive 2001/18.
587 Article 2 in conjunction with Article 3(2) of Regulation 1830/2003.
588 We recall that Canada submitted evidence which shows that Austria in February 2001 formally
expressed its support for the June 1999 declaration by the Group of Five countries. Exhibit CDA-114.
Argentina also refers to Exhibit CDA-114.
589 We note that the United States submitted a documen t which suggests that Belgium as of December
2001 also supported the June 1999 declaration by the Group of Five countries. The document, which appears to
be based on a press release, says that Belgium decided that new EC rules on traceability and labelling would
need to be formally approved before other measures could be taken. Th e document also states that Belgium
decided to discuss this issue again in October 2002. Exhibit US-79. Canada and Argentina also refer to Exhibit
US-79.
590 Declaration by the Austrian, Belgian, Finnish, German, Netherlands, Spanish and Swedish
delegations, 2194th Council Meeting - Environment, Luxembourg, 24/25 June 1999. Exhibits US-76 and -77;
CDA-3; ARG-12.

– to take a thoroughly precautionary appro ach in dealing with applications and
authorizations for the placing on the market of GMOs,
– not to authorize the placing on the market of any GMOs until it is
demonstrated that there is no adverse effect on the environment and human
health, and
– to the extent legally possible to appl y immediately the principles, especially
regarding traceability and labelling, laid down in the political agreement for a
revision of Directive 90/220/EEC reached by the Council on 24/25 June
1999.
Therefore, these delegations invite the Commission as a matter of urgency to make a
proposal for effective implementation of the provisions regarding labelling and
traceability of GMOs through the comi tology procedure foreseen in
Directive 90/220/EEC."
7.485 The declaration by the Group of Seven countries is of interest because it talks about "the
principles [… ] regarding labelling and traceability of GMOs laid down in the
[June 1999] political
agreement for a revision of Directive 90/220/EEC " (emphasis added). The parallel declaration by the
Group of Five countries, when referring to rules ensuring labelling and traceability, nowhere
references the June 1999 political agreement. Ha d the Group of Five countries wanted to see the
adoption of the provisions regarding labelling a nd traceability laid down in the June 1999 political
agreement, one would have expect ed a reference to that agreemen t along the lines of the reference
contained in the declaration by the Group of Seven countries.
7.486 We further find noteworthy that the declarati on by the Group of Seven countries calls for a
de facto implementation of the provisions regarding labelling and traceability of GMOs laid down in
the June 1999 political agreement prior to the en try into force of the agreed amendment of
Directive 90/220. Apparently, this was considered insufficient by the Group of Five countries.
Reading the declaration by the Group of Five countri es together with the declaration by the Group of
Seven countries, it seems to us that the Group of Five countries considered it insufficient to adopt the
provisions laid down in the June 1999 political agreem ent, even if those provisions were implemented
before their adoption, as the Group of Seven countries requested. It appears that the Group of Five
countries wanted to go further and adopt new ru les which the Commission was invited to propose
without delay.
7.487 Another issue which concerns the substance of the declaration by the Group of Five countries
is whether the declaration also covers applica tions for the approval of biotech food products, i.e.,
applications which fall within the scope of Regulati on 258/97. At this point, it is sufficient to note
that, in our view, the declaration can be interprete d to apply also to such applications. We will
address this issue further at paragraphs 7.1038-7.1041 below.
(ii) Commission
7.488 Unlike in the case of the Group of Five countries, the Complaining Parties did not refer the
Panel to a declaration by the Commission in which it stated an intention to delay or prevent the final
approval of applications. Nor did the Complaining Parties argue that they had provided other direct
evidence of such an intention on the part of the Co mmission. It is nevertheless clear that it is the
contention of the Complaining Parties that the Commission intentionally delayed or prevented the
final approval of applications during the relevant time period (October 1998 to August 2003). This

intention can be inferred, in the Complaining Par ties' view, from the absence of approvals during the
relevant time period and the Commission's conduct in the context of individua l approval procedures.
The Panel will address these two elements later in its analysis.
7.489 In the absence of evidence which directly est ablishes that the Commission intentionally
delayed or prevented final approvals , it is pertinent to ask why in the Complaining Parties' view the
Commission would have wanted to delay or prevent such approvals. As the Panel understands it, the
Complaining Parties' answer is that the decisi on to do so was based on political considerations.
591
More particularly, the argument essentially app ears to be that following the announcement by the
Group of Five countries that they would act as a "blocking minority" in the Regulatory Committee
and the Council, the Commission considered th at it lacked the necessary political support for
completing approval procedures by adopting its own draft measures.
7.490 It should be mentioned in this respect that th e United States and Canada in their submissions
both refer to, and quote from, the summary of a Ja nuary 2001 meeting between the lead CA in the
approval procedure concerning RR fodder beet and the applicant. 592 According to the summary,
which was prepared by the applicant and sent to th e lead CA (Denmark) by way of confirmation, the
applicant was given to understand by the lead CA that – in the applicant's words – "[t]he 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 [Regulatory Committee] vote meeting, if
there are no indications that the member-states are supporting the process and/or expected to vote
positively."
593 If the applicant's summary correctly refl ects Denmark's statement, this statement
suggests that the Commission at the time viewed the political support of member States as a necessary
precondition for it convening Regulatory Committee mee tings for votes on applications. It should be
borne in mind, however, that Denmark is one of the Group of Five countries. Hence, even if
Denmark made the statement in question, it might have overstated the importance of Group of Five
countries' support.
7.491 Canada also submitted a Commission document entitled "GMOs Issues Paper – Strategy on
Possible Ways Forward". 594 The document was prepared by th e "services" for the "Commission
orientation debate on GMOs" of 12 July 2000. Thus, it was written after the June 1999 declaration by
the Group of Five countries, but before the adopti on of Directive 2001/18. Against this background,
the document states in a passage quoted by Canada that " [o]ur objective is to have, by the end of the
conciliation process and the adoption of the revised Directive [90/220], the elements necessary to
complete the authorization process and to conve ne a meeting of the regulatory committee under
Directive 90/220/EC. If the Member States are still not prepa red to vote positively in the Committee ,
the Commission should be ready to make full use of the procedures set out in the Directive to
complete the authorization process. "595 The last sentence implies that , at the time in question, the
Commission could have considered member Stat e opposition a reason for not making full use of the
procedures envisaged in Directive 90/220 to complete the approval process. Otherwise there would
have been no point in recommending that the Co mmission should be ready to complete the approval
process. It must also be noted, however, that it cannot be assumed that the views expressed in a
strategy paper prepared by the Commission services necessarily reflect those of the Commission.

591 US reply to Panel question No. 74; US second oral statement, paras. 36-38; Exhibit US-148; US
third written submission, para. 21; Canada's second written submission, paras. 23 and 26; Canada's third written
submission, paras. 202-203; Argentina's second written submission, para. 52.
592 US third written submission, para. 92; Canada's second written submission, para. 34.
593 Exhibit EC-64/At. 120.
594 Exhibit CDA-113. The document was first submitted by Argentina as Exhibit ARG-50.
595 Exhibit CDA-113, p. 3 (emphasis added).

7.492 In the Panel's view, it is clear even without the above-mentioned statements attributed to
Denmark and the Commission services that member Stat e support might in some circumstances be an
issue for the Commission. To see wh y, it is useful to recall a fundamental aspect of the structure and
design of the EC approval procedures. Canada described this aspect in the following terms:
"Directives 90/220 and 2001/18 foresee an approval based on the lead member State's
review as the primary route to a decision. Only in relatively limited cases should the
Regulatory Committee need to become involved. And only as an exception to this
exception is the Council required to act. And finally, only as an exception to the
exception to the exception does the Commission have the final say."
596
7.493 Canada may or may not be correct with regard to what should be the "primary route to a
decision" and what should happen "only in relatively limited cases". But there can be little doubt that
the Commission's "final say" was intended by the EC legislator as a last resort, to avoid deadlocks that
might otherwise occur in the event that the me mber States in the Regulatory Committee and the
Council fail to achieve the required qualified majority. 597 Notwithstanding this, exceptional
circumstances might arise where the Commission routinely would have the final say and the
"exception to the exception to the exception", as Canada put it, would become the rule, contrary to the
design of the EC approval procedures. This could be the case, for instance, in circumstances where
member State opposition to Commission proposals is not merely sporadic but systematic, and where
the relevant member States at the same time have enough votes to act as a "blocking minority" in the
Regulatory Committee and the Council.
7.494 As noted by the Panel in its preceding remark s, the Group of Five countries in June 1999
signalled precisely such systematic opposition to final approvals. In addition, the combined votes of
the Group of Five countries enabled them to act as a "blocking minority". The Commission thus had
reason to believe that it could no longer approve applications with the (qualified majority) support of
the member States. In such highly exceptional circumstances, and considering the sensitivity of
approvals of biotech products, it is plausible that the systematic lack of political support, and indeed
opposition, by the Group of Five countries was an issue and concern for th e Commission. This
situation could, in our view, ha ve dissuaded the Commission from making full use of the relevant
procedures to complete the approval process, despite the applicable legal obligations
598.
(c) Absence of approvals during the relevant time period
7.495 The Complaining Parties assert not only that certain member States (notably the Group of
Five countries) and the Commission had the ability a nd intention to prevent the final approval of
applications during the time period in question. They also assert that these member States and the
Commission actually prevented the final approval of a pplications during that time period. That there
was an actual suspension on final a pprovals is evidenced, in the view of the Complaining Parties, by
the following two elements: (i) the number of fina l approvals in the relevant time period, and (ii)
official and internal EC documents as well as statemen ts by EC and member State officials. In the

596 Canada's third written submission, para. 196. A statement along very similar lines could be made in
respect of Regulation 258/97.
597 It is useful to note in this context that the regulatory committee procedure, whereby the Commission
is assisted by a regulatory committee, involves a delegation of implementing powers from the Council to the
Commission. See, e.g., Council Decision 1999/468 laying down the procedures for the exercise of
implementing powers conferred on the Commission. The Decision is referred to in Article 30(2) of
Directive 2001/18.
598 Article 21 of Directive 90/220; Article 13(3) and (4) of Regulation 258/97.

present Subsection, the Panel addresses the first elem ent – the issue whether there were any approvals
in the relevant time period (October 1998 to August 2003).
7.496 The Complaining Parties argue that between October 1998 and August 2003, when the
Panel's terms of referenc e were established, the European Communities failed to approve a single
biotech product under either Directives 90/220 an d 2001/18 or under Regulation 258/97. This is
despite the fact that many applications were pending during that period and that many of these
applications had been favourably assessed by the European Communities' own scientific committees.
In contrast, up to October 1998 – the date of the last approval of a biotech product – the European
Communities had approved at least ten biotech products.
599
7.497 The European Communities responds that it does not contest that other than the biotech
food products approved under the simp lified procedure of Regulation 258/97 600, there have not been
any approvals for a given period of time due to the fact that the EC regulatory regime was incomplete.
Regarding the simplified procedure of Regulati on 258/97, the European Communities states that
between October 1998 and 2004 seven biotech food products were approved.
7.498 The United States submits that the simplified procedure set out in Regulation 258/95 does
not require action by the Council or Regulatory Committee. The United States further states that the
simplified procedure does not appear to be affected by the EC moratorium.
7.499 Canada notes that the simplified procedure is only available in limited circumstances and
does not require the Commission to take a decision at Community level. Canada submits that each of
the applications referred to by the European Communities were assessed by food assessment bodies
from one member State. Other member States did not have an opportunity to block or stall this
process. That the relevant member State food assessment bodies acted on the basis of sound science
and in accordance with EC law does not, in Canada's view, disprove the existence of the moratorium.
7.500 Argentina argues that the simplified procedure of Regulation 258/97 only requires that one
member State issue an opinion that the product is "s ubstantially equivalent" to existing foods or food
ingredients. Once that opinion is issued, the marketing of the product in question cannot be prevented
by other member States or the Commission. Arge ntina submits on that basis that the simplified
procedure is not an approval procedure, but a application procedure.
7.501 The Panel notes that it is not in dispute that during the relevant time period (October 1998 to
August 2003) numerous applications for placing on th e market were awaiting approval under either
Directives 90/220 and 2001/18 or Regulation 258/97.
601
7.502 Also uncontested are the following facts:
(a) Under Directive 90/220, no application w as approved or rejected between October
1998 and October 2002, when Directive 90/220 was repealed.602

599 Canada contends that twelve biotech products we re approved. Canada's first written submission,
para. 65.
600 For an explanation of the simplified procedure, see section VII.C.3(c): Novel foods and novel food
ingredients: Regulation 258/97.
601 See Subsection (e) below entitled "Facts and histories of individual approval procedures".
602 It should be noted that, according to the European Communities, one application was withdrawn
after it had received a negative assessment. EC reply to Panel question No. 14. As the European Communities

(b) Under Directive 2001/18, no application was approved or rejected between October
2002, when Directive 2001/18 entered into force, and August 2003.
(c) Under the ordinary procedure of Regulation 258/97
603, no application was approved
or rejected between October 1998 and August 2003.
(d) Under the simplified procedure of Regulation 258/97 604, a number of biotech food
products were placed on the market between October 1998 and August 2003.605
7.503 Accordingly, with the exception of biotech products subject to the simplified procedure of
Regulation 258/97 to which the Panel will revert below, the European Communities did not approve
or reject any biotech product between October 1998 and August 2003.606
7.504 It should also be noted, however, that both before October 1998 and after August 2003, the
European Communities did approve applications fo r the placing on the market of biotech products.
Up to and including October 1998, the Eur opean Communities approved the following ten
agricultural biotech products:607
− BXN tobacco (in June 1994);
− MS1/RF1 oilseed rape (EC-161) (in February 1996; for breeding activities);
MS1/RF1 oilseed rape (EC-89) (in June 1997; for import and processing)608;
− MON soybeans (in April 1996);
− Transgenic red-hearted chicory (in May 1996);
− Bt-176 maize (in January 1997);
− MS1/RF2 oilseed rape (in June 1997)609;
− Topas oilseed rape (in April 1998);
− T25 maize (in April 1998);

provided no details, it is unclear whether this appli cation had been submitted under Directives 90/220 or
2001/18 or under Regulation 258/97.
603 The ordinary procedure is laid down in Articles 4, 6 and 7 of Regulation 258/97.
604 The simplified procedure is laid down in Article 5 of Regulation 258/97.
605 The European Communities asserts that between October 2003 and 2004 seven products were
placed on the market. But the European Communities provides no documentary support which would allow the
Panel to confirm this number. EC reply to Panel question No. 14. Evidence submitted by the United States
(Exhibit US-107, Annex 5), Canada (Exhibit CDA-25) and Argentina (Exhibit ARG-6, Annex 4) supports the
conclusion that between October 1998 and August 2003 a total of six biotech food products were placed on the
market.
606 The European Communities has pointed out that one application concerning a genetically modified
potato was withdrawn after it had received a negative assessment, but no details were provided to the Panel.
607 Exhibits US-97 and 107 (Annex 1); CDA-34 (Annex 1); ARG-6 (Annex 1). It is clear from these
exhibits that in addition to the agricultural biotech pro ducts already mentioned, several more biotech products
were approved (certain vaccines, a test kit to detect antibiotic residues in milk and certain carnation lines). Two
of these additional products were approved in October 1998.
608 MS1/RF1 oilseed rape (EC-161) and MS1/RF1 oilseed rape (EC-89) are the same products; but the
scope of the underlying applications was different. Regarding MS1/RF1 oilseed rape (EC-89), the Complaining
Parties assert that, despite the fact that the Commission took a favourable decision on the application concerning
MS1/RF1 oilseed rape, the lead CA never granted written cons ent to the placing on the market of this product.
The Panel will revert to this issue below at paras. 7.1018-7.1028.
609 The Complaining Parties assert that, despite the fact that the Commission took a favourable decision
on the application concerning MS1/RF2 oilseed rape, the lead CA never granted written consent to the placing
on the market of this product. The Panel will revert to this issue below at paras. 7.1018-7.1028.

− Bt-11 maize (EC-163) (in April 1998); and
− MON810 maize (in April 1998).

7.505 After 29 August 2003, that is to say, after th e Panel was established, and before the Panel's
second substantive meeting with the Parties, a furt her three applications concerning two different
biotech products were approved by the Commission:
− Bt-11 maize (food) was approved under Regulation 258/97 on 19 May 2004
610;
− NK603 maize was approved under Directive 2001/18 on 19 July 2004611; and
− NK603 maize (food) was approved under Regulation 258/97 on 26 October 2004612.

7.506 Like the pre-October 1998 approvals, the af orementioned post-August 2003 approvals are
relevant facts which the Panel may take into account in the context of its determination of whether the
European Communities applied a general morato rium on approvals betw een October 1998 and
August 2003. In respect of the post-August 2003 approva ls, it is important to bear in mind, however,
that they were all granted while the presen t panel proceedings were already under way.
613 T h e
European Communities contends that these approva ls are nevertheless evidence that there was no
general moratorium during the rele vant time period. Referring to th e example of Bt-11 maize (food),
which it describes as representative of other appli cations, the European Communities points out that
the relevant application was subm itted in 2000 and then steadily pro ceeded to the final approval in
2004.614 Argentina considers that the approval of Bt-11 maize (food) may well be directly attributable
to the present panel proceedings and should theref ore not be regarded as representative of other
applications.615 The United States, for its part, asserts that the existence and timing of the approval of
Bt-11 maize (food) is no coincidence and shoul d be seen against the background of the panel
proceedings and the entry into force of the new EC rules on labelling and traceability in April 2004.616
7.507 Significantly, all Complaining Parties also mainta in that prior to being approved in 2004, the
applications concerning Bt-11 maize (food), NK603 maize and NK603 ma ize (food) were affected by
the alleged general moratorium. Thus, the fact th at three applications were approved after August
2003 is not necessarily inconsistent with the Compla ining Parties' assertion that between October
1998 and August 2003 certain member States and the Commission intentionally prevented the final
approval of all applications.
7.508 It should be noted that after the Panel's sec ond substantive meeting with the Parties, the
European Communities sent two letters to the Panel a nd the other Parties, for information, stating that

610 Exhibit EC-92/At. 81; Exhibits CDA-109 and 138; EC comments on Complaining Parties' replies to
Panel questions, para. 63.
611 Exhibit CDA-137; EC comments on Complaining Parties' replies to Panel questions, para. 62. This
application was approved by the Commission pursuant to the provisions of Directive 2001/18. The record
contains no information about whether the lead CA has since granted written consent to the placing on the
market of the product in question.
612 US third written submission, para. 101; EC comments on Complaining Parties' replies to Panel
questions, para. 63. NK603 maize and NK603 maize (food) are the same products; but the scope of the
underlying applications was different.
613 The first of these approvals came a few weeks af ter the Complaining Parties filed their first written
submissions. Prior to that, the Complaining Parties ha d already outlined their cases in their requests for the
establishment of a panel. These requests are dated 7 August 2003.
614 EC first oral statement, paras. 29-32.
615 Argentina's second written submission, para. 23.
616 US third written submission, para. 15; US second written submission, paras. 47-49.

the Commission approved two additional applicati ons concerning two different biotech products.
Specifically, the European Communities stated that:
− MON863 maize was approved under Directive 2001/18 on 8 August 2005
617;
− RR oilseed rape (EC-70) was approve d under Directive 2001/18 on 31 August
2005618.

7.509 As the European Communities sent its letters for information, no supporting evidence was
provided and no arguments were ex changed in relation to the two Commission approvals. However,
the Complaining Parties did not question the Eu ropean Communities' contention that the two
applications were in fact approved by the Co mmission under Directive 2001/18. The Panel further
notes that, curiously, the approval procedure con cerning MON863 maize was never examined by the
Complaining Parties or the European Commun ities in their written or oral submissions. 619 As the
Panel has been given no detailed information on th is application and the Parties have offered no
examination of this application, the Panel will not, and indeed cannot, address it for the purposes of its
analysis of whether or not the Eu ropean Communities applied a general de facto moratorium on the
approval of biotech products between October 1998 and August 2003.
7.510 As indicated above, it is necessary to consider in more detail the simplified procedure of
Regulation 258/97 under which a number of biotech food products were placed on the market during
the relevant time period. At the request of th e Panel, the European Communities provided an
explanation of the simplified procedure, which is reproduced below in relevant part:620
"Under the simplified procedure products cannot be placed on the market without
having been notified. Application in turn is only possible if it has been demonstrated
that the product in question is substantia lly equivalent to existing foods or food
ingredients [...]
Substantial equivalence, according to Article 3(4), in principle can be demonstrated in
two ways: (1) by relying on scientific evidence available and generally recognized
and (2) by relying on an opinion delivered by one of the competent food assessment

617 The record contains no informa tion about whether the lead CA has since granted written consent to
the placing on the market of the product in question.
618 The record contains no informa tion about whether the lead CA has since granted written consent to
the placing on the market of the product in question.
619 In its first written submission, the European Communities stated that "in order to complete the
picture", it would provide a brief overview of those applications which were not mentioned in the Complaining
Parties' requests for the establishment of a panel. EC first written submission, paras. 196 and 334. While the
European Communities listed a number of applications which had been submitted under Directive 2001/18 and
were still pending, no mention was made of MON863 maize, even though that application was not mentioned in
the Complaining Parties' panel requests. Subsequently , in its reply to Panel question No. 91, the European
Communities made a passing reference to MON863 maize, stating nothing more than that the application would
be discussed in the Regulatory Committee in the autumn of 2004. In relation to DS292, we note that Canada
submitted two opinions by the GMO Scientific Panel of the European Food Safety Authority of April 2004
which concern MON863 maize. One wa s issued in respect of an application under Directive 2001/18 and the
other was issued in respect of an application under Regulation 258/97. These opinions, which post-date the date
of establishment of the Panel, were submitted, together with numerous other opinions, as attachments to a list
provided in support of Canada's general assertion that there were applications pending under Directive 2001/18
and Regulation 258/97 which had received a favourable sc ientific opinion by an EC scientific committee.
Canada's first written submission, paras. 50 and 54.
620 EC reply to Panel question No. 15.

bodies of the EU Member States (see Article 4(3)). Only the latter option, however,
is de facto applicable to GM products as there exists no generally recognised
scientific evidence on the substantial equivalence of these products. Accordingly, no
applicant for GM products under the simplif ied procedure has ever even tried to
demonstrate substantial equivalence under this first option.
In order to obtain an opinion from a co mpetent food assessment body in an EU
Member State, an applicant has to submit a dossier on, and the competent body
proceeds to a full assessment of, the product in question.
Once the competent body has reached a pos itive opinion, the applicant may proceed
to notifying the product on the basis of that opinion. The application is made to the
Commission. Neither the Commission nor another Member State, at this stage, can
prevent the application on the basis that it would not agree with the opinion. [...]"
7.511 In the European Communities' view, because biot ech food products subject to the simplified
procedure effectively require prior recognition of "substantial equivalence" through a member State
food assessment body, they effec tively require prior approval.
621 The issue therefore arises whether
the simplified procedure is an approval procedure. If it is, the fact that a number of biotech food
products were placed on the market during the releva nt time period would present the further issue of
whether the Complaining Parties are correct in cl aiming that no "applications" for the placing on the
market of biotech products were "approved" in the relevant time-frame.
622
7.512 Article 5 of Regulation 258/97, which lays dow n the simplified procedure, states that the
applicant shall "notify the Commission of the placing on the market when he does so" and that "[s]uch
applications shall be accompanied by the relevant details provided for in Article 3(4)". As pointed out
by the European Communities, the relevant deta ils commonly include an opinion delivered by a
member State food assessment body confirming the "s ubstantial equivalence" of the biotech food
product in question. Thus, the text of Article 5 ma kes clear that the applicant may proceed to place
the relevant product on the market without seeking pr ior approval or authorization. The applicant
must merely "notify" the Commission when the pr oduct is placed on the market; the Commission is
neither required nor authorized to take an authorization decision on the product. 623 Similarly, the
relevant member State food assessment body is task ed with delivering a scientific "opinion" on
"substantial equivalence"; it is not empowered to d ecide whether and on what conditions the relevant
product may be placed on the market. As noted by the European Communities, once a member State
food assessment body has delivered an opinion conf irming "substantial equivalence", neither the
relevant member State nor another member Stat e can prevent the product from being placed on the
market.624

621 Ibid.
622 See the Complaining Parties' requests for the esta blishment of a panel as contained in documents
WT/DS291/23, WT/DS292/17 and WT/DS293/17.
623 In contrast, under the ordinary procedure of Regulation 258/97, the applicant may place the product
on the market only if one of the following two conditions are met: (i) the lead CA has "decided", after an initial
assessment, that no additional assessm ent is required and has informed the applicant that it "may" place the
product on the market ( see Articles 6(3) and 4(2) of Regulation 258/97), or (ii) the Commission has taken a
favourable "authorization decision" in accordan ce with the regulatory committee procedure ( see Article 7 of
Regulation 258/97).
624 In contrast, the record demonstrat es that under the approval procedur es set out in Directives 90/220
and 2001/18 as well as in Articles 4, 6 and 7 of Regulation 258/97, applicants did not and could not proceed to
place their products on the market ev en though specialized bodies at me mber State or Community level had

7.513 In the light of the foregoing, the Panel considers that it would not be correct to say, in relation
to the biotech food products which were plac ed on the market between October 1998 and August
2003, that the placing on the market of these pr oducts was "approved", or authorized, by the
specialized member State food assessment bodies whic h confirmed their "substantial equivalence",
and even less that there were "applications" for the placing on the market of these products which
were "approved" by these specialized bodies. Accordi ngly, the Panel finds that the fact that a number
of biotech food products were placed on the market during the relevant time period does not disprove
the Complaining Parties' claim that no "applications" for the placing on the market of biotech products
were "approved" by the European Communities in the relevant time-frame.
(d) Documents and statements referring to a "moratorium"
7.514 As previously noted, in support of their assertion that certain EC member States and the
Commission actually prevented the final approval of applications during the relevant time period
(October 1998 to August 2003), the Complaining Parti es point to two elements of proof: (i) the
absence of final approvals in the re levant time period, and (ii) offici al and internal EC documents as
well as statements by EC and member State officials.
625 In this Subsection, the Panel addresses the
second element.
7.515 The Complaining Parties have submitted numer ous documents and statements which are
identified further below626 and which can be divided into five categories:
 (i) Commission documents and statements by individual Commissioners;

 (ii) Council documents;

 (iii) European Parliament documents;

 (iv) statements by member State officials; and

 (v) EC statements at the WTO.

7.516 The Complaining Parties contend that these documents and statements acknowledge and
demonstrate the existence of a general moratorium on approvals during the relevant time period.
7.517 The European Communities argues that none of the documents or statements referred to by
the Complaining Parties represents the official pos ition of the European Comm unities. The official
position of the European Communities is that ther e was no moratorium betw een 1998 and 2003 and
that there has been no moratorium since. Rather , every application is decided on its own merits,
against the background of proposed and actual new legislation and changes in scientific knowledge
and understanding.
7.518 The European Communities further argues that none of the documents and statements
referred to by the Complaining Parties pr ovide evidence of the existence of a de facto moratorium.

delivered favourable scientific opinions on these produc ts. This is because notwith standing these favourable
opinions, during the relevant time period no authorization decisions were taken in respect of these products.
625 The Complaining Parties have all stated that they rely on the relevant documents and statements as
evidence of the existence of the alleged general moratori um on approvals. US first oral statement, para. 25;
Canada's first oral statement, para. 36; Argentina's first oral statement, paras. 18-19.

They neither prove nor confirm the existence of a suspension of the approval process. Regarding the
statements by EC officials or member State offici als, the European Communities observes that they
are expressions of opinion associated with specific persons or reflect views of individual member
States. They simply describe a situation and do not assert the existence of a practice of suspending
the approval process. The Europ ean Communities submits that the fact that there have been no
authorizations for some time may be perceived from the outside as a situation of "standstill". But the
absence of a decision is not the same thing as a d ecision not to decide. The European Communities
states that the perceived "standstill" in reality is a re flection of the fact that in the relevant approval
procedures there have been requests for additiona l information on complex risk assessment and risk
management issues. Furthermore, in the great majo rity, the references in some of the documents and
statements submitted to a "moratorium" or " de facto moratorium" were made in the context of
legislative changes in the Eur opean Communities. While during that transition period approval
procedures may in some cases have suffered import ant delays, that period has ended, and so the
documents and statements referred to by the Complaining Parties do not establish a "moratorium" that
is currently in existence.
7.519 The United States responds that the Complaining Parties are not relying on casual
statements. The statements cited by the Complain ing Parties are statements made by the European
Communities' highest officials, by its official bodies and by its member States. In the United States'
view, the numerous statements from every EC en tity – member States, Commission, Council, and
Parliament – are strong evidence of the existence of a general moratorium. The United States further
argues that the relevant documents and statements do not refer simply to the fact that no biotech
products reached final decision; they uniformly refe r to the existence of a "moratorium". The United
States submits that the term "moratorium" was used because it precisely fit the situation: namely, that
the European Communities had decided not to allow any biotech application to move to final
approval.
7.520 Canada argues that the relevant documents and st atements are strong, consistent further
confirmation by the most senior officials in th e European Communities that it has maintained a
moratorium. These statements are not casual, nor are they perceptions "from the outside".
7.521 Argentina considers that the statements in question demonstrate both the existence of the
de facto moratorium and the period during which it has b een applied. The statements show that the
existence of the moratorium has been acknowledged by senior EC officials with direct competence on
the matter considered in this dispute. More over, one document – a background note from the
Council's press service of April 2004 – confirms that the moratorium was still in existence at that
time.
7.522 The Panel begins by noting that there appears to be no disagreement among the parties that
EC documents or statements by EC or member State officials may constitute evidence of the existence
of a measure. The European Communities referred in this respect to the GATT panel report on Japan
– Semi-conductors .
627 In that case, the panel considered a position paper of the responding party
which described the measure at issue as well as th e responding party's statements before the panel and
found that they provided "further confirmation" of a certain fact. 628 In the Panel's view, it cannot be
inferred from this that such documents or statements may be relied on to confirm facts that have
already been found to exist based on other evidence, but that they may not be relied on, together with
other evidence, to establish facts. At a minimum, such an inference would appear unwarranted in a
case such as this one where the existence of a de facto measure is alleged. In such cases, it is often

627 Panel Report, Japan – Trade in Semi-Conductors, BISD 35S/116.

inevitable that Complaining Parties base their comp laints largely on circumstantial evidence. This
said, it is clear that statements by individual gove rnment officials and similar evidence must be given
proper weight, which weight can only be determined in the specific circumstances of each case.
7.523 The Panel now turns to review one by one the various documents and st atements referred to
by the Complaining Parties. The documents and statements have been divided into the above-
mentioned five categories and are listed in chronologi cal order. It should be noted that in no case did
the European Communities question the authenticity of a document or statement or suggest that
statements were incorrectly reported or wrongly attributed.
(i) Commission documents and statements by individual Commissioners
7.524 Following is a list of Commission documents referred to by one or more Complaining Parties:
(a) November 2000 working document of the Commission services. A working document
of the Commission services states that "[a] gainst this background [of intense public
and political debate about the impact of genetically modified organisms on the
environment and food safety], it has become increasingly difficult to approve the
placing on the market of new GMOs unde r Directive 90/220/EEC and a parallel
situation has arisen for authorizations for products containing and derived from
GMOs under product based legislation. As a result the current authorization
procedure for commercial release of GMOs, including those that may end up in the
food chain, has ground to a standstill. [...] The Commission [in July 2000] proposed a
strategy to re-launch the authorization procedure".
629
This document refers to a "standstill" in th e "current authorization procedure". It
does not support the EC argument that ther e was a standstill because of "requests [by
member States or the Commission] for additional information on complex issues of
risk assessment and management"
630. Rather, it suggests that the standstill was the
result of public concerns and political de bate, which, according to the document,
made it difficult to approve applications. The document also notes that the
Commission proposed a strategy to "re-launch" the authorization procedure. It is not
clear why the Commission would do so if the approval procedures were held up
because the member States or the Commission were waiting for individual applicants
to provide additional information. Thus , this document implies that there was a
deliberate failure by relevant authorities to approve applications.
(b) July 2001 Commission press release . A Commission press release states that the
adoption by the Commission of new legisla tive proposals for Regulations concerning
traceability and labelling as well as genetically modified food and feed, together with
the March 2001 adoption of Directive 2001/18 , "will contribute towards the lifting of
the de facto moratorium on the commercial release of GMOs".
631

629 Advance Copy of Working Document of the Co mmission Services on Traceability and Labelling of
GMOs and Products Derived from GMOs, ENV/620/2000, November 2000, p. 1 (footnote omitted) (Exhibits
US-93; CDA-32).
631 "Commission improves rules on labelling and tracing of GMOs in Europe to enable freedom of
choice and ensure environmental safety", Commission Press Release IP/01/1095, 25 July 2001, p. 2 (Exhibit
CDA-39; also referred to by the United States).

The quoted statement suggests that in July 2001 a moratorium was in effect. Also,
the statement does not appear to "describe a factual situation"
632, but a measure that
could be "lifted". The point that the legislative proposal for new EC rules concerning
traceability and labelling would "contribute" to the lifting of the moratorium is
consistent with the June 1999 declarati on by the Group of Five countries. That
declaration said that the Group of Five countries would use their powers to suspend
approvals pending the adoption of such rules.
(c) October 2001 working paper of the Commission services . A working paper of the
Commission services states that "[t]his relu ctance to go forward with authorizations
of GMOs has resulted in a de facto moratorium on the marketing of new GMOs and
impacted on product approvals under the sector-based legislation".633
The quoted statement suggests that in Oct ober 2001 a moratorium was in effect. A
review of the document shows that the "rel uctance" referred to is the reluctance by
the Group of Five countries as first expr essed in the June 1999 declaration by the
Group of Five countries. Thus, this document supports the view that the absence of
final approvals was not the result of "requ ests for additional information" but of the
declared intention of certain member States to prevent approvals.
(d) July 2003 Commission fact sheet . A Commission fact sheet on GMO regulation
states that "[t]he revised Directive [ 90/220] and the two proposals for Regulations
[concerning traceability and labelling and on genetically modified food and feed] are
expected to pave the way for a resumption of GM authorizations in the European
Union".
634
The statement that Directive 2001/18 and the July 2001 Commission proposals for
new Regulations are "expected to pave the way for a resumption of GM
authorizations in the European Union" echoes the July 2001 Commission press
release. It also suggests that after the en try into force of Directive 2001/18 there was
no resumption of authorizations. This is c onsistent with the June 1999 declaration by
the Group of Five countries.
(e) January 2004 Communication to the Commission from the President . A
Communication to the Commission from the President of the Commission in
association with a number of other Commissioners with responsibility for biotech
products states in relevant part:635
"[D]espite the 'interim approach' [agreed on by the Commission in
July 2000 and entailing the anticipation of the key provisions
(labelling, traceability, monitoring, etc.) of Directive 2001/18]:

633 Working Paper of DG Environment and DG Health and Consumer Protection: Resumption of the
Authorization Procedure for GMOs, October 2001, p. 1 (Exhibits US-27; CDA-31).
634 "Question and Answers on the regulation of GMOs in the EU", p. 12 (Exhibits US-107 and
CDA-26).
635 Communication to the Commission (from the Pres ident in association with Mrs Wallström, Mr
Byrne, Mr Fischler, Mr Lamy, Mr Liikanen and Mr Busquin): For an orientation debate on Genetically
Modified Organisms and related issues, January 2004, p. 3 (emphasis omitted) (Exhibit CDA-33; also referred
to by the United States).

– no authorizations have been granted since October 1998
636.
[…]
To date,
– authorization procedures under the Novel Foods
Regulation are being finalised in line with the interim approach
agreed on 12 July 2000 by anticipating the key forthcoming
provisions agreed by the Council (i.e. labelling, traceability,
monitoring, etc.) into individual authorizations of GMOs. […]
- Applications under Directive 2001/18/EC are currently being
processed in accordance with the authorization procedure. […]"
The European Communities correctly notes that this communication does not confirm
the existence of a suspension of the approval process. However, it is the
Complaining Parties' assertion that there was a suspension of final approvals, and not
that there was a suspension of the pro cessing of applications. The Communication
itself states that despite the fact that the so-called "interim approach" had allegedly
been followed in respect of applications submitted under Directive 90/220 since July
2000
637, no such product had been approved before the entry into force of
Directive 2001/18. Furthermore, the statement in the Commission Communication
that "authorization procedures under the N ovel Foods Regulation are being finalised"
and that "[a]pplications under Directiv e 2001/18/EC are [...] being processed" does
not necessarily imply that the relevant app lications will be approved. Nonetheless,
based on the quoted passage of the Communication alone, it cannot be determined
whether a moratorium on approvals was in effect between October 1998 and August
2003 or whether the absence of approvals was the result of a series of delays due to
"requests for additional information".
7.525 The following statements by the Commissioner for the Environment were referred to by all
Complaining Parties:
(a) July 2000 news report . A news report notes that on 13 July 2000 the Commission at
a news conference revealed its plan to propose the above-mentioned "interim
approach" to member States. The report quotes then Commissioner Margot

636 (original footnote) With the exception of applications under the simplified procedure of the Novel
Foods Regulation (derogation from the full authorization procedure).
637 In response to a question from the Panel, the European Communities described the "interim
approach" as a practice by the Commission which "consiste d in anticipating certain stricter requirements which
were to be put in Directive 2001/18 as identified in the Council Common Position of June 1999 [...] in line with
the precautionary principle. [...] [I]t was clear that the existing legislation, i.e., Directive 90/220, did not provide
a legal basis to impose these requirements on pending applications. The notifiers, therefore, were approached to
see whether they would be willing to implement such requirements on a voluntary basis. [...] With the entry into
force of Directive 2001/18 the 'interim approach' ende d as applications could not be assessed under the new
legal basis." EC reply to Panel question No. 13.

Wallström as stating in this context that " [w]e have already waited too long to act.
The moratorium is illegal and not justified."
638
The statement attributed to the Environm ent Commissioner explicitly refers to the
existence of a moratorium in July 2000. Together with the Commissioner for Health
and Consumer Protection, the Environmen t Commissioner is responsible within the
Commission for the approval of applications for the placing on the market of biotech
products. Clearly, therefore, the statement does not reflect a "perception from the
outside"
639.
(b) October 2001 news report . A report on a news conference states that following a
meeting of the Environment Council, Comm issioner Wallström "admitt[ed] that no
end was in sight for the moratorium, which she said was an illegal, illogical, and
otherwise arbitrary line in sand."
640 She is quoted as saying that "[t]here is no other
EU legislation in the same situation where we just simply decline to take a decision"
and that "[w]e have 11 GMO seed applications approved. [...] But then there was an
arbitrary line drawn before I came into o ffice [in 2000] to stop all approval for the 13
other pending applications. But many of these 13 are simply varieties of the first 11
approved. They are essentially the same products. There is no science that says these
are more or less dangerous than others".
641
The statement attributed to the Environm ent Commissioner suggests that in October
2001 a moratorium was still in effect. It also suggests that the absence of approvals
was the result of a "decision not to decide" 642 and not, as the European Communities
contends, of delays due to requests for additional information.
7.526 The following statements by the Commissioner for Health and Consumer Protection and his
spokesperson were referred to by one or more Complaining Parties:
(a) June 2000 speech . A speech by then Commissioner David Byrne at the European
Business Summit in Brussels states that "[ t]he horizontal directive 90/220 [...] was
adopted in 1990, at a time when concern about GMOs was less obvious. The
authorization procedure became obsol ete as consumer concerns grew and
consequently, Member States have become more and more reluctant to approve the
placing on the market of new GMOs under Directive 90/220. This has resulted in a
complete standstill in the current authorizations and a de facto moratorium on the
commercial release of GMOs".
643
It should first of all be recalled that the Commissioner for Health and Consumer
Protection and the Environment Commissioner are responsible within the

638 "EU Moves to Break Gene Crop Deadlock", Reut ers, 13 July 2000 (Exhibits US-33, CDA-42 and
ARG-29).
640 "EU Moratorium on GMOs Could Last Until Tr aceability, Labeling Regime in Place," BNA Daily
Report for Executives, Regulation, Law & Economics, 30 October 2001, p. A-8 (Exhibits US-2, CDA-43,
ARG-14).
641 Ibid.
642 See EC second written submission, para. 294.
643 "Biotechnology: Building Consumer Acceptance," Speech by David Byrne, European
Commissioner for Health and Consumer Protection, European Business Summit, Brussels, 10 June 2000, p. 3
(Exhibits US-1 and CDA-44).

Commission for the approval of applications for the placing on the market of biotech
products. Hence, the remarks of the Commissioner for Health and Consumer
Protection on the functioning of the EC approval process cannot be considered
"perceptions from the outside"
644. The speech suggests that in June 2000 a
moratorium was in effect. It should also be pointed out that the quoted portion of this
speech is closely similar in content to the above-noted November 2000 and October
2001 working documents of the Commission services.
(b) November 2000 speech . A speech by Commissioner Byrne at the conference on
"Genetics and the future of Europe" in Brussels states that "[i]n the EU public
concerns about the application of biotechnol ogy in the agri-food sector have resulted
in a de-facto moratorium on authorizations of new GMOs. In fact no GMOs have
been approved over the last two years".
645
This speech echoes the June 2000 speech.
(c) July 2001 public statement . A statement by Commissioner Byrne, made on the day
the Environment Commissioner and him self presented to the Commission two
proposals for new Regulations concer ning traceability and labelling as well as
genetically modified food and feed, reads in relevant part: "The adoption of today's
proposals together with the recent adoption of the revised legislation on the deliberate
release of GMOs into the environment will build up public confidence by responding
to questions and concerns raised by the ge neral public and providing a high level of
protection for human health and the environment. This will contribute towards the
lifting of the de facto moratorium on the commercial release of GMOs and the
standstill on the authorizations of GMOs and GM-products in Europe".
646
This statement is closely similar in cont ent to the above-noted July 2001 Commission
press release. It suggests that in July 2001 a moratorium was in effect.
(d) September 2001 speech . A speech by Commissioner Byrne at an informal
Agriculture Council on new technologies in ag riculture in Alden Biesen states that
"[i]n the EU, the Scientific Committees have already assessed a number of GMOs
and concluded that they do not pose a danger to the environment or to human health.
However, these GMOs are still pending fina l approval and some of them have now
been awaiting approval for quite some time."647
The quoted passage of this speech does not e xplicitly state that the absence of final
approvals was the result of a moratorium or of reluctance by member States to
approve applications in the face of public concerns. The passage could, however, be
interpreted to imply such a statement. Such an interpretation does not seem

645 Speech by David Byrne, European Commissioner for Health and Consumer Protection, Conference
on "Genetics and the future of Europe", Brussels, 7 November 2000, p. 3 (Exhibit ARG-17).
646 "The Right to Know about GM Food", Statement by David Byrne, European Commissioner for
Health and Consumer Protection, 25 July 2001, p. 3 (Exhibits US-34, CDA-45 and ARG-18).
647 "New Technologies in Agriculture – Biotechnology", Speech by David Byrne, European
Commissioner for Health and Consumer Protection, Informal Agriculture Council, Alden Biesen, 18 September
2001, p. 7 (Exhibit ARG-8). The same statement is made in "Proposal for a regulation on GMO Food and
Feed", Speech by David Byrne, European Commissioner for Health and Consumer Protection, European
Parliament, Brussels, 11 September 2001, p. 4 (Exhibit ARG-20).

unreasonable in the light of, e.g., Commissioner Byrne's November 2000 speech, his
July 2001 statement and his subsequent October 2001 speech.
(e) October 2001 speech . A speech by Commissioner Byrne to the National Press Club
in Washington, D.C., states that "[t]he final point I wish to make on biotechnology
relates to the effective moratorium on new approvals in the EU. This is an unfortunate
situation and has helped nobody in my view. It is my firm hope and intention that we
can get the approvals process working again. I have mandated my officials to start a
dialogue with the Member States of the Eur opean Union with a view to re-starting
approvals".
648
The quoted passage suggests that there wa s a moratorium on new approvals in
October 2001. This is consistent wi th the above-mentioned October 2001 news
report quoting a similar statement by the then Environment Commissioner.
(f) October 2001 news report. A news report quotes the spokeswoman of Commissioner
Byrne as saying that "[t]he moratorium has no legal basis".649
The statement attributed to the spokesper son of Commissioner Byrne suggests that
there was a moratorium on new approvals in October 2001. Again, this is consistent
with the October 2001 news report quoting a similar statement by the then
Environment Commissioner.
(g) November 2001 speech . A speech by Commissioner Byrne at the European Voice
Conference "Farm to Fork" in Brussels states that "[d]espite our scientific advisors
having given the green light for growing and marketing GMO plants and foods, our
Member States have blocked new authoriza tions since 1998. This is, I believe, an
untenable situation".
650 Three paragraphs later, the text continues: "The effective
moratorium on new approvals in the EU is an unfortunate situation and its
continuation, in my personal view, helps nobody." 651 And another three paragraphs
later, the text says: "As a result [of the June 1999 declaration by the Group of Five
countries], the authorization of both pending and new products has come to a
grinding halt".
652
The quoted passages of this speech suggest that in November 2001 a moratorium on
new approvals was in effect. The speech further suggests that the absence of
approvals was the result of the June 1999 decl aration by the Group of Five countries,
and not of a series of delays due to requests for additional information.
(h) February 2003 news report. A news report quotes Commissioner Byrne as stating at
a press conference that "[w]e have taken account of the opinions of the scientists and

648 "A European approach to food safety an d GMOs", Speech by David Byrne, European
Commissioner for Health and Consumer Protection, National Press Club, Washington D.C., 9 October 2001,
p. 3 (Exhibit ARG-9).
649 "EU States Seek Stricter GM Labelling", Reuters, 16 October 2001 (Exhibits US-35 and CDA-46).
650 "Risk versus benefit", Speech by David Byrne, European Commissioner for Health and Consumer
Protection, European Voice Conference "Farm to Fork", 22 November 2001, p. 2 (Exhibit ARG-10; also
referred to by Canada).
651 Ibid.
652 Ibid.

put legislation in place ... now let's turn over the page! The conclusion of all this is
that we must lift the moratorium".
653
The statement attributed to Commissioner Byrne suggests that in February 2003 a
moratorium was in effect. It also suggest s that the term "moratorium" is used to
describe a measure that should be "lifted" rather than a mere "factual situation" 654
characterised by the absence of any approvals.
7.527 The following statement by the Commissioner for Trade was referred to by two Complaining
Parties:
(a) January 2002 speech. A speech by then Commissioner Pascal Lamy at the Woodrow
Wilson International Center for Scholars in Washington, D.C., states that "the current
moratorium is not plucked out of thin ai r by the Member States for protectionist
reasons: it reflects the fact that food safety is a highly sensitive and political issue for
European citizens".
655
The quoted passage of this speech suggests th at in January 2002 a moratorium was in
effect. The Trade Commissioner is not responsible within the Commission for
approvals of biotech products. However, as is evidenced by the present panel
proceedings, the absence of approvals is also a trade issue. As a result, and in view of
the similar statements made by the Co mmissioners with direct responsibility for
approvals, the view expressed by the Trade Commissioner cannot be dismissed as a
"perception from the outside".
(ii) Council documents
7.528 Following is a list of Council documents referred to by one or more Complaining Parties:
(a) July 2003 note by the General Secretariat of the Council . A note issued by the
General Secretariat of the Council to the Committee of Permanent Representatives on
the outcome of the European Parliament's second reading of the proposed new EC
rules on traceability and labelling of biotech products attributes to the rapporteur of
the relevant committee of the European Pa rliament the statement that the proposed
rules would "possibly lead to the lifting of the current moratorium."
656
The statement attributed to the rapporteur of one of the committees of the European
Parliament dealing with biotech products suggests that in July 2003 a moratorium
was in effect. While the rapporteur was not involved in the day-to-day operation of
the EC approval process, it is nevertheless reasonable to assume that he and his
committee were aware of the possible implications of the adoption of the new rules in
question, including the possible implications on the operation of the approval process.
The view apparently expressed by the rapporteur – that new EC rules on labelling and

653 "Sine die postponement of inter-ministerial meeting planned on GMOs in Washington", Agence
Europe, 6 February 2003, p. 2 (Exhibit US-37).
654 Ibid.; EC second written submission, para. 295.
655 "Steeling the EU-US Relationship for the challeng es ahead", Speech by Pascal Lamy, European
Commissioner for Trade, Washington, D.C., 25 January 2002, p. 4 (Exhibits US-89 and ARG-15).
656 Note from the General Secretariat, 3 July 2003, p. 1 (Exhibits US-38 and CDA-41).

traceability might lead to the lifting of the mo ratorium – is consis tent with the June
1999 declaration by the Group of Five countries.
(b) April 2004 background note by the General Secretariat of the Council . A
background note from the press office of the Council's General Secretariat concerning
the Agriculture and Fisheries Council of April 2004 at which the Council was to
decide on the application concerning Bt-11 maize (food) states that "[t]he adoption of
a decision to authorize Bt11 would bring an end to the current moratorium on
genetically modified food and feed in Europe".
657
This background note, which expresses the vi ew of the General Secretariat of the
Council, suggests that in April 2004 a general moratorium was in effect. The note
was issued shortly before the Council voted on the application concerning Bt-11
maize (food). It can therefore be assumed that the Council's own General Secretariat
was in a position to assess correctly the significance of the Council vote and the
context within which it took place.
(iii) European Parliament documents
7.529 Following is a list of European Parliament (" EP") documents referred to by one or more
Complaining Parties:
(a) February 2001 motion for an EP resolution . A European Parliament resolution
proposed for adoption by the Committee on In dustry, External Trade, Research and
Energy "[o]bserves that the existing de facto moratorium particularly harms small and
medium sized enterprises which, unlike multin ational corporations, are often unable
to perform their research work in countri es outside the EU", and in the following
paragraph "[w]elcomes the agreement reached between Council and Parliament in the
conciliation committee on the amendment of the directive on the release of
genetically modified organisms and the assurances given by the Commission in that
connection with regard to labelling and traceability, and considers that a clear
framework now exists for the release of ge netically modified organisms in Europe
which will ensure maximum consumer prot ection and environmental protection, and
that it would therefore not be justified to continue the de facto moratorium on the
release of GMOs".
658 The accompanying explanatory statement notes that "no
authorizations have been approved under th is directive [90/220] since October 1998.
This demonstrates a lack of mutual re cognition between Member States and a de
facto moratorium on all development".659
This motion for a resolution suggests that in February 2001 a general moratorium was
in effect. 660 The motion was sponsored by th e Committee on Industry, External
Trade, Research and Energy. It is reasonable to assume that the members of that
Committee were familiar with the situati on and concerns of researchers and the

657 General Secretariat of the Counc il, Press Office, Background for Agriculture and Fisheries Council
of 26 (and possibly 27) April 2004, 23 April 2004, p. 2 (Exhibits US-109; CDA-108; also referred to by
Argentina).
658 European Parliament, Committee on Industry, Extern al Trade, Research and Energy, Report on the
Future of the Biotechnology Industry, Motion for a European Parliament resolution, FINAL A5-0080/2001, 28
February 2001, p. 12 (Exhibit US-119).
659 Ibid., p. 20.
660 The record does not indicate whether the resolution was ever adopted by the European Parliament.

industry in the biotechnology sector and ot herwise sufficiently well informed to
express a view on whether or not a general moratorium was in effect at the time.
(b) June 2002 EP committee report . The European Parliament Committee on the
Environment, Public Health and Consumer Policy, in its report on the proposal for
new Regulations concerning traceability and labelling as well as food and feed, states
that the fragmentation of then-existing EC legislation concerning biotech products
"led to reservations and a moratorium ove r the last three years on the marketing
authorization procedures at EU level, pending the adoption of an integrated
traceability and labelling system".
661
The quoted passage from the report by the Committee on the Environment, Public
Health and Consumer Policy suggests that in June 2002 a moratorium was in effect,
and that it might remain in place until the new Regulation concerning traceability and
labelling of biotech products was adopted. The latter suggestion is consistent with
the June 1999 declaration by the Group of Five countries. The Committee on the
Environment, Public Health and Consumer Policy was not directly involved in the
operation of the EC approval procedures. Ho wever, it seems clear that in order to
report to the European Parliament on the merits of the legislative proposals, the
Committee needed to have an understanding of the political context within which the
proposals for the two new Regulations were ma de. The moratorium referred to in the
report forms part of that context.
(c) November 2002 EU bulletin . The EU Bulletin, in a summary of the content of a
resolution by the European Parliament on the Communication from the Commission
on "Life Sciences and Biotechnology – A Strategy for Europe"
662, contains the
following sentence: "With regard to food supply, the Parliament fully shares the
opinion that an end must be called to the current 'de facto' moratorium that has been
imposed on genetically modified foods since 1998, which should be lifted in 2003, to
provide greater choice and increased benefits to the consumer as well as to promote
innovation".
663
The statement attributed to the European Parliament suggests that a moratorium on
biotech food products was in effect in N ovember 2002. The reference to the year
2003 is probably a reference to the presumed date of adoption of the two proposed
Regulations on labelling and traceability as we ll as food and feed. As is confirmed
by the above-mentioned June 2002 committee report, the European Parliament was
considering these proposals at the time. While the European Parliament does not
have a role in the day-to-day operation of the EC approval procedures, it is reasonable
to assume that it would not call for the lifting of a moratorium in a resolution if there
was uncertainty as to whether such a moratorium on approvals of biotech food
products existed.

661 European Parliament, Committee on the Environment, Public Health and Consumer Policy, Report
on the proposal for a European Parliament and Counc il regulation concerning traceability and labelling of
genetically modified organisms and traceability of food a nd feed products produced from genetically modified
organisms and amending Directive 2001/18/EC, FINAL A5-0229/2002, 12 June 2002, p. 27 (Exhibits US-36
and CDA-40).
662 The Communication was not submitted to the Panel.
663 "Resolution of the European Parliament on the Communication of the Commission on 'Life
Sciences and biotechnology – A strategy for Europe", EU Bulletin, November 2002, section 1.3.64 (translated
from Spanish) (Exhibit ARG-7).

(d) March 2003 motion for an EP resolution . A motion by two Members of the
European Parliament for an EP resolution st ates in a preambular paragraph that "in
view of the risks which GMOs represent, there are no grounds for lifting the de facto
moratorium on GMO authorization, especially since no labelling and tracing system
has been introduced and no assessment has b een carried out of the impact which
GMOs may have on organic/conventional fa rming" and "[u]rges the Council and the
Commission to continue the moratorium a nd to launch a broad public debate on the
impact of GMOs on organic/conventional farming".
664
This motion for a resolution suggests that in March 2003 a moratorium was in effect,
and that it was within the power of the Council and the Commission to continue or
end it. The motion represents the view of two Members of the European
Parliament
665, but the statement that a moratorium existed in March 2003 is consistent
with the above-mentioned February 2003 news report quoting Commissioner Byrne
and the July 2003 Commission fact sheet.
(e) June 2003 statement by an EP committee rapporteur . The rapporteur of the
European Parliament Committee on the Envi ronment, Public Health, and Consumer
Policy in an explanatory statement on the recommendation for the second reading of
the Parliament on the common position of the Council with a view to adopting a new
Regulation concerning traceability and labelling of biotech products states that he is
of the view that the prompt adoption of the new Regulation, as well as of the new
Regulation concerning genetically modified food and feed, "will lead to the removal
of the 'de facto' moratorium on the approval of new GMOs [...]".
666
This statement suggests that in June 2003 a general moratorium was in effect. The
statement appears to be the same as that which is referred to in the previously
addressed July 2003 note from the General Secretariat of the Council.
(iv) Statements by member State officials
7.530 Following is a list of statements by high-ranking member State officials which were referred
to by one or more Complaining Parties:
(a) July 2003 news report . A press article reporting on the meeting of 22 July 2003 of
the Agriculture and Fisheries Council attr ibutes to the then French Agriculture
Minister the statement that "public information campaigns would be necessary in
advance of lifting the moratorium" and to It aly's Agriculture Minister the statement
that "no decision on lifting the moratorium on the authorization of GMO crops could

664 European Parliament, Motion for a European Parliament resolution on the impact of genetically
modified organisms (GMOs) on organic/conventional farming by Ilda Figueiredo and Jonas Sjöstedt, B5-
0190/2003, 18 March 2003, p. 2 (Exhibit US-120).
665 The record does not indicate whether the resolution was ever adopted by the European Parliament.
666 European Parliament, Committee on the Environment, Public Health and Consumer Policy,
Recommendation for the second reading on the common position of the Council with a view to adopting a
European Parliament and Council regulation on traceability and labelling of genetically modified organisms and
the traceability of food and feed pro ducts produced from genetically m odified organism s and amending
Directive 2001/18/EC, FINAL A5-0204/2003, 4 June 2003, p. 22 (Exhibit ARG-11).

be made until there is agreement on the European Commission proposals on
guidelines for the coexistence of GMO crops and non-GMO crops".
667
The statements attributed to the then Fren ch and Italian Agriculture Ministers suggest
that in July 2003 a moratorium was in effect. As noted above, it was the Council of
Agriculture and Fisheries Ministers that vot ed on the Bt-11 maize (food) application.
Thus, the Agriculture Ministers have direct responsibility, perhaps jointly with other
Ministers, for approvals of biotech products. Moreover, both France and Italy are
part of the Group of Five countries which ha d declared in June 1999 that they would
exercise their powers so as to suspend appr ovals. Finally, it should be noted that the
reported statements clearly use the term "moratorium" to refer to a measure that could
be lifted and not to describe a "factual situation"
668 where no approvals had been
granted.
(b) June 2004 parliamentary response . A response provided by the French Minister for
Research to a question from a Member of th e French Parliament states that "[i]n
1999, in order to take account of the leg itimate concerns of public opinion, France
and four other member States of the European Union – Denmark, Italy, Greece, and
Luxembourg – obtained a moratorium from the European Commission suspending
any new authorizations for growing and placing on the market of genetically
modified plants pending both effective rules concerning the traceability and
informative labelling of all GMO-derived products, and the necessary clarifications
concerning different aspects of the law re lating to the use of these new technologies.
[...] This moratorium period made it possible [...] to progressively reconcile the
positions of the member States and harmonize the assessment and authorization
periods. Thus [...] Directive 2001/18/EC was adopted [...]. The new Directive,
coupled with the two community regulations, 1829/2003 and 1830/2003, provides a
tight, general and very complete framework in which the Government has expressed
its full confidence when it comes to proceed ing, at the European level, with new
GMO commercial authorizations, which will be granted on a case by case basis".
669
The response by the French Minister for Research suggests that a moratorium had
been in effect since 1999 when the Group of Five countries made their declaration at
the June 1999 Environment Council. The r esponse also suggests that in June 2004
France no longer saw a need to use its powers to suspend approvals, although it is
unclear when the French Government made that decision, i.e., whether the decision
was made after the adoption in Septembe r 2003 of the new Regulations concerning
labelling and traceability as well as food and feed (as France had indicated in the June
1999 declaration by the Group of Five countries), or after their entry into force in
April 2004.

667 "EU Ag Ministers Approve GMO Traceability Plan Opposed by White House, U.S. Farmers"
International Trade Reporter, 24 July 2003, p. 1 (Exhibits US-39 and CDA-47) .
669 Reply to question No. 27131 of Mr Martin Philippe-Armand (Union for a Popular Movement
(UMP) – Marne), 12th legislature, 1 June 2004 (translation from French) (Exhibit ARG-48).

(v) EC statements at the WTO
7.531 The following WTO document was referred to by one Complaining Party:
(a) November 2001 minutes of meeting . The minutes of a meeting of the WTO
Committee on Sanitary and Phytosanitary Measures state under the heading "US
concerns on EC agricultural biotechnology approval processes" that "[t]he
representative of the European Communiti es reaffirmed the European Commission's
interest and positive actions aimed at allowing the authorization procedures to
continue. The recent meeting of the Eu ropean Environment Council had started a
very important discussion on proposals presented by the Commission to restart the
authorization procedure".
670
This statement, which was made on behalf of the European Communities, suggests
that in November 2001 a moratorium was in effect, as it refers to the need to "restart
the authorization procedure". The statemen t is consistent with the above-mentioned
July 2001 statement by Commissioner Byrne and uses language similar to that used in
the November 2000 Commission working document.
(vi) General assessment
7.532 The Panel considers that all of the above-listed documents and statements are relevant to the
issue of whether certain member States and the Commission intentionally prevented the final approval
of applications. With few exceptions, the statemen ts referred to were made by the highest-ranking
officials of the Commission or member States, or by or on behalf of key parliamentary committees.
Also, each of the Complaining Parties submitted documents or statements not just from a single
source, but from multiple EC institutions or repres entatives thereof. Many of the documents provided
were prepared directly by the competent administ rative services or parliamentary committees, and the
statements by Commissioners and Ministers were made by Commissioners and Ministers with
responsibility for biotech products. Accordingly, the documents and statements cannot be said to
represent outsiders' perspectives. For the most part, the statements referred to consist of prepared
statements, such as speeches. Such statements cannot properly be considered casual statements.
While a small number of the statements submitted were made in the context of news conferences, the
content of these statements is very similar to that of the other statements or documents submitted.
Finally, it is important to note that notwithstanding the fact that the documents and statements stem
from different EC institutions or representatives thereo f, they all consistently, albeit not identically,
refer to the existence of a "moratorium" or of a "standstill", or to a possible "resumption" of
approvals. For all these reasons, the Panel is unable to agree with the European Communities that the
documents and statements referred to by each Complaining Party provide no evidence of the existence
of a de facto moratorium.
671
7.533 The documents and statements relied on by each Complaining Party add an important element
to the evidence discussed in the previous Subsection: they poin t to a reason for the absence of
approvals during the relevant time period. The relevant documents a nd statements suggest that there
were no approvals because a moratorium on approvals was in effect. Of the twenty-six documents or

statements listed above, twenty-one explicitly use th e term "moratorium". The other five documents
are all consistent with the view that there were no approvals because a moratorium was in effect.
672
7.534 Conceptually, a moratorium on approvals implie s a temporary absence of approvals. But in
addition the concept of a moratorium on approvals im plies that the absence of approvals must be the
consequence of a deliberate temporary suspension of approvals. This is confirmed by the dictionary
definition of the term "moratorium". As noted by the European Communities, the dictionary defines
the term "moratorium" as "a postponement or de liberate temporary suspension of some activity". 673
In the light of this, the Panel considers that the re ferences in the various documents and statements to
an EC "moratorium" on approvals support what the Complaining Parties are asserting: that action
was taken by relevant authorities, or deliberately no t taken, so as to prevent approvals for a certain
period of time. The Panel is not convinced that th e relevant documents and statements use the term
"moratorium" merely to describe a "factual situation" 674 – a temporary absence of approvals. The
documents and statements do not support such a conclusion. For example, the November 2000
speech by Commissioner Byrne stat es that "public concerns [… ] have resulted in a de-facto
moratorium on authorizations of new GMOs. In f act no GMOs have been approved over the last two
years".675 If the term "moratorium" in the first part of this statement were understood as merely
referring to a temporary absence of approvals, it would be unclear why the term " de facto" was used.
It makes little sense to say that there was a de facto absence of approvals. Conversely, it makes sense
to say that there was a de facto suspension of approvals.
7.535 The European Communities appears to argue in the alternative that the references to a
"moratorium" were made, for the most part, duri ng what it refers to as the "transition period" from
1998 to 2001. 676 During that period, Directive 90/220 was being revised and the new
Directive 2001/18 – the Directive amending Directive 90/220 – entered into force. The European
Communities submits that the documents and statem ents which were made during that period and
which refer to a "moratorium" all imply that the "moratorium" would end when the transition period
ends. It is correct that a number of documents and statements indicate that the adoption of
Directive 2001/18 would contribute to the lifting of the "moratorium". However, there is no
document or statement which suggests that this w ould be a sufficient condition for the lifting of the
"moratorium". Rather, the documents or statemen ts mention the new Regulation concerning labelling
and traceability as an additional condition, which is consistent with the June 1999 declaration by the

672 It should nonetheless be recalled that the January 2004 Communication to the Commission and the
September 2001 speech by Commissioner Byrne, when considered in isolation from the other documents and
statements, could also be interpreted so as to be consistent with the European Communities' view that the
absence of approvals was due to "requests for additional information".
673 The New Shorter Oxford English Dictionary , L. Brown (ed.) (Clarendon Press, 1993), Vol. I,
p. 1828.
675 Similar language was used in Commissioner Byrne's June 2000 speech and in the October 2001
Commission working paper.
676 The European Communities' submissions are less than clear regarding when the so-called "transition
period" ended. The Panel is assuming that the European Communities meant to argue that the period ended in
2001, when Directive 2001/18 was adopted. EC first written submission, para. 4; EC second written
submission, paras. 292. Other EC statements appear to suggest, however, that the period ended in 2003. EC
second written submission, para. 293. But the relevance of 2003 is nowhere explained. Directive 2001/18,
which is referred to in the aforemen tioned paragraphs of the EC written submissions, came into force in 2002.
In contrast, in none of the aforementioned paragraphs of the EC submissions is there a reference to the adoption
in 2003 of the new EC regulations on labelling and traceability as well as food and feed. In any event, the
Panel's analysis of the EC argument about the transition period is unaffected by the issue of whether that period
ended in 2001 or 2003.

Group of Five countries.
677 Moreover, all three Complaining Pa rties have referred to documents or
statements which suggest that a moratorium was s till in effect after the adoption of Directive 2001/18
in March 2001, and even after the entry into force of that Directive in October 2002. 678 In fact, the
April 2004 background note by the Council's Genera l Secretariat, which was relied on by all
Complaining Parties, suggests that a moratorium con tinued to be in effect even after the adoption in
September 2003 of the new Regulation concerning labelling and traceability. The note also implies
that a moratorium was in effect in August 2003, the date of establishment of this Panel.679
7.536 It should be mentioned as well that all Comp laining Parties have submitted a document or
statement which refers to the fact that no appli cations have been approve d under Directive 90/220
since October 1998.680 However, the fact that no applications have been approved since October 1998
does not necessarily mean that a moratorium was in effect as from October 1998. None of the
documents or statements submitted by the United St ates and Canada suggests that a moratorium was
in effect as of October 1998. The June 2002 EP committee report refers to "a moratorium over the
last three years", implying that a moratorium was in effect since June 1999, which is when the Group
of Five countries issued their jo int declaration. Argentina subm itted one document, the November
2002 EU Bulletin, which refers to an EP resoluti on according to which "the current 'de facto'
moratorium that has been imposed on genetically modified foods since 1998 […] should be lifted in
2003". This suggests that a de facto moratorium was in effect since 1998. It is possible, though, that
the year 1998 was referred to simply because after 1998 no applications were approved until 2004. In
any event, other statements and documents su bmitted by Argentina – the November 2001 speech by
Commissioner Byrne 681 and the June 2004 parliamentary response by the French Minister for
Research682 – support the view that a moratorium was in effect only as from June 1999. 683 In the light

677 See, e.g., the July 2001 Commission press release; the July 2003 Commission fact sheet; the July
2001 statement by Commissioner Byrne; and the June 2004 parliamentary response by the French Minister for
Research.
678 See, e.g., the July 2003 Commission fact sheet; the February 2003 news report quoting
Commissioner Byrne; the July 2003 note by the Council's General Secretariat; the April 2004 background note
by the Council's General Secretariat; the March 2003 motion for an EP resolution; the June 2003 statement by
an EP committee rapporteur; and the July 2003 news report quoting Ministers of France and Italy.
679 The July 2003 Commission fact sheet, the July 2003 note by the Council's General Secretariat, the
June 2003 statement by an EP committee rapporteur and the July 2003 news report quoting Ministers of France
and Italy all indicate that a moratorium was in effect in June and July of 2003.
680 See the January 2004 Communication to the Commission; the November 2000 speech by
Commissioner Byrne; and the February 2001 motion for an EP resolution.
681 Commissioner Byrne's speech sugges ts that it was as a result of the positions expressed by the
Group of Five countries in 1999, specifically their positions expressed in the June 1999 joint declaration, that
"the authorization of both pending and new products has come to a grinding halt". The speech in question also
contains the statement that "[d]espite our scientific advisors having given the green light for growing and
marketing GMO plants and foods, our Member States have blocked new authorizations since 1998". The Panel
understands this statement to refer to the fact that in four successive votes held in the Regulatory Committee
from October 1998 onwards, the Regulatory Committee fa iled to achieve a qualified majority, even though the
relevant applications had all received favourable opinions from an EC scie ntific committee. After these four
votes, no further votes were held in the Regulatory Committ ee prior to the date of establishment of this Panel.
EC reply to Panel question No. 96(c). As is explained in more detail below, in the Panel's view, the votes in
question do not support the view that a moratorium was in effect as from October 1998. See, infra,
para. 7.1248.
682 The Minister's response, in what seems to be a refe rence to the fact that the Group of Five countries
issued a joint declaration in June 1999, states that it was in 1999 that the Group of Five countries gained the
Commission's support for a moratorium.

of this, the Panel does not consider that the documents and statements submitted by each Complaining
Party permit the inference that a general de facto moratorium was in effect before June 1999.
7.537 The documents and statements are important also because they lend support to the
Complaining Parties' assertion that the Eur opean Communities applied an across-the-board
moratorium, i.e., a moratorium applicable to all pending and new applications for the approval of
biotech products. Many of the documents and st atements relied on by each Complaining Party
explicitly refer to a generally applicable moratorium.
684 Others refer more broadly to a
"moratorium".685 However, given the absence of a textua l qualifier, and reading the statements and
documents concerned together with others, there is no reason to assume that the broad references to a
"moratorium" should be understood as meaning that th e "moratorium" in question was selective, that
is to say, that it applied to only some applicati ons. Separately, it should be pointed out that the
documents and statements relied on by each Compla ining Party suggest that an across-the-board
moratorium was in effect between June 1999 and August 2003.686
7.538 It has been observed above that almost all of th e relevant documents and statements refer to a
"moratorium" on approvals and that this implies that actions were taken by relevant authorities, or
deliberately not taken, so as to prevent approvals for a certain period of time. The Complaining
Parties assert that the relevant authorities are cer tain member States – notably the Group of Five
countries – and the Commission, and that they intent ionally prevented applications from reaching the
stage of final approval. The documents and statem ents provide some, albeit limited, confirmation of
this assertion. To begin with, according to th e October 2001 news report, Commissioner Wallström
characterized the "moratorium" as a "situation where we just simply decline to take a decision".
While this statement does not make clear who is me ant by "we", it tends to confirm that there was a
"decision not to make final decisions" and not to a llow final approvals. Furthermore, all Complaining
Parties have relied on documents or statements whic h suggest that the "moratorium" is the result of

683 See also para. 7.1254 et seq . for our discussion of Argentina's argument that the Commission's
conduct prior to the June 1999 declaration by the Group of Five countries confirms the existence of a general
moratorium on approvals as from October 1998.
684 See, e.g., the October 2001 Commission working paper ("a de facto moratorium on the marketing of
new GMOs"); the July 2001 statement by Commissioner Byrne ("the de facto moratorium on the commercial
release of GMOs and GM-products"); the April 2004 background note by the Council's General Secretariat ("the
current moratorium on genetically modified food and feed"); the February 2001 motion for an EP resolution
("the de facto moratorium on the release of GMOs"); the June 2002 EP committee report ("a moratorium [… ] on
the marketing authorization procedures at EU level" ); the November 2002 EU Bulletin summarizing an EP
resolution ("the current 'de facto' moratorium that has been imposed on genetically modified foods since 1998");
the June 2003 statement by an EP co mmittee rapporteur ("the 'de facto' moratorium on the approval of new
GMOs"); the July 2003 news report quoting the Agri culture Minister of Italy ("the moratorium on the
authorization of GMO crops"); and the June 2004 parliame ntary response by the French Minister for Research
("a moratorium [...] suspending any new authorizations for growing and placing on the market of genetically
modified plants ").
685 See, e.g., the July 2000 news report quoting Commissioner Wallström; the October 2001 news
report quoting Commissioner Wallström; the October 2001 news report quoting the spokeswoman for
Commissioner Byrne; the January 2002 speech by Commissioner Lamy; and the July 2003 note by the General
Secretariat of the Council.
686 See, e.g., the November 2000 Commission working document; the November 2000 speech by
Commissioner Byrne; the June 2002 EP committee report; the November 2002 EU Bulletin summarizing an EP
resolution; the July 2003 Commission fact sheet; the Ju ne 2003 statement by an EP committee rapporteur; the
July 2003 news report quoting the Agriculture Minister of Italy; the April 2004 background note by the
Council's General Secretariat; and the June 2004 parliamentary response by the French Minister for Research.

member State opposition to approvals.
687 In addition, the March 2003 motion for a European
Parliament resolution, which was referred to only by the United States, implies that the "continuation"
of the "moratorium" depends not only on the member States but also the Commission. 688 Similarly,
the June 2004 parliamentary response by the French Minister for Research, which was referred to
only by Argentina, implies that a "moratorium" could not have been imposed without Commission
involvement.689
(vii) Official EC position
7.539 The final point to be addressed is the EC argument that whatever the documents or statements
submitted by the Complaining Parties may say, none of them represents the official position of the
European Communities. For its official position, the European Communities refers the Panel to the
following two documents:690
(a) Commission press release of May 2003 . This press release was issued on the day the
United States announced its intention to f ile a WTO complaint. It quotes then Trade
Commissioner Pascal Lamy as saying that "[t] he US claim that there is a so-called
'moratorium', but the fact is that the EU has authorized GM varieties in the past and is
currently processing applications".691
(b) EC opening statement during the consultations of June 2003 . This statement was
delivered by the European Communities during the consultations preceding the
present panel proceedings. It states that "[u]nder the old regime, 18 GMOs were
approved. With the new rules [contained in Directive 2001/18], pending applications
have been revised and they are being examined with a view to making decisions on
the authorization of new products. Current ly 20 applications are being examined
under Directive 2001/18. That is a fact: not an allegation, not an opinion, not a press
statement."
692
7.540 The Panel notes that neither of these statements contradicts the Complaining Parties' basic
assertions. As already discussed in the previous Subsection, the Complaining Parties do not dispute
the fact that biotech products were approved pr ior to October 1998. Nor do they contest that
applications were being processed, or examin ed, between October 1998 and August 2003. The
Complaining Parties' assertion is that the European Communities imposed a de facto moratorium on
final approvals. According to the Complaining Part ies, under this type of moratorium, applications
were in most cases allowed to complete some stages of the EC approval process, but in no case were
they allowed to proceed to the stage of final a pproval. The documents a nd statements submitted by

687 See, e.g., the October 2001 Commission working pape r; the June 2000 speech by Commissioner
Byrne; the November 2001 speech by the same Commissioner (referring specifically to the Group of Five
countries); and the January 2002 speech by Commissioner Lamy.
688 The motion urges "the Council and the Commission to continue the moratorium".
689 The response states that the Group of Five countries "obtained a moratorium from the European
Commission suspending any new authorizations".
691 "European Commission regrets US decision to file WTO case on GMOs as misguided and
unnecessary", Commission Press Release IP/03/681, 13 May 2003, p. 1 (Exhibit EC-113).
692 Exhibit EC-112, p. 2.

each Complaining Party support the assertion that the "moratorium" affected the final approval of
applications, but not necessarily their processing at every step in the process.
693
(e) Facts and histories of individual approval procedures
7.541 In their submissions to the Panel, the Compla ining Parties have also addressed individual
applications for the placing on the market of biotech products. According to the Complaining
Parties, the approval procedures for these applications confirm that certain member States and/or the
Commission did in fact prevent the final approva l of applications in the manner asserted by the
Complaining Parties. In other words, in the Complaining Parties' view , the relevant approval
procedures confirm that member States and/or the Commission suspended the approval of
applications through one or more of the acts and/or omissions identified in Subsection (a) above.
7.542 In discussing individual approval procedures, th e Complaining Parties in their first written
submissions relied largely on pub licly available information. 694 Subsequently, they mainly used the
information submitted by the European Communities at its own initiative or at the request of the
Panel. It should be noted in this respect that most of the information relating to individual
applications is in the sole possession of memb er States, the Commission and the applicants.
However, some information – e.g., the minutes of Regulatory Committee meetings or
communications between member States and the Co mmission – is in the exclusive possession of the
European Communities. Also, while some of the a pplicants are US companies, others are European
companies. There do not appear to be any a pplicants which are Canadian or Argentinean
companies.695 The Panel notes nonetheless that all of the Complaining Parties produce for export
products subject to this complaint.
7.543 The European Communities argues that the claims relating to the general moratorium
collapse when the specific facts and history of each approval procedure are considered. The European
Communities submits that an analysis of the facts shows that during the relevant time period (October
1998 to August 2003) there were no acts and omissi ons that stalled applications at key decision-
making stages in the approval process. The proces sing of individual applica tions continued without
interruption, and applications were not systematically stalled.
7.544 According to the European Communities, in assessing applications, the competent authorities
tried to take account of the changing EC legislativ e and regulatory framework as well as the evolving
scientific debate. In some cases, this necessita ted long discussions between the lead CA and the
applicant on a number of scientific or regulatory i ssues that were not appropriately addressed in the
original application, which delayed the forwarding of applications to the Community level. In other
cases, discussions took place at Community level, be fore and/or after the opinion of the EC scientific

693 See, e.g., the July 2001 Commission press release; the October 2001 Commission working paper;
the July 2003 Commission fact sheet; the October 2001 news report quoting Commissioner Wallström; the June
2000 speech by Commissioner Byrne; the November 2000 speech by Commissioner Byrne; the July 2001
statement by Commissioner Byrne; the October 2001 speech by Commissioner Byrne; the November 2001
speech by Commissioner Byrne; the March 2003 motion for an EP resolution; the June 2003 statement by an EP
committee rapporteur; the July 2003 news report quoting the Italian Agriculture Minister; and the June 2004
parliamentary response of the French Minister for Research.
694 See, e.g., Exhibits US-30 and -31; CDA-26 and -34; ARG-6.
695 The European Communities argues that the relevant information should have been known to the
Complaining Parties before the initiation of these proc eedings, through their contacts with applicants. EC
second written submission, para. 254. Canada indicated th at it consulted with applicants in preparing its case,
but nevertheless suggests that it did not have full access to the information in question, despite a request to the
European Communities for disclosure during the consultations. Canada's third written submission, para. 8.

committees, among various member States. Furthermor e, an important number of applications were
withdrawn by the applicants because of various comme rcial reasons and changes in strategies. There
is, however, no consistent pattern in respect of the applications pending during the relevant time
period. Each application was dealt with on its ow n merits. In the light of this, the Panel cannot
determine whether there was a general "moratorium" without looking at the decisions and actions
taken in relation to each individual application. The Panel must consider each of the relevant
approval procedures for the applications.
7.545 Finally, the European Communities submits that even if the delays that affected certain
approval procedures before, and becau se of, the adoption of new legislation were to be seen as the
result of a measure (the alleged "moratorium"), th at measure would have ended with the entry into
force of that legislation, namely with the entry into force in January 2003 of Directive 2001/18.
7.546 The Panel notes the contention of all Parties that the facts and history of individual approval
procedures confirm their respective positions. The Eu ropean Communities in particular insists on the
importance of individual application histories, arguing that no conclusion can be drawn with regard to
whether a general moratorium on approvals was in effect between October 1998 and August 2003
until and unless each application has been consider ed individually. Furt her below, the Panel
undertakes a separate analysis of each relevant application.
7.547 The applications covered by the Panel's anal ysis are those mentioned by the Complaining
Parties in their requests for the establis hment of a panel, with one exception.
696. We are mindful of
the fact that the Complaining Parties' panel request s mention specific applications in connection with
their product-specific claims, and not in connection with their general moratorium claim. However,
we are referring to the panel requests here merely to identify the applications covered by our analysis.
Since the Complaining Parties' claim in respect of the alleged general moratorium is that the
moratorium was applicable to any and all app lications pending between October 1998 and August
2003, it is clear that, for the purposes of establishing the general moratorium claim, each of the
Complaining Parties may put forward evidence an d arguments in respect of any and all pending
applications.
7.548 The applications mentioned by the Complaining Parties in their panel requests include those
which were withdrawn between Oc tober 1998 and August 2003. We think that they are pertinent to
the Panel's assessment of whether the alleged general de facto moratorium on final approvals existed.
Up until the date of their withdrawal, these app lications, and the releva nt approval procedures,
constitute factual evidence which the Panel is not only entitled to take into account, but is required to
take into account in view of its obligation to ma ke an objective assessment of the facts of the case.
We also note that the findings we make with regard to the relevant approval procedures relate to the
Complaining Parties' claim that the European Communities applied a general moratorium on final
approvals. They do not relate to the issue of the WTO-consistency of actions or omissions by relevant
EC entities in the context of the approval procedures in question.
7.549 The Panel's analysis also covers one additi onal application referred to by the European
Communities.697 It does not cover eight other applicati ons which were mentioned by the European

696 The application concerning T14 maize was men tioned by Argentina. However, according to
information provided by the European Communities, that application, which was submitted to France in June
1996, was withdrawn by the applicant on 15 July 1998. Exhibit EC-156/At. 57. In other words, the approval
procedure concerning T14 maize was terminated prior to the alleged moratorium period (October 1998 to
August 2003).
697 Application concerning Transgenic green-hearted chicory.

Communities "in order to complete the picture".
698 Regarding the eight applications mentioned by the
European Communities for completeness' sake, we note that seven of these were submitted under
Directive 2001/18. Of those seven, three were submi tted after the date of establishment of this Panel
(29 August 2003) 699. They are not relevant to a determina tion of whether a general moratorium was
in effect until 29 August 2003. One ap plication was submitted in July 2003 700, which means it had
been assessed by the relevant member State for only one month when this Panel was established. 701
For the remaining three applications, unlike for a ll applications referred to by the Complaining
Parties, the European Communities submitted no de tailed chronologies with supporting documents.
Instead, it provided status reports which indicate the st ate of play of the applications in the spring of
2004.
7.550 In the European Communities' view, these status reports demonstrate that the relevant
approval procedures are "proceeding smoothly".702 However, one of the three applications in question
appears to have been delayed at the member Stat e level as a result of a request by the competent
member State authorities for additional information. 703 Another application, an application submitted
to the United Kingdom, was apparently also delayed at the member State level at the time this Panel
was established.704 The report provided by the European Communities does not indicate any reason
for this delay. The last of the three applicati ons was submitted to Germany. This application was
apparently assessed quickly, and favourably, by th e competent German authorities. However, when
the application moved to Community level, desp ite the favourable assessment by Germany, other
member States appear to have raised objecti ons to the placing on the market of this product. 705 The
report provided by the European Communities does not contain any information about the basis for
these objections. 706 In the light of the foregoing, the Panel does not consider that the information
supplied by the European Communities in respect of the three above-mentioned applications is
sufficient to support the inference that no general mo ratorium on final approvals was in effect before
or in August 2003.
7.551 The eighth application which was mentione d only by the European Communities was
submitted to Germany under Regul ation 258/97 and apparently con cerns the same product that was
submitted to Germany under Direct ive 2001/18. In respect of this application, the European
Communities provided neither a chronology with att achments nor a status report indicating the state
of play. The European Communities merely indicat es that the application was submitted in 2003 and

698 EC first written submission, para. 334. It should be recalled that the application concerning
MON863 maize is not part of the eight applications mentioned by the European Communities. As explained
previously, due to the fact that the Panel has no informat ion on this application other than an EC letter stating
that in September 2005 the application was approved by the Commission under Directive 2001/18, the Panel is
not in a position to determine whether or not the hist ory of the approval procedure concerning MON863 maize
is consistent with the Complaining Parties' contention that a general moratorium on approvals was in effect
between October 1998 and August 2003.
699 Exhibits EC-103 (maize), -108 (rice) and -109 (cotton).
700 Exhibit EC-107 (maize).
701 Pursuant to Article 14(2) of Directive 2001/18, a member State ha s 90 days from the date of receipt
of an application to prepare an assessment report on the application.
703 Exhibit EC-104 (sugar beet).
704 Exhibit EC-105 (maize). The United Kingdom took more than 13 months to prepare and forward its
assessment report instead of the 90 days laid down in Article 14(2) of Directive 2001/18.
705 Exhibit EC-106 (maize).
706 The report suggests that the member States were unable to reach an agreement and that the
application was therefore referred to an EC scientific committee for an opinion. However, this was after the
present Panel had been established.

quickly moved up to the Community level, where it appears to have run into objections from other
member States.
707 In respect of this application as well, the Panel does not consider that the
information supplied by the European Communities is sufficient to support the inference that no
general moratorium on final approvals was in effect until August 2003.
7.552 In the remainder of this Subsection, the Panel will examine the facts and histories of all other
relevant applications with a view to determining whether they are consistent with the Complaining
Parties' contention that during the relevant time period (October 1998 to August 2003) the European
Communities applied a general moratorium on final a pprovals, or whether they are inconsistent with
the Complaining Parties' contention and hence lead to the "collapse" of the Complaining Parties'
claims in relation to the general moratorium, as th e European Communities asse rts. The structure of
this examination reflects the arguments of the Comp laining Parties. More specifically, the Panel's
examination is structured according to the acts and omissions through which, in the Complaining
Parties' view, the European Communities gave effect to the alleged general moratorium on approvals.
The Panel will first address applications submi tted under Directives 90/220 and/or 2001/18.
Thereafter, the Panel will address applications submitted under Regulation 258/97.
7.553 Once the Panel has completed its analysis of individual approval procedures, it will focus on
the conduct of Group of Five countries generally, not ably their voting behaviour and their objections
to favourable assessments by lead CAs. In add ition, the Panel will address certain conduct by the
Commission prior to the June 1999 declaration by the Group of Five countries.
(i) Deliberate Release – Applications submitted under Directive 90/220 and/or
Directive 2001/18
7.554 The Panel first turns to address those of the re levant applications which were submitted and
dealt with under the provisions of Directive 90/ 220 and, subsequently, Directive 2001/18 concerning
the deliberate release of GMOs into the environment. It is useful to recall in this regard that in
accordance with Article 36 of Directive 2001/18, Dir ective 90/220 was repealed on 17 October 2002.
Furthermore, Article 35 of Directive 2001/18 provides that applications which were received pursuant
to Directive 90/220 and in respect of which the procedures under Directive 90/220 were not
completed by 17 October 2002, were subject to Di rective 2001/18 as of that date. Pursuant to
Article 35, such pending applications had to be co mplemented by the applicants in accordance with
Directive 2001/18. The date by which applicants had to do so was 17 January 2003.
7.555 We further recall that this means that irresp ective of the procedural stage reached by an
application under Directive 90/220, an appli cation which was updated in accordance with the
requirements of Directive 2001/18 had to go th rough all procedural stages provided for in
Directive 2001/18, beginning with the initial assessment by the lead CA. 708 However, according to
the European Communities, any results and conclusions reached under the procedures of
Directive 90/220 on the basis of the then-existing data and information were in principle still relevant
under the procedures of Directive 2001/18 and hence did not need to be re-examined.
7.556 In reviewing the approval procedures conducted fo r the relevant applications, we will first
focus on the Commission's conduct. Subsequently, we will also consider the conduct of individual
member States acting as lead CAs.

708 It is useful to recall that the Complaining Parties did not challenge the obligation contained in
Article 35 of Directive 2001/18.

7.557 Before commencing our examination of indivi dual approval procedures, we should note that
the European Communities acknowle dges that delays occurred in some approval procedures which
were pending under Directive 90/220. According to the European Communities, these delays
occurred because of the adoption of Directive 2001/18. The European Communities argues, however,
that after the entry into force of Directive 2001/ 18 all approval procedures have been proceeding
normally. We will revert to this argument after reviewing all relevant applications.
Failure by the Commission to submit a draft measure to the Council

7.558 In support of their assertion that the European Communities applied a general moratorium on
approvals the Complaining Parties have pointed to a number of approval procedures in which the
Commission failed to submit to the Council a draft measure on the relevant applications. We consider
these approval procedures below, recalling that Article 21 of Directive 90/220 provides in relevant
part that "[i]f the measures envisaged [by the Commission] are not in accordance with the opinion of
the [Regulatory] committee, or if no opinion is delivered, the Commission shall, without delay,
submit to the Council a proposal relating to the measures to be taken".
Bt-531 Cotton (EC-65)
7.559 The application concerning Bt-531 cotton was first submitted to Spain (lead CA) in
December 1996, and was provided to the Commissi on for circulation to all member States in
December 1997. Following a positive opinion by the SCP on 14 July 1998, the Commission launched
inter-service consultations on a draft measure to be submitted to the Regulatory Committee on
4 September 1998. The Regulatory Committee at its meeting of 22 February 1999 voted on the draft
measure submitted by the Commission, but failed to reach the qualified majority necessary to deliver
an opinion. Accordingly, on 7 May 1999, the Co mmission launched inter-service consultations on a
draft measure to be submitted to the Council. Bu t at no point prior to 17 October 2002, the date of
repeal of Directive 90/220, did the Commission submit a draft measure to the Council.
7.560 The United States argues that the Commission was required under EC law to submit a draft
measure to the Council "without delay". The United St ates submits that despite that legal obligation,
the Commission failed to do so, with the result that the application languished for over three years
without any activity other than purported inter-service consultations, until the application was updated
in early 2003 to meet the requirements of Directive 2001/18. According to the United States, the
"inter-service consultations" which the Commi ssion launched in May 1999 and the Commission's
failure to adhere to its legal obligation to act "without delay" confirm the existence of a moratorium.
7.561 Canada also argues that despite the positive opini on by the lead CA, the positive opinion by
the SCP and the failure of the Regulatory Committee to deliver an opinion and despite an express
legal obligation to do so, the Commission failed to submit to the Council a draft measure in order to
break the deadlock at the Regulatory Committee in accordance with the legal obligation under
Directive 90/220. According to Canada, the inte r-service consultations following the Regulatory
Committee vote and which were going on for close to four years resulted in a suspension of the
approval procedure. In Canada's view, the only reasonable explanation for the time taken by the
Commission to conduct inter-service consultations is the existence of a moratorium.
7.562 Argentina argues that instead of submitting a draft measure to the Council, the Commission
intentionally stalled the approval procedure concer ning Bt-531 cotton until the application had to be
resubmitted under Directive 2001/18. Argentina maintains that the Commission did so by starting
inter-service consultations, a phase not foreseen in the relevant EC legislation. In Argentina's view,

the Commission's inter-service consultations are evid ence of the existence of a moratorium inasmuch
as they reveal the European Communities' intention not to allow the final approval of applications.
7.563 The European Communities argues that the Regulatory Committee failed to reach a
qualified majority because a number of member States raised legitimate scientific concerns which had
not been addressed in any of the applicant's pr evious submissions. The European Communities
submits that long after the vote in the Regulatory Committee, on 25 July 2001, the applicant provided
the required additional information, and that the tran slation of this material was not made available
until February 2002. According to the European Co mmunities, if there was a three-year delay after
the Regulatory Committee vote, it was because of th e time taken by the applicant to provide the
required additional information.
7.564 The United States responds that nothing in the record indicates that the applicant was ever
requested to submit additional information to a ddress the member State statements made at the
Regulatory Committee meeting. According to the Un ited States, the applicant was not responding to
any request, but, on its own initiative, provided additiona l information to the lead CA as the state of
scientific knowledge had advanced since the first su bmission of the application more than four years
before. The United States submits that this info rmation was submitted as part of the applicant's
commitment to stewardship and initiatives to prov ide additional relevant new information as it
becomes available.
709
7.565 Argentina also considers that the additional information was provided by the applicant on its
own initiative, as the record does not indicate that the applicant was specifically requested by the
European Communities to provide that information.
7.566 The European Communities disagrees with the United States and Argentina, maintaining
that the applicant was formally requested to submit the information in question.
7.567 The Panel begins its analysis by noting that on 25 July 2001, more than two years after the
Commission launched inter-service consultations on a draft measure to be submitted to the Council,
the applicant sent a letter to the lead CA providing an updated and extended molecular
characterization of Bt-531 cotton and a safety assessment of Bt-531 cotton (analysis of flanking
regions). The letter by the applicant does not state that the information it contains was provided in
response to a specific request from the lead CA or another agency (another CA, the Commission, the
SCP, etc.).710 Nor does it indicate that the lead CA or the Commission had any knowledge that the
applicant would be providing the additional information in question.
7.568 The European Communities has noted that at the Regulatory Committee meeting of February
1999, Austria, Sweden and the United Kingdom made written statements in support of their votes. 711
As also noted by the European Communities, these statements related to concerns about the presence
of an antibiotic resistance marker gene, possibl e non-target effects on beneficial insects and the
sufficiency of the monitoring plan to analyse indi rect effects of Bt-531 cotton. None of these
statements specifically call for an updated molecula r characterization of Bt-531 cotton or a safety

709 The United States submitted a statement from the applicant in which it confirms to the United States
that it provided the information in question without a previous specific request from relevant authorities and that
it did so to provide supplementary information that comes to light as a result of ongoing research and to help
advance the approval process. Exhibit US-137.
710 Exhibit EC-65/At. 61.
711 Austria and the United Kingdom voted against, Sweden in favour of the proposed draft measure.
Exhibit EC-65/At. 59.

assessment (analysis of flanking regions). Ther e is therefore no indication that the applicant
submitted the July 2001 information in response to the written statements made at the February 1999
meeting of the Regulatory Committee.
712
7.569 Regarding the possibility that the information su bmitted by the applicant in July 2001 was in
response to requests for information or concerns put forward prior to the February 1999 meeting of
the Regulatory Committee 713, it should be observed that the lack of that information did not prevent
the Commission from submitting a draft measure to a vote by the Regulatory Committee, and it did
not prevent the Regulatory Committee from holding a vote on that measure. We therefore fail to see
how the lack of the same information could provide a justification for the Commission's failure to
submit a draft measure to the Council.
7.570 At any rate, based on the date of the applicant' s letter (July 2001) and the type of information
provided (an updated molecular charac terization) we are not convinced that the applicant's July 2001
letter was intended as a direct response to a specifi c request for information from before February
1999.714 The date of the letter and type of inform ation provided rather suggest that the applicant
sought to update its application in accordance w ith some of the requirements of Directive 2001/18,
which had been adopted in March 2001. Th e European Communities itself advances this
circumstance as constituting one of the reasons for the July 2001 letter, stating that by July 2001
"Directive 2001/18 had been adopted [...] and, as me ntioned several times, applicants were updating
their dossiers to match the new requirements".715 In our view, the applicant in this approval procedure
might well have done so in the hope that the upda ted information would make it possible for its
application to be approved while Directive 90/220 was still in force.
7.571 It follows from the above remarks that there is no evidence to suggest that the Commission
was waiting for the additional information provided by the applicant and that this was why the
Commission did not submit a draft measure to the Council. Indeed, even after the applicant had
provided the information, the Commission did not forward a draft measure to the Council, although
Directive 90/220 remained in force for another seventeen months, until October 2002.
7.572 It appears that the European Communities also seeks to explai n the Commission's failure to
act by the fact that the draft measure which the Commission had submitted to a vote in the Regulatory
Committee in February 1999 failed to achieve a qua lified majority and that at that same meeting
Austria, Sweden and the United Kingdom made statements in support of their votes. According to the

712 It is also not clear that the content of the statements in question was ever brought to the attention of
the applicant. According to the Complaining Partie s, the minutes of Regulatory Committee meetings are
confidential. The European Communities states that an y request for information, comment or objection by a
member State is automatically forwarded, through the lead CA, to the applicant (EC reply to Panel question No.
200). But the European Communities did not say that this also applies to comments or written statements made
in the context of a Regulatory Committee meeting.
713 The European Communities appears to make this point in its reply to Panel question No. 200.
714 In its reply to Panel question No. 200, the European Communities suggests that the July 2001
information was provided in response to concerns raised by CAs other than the lead CA (see the references, e.g.,
to EC-65/At. 16-25). However, the Panel has seen no evid ence, nor has it been informed, that the lead CA ever
transmitted the July 2001 information to the Commission and other CAs. If, as it seems, this did not happen,
then it would be difficult to accept th e European Communities' suggestion that the information was provided in
response to requests for information or concerns put forward by other CAs.
715 EC reply to Panel question No. 200.

European Communities, these statements expressed leg itimate scientific concerns that had not been
previously addressed by the applicant.
716
7.573 As no qualified majority was reached at the Regulatory Committee meeting, it seems
reasonable to assume that the Commission used its inter-service consultations to analyse the reasons
for the outcome of the vote in the Regulatory Committee and to determine, in the light of the results
of such an analysis, whether it would be appropriate to modify the Commission's draft measure before
it was sent on to the Council, and if so, how. 717 The statements by Austria and the United Kingdom
could have been relevant to that task.718
7.574 In the present case, however, the Commission apparently never completed this task, even
though the Commission launched its inter-service consu ltations more than three years before the date
of repeal of Directive 90/220. It should be noted in this regard that in other approval procedures, the
Commission was able to prepare and submit draf t measures to the Council within a few months,
despite the fact that some member States voted against the Commission's draft measure and that some
made written statements. 719 Moreover, the European Communities does not assert that Austria and
the United Kingdom raised new or particularly comp lex scientific concerns. We are therefore not
convinced that either the absence of a qualified ma jority vote in the Regulatory Committee or the
statements made by the aforementioned member States explain the Commission's failure, over a three-
year period, to submit a draft measure to the Council.
7.575 The Complaining Parties consider that the Co mmission's failure to act rather reflects the
adoption by the European Communities of a general moratorium, that is to say, of a decision not to
allow any application to proceed to final approval. It is pertinent to note in this regard that the
Commission launched its inter-service consultations w ith regard to Bt-531 cotton shortly before the
June 1999 declaration by the Group of Five countri es. At the time it conducted its inter-service
consultations, the Commission thus had reason to believe that the Group of Five countries would act
as a "blocking minority" in the Council, and that if that were to happen, the Commission would be
required under Directive 90/220 to adopt th e draft measure it submitted to the Council.
720 It is the
contention of the Complaining Parties that the Commission was instrumental in the adoption and
application of the alleged genera l moratorium and that it decided not to discharge its responsibility
under Directive 90/220 to complete approval procedur es, in view of opposition of the Group of Five
countries. In our view, the Commission's failure, over a three-year period, to submit a draft measure

716 As pointed out by the United States, however, the c oncerns referred to in the statements by Austria,
Sweden and the United Kingdom were addressed in the SCP opinion. Exhibit EC-65/At. 47, paras. 6.2.1 and
6.3.3-6.3.4.
717 The Panel does not agree with Argentina that the very fact that the Commission launched inter-
service consultations is evidence of a de facto moratorium on approvals. We address this further infra,
paras. 7.1254-7.1261.
718 We note that Sweden voted in favour of the Commission's draft measure and that Sweden's
statement suggests that its concerns were met.
719 In the approval procedure concerning NK603 maize (Exhibit EC-76) and conducted under
Directive 2001/18, the Commission submitted a draft m easure to the Council little over one month after the
Regulatory Committee had failed to reach a qualified majority. At that meeting, Austria made a statement in
support of its negative vote. Exhibit EC-76/At. 72. In the approval procedure concerning Bt-11 maize (Exhibit
EC-92) and conducted under Regulation 258/97, the Commission adopted a draft measure and referred it to the
Council less than two months after th e Regulatory Committee had failed to r each a qualified majority. At that
meeting, several member States made statements in support of their votes. Exhibit EC-92/At. 70.
720 Article 21 of Directive 90/220 states in relevant part that " [i]f, on the expiry of a period of three
months from the date of referral to the Council, the Council has not acted, the proposed measure shall be
adopted by the Commission".

concerning Bt-531 cotton to the Council is consiste nt with the contention that the Commission made
and followed such a decision.
7.576 In the light of the above considerations, we c onclude that the Commission's failure after the
February 1999 Regulatory Committee meeting to s ubmit a draft measure concerning Bt-531 cotton to
the Council is consistent with the Complaining Part ies' assertion that during the relevant time period
the European Communities applied a general moratorium on final approvals.
RR-1445 cotton (EC-66)
7.577 The application concerning RR-1445 cotton was first submitted to Spain (lead CA) in June
1997, and was provided to the Commission for circul ation to all member States in December 1997.
Following a positive opinion by the SCP conc erning RR-1445 cotton on 14 July 1998, the
Commission launched inter-service consultations on a draft measure to be submitted to the Regulatory
Committee on 4 September 1998. The draft measure was submitted to the Re gulatory Committee for
a vote using a written procedure on 26 November 1998, with a deadline for the vote of 18 December
1998. The deadline for the vote was extended twice, following requests from various member States,
until 22 February 1999. The Regulatory Committee fa iled to reach a qualified majority decision, and
the Commission again launched inter-service consulta tions on 7 May 1999. At no point prior to 17
October 2002, the date of repeal of Directive 90/ 220, did the Commission submit a draft measure to
the Council. The application was updated and re -submitted under Directive 2001/18 on 16 January
2003. As of 29 August 2003, no draft measure has been submitted by the Commission to the Council
under Directive 2001/18.
7.578 The United States argues that the Commission was required under EC law to submit a draft
measure to the Council "without delay" following the inability of the Regulatory Committee to reach
a decision on 22 February 1999. The United States contends that the Commission refused to do so,
however, and, as a result, further consideration of this application was indefinitely suspended as of
February 1999. The Commission took no further action on this application for nearly four years,
other than purported inter-service consultations , until the applicant was forced to update its
application in January 2003 and to re-submit it under Directive 2001/18. The United States contends
that only the existence of a moratorium explains the failure of the European Communities to move the
application forward after its positive assessment by the relevant EC scientific body.
7.579 Canada argues that despite the positive opinion by the lead CA, the positive opinion by the
SCP and the failure of the Regulatory Committee to deliver an opinion and despite an express legal
obligation to do so, the Commission failed to submit to the Council a draft measure in order to break
the deadlock at the Regulatory Co mmittee in accordance with the obligation under Directive 90/220.
Canada also argues that inter-service consultations had taken place earlier for this product, prior to the
submission of a draft decision to the Regulatory Committee. Following the failure of the Regulatory
Committee to reach a decision, the approval procedure for RR-1445 cotton was completely suspended
for four years. Canada maintains that the only r easonable explanation as to why an additional four-
year inter-service consultation was required is the existence of the moratorium.
7.580 Argentina argues that RR-1445 cotton, like other a pplications with a positive scientific
opinion from 1998, was stalled by inter-service cons ultations. The lack of action on this product by
the Commission for four years following the failure of the Regulatory Committee to reach a decision
is further evidence of the de facto moratorium.
7.581 The European Communities notes that eight member States raised objections or had
comments on issues related mainly to compositional analysis, molecular characterization, antibiotic

marker genes, safety and long-term effects on the environment – prior to the assessment and
favourable opinion by the SCP. The European Communities argues that the Regulatory Committee
failed to reach a qualified majority decision because a number of member States maintained
objections, in particular because of concerns related to long-term effects of herbicide tolerant crops on
the environment, to the presence of an antibiotic r esistance marker gene, residue-limit levels, and to
the effects on biodiversity of changes in herb icide tolerant crop management. The updated
application submitted in January 2003 by the app licant under Directive 2001/18 was still incomplete
with respect to a monitoring plan. The European Communities maintains, therefore, that any delay
which has occurred is entirely legitimate and related to risk assessment and management
considerations.
7.582 The United States responds that the four-year delay following the failure of the Regulatory
Committee to reach a decision was not caused by a pending request to the applicant for additional
information. The evaluation by the SCP had addr essed all of the concerns raised by the member
States at the level of the Regulatory Committee, incl uding antibiotic resistance marker genes, toxicity
to non-target organisms, and out-crossing from the transgenic plants, and came to the conclusion that
the placing on the market of RR-1445 cotton with the purpose of being used as any other cotton was
not likely to cause adverse effects on human health or the environment. None of the member States
objecting at the Regulatory Committee offered any competing risk assessment or scientific evidence
for their objections, nor did they identify any specifi c inadequacies in the SCP review. Nothing in the
record indicates that the Commission communicated any scientific concerns to the applicant or
identified any shortcomings in the application following the lack of a decision by the Regulatory
Committee in February 1999.
7.583 Argentina also considers that all of the concer ns identified by member States in their
objections at the Regulatory Committee had been fu lly addressed by the SCP. Furthermore, this
product had also received a favourable opinion under Regulation 258/97 on novel foods and food
ingredients with respect to oil derived from RR-1445 cotton. The opinion of the Advisory Committee
on Novel Foods and Processes was that oil from RR- 1445 cotton is substantially equivalent to
conventional cottonseed oil in terms of composition, nutritional value, metabolism, intended use and
level of undesirable substances.
7.584 The Panel notes that, following the failure of th e Regulatory Committee to reach a decision
on 22 February 1999, and the re-launching of inter- service consultations on 7 May 1999, there is no
record of any further action on this application be fore the repeal of Directive 90/220 in October 2002
and its replacement by Directive 2001/18. The record of the consultation of the Regulatory
Committee by written procedure regarding a draft Commission Decision concerning the placing on
the market of RR-1445 cotton does not contain any indication of a specific request to the applicant for
further information.
721
7.585 Four member States provided statements in support of their votes (Sweden, United Kingdom,
Austria and Italy). All of the statements are very brief, and none includes a scientific evaluation or
risk assessment in support of the views expressed. The UK competent authority voted against the
draft measure stating that its disagreement is with respect to the marketing of the product for use in
animal feed, due to the use of an antibiotic resistance marker gene in the product. Furthermore, while
raising no concerns in terms of potential risks to the UK environment, the United Kingdom draws the
attention of other member States where the cotton may be widely grown to potential negative impacts
on biodiversity arising from changes in crop management methods. The Austrian competent authority
abstained from voting indicating that the assessme nt of the risk especially from the use of the

721 Exhibit EC-66/At. 57.

antibiotic resistance marker has not been sufficient for approval of a product which could be used as
feed. Furthermore, Austria indicates that specifi c labelling requirements should be mentioned in the
Commission Decision. The Swedish competent author ity voted against the draft measure referring to
earlier views that herbicide tolerant crops should not be placed on the market until the long-term
effects of such crops on the environment have been better analysed, and common principles for
evaluation and monitoring of potential risks connected to the cultivation of herbicide tolerant crops
established. Italy, which voted in favour of th e decision, stated that the use of Roundup-Ready
herbicide on the cotton plant should be authori zed only if the glyphosate metabolites and relevant
residues were within the limits established by EC regulations.
7.586 We note that the evaluation of the SCP specifi cally addressed potential risks from the use of
the antibiotic resistance marker gene in the product if used as animal feed. The SCP noted that it was
"unlikely" that either gene which conferred resistance would survive processing. However, it went on
to consider the potential risk if this "theoretically possible" and "extremely unlikely chain of events"
occurred, and concluded that the introduction of either resistant gene would not increase existing risks
to any significant effect, nor did they identify any potential risks from the "equally remote possibility"
that the gene would be transformed and expressed. These findings were subsequently confirmed in a
January 1999 report by the French CA, the Commission du Génie Biomoléculaire.
7.587 In response to a question from the Panel, one of the experts advising the Panel, Dr. Squire,
observed that the issue of antibiotic resistance was considered in th e SCP's opinion and found not to
pose a risk. Furthermore, he notes that although ther e is now a widespread pe rception that antibiotic
resistance should not be introduced through herbicid e resistant products, cotton occupies a very small
area in Europe and does not present potential problems of the type that might be associated with other
crops.
722
7.588 The SCP also specifically considered risks to non-target organisms and resistance and
tolerance concerns. In response to a question by the Panel, another expert advising the Panel, Dr.
Andow, stated his view that because the SCP considered that the risks of indirect effects or long-term
and spatial scale effects on non-target organisms, and of effects associated with changes in the
cropping system or the evolution of resistance in we eds to glyphosate, were inconsequential, the SCP
did not propose a monitoring plan. Dr. Andow consid ered that the scientific issues raised by the
objecting member States could be addressed in a monitoring plan, but that the necessity of a
monitoring plan could not be determined from these objections. 723 Dr. Squire further noted that
neither the applicant nor EC competent authoriti es had proposed suitable criteria on which to base
monitoring.724
7.589 Although the European Communities stated that following the positive opinion of the
Scientific Committee, the applicant entered into disc ussions with the lead CA on a further rat feeding
study, no evidence was provided to the Panel w ith regard to these discussions or the possible
outcome, nor with respect to whether these discussions were undertaken and/or concluded prior to the
scheduled vote in the Regulatory Committee.725
7.590 As no qualified majority was reached by th e Regulatory Committee, it is reasonable to
assume that the purpose of the inter-service consu ltations launched by the Commission in May 1999
was to analyse the reasons for the outcome of the vote in the Regulatory Committee and to determine,

722 Annex H, para. 480.
723 Ibid, paras. 449-450.
724 Ibid, para. 467.

in the light of such an analysis, whether it w ould be appropriate to modify the Commission draft
measure before it was sent to the Council.
726
7.591 However, in the case of RR-1445 cotton it app ears that the Commission never completed this
task, even though the inter-service consultations were started more than three years before the repeal
of Directive 90/220. There is no evidence to sugg est that there was any further contact with the
applicant following the vote of the Regulatory Co mmittee in February 1999, and even less that any
further information was requested from the applicant. The Commiss ion's failure to submit a draft
measure to the Council before the repeal of Directive 90/220 contrasts with other approval
procedures, in which the Commission was able to prepare and submit draft measures to the Council
within a few months of a failure of the Regulatory Committee to reach a decision, despite the fact that
some member States voted against the Co mmission's draft measure in those cases. 727 We are not
convinced that either the absence of a qualifie d majority in the Regulatory Committee or the
statements made by the above-mentioned member St ates explain the Commission's failure, over more
than a three-year period, to submit a draft measure to the Council.
7.592 The Complaining Parties consider that the Commission's failure to act reflects the adoption by
the European Communities of a general moratorium, th at is to say, of a decision not to allow any
application to proceed to final approval. It is pe rtinent to note in this regard that the Commission
launched its inter-service consulta tions with regard to RR-1445 cott on shortly before the June 1999
declaration by the Group of Five countries. At the time it conducted its inter-service consultations,
the Commission thus had reason to believe that the Group of Five countries would act as a "blocking
minority" in the Council, and that if that were to happen, the Commission would be required under
Directive 90/220 to adopt the draft measure it submitted to the Council. 728 We recall that it is the
contention of the Complaining Parties that the Commission was instrumental in the adoption and
application of the alleged genera l moratorium and that it decided not to discharge its responsibility
under Directive 90/220 to complete approval procedur es, in view of opposition to final approvals by
the Group of Five countries. In our view, the Commission's failure, over a three-year period, to
submit a draft measure concerning RR-1445 cotton to the Council is consistent with the contention
that the Commission made and followed such a decision.
7.593 In the light of the above considerations, we c onclude that the Commission's failure after the
February 1999 Regulatory Committee meeting to submit a draft measure concerning RR-1445 cotton
to the Council is consistent with the Complaining Parties' assertion that during the relevant time
period the European Communities applied a general moratorium on final approvals.

726 The Panel does not agree with Argentina that the very fact that the Commission launched inter-
service consultations is evidence of a de facto moratorium on approvals. We address this further infra,
paras. 7.1254-7.1261.
727 In the approval procedure concerning NK603 maize (Exhibit EC-76) and conducted under
Directive 2001/18, the Commission submitted a draft m easure to the Council little over one month after the
Regulatory Committee had failed to reach a qualified majority. At that meeting, Austria made a statement in
support of its negative vote. Exhibit EC-76/At. 72. In the approval procedure concerning Bt-11 maize (Exhibit
EC-92) and conducted under Regulation 258/97, the Commission adopted a draft measure and referred it to the
Council less than two months after th e Regulatory Committee had failed to r each a qualified majority. At that
meeting, several member States made statements in support of their votes. Exhibit EC-92/At. 70.
728 Article 21 of Directive 90/220 states in relevant part that " [i]f, on the expiry of a period of three
months from the date of referral to the Council, the Council has not acted, the proposed measure shall be
adopted by the Commission".

MON809 maize (EC-83)
7.594 The application concerning MON809 maize was fi rst submitted to the competent authority of
France (lead CA) in December 1995, with the re quest for approval of both MON810 and MON809.
In March 1996, a new application was submitted concerning only MON809. The application was
forwarded to the Commission and to all member States in August 1996. A favourable opinion was
issued by the SCP on 19 May 1998. Inter-service consultations were launc hed on 12 June 1998 and
concluded on 19 July 1998. The consultation of the Regulatory Committee was launched on
4 September 1998, and closed on 23 October 1998 without a decision. On 22 April 1999, the
Commission launched an internal procedure for the adoption by the Commission of a draft measure to
be submitted to the Council, but this procedure was suspended on 29 April 1999. The application was
withdrawn by the applicant on 4 October 2002.
7.595 The United States observes that this application was forwarded to the Commission with a
favourable opinion from the lead CA, and that it received a positive opinion from the SCP. When the
Regulatory Committee failed to reach a decision on the Commission’s draft measure in October 1998,
the Commission refused to submit the measure to the European Council as required by EC law.
Because of the failure of the Commission to pro ceed with this application, the application was
withdrawn in October 2002.
7.596 Canada notes that this product was assessed both under Directive 90/220 and under
Regulation 258/97. The safety assessments undertaken by both the SCP and the Scientific Committee
for Food (SCF) concluded that this product raised no concerns with respect to the environment or
animal and human health.
7.597 The European Communities notes that after assessment by the SCP, the application was
withdrawn by the applicant in October 2002. Th e applicant gave no reason for the withdrawal. The
European Communities notes that an important number of applications have been withdrawn by the
respective companies because of various commercial reasons and changes in strategies.
7.598 The United States argues that this failed application provides direct, compelling evidence of
the existence of a general moratorium. This appli cation languished in the approval process for years,
for no apparent reason other than the moratori um, and the withdrawal evinces the applicant's
frustration with the European Communities’ suspen sion of its approval process. The United States
further notes that there was no need to explicitly mention the delays in the notice of withdrawal. Over
time, as the delays mounted, in some cases the co mmercial incentive for seeking approval changed.
Second, the companies have a str ong incentive to maintain cordial re lations with EC regulators, and
saw no advantage of complaining to EC regulators about the length of the delays resulting from the
moratorium.
7.599 Canada observes that given rapid advancements in the field of biotechnology, protracted
delays in an approval process may cause products submitted for approval by 1998 to become obsolete.
Also, given the considerable time and financial res ources necessary to support an application, it may
not be commercially justified to proceed with the application in the face of the legal uncertainty
created by the moratorium. Canada argues that the sheer number of withdrawals (thirteen under
Directives 90/220 and 2001/18 and six under Regulati on 258/97) is evidence of the impact of the
moratorium. Canada maintains that it is unde rstandable in the circumstances that companies
withdrawing applications did not cite undue delays in the processing of applications as reasons for the
withdrawal. As companies have an interest in maintaining a good working relationship with the
regulatory authorities responsible for approving their products, it is reasonable to expect companies to
act with circumspection.

7.600 Argentina also argues that although applications received positive scientific opinions,
favouring their approval, the procedure for their approva l was stalled, and some had to be withdrawn.
Argentina also considers that the silence of the a pplicants cannot be taken as evidence of satisfaction
with the process, but rather was due to the appli cants' concern with maintaining good relations with
the approving authorities.
7.601 The Panel notes that six months following the failure of the Regulatory Committee to deliver
an opinion on this application, on 22 April 1999, the Commission launched an internal written
procedure for the adoption by the Commission of a draft measure to be submitted to the Council. This
draft measure was for the approval of MON809. In circulating this proposal, the Commission noted
that the applicant had undertaken to provide labelling of bags of seeds; to provide a detailed technical
guide to purchasers of the seed; and to inform tr aders regarding the full pr oduct description of the
modified seeds. Furthermore, the Commission noted that the applicant had developed a management
strategy to minimize the development of insect r esistance and had offered to inform the Commission
and member States of the results of monitoring in th is regard. However, one week later, on 29 April
1999, the Commission suspended the written procedure for approval, citing the need to verify the
monitoring plan with respect to the development of insect resistance in light of the recommendations
adopted in March 1999 by the SCP with respect to surveillance of resistance.
729
7.602 The chronology of this application, as provide d by the European Communities, indicates that
additional questions were sent to the SCP, apparently in the context of the safeguard measure adopted
by Austria with regard to MON810 maize. 730 Like MON809, MON810 is a modified Bt maize. No
evidence has been provided of such additional quest ions, and by whom these questions were asked.
However, in correspondence dated 15 June 1999, the applicant seeking the approval of MON809
maize submitted a further assessment of the like lihood of adverse effects on Lepidoptera species to
the French competent authority, apparently in resp onse to a request. The applicant noted that this
evidence had previously been provided to the co mpetent authorities of the United Kingdom in the
context of the assessment of MON809 for food and feed safety.
7.603 On 24 September 1999, the SCP issued an opinion on Austria's safeguard measure on
MON810. The Austrian competent authority had in dicated that its safeguard measure was taken in
light of a study which addressed possible adverse effects of pollen from genetically modified Bt maize
on the monarch butterfly. The SCP considered th e evidence available regarding potential undesired
effects of the Bt toxin on non-target insects, incl uding on the Lepidopteran species in Europe. The
SCP evaluated this evidence not only with respec t to MON810, but also with respect to other
genetically modified maize lines which had previous ly been approved (Bt-176 and Bt-11), and with
respect to products whose approval was pending, including MON809 and Bt-531 cotton. With
respect in particular to MON809, the SCP noted that the protoxin had not been detected in pollen.
7.604 The SCP concluded that there was no reason to change its previous advice to the Commission
on the Bt crops which it had previously evaluated. It recalled its previous statement that it would be
sensible to conduct monitoring in post-release situ ations, and endorsed the practice of monitoring,
with appropriate and adequately targeted methodology, the large-scale introduction of such crops in
order to detect any deleterious impact on non-ta rget insect populations. There was no specific
reference in this regard to MON809.
7.605 Given this second favourable opinion by the SCP, it seems reasonable to assume that the
Commission would rapidly have proceeded to submit a draft measure to the Council on MON809.

729 Exhibit EC-83/At. 70.
730 We discuss this safeguard measure below in Section VII.F of our Report.

This was not the case, however. Neither is there any indication that the applicant was requested to
provide any further information on a monitoring plan for potential effects of MON809 on non-target
insects. Indeed, there does not appear to have been any further action by the Commission on this
application during the three years following the second favourable opinion of the SCP, and in October
2002 the applicant withdrew the application without citing a reason.
7.606 The Complaining Parties consider that the Commission's failure to act reflects the adoption by
the European Communities of a general moratorium, th at is to say, of a decision not to allow any
application to proceed to final approval. It is per tinent to note in this regard that the Commission did
not complete its suspended internal written proced ure for the adoption of the draft measure to be
submitted to the Council after the June 1999 declara tion by the Group of Five countries. Following
this declaration, and despite the favourable opinion of the SCP, the Commission had reason to believe
that the Group of Five countries would act as a "blocking minority" in the Council, and that if that
were to happen, the Commission would be required under Directive 90/220 to adopt the draft measure
it submitted to the Council.
731 We recall that it is the contention of the Complaining Parties that the
Commission was instrumental in the adoption and a pplication of the alleged general moratorium and
that it decided not to discharge its responsib ility under Directive 90/220 to complete approval
procedures, in view of opposition to final approvals by the Group of Five countries. In our view, the
Commission's failure, over a three-year period, to submit a draft measure concerning MON809 to the
Council is consistent with the contention that the Commission made and followed such a decision.
7.607 We consider that the fact that the applicant di d not specifically cite a general EC moratorium
on approvals as a reason for the withdrawal of th e application is not inconsistent with the
Complaining Parties' assertion that the Europ ean Communities applied a general moratorium on
approvals. As was pointed out by the Complaining Parties, if a moratorium was in effect, there are
plausible explanations for why the applicant did not specifically cite the alleged moratorium or
resulting delays as a reason for withdrawing the application concerning MON809 maize.
7.608 In the light of the above considerations, we c onclude that the Commission's failure to submit
a draft measure concerning MON809 maize to the Council after the September 1999 favourable
opinion of the SCP is consistent with the Complain ing Parties' assertion that during the relevant time
period the European Communities applied a general moratorium on final approvals.
Transgenic tomato (EC-84)
7.609 The application concerning the Transgenic tomato is for the planting, growing, harvesting and
processing of tomatoes into non-viable products and was first submitted to the competent authority of
Spain (lead CA) in November 1996. In Novemb er 1997, the application was forwarded to the
Commission with a favourable opinion from the lead CA, and circulated to all member States the
following month. Another application regard ing the same product was also submitted under
Regulation 258/97 to the United Kingdom in March 1998 (EC-100). In June 1998, the SCP issued a
favourable opinion indicating that there was no evid ence that the production and consumption of the
transgenic tomato was likely to cause adverse effects on human or animal health or the environment.
According to the information provided by the European Communities, Commission inter-service
consultations were concluded in October 1998. Consultation of the Regulatory Committee was
launched in November 1998, and on 18 December 1998 the Regulatory Committee failed to reach a
decision by qualified majority. In February 2002, the application was withdrawn.

731 Article 21 of Directive 90/220 states in relevant part that " [i]f, on the expiry of a period of three
months from the date of referral to the Council, the Council has not acted, the proposed measure shall be
adopted by the Commission".

7.610 The United States argues that despite favourable opinions from the lead CA and the SCP,
when the Regulatory Committee fa iled to approve the Commission’s draft measure, the Commission
refused to submit the measure to the Council, as re quired by EC law. The United States maintains
that this refusal to submit the measure to the Council is evidence of the existence of a general
moratorium.
7.611 The European Communities notes that in the written procedure for a vote by the Regulatory
Committee in December 1998, both Denmark and Italy voted in favour of approval of the transgenic
tomato. The European Communities points to the fact that this application was withdrawn prior to the
establishment of the Panel and that the applicant gave as the reason for the withdrawal "commercial
re-positioning" following a merger with another company.
7.612 The United States argues that the application was withdrawn because of the European
Communities’ excessive delay in carrying out the approval process, despite the positive assessment
from the SCP. The United States maintains that although a company may not have cited undue delays
in its withdrawal letter, over time, as the delays mounted, in some cases the commercial incentive for
seeking approval changed. Furthermore, according to the United States, the companies had a strong
incentive to maintain cordial relations with EC regulators and saw no advantage of complaining to EC
regulators about the length of the delays, which the United States maintains results from the
moratorium.
7.613 Canada argues that given rapid advancements in the field of biotechnology, protracted delays
in an approval process may cause products submitted fo r approval by 1998 to become obsolete. Also,
given the considerable time and financial resources necessary to support an application, it may not be
commercially justified to proceed with the applica tion in the face of the legal uncertainty created by
the moratorium. Canada argues that the sheer number of withdr awals (thirteen under Directives
90/220 and 2001/18 and six under Regulation 258/97) is evidence of the impact of the moratorium.
Furthermore, Canada maintains that it is unde rstandable in the circumstances that companies
withdrawing applications did not cite undue delays in the processing of applications as reasons for the
withdrawal. As companies have an interest in maintaining a good working relationship with the
regulatory authorities responsible for approving their products, it is reasonable to expect companies to
act with circumspection.
7.614 Argentina argues that although applications recei ved positive scientific opinions, favouring
their approval, the procedure for their approval was stalled, and some had to be withdrawn. Argentina
maintains that these withdrawals were the result of th e moratorium. Argentina also considers that the
silence of the applicants cannot be taken as evidence of satisfaction with the process, but rather was
due to the applicants' concern with maintaining good relations with the approving authorities.
7.615 The Panel notes that although the Regulatory Committee failed to reach a decision by
qualified majority in November 1998, the record of the votes (written procedure) indicates that no
member State objected. France failed to submit a vote. Austria, Greece, Ireland, Luxembourg and
Sweden abstained and statements were provided by Austria, Greece and Sweden. The Panel remarks
that Austria's competent authority concurred that the "state-of-the-art" risk assessment "did not
indicate any specific challenges to human health an d the environment"; however, Austria suggested
that any potential effects of large-scale cultivation be monitored "as generally agreed in discussions
on the amendment of Directive 90/220/EEC", and that specific labelling requirements should be
mentioned at least in the recitals.732

732 Exhibit EC-84/At. 45.

7.616 On the other hand, the statement submitted by Greece consisted of a single sentence: "We
support the idea of a 'Moratorium' for G.M. O.s as presented by some Member-States".
733 S w e d e n
unsuccessfully requested an extension of the vote unt il the safety of the transgenic tomato as food had
been assessed, to ensure co-ordination and coheren ce between decisions taken with regard to release
into the environment and novel foods.
7.617 We note that within two months following the fa ilure of the Regulatory Committee to reach a
decision, the applicant provided clarification that the transgenic tomato wa s bred solely for the
processing tomato industry and would not be availa ble directly to consumers. Furthermore, on
23 September 1999, the Scientific Committee on Food (SCF) expressed a favourable opinion
regarding the safety of processed products produced fo rm the transgenic tomato in the context of
Regulation 258/97 on novel foods.
7.618 We do not consider that any of the specific c oncerns identified by member States during the
consultation of the Regulatory Committee pertain sp ecifically to the safety assessment of transgenic
tomatoes for cultivation and processing. Furthermore, all of the concerns previously identified by
member States were addressed in the evaluations undertaken by the SCP and the SCF, and the
European Communities has not argued that any subs tantive concerns were raised by any member
State subsequent to these assessments. It coul d therefore be expected that the Commission would
have submitted a draft measure to the Council "without delay" with respect to the applications for the
cultivation and processing of transgenic tomatoes.
7.619 Indeed, the documentation provided to us indicates that the Commission began preparing a
draft measure for submission to the Council in Febr uary 1999, and six months later, in August 1999,
launched an internal written procedure for the adop tion of the draft measure by the Commission.
However, there is no indication that this draft measure was ever actually submitted to the Council, and
no evidence of any Council action with regard to this application. The European Communities has
provided no explanation for the failure to submit this draft measure to the Council, as required by
Directive 90/220. No documentation has been provid ed with regard to any consideration of this
application after the 23 September 1999 positive assessment by the SCF of the processed tomato
products, until the withdrawal of the application und er Directive 90/220 more than two years later, in
February 2002.
7.620 The Complaining Parties consider that the Commission's failure to act reflects the adoption by
the European Communities of a general moratorium, th at is to say, of a decision not to allow any
application to proceed to final approval. It is per tinent to note in this regard that the Commission did
not complete its internal written procedure for the adoption of the draft measure to be submitted to the
Council after the June 1999 declaration by the Group of Five countries. Following this declaration,
and despite the favourable opinion of the SCP (and the SCF), the Commission had reason to believe
that the Group of Five countries would act as a "blocking minority" in the Council, and that if that
were to happen, the Commission would be required under Directive 90/220 to adopt the draft measure
it submitted to the Council. 734 We recall that it is the contention of the Complaining Parties that the
Commission was instrumental in the adoption and a pplication of the alleged general moratorium and
that it decided not to discharge its responsib ility under Directive 90/220 to complete approval
procedures, in view of opposition to final approvals by the Group of Five countries. In our view, the
Commission's failure, for a period of more than two years after launching its internal written

733 Ibid.
734 Article 21 of Directive 90/220 states in relevant part that " [i]f, on the expiry of a period of three
months from the date of referral to the Council, the Council has not acted, the proposed measure shall be
adopted by the Commission".

procedure, to submit a draft measure to the Coun cil is consistent with the contention that the
Commission made and followed such a decision.
7.621 The European Communities points out that in November 1998, at the Regulatory Committee
stage, Denmark and Italy voted in favour of approval of the transgenic tomato under Directive 90/220.
In June 1999, these two member States became pa rt of the Group of Five countries supporting a
general moratorium. The votes by Denmark and Italy do not support the conclusion that there was
systematic member State opposition to final approva ls already as from October 1998, but they are not
inconsistent with the application of a general moratorium at least as from June 1999.
7.622 Regarding the fact that the applicant did not specifically cite a general EC moratorium on
approvals as a reason for the withdrawal of the appli cation, we have already noted with respect to the
application concerning MON809 maize that this is not inconsistent with the Complaining Parties'
assertion that a general moratorium on approvals was in effect.
7.623 In light of the above considerations, we conc lude that the Commission's failure after August
1999 to submit a draft measure concerning the cultiva tion and processing of the transgenic tomato to
the Council is consistent with the Complaining Pa rties' assertion that at least as from June 1999 the
European Communities applied a general moratorium on final approvals.
Failure by the Commission to re-convene th e Regulatory Committee for a vote on a draft
measure
7.624 In support of their assertion that the European Communities applied a general moratorium on
approvals the Complaining Parties have pointed to a number of approval procedures in which the
Commission failed to re-convene the Regulatory Co mmittee for a vote on a draft measure, after the
Regulatory Committee had met, but not taken a vo te on the draft measure. We consider these
approval procedures below, recalling that Article 21 of Directive 90/220 provides in relevant part that
"[t]he representative of the Commission shall submit to the committee a draft of the measures to be
taken. The committee shall deliver its opinion on the draft within a time limit which the chairman
may lay down according to the urgency of the matter."
Falcon oilseed rape (EC-62)
7.625 The application concerning Falcon oilseed rape was first submitted to Germany (lead CA) in
April 1996, and was provided to the Commission for circulation to all member States in December
1996. Following a positive opinion by the SCP concerning Falcon oilseed rape on 14 July 1998, the
Commission launched inter-service consultations on a draft measure to be submitted to the Regulatory
Committee on 4 September 1998. The Regulatory Co mmittee met twice, on 29 October 1999 and on
9 March 2000, to consider the draft measure submitt ed by the Commission. At neither meeting was
there a vote on the draft measure. The Regulatory Committee did not meet again to take a vote on the
draft measure. On 17 October 2002, Directive 90/220 was repealed.
7.626 The United States initially argued that the Commission in this procedure did not submit a
draft measure to the Regulatory Committee. Late r, the United States argued that the Regulatory
Committee twice failed to vote on a draft measure a nd that after the second attempt, the Commission
never submitted a draft measure to the Regulatory Committee again. The United States also submits
that in accordance with Article 21 of Directive 90/220, in the absence of action by the Regulatory
Committee, the Commission was required to submit a draft measure, whether favourable or negative,
to the Council. According to the United States, the Commission failed to do so for no other reason
than the general moratorium.

7.627 Canada argues that this product was stalled at Community level for many years.
7.628 Argentina noted that the inter-service consu ltation phase effectively prevented all
applications with positive scientific opinions in 1998, including Falcon oilseed rape, from moving
forward. The application of Falcon oilseed rape was prevented from reaching the Regulatory
Committee voting stage as of 4 September 1998 and until June and October 1999, where it was not
voted on.
7.629 The European Communities argues that the United States is mistaken in saying that the
Commission failed to submit a draft measure to the Regulatory Committee. The Commission
launched a voting procedure in J une 1999, and the Regulatory Committee met twice on the matter.
The Regulatory Committee did not vote on 9 March 2000 because it came to the conclusion that
further information was needed on the assessment of the effect of the new protein expressed by the
GM plant on the biogeochemical cycle and the food chain, as well as the likelihood of spreading. The
European Communities also states that in May 20 01, the applicant modified the scope of its
application, and that after that, the application pro ceeded with further submissions by the applicant of
additional information.
7.630 The United States responds that the only information th at could have been requested at the
March 2000 Regulatory Committee mee ting was the information requested by Italy concerning the
effect of the transgenic product on the biogeochemical cycles, on the food chain and on the spreading
of the gene due to the possibility of crossing betw een the GM and wild species. The United States
points out in this respect that the applicant responded to Italy's request on 30 November 2000 even
though, in the United States' view, Italy's request was not scientifically justified.
7.631 The Panel must first address the United St ates' understanding of Article 21 of
Directive 90/220. Article 21 of Directive 90/220 states that if "no opinion is delivered" by the
Regulatory Committee, the Commission must submit a draft measure to the Council. The United
States suggests that after the March 2000 meeting of the Regulatory Committee, the Commission was
required to submit another draft measure to the Re gulatory Committee and/or was required to submit
a draft measure to the Council.
735 The Commission in this case submitted a draft measure to the
Regulatory Committee which was on th e agenda of the October 1999 me eting. No vote was held on
that measure at that meeting.736 The record does not indicate that a different draft measure was on the
agenda of the March 2000 meeting of the Regulatory Committee. Therefore, the Panel does not see
what is the basis for the United States' argument th at after the March 2000 meeting, there was a need
for the Commission to submit another draft measure, or to re-submit the same draft measure, to the
Regulatory Committee.
7.632 The Panel is also not persuaded that in the absence of a vote by the Regulatory Committee,
the Commission was required to submit a draft measure directly to the Council. If that were the case,
the Commission should have submitted a draft measure to the Council after the Regulatory
Committee failed to vote on Falcon oilseed rape at its meeting in October 1999. Instead, the
Commission convened another Regulatory Committ ee meeting in March 2000. In the Panel's
understanding, the phrase "no opinion is delivered" is intended to refer to a situation where the

735 US third written submission, paras. 107-108.
736 Exhibit EC-62/At. 87.

Regulatory Committee votes on a draft measure, but fails to achieve the required qualified majority in
favour or against the measure.
737
7.633 The Panel agrees with the United States, howev er, that after the March 2000 meeting of the
Regulatory Committee, it was for the Commission to take action. The next step indicated by
Article 21 of Directive 90/220 was for the Commissi on to convene another m eeting with a view to
obtaining a vote on its draft measure. 738 Therefore, the question to be examined is why this did not
happen.
7.634 There is no direct evidence on the record to show why the Regulatory Committee did not
proceed to a vote on Falcon oilseed rape at the March 2000 meeting. 739 From other evidence before
the Panel, two separate reasons can nevertheless be inferred. One reason appears to be a request for
information from the Italian CA. That request wa s transmitted to the lead CA on 14 March 2000, and
the lead CA forwarded it to the applicant.
740 The applicant provided the information requested to the
lead CA on 13 November 2000. In its letter, the applicant notes that all the issues on which Italy
requested more information "were indeed already addressed by the European Scientific Committee on
Plants (SCP)" when evaluating the application in question and that they had also already been
addressed in documents provided by the applicant in November 1999.741
7.635 The other reason for the Regulatory Committee's fa ilure to vote appears to be a letter sent by
the applicant to the Commission the day before the March 2000 Regulatory Committee meeting. 742
As can be gathered from a letter of 20 April 2000 by the German lead CA to the applicant 743, the
applicant should have sent its letter to the lead CA rather than the Commission. The Commission
apparently shared the applicant's letter with the lead CA at the March 2000 Regulatory Committee
meeting, and the lead CA then distributed it to the other member States present at the meeting.
According to the letter by the lead CA, the applican t's letter gave rise to conf usion. The lead CA's
letter states that it was unclear whether the applicant's letter sought to modify the application such that
the product would no longer be placed on the market soon after the application was approved, but
only as from 2003. 744 The lead CA notes that the uncertain ty over the applicant's intentions meant
that the decision had to be postponed so that cl arification could be sought from the applicant.
Consistent with this account, the lead CA's letter e nds by asking the applicant for clarification. As

737 See the result of the consultation of the Regulatory Committee by written procedure in the procedure
concerning Bt cotton where member States voted, but the result was that the "Committee did not give an opinion
on the measures" (emphasis omitted). Exhibit EC-65/At. 59.
738 This is consistent with the "Summary of the Conclusions of the Committee at its [12th] Meeting on
29 October 1999" where it is stated that the " Commission informed delegates that the next meeting could be
held on 8 December 1999". Exhibit EC-62/At. 87 (emphasis added). See also the Commission's note of 20
September 1999 to the member States , wherein it is stated that the " Commission is planning to hold the 12 th
meeting of the Regulatory Committee [… ] on 25 October 1999". Exhibit EC-63/At. 76 (emphasis added).
739 The record contains a summary of the conclusions for the October 1999 Regulatory Committee
meeting, but not for the March 2000 meeting.
740 Exhibit EC-62/At. 95. This fax of 14 March 2000 from the Italian CA to the lead CA specifically
"refer[s] to the conclusion of the last meeting of the Regulatory Committee meeting".
741 Exhibit EC-62/At. 97.
742 The record does not contain a copy of that letter.
743 Exhibit EC-62/At. 96.
744 According to the lead CA, the applicant's letter of 8 March 2000 expanded on a letter of 28 February
2000 which the applicant sent to the lead CA and wh ich was subsequently forwarded to the other member
States. The lead CA notes that while it had not itself understood the February 2000 letter as a request for a
modification of the application, some uncertainty nevert heless arose in this respect once other member States
became aware of the content of the letter. Exhibit EC-62/At. 96.

already pointed out, the lead CA's letter dates from 20 April 2000. From the record it appears that the
applicant did not provide the requested clarification until 29 May 2001.
745 On the same date, the
applicant provided the lead CA with a set of docum ents which it said confirmed that its application
was already in line with the main provisions of Di rective 2001/18, which had been adopted in March
2001.746
7.636 From the foregoing it would appear that as from the end of May 2001, when the applicant
provided the clarification sought by the lead CA , the two above-mentioned reasons could no longer
explain the Commission's failure to call another meeting of the Regulatory Committee for a vote on
Falcon oilseed rape.747 Directive 90/220 was not repealed until 17 October 2002. In the Panel's view,
there would thus have been e nough time to convene another Regul atory Committee meeting and for
the Commission to adopt its draft measure in the event of a favourable vote.748
7.637 We note that the United States considers that the Commission's failure to act reflects the
adoption by the European Communities of a general moratorium, that is to say, of a decision not to
allow any application to proceed to final approval. It should be re called that following the June 1999
declaration by the Group of Five countries, the Commission had reason to believe that the Group of
Five countries would act as a "blocking minority" both in the Regulatory Committee and in the
Council. In this procedure, the Commission called two Regulatory Committee meetings after the June
1999 declaration by the Group of Five countries, but the Regulatory Committee did not vote on either
occasion, and the Commission did not convene a thir d meeting. The Complaining Parties contend
that the Commission was instrumental in the a doption and application of the alleged general
moratorium and that it decided not to discharge its responsibility under Dir ective 90/220 to complete
approval procedures, in view of opposition to fina l approvals by the Group of Five countries. The
Commission's failure to call a third Regulatory Comm ittee meeting after May 2001 is consistent with
the existence of such a decision by the Commissi on. The Commission could have considered that
some member States simply did not wish to see the Commission call another vote on its draft
measure. Or it could have considered that the Re gulatory Committee would finally vote at the next
meeting, but that due to the "blocking minority" of the Group of Five countries in the Regulatory
Committee and the Council, a favourable draft m easure would not achieve the required qualified
majority and that the Commission would have to complete the procedure by adopting its draft
measure.
7.638 In the light of the above considerations, we conclude that the Commission's failure to convene
another Regulatory Committee meeting concerning Falc on oilseed rape after Ma y 2001 is consistent
with the Complaining Parties' assertion that during the relevant time period the European
Communities applied a general moratorium on final approvals.
MS8/RF3 oilseed rape (EC-63)
7.639 The application concerning MS8/RF3 oilseed rape was first submitted to Belgium (lead CA)
in September 1996, and was provided to the Commission for circulation to all member States in

745 The applicant stated that once the application concerning Falcon oilseed rape was approved there
would initially be large-scale releases in the European Communities that would remain limited to identified
users. At the earliest as of 2003, there would be full commercial release of the product in question. Exhibit
EC-62/At. 99.
746 Exhibit EC-62/At. 98.
747 As noted above, we are not aware of any other reasons.
748 We note in this regard that the March 2000 Regulatory Committee meeting was held four months
after the first Regulatory Committee meeting in October 1 999 and that after that October meeting the applicant
had also submitted additional information.

January 1997. Following a positive opinion by the SCP concerning MS8/RF3 oilseed rape on 19 May
1998, the Commission on 4 September 1998 launched in ter-service consultations on a draft measure
to be submitted to the Regulatory Committee . The Regulatory Committee met twice, on 29 October
1999 and on 9 March 2000, to consider the draft me asure submitted by the Commission. At neither
meeting was there a vote on the draft measure. The Regulatory Committee did not meet again to take
a vote on the draft measure. On 17 October 2002, Directive 90/220 was repealed and replaced by
Directive 2001/18.
7.640 The United States initially argued that the progress of the application concerning MS8/RF3
oilseed rape stalled when the Commission refused to submit a draft measure to the Regulatory
Committee as required by the approval process. Late r, the United States argued that the Regulatory
Committee twice failed to vote on a draft measure, and that after the second attempt the Commission
never submitted a draft measure to the Regulatory Committee again.
7.641 Canada argues that since the application went to the Community level, member States took
approximately 12 months to put forth their objections to the application, and after the SCP issued its
positive opinion on the application, the European Communities took another 12 months to address the
recommendations contained in the SCP opinion, including a monitoring plan. Although the
application was discussed at the Regulatory Committee in the summer of 1999, the Commission failed
to submit a draft measure for a vote by the Regulat ory Committee, and instead imposed the "interim
approach". Canada notes that in August 1999 the ap plicant proposed to voluntarily agree to meet the
requirements of the Council's June 1999 Common Position. On the basis of these commitments, the
Commission invited the applicant to present its proposal to the Regulatory Committee in October
1999. However, while the Regulatory Committee agai n considered the proposal, it failed to hold a
vote. Subsequently, the applicant made further proposals as a further attempt to address concerns
expressed by member States. However, although the matter went yet again before the Regulatory
Committee in March 2000, it failed to hold a vote.
7.642 Canada also points to the delay in the comp letion of the approval procedure following the
failure of the Regulatory Committee to adopt the draft measure approving MS8/RF3 oilseed rape in
March 2000. Canada notes in this regard the effo rts made by the applicant to respond to further
requests by the lead CA. Canada observes that wh ile the lead CA finally accepted the applicant's
proposed post-marketing monitoring plan and agri cultural guidelines in May 2002, the European
Communities provided no information to explain the delay between May 2002 and early January
2003, when the applicant submitted a further updated dossier under Article 35 of Directive 2001/18.
As Directive 90/220 was repealed in October 2002, the application was effectively returned to the
member State level, thus causing a 7.5- year delay in processing this application.
7.643 Argentina notes that the inter-service consulta tion phase effectively prevented all
applications with positive scientific opinions in 1998, including MS8/RF3 oilseed rape, from moving
forward. The application MS8/RF3 oilseed ra pe was prevented from reaching the Regulatory
Committee voting stage until June and October 1999, where it was not voted on.
7.644 The European Communities argues that the United States is mistaken in saying that the
Commission failed to submit a draft measure to the Regulatory Committee. The Commission
launched a voting procedure in J une 1999, and the Regulatory Committee met twice on the matter.
The Regulatory Committee did not vote on 9 Marc h 2000 because Italy raised scientific issues
regarding the "effects of the transgenic product on the biogeochemical cycles and on food chains" and
the likelihood of spreading. Italy's concerns re flected new information concerning the impact of
herbicide regimes associated with cultivation of GM herbicide tolerant oil seed rape on biodiversity
which had recently been made public at the time of the meeting. The European Communities further

states that in May 2001, the applicant modified the scope of its application, and that after that, the
application proceeded with further submissions by the applicant of additional information.
7.645 Canada notes that Italy's questions had already b een addressed in the application dossier and
by the SCP. Further, the attempts to raise c oncerns about impacts of herbicide use on farmland
biodiversity inappropriately linked co ncerns related to herbicide use to approval of a seed variety.
Canada notes that 1) for all other seed varieties, se ed approval legislation is distinct from the pesticide
approval legislation; 2) herbicide use is one of many factors that may have an impact on farmland
biodiversity; and 3) EC member States have actually authorized the use of glufosinate-ammonium for
general use as well as for specific use on genetically m odified herbicide-tolerant crops. Canada also
counters that the European Communities fails to point out that the submission of further information
by the applicant was necessary because the information requirements were either unclear or changing.
7.646 Canada further notes that at th e same time that the Commission submitted a draft proposal to
the Regulatory Committee in June 1999, the Envi ronment Council adopted the "Common Position"
and five EC member States issued their Declar ation openly opposing the approval of any biotech
product. The applicant voluntarily agreed to fulfill th e requirements of the future legislation set out in
the "Common Position".
749
7.647 The European Communities maintains that in the summer of 1999, in view of the proposed
modification of the legislation, and on the basis of the Common Position by the Environment Council,
the applicant voluntarily committed to anticipate in its application a number of the additional
requirements that the proposed modifications we re meant to address. The applicant submitted
undertakings and commitments on a number of is sues including post-market monitoring, traceability
and labelling. The lead CA, other member States' CAs and the Commission discussed commitments
and undertakings by the applicant, and in particular monitoring plans, into 2002. By then,
Directive 2001/18 had been approved and it was decide d to continue the evaluation of the dossier
under the old legislative regime provided that the provisions of the new Directive were taken into
account by the applicant voluntarily and became legally binding. In February 2002, the lead CA
asked the applicant to complete th e dossier with required data on, inter alia , reference material
concerning the events MS8 and RF3. The applicant did not reply in that year.
7.648 The Panel notes that after the March 2000 meeting of the Regulatory Committee, it was for
the Commission to take action. The next step indi cated by Article 21 of Directive 90/220 was for the
Commission to convene another meeting with a view to obtaining a vote on its draft measure.
750
Therefore, the question to be examined is why this did not happen.
7.649 The record does not indicate why the Regulat ory Committee did not proceed to a vote on
MS8/RF3 oilseed rape at the March 2000 meeting. 751 One reason may have been a request for
information from the Italian CA. Italy transmitte d its request to the lead CA on 14 March 2000, and
the lead CA then forwarded it to the applicant. 752 The applicant provided the information requested

749 Exhibit EC-63/At. 72.
750 This is consistent with the "Summary of the Conclusions of the Committee at its [12th] Meeting on
29 October 1999" where it is stated that the "Commission informed delegates that the next meeting could be
held on 8 December 1999". Exhibit EC-62/At. 87 (emphasis added). See also the Commission's note of 20
September 1999 to the member States, wherein it is stated that the "Commission is planning to hold the 12 th
meeting of the Regulatory Committee [… ] on 25 October 1999". Exhibit EC-63/At. 76 (emphasis added).
751 The record contains a summary of the conclusions for the October 1999 Regulatory Committee
meeting, but not for the March 2000 meeting.
752 Exhibit EC-63/At. 87. This fax of 14 March 2000 from the Italian CA to the lead CA specifically
"refer[s] to the conclusion of the last meeting of the Regulatory Committee meeting".

by Italy to the lead CA on 13 November 2000. In its letter, the applicant no tes that all the issues on
which Italy requested more information "were ind eed already addressed by the European SCP " when
evaluating the application in question and that th ey were also already addressed in November 1999
documents provided by the applicant.
753 This communication was also circulated to all other CAs and
the Commission. We further note that in response to a question from the Panel, one of the experts
advising the Panel, Dr. Nutti, expressed the view th at the request for further information was not
necessary to ensure the conclusi ons for the safety assessment of th e newly expressed protein in the
food chain.754
7.650 In June 2001, the applicant sent a letter to the lead CA which clarified certain aspects of the
application, including its scope. There is no indica tion that this clarification had been requested.
However, the applicant's letter noted that fo llowing the March 2000 meeting of the Regulatory
Committee the clarification appeared necessary. 755 In a separate letter of the same date, "following
the revision of Directive 90/220/EEC", the applican t also submitted updated information to the lead
CA, including an updated environmental risk assessm ent, a post-market monitoring plan, agricultural
guidelines, additional information regarding identification and labelling and information for the public
concerning the product in question. 756 The letter stated that this information confirmed that the
application was already "in line with the main provisions" of Directive 2001/18, which had been
adopted in March 2001. The letter requested the lead CA to inform the other member States about the
new set of documents at the next Regulatory Committee meeting.
757 There is no indication that the
lead CA ever forwarded the new documents to th e other member States and to the Commission. A
meeting of CAs was held two weeks after the app licant submitted the additional information, but the
Panel has no information about what was discussed at that meeting. It is clear from the record,
however, that the lead CA confirmed receipt of th e new documents only in July 2001. The lead CA
informed the applicant that it had forwarded the do cuments to the relevant scientific committee of the
Belgian Biosafety Council (hereaf ter the "BBC") for an opinion.
758 No reason was given for why an
opinion had been requested.
7.651 Regarding the clarification provided by the app licant in June 2001, we note that there is
nothing in the record to suggest that the Commission was "waiting" for the June 2001 clarification. If
the Commission was not waiting for that clarification, then it could not provide an explanation for the
Commission's failure to re-convene the Regulat ory Committee sometime between December 2000
and June 2001. On the other hand, if the Comm ission had been waiting for clarification from the
applicant, it could be expected that the Commissi on would have inquired with the lead CA whether
the applicant had provided clarification. There is no evidence that the Commission did so.
7.652 Regarding the updated information also provide d by the applicant in June 2001, it is
important to remember that the applicant provided that information, not pursuant to a requirement
flowing from the provisions of Directive 90/220, but in an effort to convince member States to vote in
favour of approving its application. Also, the lead CA had not been requested to offer an assessment
of that additional information before transmitting it to the other member States and the Commission.
Notwithstanding this, the lead CA requested an opi nion of the BBC. However, it seems that for the
BBC, it was not obvious that an opinion was n eeded. In November 2001, the BBC discussed the
information in question. According to the minutes of the internal discussion, "no opinion on the part

753 Exhibit EC-63/At. 88.
754 Annex H, para. 331.
755 Exhibit EC-63/At. 92.
756 Exhibit EC-63/At. 91.
757 Ibid.
758 Exhibit EC-63/At. 93.

of the Biosafety Advisory Council was necessary prio r to the forwarding of these documents to the
European Commission; and in the past such additio nal information had already been sent straight to
the Commission on several occasions."
759 However, as this was the first time a company had
submitted a monitoring plan, agricultural guidelines and public dossier, the BBC "thought it advisable
to ask the Biosafety Advisory Council to discu ss these documents before forwarding them to the
European Commission." 760 It was noted that in this way the relevant experts would have an
opportunity to gain experience in the evaluation of such documents.761
7.653 We are not convinced that a lead CA asse ssment of the updated information was required
before that information could be transmitted to the Commission and the other CAs, and that the
Commission therefore needed to wait for the lead CA's ass essment before re-convening the
Regulatory Committee. Indeed, we recall that in the approval procedure concerning Falcon oilseed
rape, a different lead CA did not find it necessary to make an assessment of additional information
submitted by an applicant to document that its a pplication was already in line with the main
provisions of Directive 2001/18.
7.654 In any event, in the approval procedure c oncerning MS8/RF3 oilseed rape, the applicant
replied to the last pending question of the BBC in early May 2002. 762 The record shows no further
developments in this approval procedure until Oc tober 2002, when Directive 90/220 was repealed.
Thus, there is no indication that the BBC ever pr ovided its opinion on the J une 2001 information to
the lead CA. Even assuming that the Commission kn ew about the updated info rmation of June 2001,
and even assuming that it was justifiable in princi ple for the Commission to let the lead CA undertake
some assessment of the information, it remained the Commission's responsibility to seek a vote by the
Regulatory Committee on its draft measure. Yet even as the date of repeal of Directive 90/220 was
approaching, the Commission apparently did not request the lead CA promptly to finish its assessment
of the updated information and to circulate it together with that information so that a further attempt at
completing the approval procedure under Directive 90/220 could be made.763
7.655 From the foregoing it would appear that at the very latest in the summer of 2002, once the
applicant had replied to the last pending ques tion of the BBC in May 2002, the Commission could
have re-convened the Regulatory Committee for a vote on the application concerning MS8/RF3
oilseed rape. As Directive 90/220 was not repealed until 17 October 2002, we think there would have
been enough time for the Commission to adopt its draf t measure in the event of a favourable vote in
the Regulatory Committee and for the lead CA to give its written consent.
7.656 The Complaining Parties consider that the Commission's failure to act reflects the adoption by
the European Communities of a general moratorium on the approval of biotech products. It should be
recalled that following the June 1999 declaration by the Group of Five countries, the Commission had
reason to believe that the Group of Five countries would act as a "blocking minority" both in the
Regulatory Committee and in the Council. In this procedure, the Commission called two Regulatory
Committee meetings after the June 1999 declara tion by the Group of Five countries, but the
Regulatory Committee did not vote on either occasion, and the Commission did not convene a third

759 Exhibit EC-63/At. 102.
760 Ibid.
761 Ibid.
762 Exhibit EC-63/At. 108. The applicant also indicated readiness to follow a suggestion by the BBC
regarding information to the public, subject to further clarification by the BBC.
763 If the Commission did not know about the updated information submitted by the applicant in
June 2001, then the existence of that information could not provide a justification for the Commission's failure
to re-convene the Regulatory Committee after December 2000.

meeting. We recall that in the Complaining Par ties' view, the Commission was instrumental in the
adoption and application of the alleged general mora torium and that it decided not to discharge its
responsibility under Directive 90/220 to complete appr oval procedures, in view of opposition to final
approvals by the Group of Five countries. Th e Commission's failure to call a third Regulatory
Committee meeting after May 2001 is consistent with the existence of such a decision by the
Commission. The Commission could have considered that some member States simply did not wish
to see the Commission call another vote on its draft measure. Or it could have considered that the
Regulatory Committee would finally vote at the next meeting, but that due to the "blocking minority"
of the Group of Five countries in the Regulator y Committee and the Council, a favourable draft
measure would not achieve the required qualified ma jority and that the Commission would have to
complete the procedure by adopting its draft measure.
7.657 In the light of the above considerations, we conclude that the Commission's failure to
re-convene the Regulatory Committee for a vote on th e application concerning MS8/RF3 oilseed rape
in the summer of 2002 (at the latest) is consistent with the Complaining Parties' assertion that during
the relevant time period the European Communities applied a general moratorium on final approvals.
RR fodder beet (EC-64)
7.658 The application concerning RR fodder beet was first submitted to Denmark (lead CA) in
February 1997, and was provided to the Commission for circulation to all member States in October
1997. Following a positive opinion by the SCP c oncerning RR fodder beet on 23 June 1998, the
Commission launched inter-service consultations on a draft measure to be submitted to the Regulatory
Committee on 4 September 1998. The Regulatory Co mmittee met twice, on 29 October 1999 and on
9 March 2000, to consider the draft measure submitt ed by the Commission. At neither meeting was
there a vote on the draft measure. The Regulatory Committee did not meet again to take a vote on the
draft measure. On 17 October 2002, Directive 90/220 was repealed.
7.659 The United States argues that the Commission failed to submit a draft measure to the
Regulatory Committee. Later, the United States ar gues that the Regulatory Committee twice failed to
vote on a draft measure and that after the second a ttempt, the Commission failed to re-submit a draft
measure to the Regulatory Committee.
7.660 Canada argues that the Commission did not submit a draft measure for a vote by the
Regulatory Committee, even though the lead CA issued a positive opinion on the application on 7
October 1997, the SCP issued a positive opinion on the application on 23 June 1998 and the applicant
responded to all the questions posed by the lead CA on 27 April 1998.
7.661 Argentina noted that the inter-service consu ltation phase effectively prevented all
applications with positive scientific opinions in 1998, including RR fodder beet, from moving
forward. The application for RR Fodder beet was prevented from reaching the Regulatory Committee
voting stage until October 1999, when it was not voted on.
7.662 The European Communities argues that the United States is mistaken in saying that the
Commission failed to submit a draft measure to the Regulatory Committee. The Commission
launched a voting procedure in June 1999, and th e Regulatory Committee met twice on the matter –
first in October 1999 and then in March 2000. The Regulatory Committee did not vote in October
1999 due to outstanding requests for information.
7.663 The Panel
 recalls that after the March 2000 meeting of the Regulatory Committee, it was for
the Commission to take action. The next step indi cated by Article 21 of Directive 90/220 was for the

Commission to convene another meeting with a view to obtaining a vote on its draft measure.
764
Therefore, we need to examine why the Commission did not do so.
7.664 There is no direct evidence on the record to show why the Regulatory Committee did not
proceed to a vote on RR fodder beet at the March 2000 meeting. 765 One reason appears to be a
request for information from the Italian CA. Th at request was transmitted to the lead CA on 14
March 2000, and the lead CA forwarded it to the applicant. 766 The applicant provided the requested
information to the lead CA on 12 July 2000. In its letter, the applicant notes in regard to its answers
to the questions raised by the Italian CA that "there are no new data in the document, only
clarifications".767 With its July 2000 letter, the app licant also provided data on molecular
characterization which were appare ntly generated at the request of the United Kingdom's CA. The
letter noted the applicant's understanding that the UK experts reached the conclusion that this data did
not provide new information after they had revi ewed a previously submitted data package which
"addressed sufficiently the UK questions".768
7.665 The conclusion of the July 2000 letter states that, in the applicant's view, all objections raised
by the CAs within the 60-day period provided for in Directive 90/220 had now been fully addressed.
The applicant therefore requested the lead CA to in form all member States that the application dossier
was complete and that a decision should be taken at Community level.769 The applicant sent a copy of
its July 2000 letter to the Commission.
7.666 There is no indication that the lead CA forw arded the new documents to the other member
States. In fact, the issue of when the documents were to be forwarded was discussed in a meeting
held between the lead CA and the applicant in January 2001. 770 In February 2001, the applicant
suggested to the lead CA, in view of the "very volatile" EC regulatory context, that it forward the
documents after the adoption of Directive 2001/18 (which came in March 2001) and the circulation of
a Commission proposal on new EC rules concerning labelling and traceability (which came in July
2001).
771 However, the record shows that the lead CA did not follow the applicant's suggestion, and
the documents were not provided to other member States while Directive 90/220 was still in force.
7.667 As noted earlier, the Commission received a copy of the applicant's July 2000 letter, and this
letter addressed all outstanding issues. Notwithst anding this, even as the date of repeal of
Directive 90/220 was approaching, the Commission appa rently did not request the lead CA promptly
to circulate the additional information provided by th e applicant in July 2000 so that a further attempt
at completing the approval procedure under Directive 90/220 could be made. We recall in this regard
that it was the Commission's responsibility to seek a vote by the Regulatory Committee on its draft
measure.

764 This is consistent with the "Summary of the Conclusions of the Committee at its [12th] Meeting on
29 October 1999" where it is stated that the "Commission informed delegates that the next meeting could be
held on 8 December 1999". Exhibit EC-62/At. 87 (emphasis added). See also the Commission's note of 20
September 1999 to the member States, wherein it is stated that the "Commission is planning to hold the 12 th
meeting of the Regulatory Committee [… ] on 25 October 1999". Exhibit EC-63/At. 76 (emphasis added).
765 The record contains a summary of the conclusions for the October 1999 Regulatory Committee
meeting, but not for the March 2000 meeting.
766 Exhibit EC-64/At. 116. This fax of 14 March 2000 from the Italian CA to the lead CA specifically
"refer[s] to the conclusion of the last meeting of the Regulatory Committee meeting".
767 Exhibit EC-64/At. 119.
768 Ibid.
769 Ibid.
770 Exhibit EC-64/At. 120.
771 Ibid.

7.668 From the foregoing it would appear that after July 2000, once the applicant had provided the
additional information sought by the Italian CA, or at the latest as from the summer of 2001, when the
Commission circulated its proposal for new EC rules on labelling and traceability, the Commission
could have re-convened the Regulatory Committe e for a vote on the application concerning RR
fodder beet. Directive 90/220 was not repealed un til 17 October 2002. In our view, there was thus
enough time for the Commission to adopt its draft meas ure in the event of a favourable vote in the
Regulatory Committee and for the lead CA to give its written consent.
7.669 The Complaining Parties consider that the Commission's failure to act reflects the adoption by
the European Communities of a general moratorium on the approval of biotech products. It should be
recalled that following the June 1999 declaration by the Group of Five countries, the Commission had
reason to believe that the Group of Five countries would act as a "blocking minority" both in the
Regulatory Committee and in the Council. In this procedure, the Commission called two Regulatory
Committee meetings after the June 1999 declara tion by the Group of Five countries, but the
Regulatory Committee did not vote on either occasion, and the Commission did not convene a third
meeting. We recall that, in the Complaining Par ties' view, the Commission was instrumental in the
adoption and application of the alleged general mora torium and that it decided not to discharge its
responsibility under Directive 90/220 to complete appr oval procedures, in view of opposition to final
approvals by the Group of Five countries. Th e Commission's failure to call a third Regulatory
Committee meeting is consistent with the existen ce of such a decision by the Commission. The
Commission could have considered that some member States simply did not wish to see the
Commission call another vote on its draft measure. Or it could have considered that the Regulatory
Committee would finally vote at the next meeting, but that due to the "blocking minority" of the
Group of Five countries in the Regulatory Committ ee and the Council, a favourable draft measure
would not achieve the required qualified majority a nd that the Commission would have to complete
the procedure by adopting its draft measure.
7.670 In the light of the above considerations, we conclude that the Commission's failure to re-
convene the Regulatory Committee for a vote on the a pplication concerning RR fodder beet after July
2000 is consistent with the Complaining Parties' assertion that during the relevant time period the
European Communities applied a general moratorium on final approvals.
Failure by the Commission to submit a draft measure to the Regulatory Committee

7.671 In support of their assertion that the European Communities applied a general moratorium on
approvals the Complaining Parties have pointed to a number of approval procedures in which the
Commission failed to submit to the Regulator y Committee a draft measure on the relevant
applications. We consider these approval pr ocedures below, recalling that Article 21 of
Directive 90/220 provides in relevant part that "[t]he representative of the Commission shall submit to
the committee a draft of the measures to be taken".
Transgenic potato (EC-67)
7.672 The application concerning Transgenic potato was first submitted to Sweden (lead CA) in
August 1996, and was provided to the Commission for circulation to all member States in June 1998.
Following a positive opinion by the SCP concerning the Transgenic potato on 18 July 2002, the
Commission did not submit a draft measure to the Regulatory Committee. In October 2002,
Directive 90/220 was repealed. The appli cant submitted an updated application under
Directive 2001/18 in January 2003, and it was provided to the Commission for circulation to all
member States in May 2004.

7.673 The United States argues that after the Transgenic potato received a favourable opinion from
the SCP, the Commission failed to submit a draft measure to the Regulatory Committee, with the
consequence that the considerati on of this application was susp ended until the application was
resubmitted under Directive 2001/18.
7.674 Argentina argues that the application concerning the Transgenic potato was stalled and hence
never reached the Regulatory Committee stage. Arge ntina points out in this regard that after the
favourable SCP opinion of July 2002, there was neither an inter-service consultation phase in the
Commission nor any other movement until Directive 2001/18 entered into force.
7.675 The European Communities points out that the SCP in this procedure took more than three
and a half years to assess the Transgenic potato. The European Communities submits that when the
SCP issued its opinion in July 2002, Directive 2001/18 was about to enter into force and it was clear
that the application had to be updated in the light of the new Directive.
7.676 The Panel understands the European Communities to argue that the Commission did not
submit a draft measure to the Regulatory Committee because the SCP provided its opinion only three
months before the date of repeal of Directive 90/220. This argument presents the issue whether the
Commission could have reached the conclusion that three months would be insufficient to approve the
application concerning the Transgenic potato.
7.677 Before the Transgenic potato could be approved, a number of procedural steps remained to be
undertaken and completed. The Commission had to prepare a draft measure and submit it to the
Regulatory Committee; the Regulatory Committee had to meet and vote on the draft measure; in the
event of a favourable vote in the Regulatory Co mmittee, the Commission had to adopt its draft
measure; and finally, the lead CA had to give its written consent so that the product could be placed
on the market
772. In our assessment, it is possible that the Commission reached the conclusion that
even if all relevant actors proceeded with a sense of urgency, the aforementioned steps could not all
be completed within three months. 773 Similarly, it is possible that this was the reason why the
Commission did not undertake any steps to move the process forward, e.g., by launching inter-service
consultations on a draft measure to be submitted to the Regulatory Committee.774
7.678 The United States and Argentina consider that the Commission's failure to act reflects the
adoption by the European Communities of a general moratorium, that is to say, of a decision not to
allow any application to proceed to final approva l. The Complaining Parties contend that the
Commission was instrumental in the adoption and a pplication of the alleged general moratorium and
that it decided not to prevent the Group of Five countries from blocking the approval of applications.
The fact that in the procedure concerning the Transgenic potato the Commission did not submit a
draft measure to the Regulatory Committee is consiste nt with this contention. The Commission could
have considered that due to the "blocking minority" of the Group of Five countries in the Regulatory
Committee and the Council, a favourable draft m easure would not achieve the required qualified
majority and that the Commission would then have to complete the procedure by adopting its draft
measure. As noted, however, the Commission's fail ure to forward a draft measure to the Regulatory

772 Article 13(4) of Directive 90/220.
773 We nevertheless note that in the procedure concerning NK603 maize, the Regulatory Committee
voted on the application less than three months after EFSA issued its opinion. Exhibit EC-76/At. 72. This
suggests that if indeed more than three months were necessary, in the best-case scenario, to complete the
procedure, it might not have taken much more than that.
774 From the evidence before us, it seem s that unlike in other procedures ( see, e.g., Exhibits
EC-62/At. 76; EC-65/At. 48), the Commission in this procedure did not launch inter-service consultations on a
draft measure to be submitted to the Regulatory Committee.

Committee might also reflect the Commission's c onclusion that even in the best of cases the
application could not have been approved before the date of repeal of Directive 90/220.
7.679 In the light of the above considerations, we c onclude that the Commission's failure to submit
a draft measure concerning the Transgenic potato to the Regulatory Committee following the issuance
in July 2002 of the SCP's opinion is consistent with the Complaining Parties' assertion that during the
relevant time period the European Communities applied a general moratorium on final approvals.
Liberator oilseed rape (EC-68)
7.680 The application concerning Liberator oilseed ra pe was first submitted to Germany (lead CA)
in January 1998, and was provided to the Commission for circulation to all member States in January
1999. The SCP issued a favourable opinion on 30 November 2000. Following the issuance of the
SCP opinion, the Commission did not submit a draft measure to the Regulatory Committee before
Directive 90/220 was repealed. The applicant provided an updated application under
Directive 2001/18 on 16 January 2003.
7.681 The United States argues that after Liberator oilseed rape received a favourable opinion from
the SCP the Commission failed to submit a draft m easure to the Regulatory Committee. The United
States notes that this resulted in a two-year de lay, since no action was taken on the application until
November 2002 when the applicant was requested to pr ovide an update in light of the entry into force
of Directive 2001/18. The United States submits that there is no indication of any problem with the
application during the two-year gap, nor of any a dditional information needed for final approval.
According to the United States, the lengthy de lay after the SCP opinion was issued provides
compelling evidence of the existence of a general moratorium.
7.682 Argentina argues that the application concerning Li berator oilseed rape was stalled for two
years and never reached the Regulatory Committee stag e. Argentina points out in this regard that
after the favourable SCP opinion of November 2000 , there was neither an inter-service consultation
phase in the Commission nor any other movement until November 2002.
7.683 The European Communities argues that the SCP opinion on Liberator oilseed rape
recommended "an agreed code of practice for field management of the particular modified crop
involving the active participation of the applicant to promote best practice by farmers".
775 T h e
European Communities submits that contrary to what it had done in the parallel dossier on Falcon
oilseed rape, the applicant did not present any propo sal for a code of practice following the opinion of
the SCP and that it did not manifest itself with the lead CA at all until the lead CA in November 2002
sent the applicant a letter reminding it of the need to up-date the application by January 2003.
7.684 The Panel understands the European Communities as asserting that the applicant in this case
should on its own initiative and without a specific requ est by the lead CA have presented a code of
practice for the field management of the Liberator oil seed rape and that the applicant's failure to do so
explains the Commission's failure to submit a draft measure to the Regulatory Committee.
7.685 In considering the European Communities' assertion, the first thing to be noted is that it was
the Commission, not the applicant, that requested an opinion from the SCP.
776 Accordingly, when the
SCP stated that " [i]t is recommended that the introduction of herbicide tolerant crops should be

775 Exhibit EC-68/At. 88.
776 Exhibit EC-68/At. 86.

accompanied by [… ] an agreed code of practice for field management [… ]"
777, the SCP was in our
understanding recommending that the Commission seek to agree on a code of practice with the
applicant. However, there is no evidence that th e applicant was ever requested by the Commission or
the lead CA to propose a code of practice in accordance with the SCP's recommendation. We
therefore see no reason to assume that it was for th e applicant to take the initiative and prepare a
response to the SCP recommendation.
7.686 The European Communities correctly points out that in the approval procedure concerning
Falcon oilseed rape, the applicant wrote a letter to the Commission soon after the SCP had issued its
opinion on the product in question. The applicant' s letter refers to certain recommendations made by
the SCP concerning optimal deployment in agriculture and indicates the applicant's intention to make
available to users relevant information on management schemes. 778 However, there is nothing in the
applicant's letter to suggest that the applicant was requested to respond to the SCP's recommendations.
In the absence of a reference in th e letter to a request or requirement, it may be assumed that the letter
was sent at the applicant's own initiative. In our view, the letter at issue does not therefore support the
EC argument that the applicant in the procedure concerning Liberator oilseed rape was supposed to
present a proposal for a code of practice once the SCP had issued its opinion.
7.687 For the reasons set out above, we are not persuaded by the European Communities'
explanation that the Commission did not submit a draft measure to the Regulatory Committee because
it was waiting for the applicant to propose a code of pr actice. In any event, th e fact that the applicant
did not present a proposal in our view was not an obstacle to the Commission launching inter-service
consultations on a draft measure. From the evidence before us, however, it seems that unlike in other
procedures
779, the Commission in this procedure never even launched such consultations. This further
undermines the EC assertion that the Commission was waiting for the applicant.
7.688 The SCP opinion in this procedure dates from November 2000. Directive 90/220 was not
repealed until almost two years later. In our assessment, there was thus enough time for the
Commission to launch and complete inter-service cons ultations on a draft measure to be submitted to
the Regulatory Committee and for the Commission to adopt its draft measure in the event of a
favourable vote in the Regulatory Committee.780
7.689 The United States and Argentina consider that the Commission's failure to act reflects the
adoption by the European Communities of a general moratorium, that is to say, of a decision not to
allow any application to proceed to final approva l. The Complaining Parties contend that the
Commission was instrumental in the adoption and a pplication of the alleged general moratorium and
that it decided not to prevent the Group of Five countries from blocking the approval of applications.
The fact that in the procedure concerning Liberator oilseed rape the Commission did not submit a
draft measure to the Regulatory Committee is consiste nt with this contention. The Commission could
have considered that due to the "blocking minority" of the Group of Five countries in the Regulatory
Committee and the Council, a favourable draft m easure would not achieve the required qualified

777 Exhibit EC-68/At. 88.
778 Exhibit EC-62/At. 75. In our view, it is doubtful th at the applicant's statement of its intentions with
respect to management schemes can be said to amount to a proposal for a code of practice, as the European
Communities contends.
779 See, e.g., Exhibits EC-62/At. 76; EC-65/At. 48.
780 We note, by way of example, that in the pr ocedure concerning NK603 maize, the Regulatory
Committee voted on the application less than three months after the EFSA issued its opinion. Exhibit
EC-76/At. 72.

majority and that the Commission would then have to complete the procedure by adopting its draft
measure.
7.690 In the light of the above considerations, we c onclude that the Commission's failure to submit
a draft measure concerning Liberator oilseed rape to the Regulatory Committee following the issuance
in November 2000 of the SCP's opini on is consistent with the Compla ining Parties' assertion that
during the relevant time period the European Co mmunities applied a general moratorium on final
approvals.
Bt-11 maize (EC-69)
7.691 The application concerning Bt-11 maize (EC-69) was first submitted to France (lead CA) in
May 1996, and was provided to the Commission for circulation to all member States in May 1999.
The SCP issued a favourable opinion on Bt-11 maize on (EC-69) 30 November 2000. Following the
issuance of the SCP opinion, the Commission did not submit a draft measure to the Regulatory
Committee. In October 2002, Directive 90/220 was re pealed. Under the new Di rective, the applicant
submitted the updated application on 15 January 2003. As of the establishment of the Panel, the
application was still under assessment under Directive 2001/18.
7.692 The United States argues that after Bt-11 maize (EC-69) received a favourable opinion from
the SCP in November 2000, the Commission failed to submit a draft measure to the Regulatory
Committee. The United States notes that, under the EC’s approval system, the next step after the SCP
favourable opinion should have been to submit the application for approval by the EC’s Regulatory
Committee, but that there is no action on the applicat ion for 2 years after the SCP opinion and instead
the next entry is an "evaluation of updates by the lead CA" in October 2002, which is unexplained and
unsupported by any exhibit or attachment. Accordi ng to the United States, the lengthy delay after the
SCP opinion was issued provides compelling evidence of the existence of a general moratorium.
7.693 Argentina argues that Bt-11 maize (EC-69) received a positive opinion from the SCP on 30
November 2000, but there was no further moveme nt on the application until Directive 2001/18 took
effect, and the application had to be resubmitted. The application was thus stalled for two years.
7.694 The European Communities argues that, after the SCP opinion, further discussions were
held between the lead CA, the applicant and the Commission, and they went on until well into 2002.
The European Communities notes in this respect that the SCP recommended a monitoring plan, and
that the issue of the monitoring plan remained unsettled. The European Communities further points
out that in May 2002 the applicant submitted additional information, including supplementary
sequence information on the molecular characterisa tion of the Bt-11 line, taking into account the
provisions of the new Directive, inter alia on monitoring, traceability and labelling.
7.695 The United States responds that the monitoring plan referred to in the SCP opinion is an
Insect Resistance Management (IRM) plan, but that the SCP never recommended any changes to the
applicant's proposed IRM plan. The United States also notes that the only other mention of
monitoring was with respect to changes in field popul ations of non-target insects, but that the SCP did
not request a monitoring plan on non-target insects, nor did it note any deficiency in the application.
Moreover, the United States argues that nothing in the record indicates that EC regulators ever
approached the applicant either to identify a problem, or to request additions to the application.
7.696 The Panel understands the European Communities as asserting that the Commission did not
send a draft measure to the Regulatory Committee b ecause, after the SCP opinion, the lead CA, the
applicant and the Commission continued discussions on a monitoring plan well into 2002. The Panel

also understands the European Communities as as serting that the applicant submitted additional
information in May 2002, just before the new Directive entered into force.
7.697 Regarding the monitoring plan, we note that th e SCP, in its opinion concerning Bt-11 maize
(EC-69), stated that "there is no evidence to indi cate that the placing on the market for cultivation
purposes of maize line Bt-11 […] is likely to cause adverse effects on human health and the
environment", but nonetheless concluded that "[t]he SCP should be kept informed of the results of
monitoring and research studies in Member States with particular regard to the development of insect
resistance"
781. The SCP, in another paragraph of its opi nion, also states that "[s]uch monitoring [as
developed by the Expert Group on Monitori ng for Insect Resistance to Bt toxins] should be carried
out in Bt-Maize and should provide an adequate frame work to delay the onset of resistance in the
target pest."782
7.698 Thus, while the European Communities is correct that the SCP recommended monitoring, it is
important to recall that it was the Commission, not the applicant, that requested an opinion from the
SCP. Accordingly, when the SCP expressed its inte rest in the implementation of a monitoring plan,
the SCP was, in our understanding, addressing itself to the Commission, not the applicant. There is
no evidence that the Commission or the lead CA ever requested the applicant to propose a monitoring
plan in accordance with the SCP's opinion.
7.699 We note that the applicant submitted additiona l information in May 2002 which included a
monitoring plan. However, as the European Communities itself has suggested, it appears this
information was submitted with a view to updating th e application in anticipation of the entry into
force of the new requirements contained in Directive 2001/18.783
7.700 For the reasons set out above, we are not persuaded by the European Communities'
explanation that the Commission did not submit a draft measure to the Regulatory Committee because
the SCP recommended a monitoring plan and the propo sal by the applicant remained unsettled. In
any event, the fact that the SCP stated that monito ring should be carried out in our view was not an
obstacle to the Commission launching inter-service consultations on a draft measure. From the
evidence before us, however, it seems that unlike in other procedures, the Commission in this
procedure never launched such c onsultations. This further undermines the EC assertion that the
Commission did not forward a draft measure to th e Regulatory Committee because the issue of the
monitoring plan remained unsettled.
7.701 Regarding the additional inform ation submitted by the applic ant in May 2002, we have
already observed that this information was appare ntly voluntarily submitted with a view to updating
the application in anticipation of the entry into force of the new requirements contained in
Directive 2001/18. There is no evidence that this additional information was submitted at the request
of the Commission or the lead CA. In other words, there is no reason to believe that the Commission
was waiting for this information. In our view, th erefore, the May 2002 information does not explain
the Commission's failure to submit a draft measure to the Regulatory Committee between November
2000 and May 2002.
7.702 We note that the SCP opinion in this procedure dates from November 2000. Directive 90/220
was not repealed until almost two years later. In our assessment, there was thus enough time for the

781 Exhibit EC-69/At. 83.
782 Ibid. (emphasis added).
783 The European Communities provided the Panel with a list of the appendices submitted by the
applicant, but not with the accompanying cover letter. Exhibit EC-69/At. 84.

Commission to launch and complete inter-service cons ultations on a draft measure to be submitted to
the Regulatory Committee and for the Commission to adopt its draft measure in the event of a
favourable vote in the Regulatory Committee.
784
7.703 The United States and Argentina consider that the Commission's failure to act reflects the
adoption by the European Communities of a general moratorium, that is to say, of a decision not to
allow any application to proceed to final approva l. The Complaining Parties contend that the
Commission was instrumental in the adoption and a pplication of the alleged general moratorium and
that it decided not to prevent the Group of Five countries from blocking the approval of applications.
The fact that in the procedure concerning Bt-11 maize (EC-69) the Commission did not submit a draft
measure to the Regulatory Committee is consistent w ith this contention. The Commission could have
considered that due to the "blocking minority" of the Group of Five countries in the Regulatory
Committee and the Council, a favourable draft m easure would not achieve the required qualified
majority and that the Commission would then have to complete the procedure by adopting its draft
measure.
7.704 In the light of the above considerations, we c onclude that the Commission's failure to submit
a draft measure concerning Bt-11 maize (EC-69) to the Regulatory Committee following the issuance
in November 2000 of the SCP's opini on is consistent with the Compla ining Parties' assertion that
during the relevant time period the European Co mmunities applied a general moratorium on final
approvals.
GA21 maize (EC-78)
7.705 The application concerning GA21 maize (EC-78) (C/ES/98/01)
785 was first submitted to Spain
(lead CA) in May 1998, and was provided to the Commission for circulation to all member States in
June/July 1999. The SCP issued a favourable opinion on 22 September 2000. Following the issuance
of the SCP opinion, the Commission did not submit a draft measure to the Regulatory Committee. In
October 2002, Directive 90/220 was repealed. The a pplicant submitted an updated application to the
lead CA under Directive 2001/18 on 15 January 2003. As of the establishment of the Panel, the
application was still being assessed at Community-level deliberation under Directive 2001/18. On 15
September 2003, the application was withdrawn.
7.706 The United States argues that even though GA21 maize (EC-78) was forwarded by the lead
CA to the Commission with a favourable opinion, and it also received a favourable risk assessment
from the SCP, the consideration of this app lication was indefinitely suspended because the
Commission refused to submit a draft measure to the Regulatory Committee.
7.707
Canada argues that GA21 maize (EC-78) received a positive opinion from the lead CA in
May 1998 and the applicant answered all the questi ons posed by the lead CA. In addition, GA21
maize (EC-78) received positive opinion from the SC P in September 2000, the consultations with
relevant member States were completed, and the scope of the application was reduced to exclude
cultivation. Despite these facts, the Commission fa iled to submit a draft measure to the Regulatory
Committee.

784 We note, by way of example, that in the pr ocedure concerning NK603 maize, the Regulatory
Committee voted on the application less than three months after EFSA issued its opinion. Exhibit EC-76/At. 72.
785 A separate application for approval of GA21 maize was submitted to the United Kingdom ( see
EC-85).

7.708 Argentina argues that once the SCP issued its favourable opinion on 22 September 2000, the
procedure on this application was suspended. Upon the replacement of Directive 90/220 by
Directive 2001/18, the application had to be re-s ubmitted. However, the approval process has not
made any progress since that time.
7.709 The European Communities argues that after assessment at both national and European
Community level, the application was withdraw n by the applicant on 15 September 2003. The
European Communities further notes that the applicant, in its withdrawal letter, gave three reasons for
the withdrawal: first, the progress in the approval procedure of another Roundup Ready maize to a
more advanced stage than the GA21 maize (EC-78) application; second, the introduction of the new
regulations concerning commercialisation of GM products in the European Communities; and third,
the change of the company's commercial priorities.
7.710 The United States responds that, once the SCP rendered a favourable opinion on 22
September 2000, all activity unexpectedly ceased at the Commission level and that 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. The United States adds
that the only activity that occurred after the SCP’s positive opinion was efforts by the applicant to re-
start the process, including the applicant's voluntary offer in September 2001 to update the application
(in the form of undertakings) to the requirements of the impending Directive 2001/18. Furthermore,
the United States argues that although the ap plicant submitted all necessary supplementary
information according to Directive 2001/18 to the lead CA on 15 January 2003, no action was taken
in the following eight months, either by the lead CA or the Commission, to move the product towards
consideration by the Regulatory Committee.
7.711 The United States argues that the applicati on was withdrawn because of the European
Communities' excessive delay in carrying out the approval process, despite the positive assessment
from the SCP. The United States maintains that although a company may not have cited undue delays
in its withdrawal letter, over time, as the delays mounted, in some cases the commercial incentive for
seeking approval changed. Furthermore, according to the United States, the companies had a strong
incentive to maintain cordial relations with EC regulators and saw no advantage of complaining to EC
regulators about the length of the delays, which the United States maintains results from the
moratorium.
7.712 Canada argues that given rapid advancements in the field of biotechnology, protracted delays
in an approval process may cause products submitted fo r approval by 1998 to become obsolete. Also,
given the considerable time and financial resources necessary to support an application, it may not be
commercially justified to proceed with the applica tion in the face of the legal uncertainty created by
the moratorium. Canada argues that the sheer number of withdr awals (thirteen under Directives
90/220 and 2001/18 and six under Regulation 258/97) is evidence of the impact of the moratorium.
Furthermore, Canada maintains that it is unde rstandable in the circumstances that companies
withdrawing applications did not cite undue delays in the processing of applications as reasons for the
withdrawal. As companies have an interest in maintaining a good working relationship with the
regulatory authorities responsible for approving their products, it is reasonable to expect companies to
act with circumspection.
7.713 Argentina
 likewise argues that although applicatio ns received positive scientific opinions,
favouring their approval, the procedure for their approva l was stalled, and some had to be withdrawn.
Argentina maintains that these withdrawals were the result of the moratorium. Argentina also
considers that the silence of the applicants ca nnot be taken as evidence of satisfaction with the

process, but rather was due to th e applicants' concern with maintaining good relations with the
approving authorities.
7.714 The Panel understands the European Communities to argue that after the SCP opinion, the
application was being assessed according to the procedures. We recall that according to the
procedures set out in Directive 90/220, after the issuance of the SCP opinion, it was for the
Commission to submit a draft measure to the Regulatory Committee for a vote. The Commission did
not do so, however. Indeed, it seems that unlike in other procedures
786, the Commission in this
procedure never launched inter-service consultations on a draft measure.
7.715 We note that the SCP's favourable opinion stat ed that "[t]he applicant should however
establish a monitoring plan to identify unexpect ed and unusual events and analyse grower
experiences, in order to develop and implement an y necessary changes in crop management practices
in response to the results of monitoring." 787 However, as with the approval procedures we have
considered earlier, there is no evidence that th e Commission or the lead CA ever requested the
applicant to propose a monitoring plan in accordan ce with the SCP's opinion. In January 2003, the
applicant submitted an updated application, including a monitoring plan. But this information was
submitted at the applicant's initiative, in anticipatio n of the entry into force of the new requirements
contained in Directive 2001/18, and not because th e applicant was requested to address the SCP
opinion.788 Therefore, there is no reason to believe that the Commission was waiting for the applicant
to put forward a monitoring plan, or, indeed, to provide any of the other additional information
submitted by the applicant in January 2003.
7.716 We note that four months after the SCP issued its opinion, in January 2001, the applicant sent
a letter to the lead CA requesting that the scope of its application be limited to import only and no
longer include cultivation. 789 In March 2001, the lead CA informed the Commission that it had no
objection to the applicant's request. 790 There is no indication that the Commission opposed the
applicant's request. While the scope of the applic ation was relevant to the draft measure to be
submitted by the Commission to the Regulatory Committ ee, the requested change of scope did not, in
our view, present an obstacle to the Commission launc hing, or continuing, in ter-service consultations
on a draft measure.
7.717 Nor do we see a possible obstacle in the fact th at Directive 90/220 was repealed in October
2002. Indeed, the SCP opinion in this procedur e dates from September 2000. In our assessment,
there was thus enough time for the Commission to la unch and complete inter-service consultations on
a draft measure to be submitted to the Regulat ory Committee and for the Commission to adopt its
draft measure in the event of a favourable vote in the Regulatory Committee.791
7.718 For the reasons set out above, we are not persuaded by the European Communities' assertion
that the application concerning GA21 maize (EC-78 ) was being assessed according to the procedures
until it was withdrawn by the applicant. The fact that the applicant's September 2003 letter
withdrawing the application did not specifically st ate that the application was not being processed
according to the procedures provided for in Directiv e 90/220, and that the letter did not specifically

786 See, e.g., Exhibits EC-62/At. 76; EC-65/At. 48.
787 Exhibit EC-78+85/At. 90.
788 Exhibit EC-78+85/At. 94.
789 Exhibit EC-78+85/At. 91.
790 Exhibit EC-78+85/At. 92.
791 We note, by way of example, that in the pr ocedure concerning NK603 maize, the Regulatory
Committee voted on the application less than three months after the SCP issued its opinion. Exhibit
EC-76/At. 72.

cite a general moratorium as a reason for the withdr awal of the application does not confirm the EC
assertion. As we have noted in the context of our discussion of other approval procedures, the
Complaining Parties have identified plausible explanations for why an applicant might not mention a
moratorium in a withdrawal letter if a moratorium was in effect.
7.719 The Complaining Parties consider that the Commission's failure to act reflects the adoption by
the European Communities of a general moratorium, th at is to say, of a decision not to allow any
application to proceed to final appr oval. We also recall that the Complaining Parties contend that the
Commission was instrumental in the adoption and a pplication of the alleged general moratorium and
that it decided not to prevent the Group of Five countries from blocking the approval of applications.
The fact that in the procedure concerning GA21 maize (EC-78) the Commission did not submit a draft
measure to the Regulatory Committee is consistent w ith this contention. The Commission could have
considered that due to the "blocking minority" of the Group of Five countries in the Regulatory
Committee and the Council, a favourable draft m easure would not achieve the required qualified
majority and that the Commission would then have to complete the procedure by adopting its draft
measure.
7.720 In the light of the above considerations, we c onclude that the Commission's failure to submit
a draft measure concerning GA21 maize (EC-78) to the Regulatory Committee following the issuance
in September 2000 of the SCP's opini on is consistent with the Compla ining Parties' assertion that
during the relevant time period the European Co mmunities applied a general moratorium on final
approvals.
GA21 maize (EC-85)
7.721 The application concerning GA21 maize (EC-85) was first submitted to the United
Kingdom
792 (lead CA) towards the end of 1997 793. The lead CA forwarded the application to the
Commission on 15 October 1999. The Commission circulated the application to all member States in
December 1999. After receiving comments and obj ections from member States, the Commission did
not submit a draft measure to the Regulatory Comm ittee and the application was withdrawn by the
applicant with a letter of 29 March 2001794.
7.722 The United States argues that the Commission failed to submit a draft measure to the
Regulatory Committee after completion of the MS consultation in February 2000.
7.723 Canada argues that the Commission failed to submit a draft measure to the Regulatory
Committee after completion of the consultations with relevant member States in February 2000.
7.724 Argentina argues the procedure had taken 3 years a nd 5 months without the adoption of a
definitive decision concerning its approval. Accordi ng to Argentina, the application was submitted to
the lead CA on 6 November 1997 under Directive 90/220 and still had not reached the Regulatory
Committee stage when the Directiv e 2001/18 entered into force. The application was withdrawn on
29 March 2001.
7.725 The European Communities argues that after discussions between the lead CA and the
applicant, the application was withdrawn by the ap plicant with its letter dated 29 March 2001. The

792 See also the approval procedure concerning GA21 maize (Spain) (EC-78) above.
793 The precise date on which the application was submitted to the United Kingdom is unclear from the
information before the Panel.
794 Exhibit EC-78/At. 93.

applicant referred to "the unexpected commercial constraints" and the parallel application for GA21
maize in Spain as justification for its withdrawal.
7.726 The United States maintains that although a company may not have cited undue delays in its
withdrawal letter, over time, as the delays mounted , in some cases the co mmercial incentive for
seeking approval changed. Furthermore, according to the United States, the companies had a strong
incentive to maintain cordial relations with EC regulators and saw no advantage of complaining to EC
regulators about the length of the delays, which the United States maintains results from the
moratorium.
7.727 Canada argues that given rapid advancements in the field of biotechnology, protracted delays
in an approval process may cause products submitted fo r approval by 1998 to become obsolete. Also,
given the considerable time and financial resources necessary to support an application, it may not be
commercially justified to proceed with the applica tion in the face of the legal uncertainty created by
the moratorium.
7.728 Canada further argues that the sheer number of withdrawals (thirteen under Directives 90/220
and 2001/18 and six under Regulation 258/97) is evidence of the impact of the moratorium.
Furthermore, Canada maintains that it is unde rstandable in the circumstances that companies
withdrawing applications did not cite undue delays in the processing of applications as reasons for the
withdrawal. As companies have an interest in maintaining a good working relationship with the
regulatory authorities responsible for approving their products, it is reasonable to expect companies to
act with circumspection.
7.729 Argentina likewise argues that although applicatio ns received positive scientific opinions,
favouring their approval, the procedure for their approva l was stalled, and some had to be withdrawn.
Argentina maintains that these withdrawals were the result of the moratorium. Argentina also
considers that the silence of the applicants ca nnot be taken as evidence of satisfaction with the
process, but rather was due to th e applicants' concern with maintaining good relations with the
approving authorities.
7.730 The Panel understands the European Communities to be asserting that the reason why the
Commission did not forward a draft measure to the Regulatory Committee is that the applicant did not
sufficiently respond to the comments and objections put forth by the member States.
7.731 The chronology provided to us by the Europ ean Communities indicates that some member
States submitted comments, questions and objections on this application after it was circulated
together with the lead CA's favourable assessment. The applicant on 17 February 2000 provided
prompt responses to requests for additional inform ation and for clarification from several member
States.
795 On 18 February 2002, additional member States raised objections. These objections do not
appear to have included new requests for information or clarification. 796 At any rate, there is no
evidence that these objections were conveyed to the a pplicant and that the applicant indicated that it
would respond to them. This is in contrast w ith the approval procedure concerning the GA21 maize
application submitted to Spain (EC-78), in which th e Commission sent to the applicant the substance
of the objections by the member States and in wh ich the applicant responded to them before the
Commission sought an opinion from the SCP.797

795 Exhibit EC-78+85/At. 41.
796 Exhibit EC-78+85/Ats. 42-44.
797 Exhibit EC-78+85/At. 77 and 79.

7.732 We note that in cases where member States raised objections to the approval of an
application, the Commission routinely sought an opinion from the SCP before submitting a draft
measure to the Regulatory Committee, even though there was no legal obligation under
Directive 90/220 to do so.
798. However, the Commission did not send this application to the SCP for
review. In contrast, in February 2000, the paralle l application submitted to Spain (EC-78) was already
being reviewed by the SCP, for it had been sent to the SCP on 29 October 1999. 799 The SCP issued a
favourable opinion on GA21 maiz e (EC-78) on 22 September 2000. 800 Even if it were assumed,
arguendo, that the Commission saw no need to request an additional and separate SCP opinion on
GA21 maize (EC-85) and was waiting for the SCP opinion on GA21 maize (EC-78), the fact remains
that the Commission apparently did not launch inter-service consultations on a draft measure
concerning GA21 maize (EC-85) even after the SCP had issued its opinion on GA21 maize (EC-78).
7.733 On 29 March 2001, the applicant withdrew its application. Since the last member State
objections were filed already in mid-February 2 000 and since, assuming it was relevant, the SCP
opinion on GA21 maize (EC-78) was issued in September 2000, it is clear to us that the withdrawal of
the application in March 2001 does not explain th e Commission's failure to launch inter-service
consultations and/or to forward a draft measure to the Regulatory Committee.801
7.734 The Complaining Parties consider that the Commission's failure to act reflects the adoption by
the European Communities of a general moratorium, th at is to say, of a decision not to allow any
application to proceed to final approval. We also recall the Complaining Parties' contention that the
Commission was instrumental in the adoption and a pplication of the alleged general moratorium and
that it decided not to prevent the Group of Five countries from blocking the approval of applications.
The fact that in the procedure concerning GA21 maize (EC-85) the Commission did not submit a draft
measure to the Regulatory Committee is consistent w ith this contention. The Commission could have
considered that due to the "blocking minority" of the Group of Five countries in the Regulatory
Committee and the Council, a favourable draft m easure would not achieve the required qualified
majority and that the Commission would then have to complete the procedure by adopting its draft
measure.
7.735 In our view, the fact that the applicant did no t specifically cite a general EC moratorium on
approvals as a reason for the withdrawal of the app lication is not inconsistent with the Complaining
Parties' assertion that the European Communities app lied a general moratorium on approvals. As was
pointed out by the Complaining Parties, if a moratorium was in effect, there are plausible explanations
for why the applicant did not specifically cite the alleged moratorium or resulting delays as a reason
for withdrawing the application concerning GA21 maize (EC-85).
7.736 In the light of the above considerations, we c onclude that the Commission's failure to submit
a draft measure concerning GA21 maize (EC-85) to the Regulatory Committee after the member
States expressed their views on the dossier in Febr uary 2000 is consistent with the Complaining
Parties' assertion that during the relevant time pe riod the European Communities applied a general
moratorium on final approvals.

798 EC reply to Panel question No. 133.
799 Exhibit EC-78/At. 82.
800 Exhibit EC-78/At. 90.
801 We note, by way of example, that in the pr ocedure concerning NK603 maize, the Regulatory
Committee voted on the application less than three months after the SCP issued its opinion. Exhibit
EC-76/At. 72.

T25 x MON810 maize (EC-86)
7.737 The application concerning T25 x MON810 ma ize was first submitted to the Netherlands
(lead CA) in June 1998, and was provided to the Commission for circulation to all member States in
May 1999. Following a positive opinion by the SC P concerning T25 x MON810 maize on 6 June
2000, the Commission did not submit a draft measur e to the Regulatory Committee. In December
2002, the application was withdrawn.
7.738 The United States argues that, despite the SCP's favourable risk assessments, the
Commission refused to submit a draft measure to the Regulatory Committee as required by EC law,
which led to the withdrawal of the application on 12 December 2002.
7.739 The European Communities argues that, after assessment by the SCP, the application was
withdrawn by the applicant by its letter date d 12 December 2002, which pointed to "entirely
commercial reasons" as the justification for its withdrawal.
7.740 The United States argues that the application was withdrawn because of the European
Communities' excessive delay in carrying out the approval process, despite the positive assessment
from the SCP. The United States maintains that although a company may not have cited undue delays
in its withdrawal letter, over time, as the delays mounted, in some cases the commercial incentive for
seeking approval changed. Furthermore, according to the United States, the companies had a strong
incentive to maintain cordial relations with EC regulators and saw no advantage of complaining to EC
regulators about the length of the delays, which the United States maintains results from the
moratorium.
7.741 The Panel understands the European Communities as asserting that the Commission did not
send a draft measure to the Regulatory Committee because, after the SCP opinion, the application was
being assessed according to the procedures and then was withdrawn by the applicant.
7.742 We recall that according to the procedures set out in Directive 90/220, after the issuance of
the SCP opinion, it was for the Commission to s ubmit a draft measure to the Regulatory Committee
for a vote. The Commission did not do so, howe ver. Indeed, it seems that unlike in other
procedures
802, the Commission in this procedure never launc hed inter-service consultations on a draft
measure.
7.743 We further note that in contrast with other SCP opinions, the SCP opinion on T25 x MON810
maize did not contain any recommendation for monitoring. 803 Moreover, there is no evidence that the
Commission had requested, and was waiting for, further information from the applicant.
Accordingly, we are not persuaded by the European Communities' explanation that the application
was being assessed according to th e procedures until it was withdrawn by the applicant in December
2002.
7.744 The SCP opinion in this procedure dates from June 2000. Directive 90/220 was not repealed
until more than two years later. In our assessme nt, there was thus enough time for the Commission to
launch and complete inter-service c onsultations on a draft measure to be submitted to the Regulatory

802 See, e.g., Exhibits EC-62/At. 76; EC-65/At. 48.
803 Exhibit EC-86/At. 66.

Committee and for the Commission to adopt its draft m easure in the event of a favourable vote in the
Regulatory Committee.
804
7.745 The United States considers that the Commission' s failure to act reflects the adoption by the
European Communities of a general moratorium, th at is to say, of a decision not to allow any
application to proceed to final approval. We also recall the Complaining Parties' contention that the
Commission was instrumental in the adoption and a pplication of the alleged general moratorium and
that it decided not to prevent the Group of Five countries from blocking the approval of applications.
The fact that in the procedure concerning T 25 x MON810 maize the Commission did not submit a
draft measure to the Regulatory Committee is consiste nt with this contention. The Commission could
have considered that due to the "blocking minority" of the Group of Five countries in the Regulatory
Committee and the Council, a favourable draft m easure would not achieve the required qualified
majority and that the Commission would then have to complete the procedure by adopting its draft
measure.
7.746 In our view, the fact that the applicant did no t specifically cite a general EC moratorium on
approvals as a reason for the withdrawal of the app lication is not inconsistent with the Complaining
Parties' assertion that the European Communities app lied a general moratorium on approvals. As was
pointed out by the United States, if a moratorium wa s in effect, there are plausible explanations for
why the applicant did not specifically cite the alle ged moratorium or resulting delays as a reason for
withdrawing the application concerning T25 x MON810 maize.
7.747 In the light of the above considerations, we c onclude that the Commission's failure to submit
a draft measure concerning T25 x MON810 maize to the Regulatory Committee following the
issuance in June 2000 of the SCP's opinion is consis tent with the Complaining Parties' assertion that
during the relevant time period the European Co mmunities applied a general moratorium on final
approvals.
Transgenic red-hearted chicory (EC-77)
7.748 The application concerning Transgenic re d-hearted chicory was notified twice under
Directive 90/220. The first application (C/NL/94/25) was submitted to the Netherlands (lead CA) in
December 1994. This application was approved at the Community level in May 1996. In accordance
with an agreement between the lead CA and th e Commission, this approval covered only breeding
activities, not food or feed uses. In March 2003, the applicant requested the withdrawal of the
marketing approval for breeding activities and obtained the requested withdrawal on 24 April 2003.
805
7.749 Following the 1996 approval for breeding activ ities, the applicant submitted an application
(C/NL/94/25/A) under Directive 90/220 to the Netherlands and the Commission in September 1996
requesting that approval be extended to use of this product for human and animal consumption. At
the time of the second application, the Regulation 258/97 had not been adopted, but subsequently, in
April 1998, the applicant began the application pr ocess for this product under Regulation 258/97 as
well, by submitting an application to the Netherla nds. Under the Directive, the SCP issued a
favourable opinion on Transgenic red-hearted chic ory for food and feed use on 18 December 1998,
whereas the Scientific Committee on Foodstuffs (SCF) did not complete its assessment.

804 We note, by way of example, that in the pr ocedure concerning NK603 maize, the Regulatory
Committee voted on the application less than three months after the SCP issued its opinion. Exhibit
EC-76/At. 72.
805 Exhibit EC-77/Ats. 43 and 44.

7.750 The European Communities argues that the application concerning this product was
introduced in the Netherlands in 1996 and that after assessment at both national and European
Community level, the application was withdrawn by the applicant in April 2003. The applicant gave
two reasons for the withdrawal: first, the absence of a market for these products; and second, the fact
that the applicant preferred not to be associated with GMOs any longer.
7.751 The United States argues that in many cases the withdrawal of applications resulted from the
applicant's frustration with the European Communi ties' suspension of its approval process, although
the applicant may not have explicitly so indicated in it reasons for withdrawal. Over time, as the
delays mounted, in some cases the commercial in centive for seeking approval changed. In addition,
the companies have a strong incentive to maintain cordial relations with EC regulators, and saw no
advantage of complaining to EC regulators a bout the length of the delays resulting from the
moratorium.
7.752 Canada observes that given rapid advancements in the field of biotechnology, protracted
delays in an approval process may cause products submitted for approval by 1998 to become obsolete.
Also, given the considerable time and financial res ources necessary to support an application, it may
not be commercially justified to proceed with the application in the face of the legal uncertainty
created by the moratorium. Canada argues that the sheer number of withdrawals (thirteen under
Directives 90/220 and 2001/18 and six under Regulati on 258/97) is evidence of the impact of the
moratorium. Canada maintains that it is unde rstandable in the circumstances that companies
withdrawing applications did not cite undue delays in the processing of applications as reasons for the
withdrawal. As companies have an interest in maintaining a good working relationship with the
regulatory authorities responsible for approving their products, it is reasonable to expect companies to
act with circumspection
7.753 Argentina also argues that although applications received positive scientific opinions,
favouring their approval, the procedure for their approva l was stalled, and some had to be withdrawn.
Argentina also considers that the silence of the a pplicants cannot be taken as evidence of satisfaction
with the process, but rather was due to the appli cants' concern with maintaining good relations with
the approving authorities.
7.754 The Panel begins its analysis by noting two fact ors which complicate the review of the
procedure for the approval of the Transgenic red-hearted chicory under Directive 90/220. First, the
food safety aspects of Transgenic red-hearted chic ory were evaluated both under Directive 90/220
(EC-77)
 and under Regulation 258/97 (EC-97). A number of documents in the later stages of the
application were filed in both approval procedures, which indicates that at a certain point in time,
these applications began to be processed together . Many of the documents relating to the two
applications are identical. 806 Hence, the evaluation of the approval procedure conducted under
Directive 90/220 requires consideration of documen tation submitted with the chronologies for both
Exhibit EC-77 and EC-97.

806 The following documents are identical: Exhibits EC-77/At. 93 and EC-97/At. 25 (on 14 November
2000); Exhibits EC-77/At. 94 and EC-97/At. 29 (on 11 June 2001); Exhibits EC-77/At. 95 and EC-97/At. 30 (on
18 June 2001); Exhibits EC-77/At. 97 and EC-97/At. 31 (24 July 2001). In addition, the document filed as
Exhibit EC-97/At. 23 (on 10 July 2000) can be found amongst the documents filed as Exhibit EC-77/At. 93, and
the document filed as Exhibit EC-77/At. 96 (12 July 2001) can be found amongst the documents filed as Exhibit
EC-97/At. 31. Moreover, it appears that the entry "SCF review" (24 April 2001) in Exhibit EC-77 is the same
as the entry "SCF additional request to the applicant" filed as Exhibit EC-97/At. 28.

7.755 Secondly, the same applicant submitted applicatio ns for Transgenic green-hearted chicory
under both Directives 90/220 (EC-110) and Regul ation 258/97 (EC-98) in parallel with the
applications for Transgenic red-hearted chicory. The record for Transgenic red-hearted chicory
overlaps substantially with th at for Transgenic green-hearte d chicory. In some cases the
documentation submitted by the European Communiti es for a particular product actually provides
information on two products. For example, on 23 April 1998, the Dutch Provisional Commission for
Food Safety submitted to the European Commission a positive assessment
807 of both Transgenic
green-hearted chicory and red-hearted chicory under the Directive 90/220. Yet this assessment was
not included in the EC chronology for Transgenic red-hearted chicory.
7.756 Turning now to examine the procedure for the a pproval of the Transgenic red-hearted chicory
under Directive 90/220, we note that the SCP ev aluated feed and food safety aspects of this
application under the Directive.808 The SCP issued an opinion in December 1998, stating that "against
the background of available knowledge, there is no ev idence to indicate that the placing on the market
of [red-hearted chicory] will cause adverse effects on human health and the environment".809
7.757 We recall that according to the procedures set out in Directive 90/220, after the issuance of
the SCP opinion, it was for the Commission to s ubmit a draft measure to the Regulatory Committee
for a vote. The Panel notes that, in March 1999 after the SCP's favourable opinion, the Commission
circulated an internal proposal for a draft measu re to be submitted to the Regulatory Committee on
which inter-service consultations were later launched.
810. These consultations were closed on 26 May
1999.811 The result of these consultations shows that one of the Commission services concerned
expressed the view that the SCF needed to be c onsulted before the Regulatory Committee would be
convened for a vote on the draft measure. 812 While it is clear from the record that the Regulatory
Committee was not convened afte r the Commission completed its inter-service consultations, the
record does not indicate that the Commission sought an opinion from the SCF.
7.758 However, documentation contained in Exhi bit EC-97 concerning the procedure under
Regulation 258/97 indicates that, in the meantime, the Commission had requested an evaluation by
the SCF on 29 April 1999, as required by Article 11 of Regulation 258/97. 813 Exhibit EC-97 suggests
that in September 2001 the applicant asked the SC F to suspend its assessment of the red-hearted
chicory under Regulation 258/97. 814 Subsequently, in May 2003, the applicant requested the SCF to
withdraw the dossier altogether. 815 Thus, it is clear that the SCF did not complete its assessment
before September 2001, and it appears that it was no longer reviewing the application in question after
that date.
7.759 There is no question that the Commission had enough time, once it had completed its inter-
service consultations in May 1999, to submit its dr aft measure to the Regulatory Committee and to
adopt its draft measure in the event of a fa vourable vote in the Regulatory Committee while
Directive 90/220 was still in force. Based on the foregoing elements, it may be that the Commission
decided not to convene the Regulatory Commi ttee for a vote on its draft measure under

807 Exhibit EC-110/At. 6.
808 Exhibit EC-77/At. 86.
809 Ibid., p. 5.
810 Exhibit EC-77/Ats. 87 and 89.
811 Exhibit EC-77/At. 90.
812 Ibid.
813 Exhibit EC-97/At. 19.
814 Exhibit EC-97 contains no supporting document.
815 Exhibit EC-97/At. 32.

Directive 90/220 until the SCF had completed its re view of the Transgenic red-hearted chicory under
Regulation 258/97.
7.760 Regarding the SCF's review of Transgenic red-hearted chicory, we note that in a
communication to the SCF of 14 November 2000, the applicant expressed frustration with the
progress of evaluation of the product, and in particular with a July 2000 request by the SCF for further
information about substantial equivalence.
816 The applicant noted that much information had been
provided to permit the determinati on of substantial equivalence betw een the transgenic chicory and
conventional chicory, and expressed the view that "it does not make sense to continue year after year
with experiments without having any indication th at there is no substantial equivalence". The
applicant also expressed concern that since the SCF had not indicated whether it would accept the
new experiments as proposed by the applicant, "thi s might be a new reason for the SCF to ask the
company to do new experiments after the proposed experiments have been finished". The total
process would thus take at least three additional years, and the applicant indicated that the time
necessary to conduct the required additional field tria ls would have negative fi nancial implications.
The applicant stressed that "the pr ocedure, time, energy and costs are disproportionate compared to
conventional breeding programs. This may lead to the conclusion that development and marketing of
transgenic vegetable crops in th e European Union do not have any opportunity." The applicant
provided additional information from various years of fi eld introductions to substantiate its claims of
substantial equivalence, and requested that the SC F extract its conclusions and take decisions based
on the information available at that time.
7.761 Five months after the communication from the applicant, in April 2001, the SCF informed the
applicant that it would accept the data provided regarding field studies, and requested additional
information regarding nutritional composition. 817 Dr. Nutti, one of the experts advising the Panel,
considered that the information requested by the SCF regarding the nutritional composition was
"important for the nutritional evaluation of the product".818 The Panel accepts Dr. Nutti's view. But it
is not convinced that the SCF's information request could not have been made at an earlier stage of the
SCF's review. In response to the SCF's new request for information, the applicant indicated that it had
not yet decided whether to execute additional experiments. 819 It expressed concern that the question
regarding antibiotic resistance markers would need to be resolved before new experiments were
started, and requested clarification regarding whether products containing antibiotic resistance
markers would be permitted to enter the EC market af ter the entry into force of Directive 2001/18. In
July 2001, the Commission indicated that the provisions of Directive 2001/18 did not include a
general legal ban on antibiotic resistance marker genes as such but linked their phasing out to certain
qualifiers.
820 The Commission also indicated that consideration of the applications for red-hearted
chicory was suspended until the information requested by the SCF had been provided. 821 No further
responses came from the applicant after the July 2001 clarifications by the Commission. As
previously noted, in September 2001 the applicant asked the SCF to suspend its review of the red-
hearted chicory.
7.762 We recall the Complaining Parties' asserti on that the European Communities applied a
general moratorium on final approvals between Oc tober 1998 and August 2003. We also recall the
Complaining Parties' contention that the Commission was instrumental in the adoption and

816 Exhibit EC-77/ At. 93.
817 Exhibit EC-97/At. 28.
818 Annex H, para. 762.
819 Exhibit EC-77/At. 94. See also Exhibit EC-97/At. 29.
820 Exhibit EC-77/At. 97. See also Exhibit EC-97/At. 31.
821 Ibid.

application of the alleged genera l moratorium and that it decided not to prevent the Group of Five
countries from blocking the approval of applications. It is pertinent to note in this regard that the
Commission's failure to forward its draft measure concerning Transgenic red-hearted chicory to the
Regulatory Committee coincided with the June 1999 declaration by the Group of Five countries. In
this situation, the Commission could have considered that due to the "blocking minority" of the Group
of Five countries in the Regulatory Committe e and the Council, a favourable draft measure
concerning Transgenic red-hearted chicory would not achieve the required qualified majority and that
the Commission would then have to complete the procedure by adopting its draft measure. Therefore,
the fact that in the procedure concerning Transg enic red-hearted chicory the Commission did not
submit a draft measure to the Regulatory Committee is in principle consistent with the Complaining
Parties' contention that a general moratorium on approvals was being applied.
7.763 We have said that the Commission may have decided not to convene the Regulatory
Committee for a vote on its draft measure under Di rective 90/220 until the SCF had completed its
review of the red-hearted chicory under Regulation 258/97. If this was the case, this would neither
confirm nor contradict the Complaining Parties' assertion that the Commission was instrumental in the
application of a general moratorium on approvals. In our view, it would not confirm the Complaining
Parties' assertion because the Commission might also have waited for the SCF opinion if no general
moratorium was in effect at the time. We note in this respect the special and unusual circumstance
that the food safety of Transgenic red-hearted ch icory was being evaluated concurrently under both
Directive 90/220 and Regulation 258/97. At the same time, we consider that the possibility that the
Commission was waiting for the SCF opinion would not contradict the Complaining Parties' assertion
because even if the SCF had completed its review, the Commission might still not have forwarded its
draft measure to the Regulatory Committee.
822 This can be seen from the above-mentioned approval
procedures, where the Commission failed to submit draft measures to the Regulatory Committee.
7.764 We note the European Communities' argument th at the application concerning Transgenic
red-hearted chicory was withdrawn in March 2003 without any reference to a moratorium. According
to the information before the Panel, what the app licant did in March 2003 was to request the lead CA
to withdraw its consent to the placing on the market of Transgenic red-hearted chicory. It is not clear
why the applicant would have made a reference to a moratorium on approvals when it had already
secured approval. Furthermore, we have seen no evidence of a withdrawal of the application
submitted under Directive 90/220 for feed and food uses. At any rate, even if the application
submitted under Directive 90/220 for feed and food uses had been withdrawn and the applicant had
not specifically cited a general EC moratorium on approvals as a reason for the withdrawal, we think
this would not be inconsistent with the Complaini ng Parties' assertion that the European Communities
applied a general moratorium on approvals. As w as pointed out by the Complaining Parties, if a
moratorium was in effect, there are plausible expl anations for why the app licant did not specifically
cite the alleged moratorium or resulting delays as a reason for withdrawing the application concerning
Transgenic red-hearted chicory.
7.765 In the light of the above considerations, we c onclude that the Commission's failure to submit
a draft measure concerning Transgenic red-hearte d chicory to the Regulatory Committee following
the completion of its inter-service consultations in May 1999 is consistent w ith the contention of the
Complaining Parties that the European Communities applied a general moratorium during the relevant
time period.

822 We note in this regard that after the applicant had asked the SCF in September 2001 to suspend its
review of Transgenic red-hearted chicory under Regulation 258/97, the Commission did not transmit to the
Regulatory Committee its draft measure in the approval procedure conducted under Directive 90/220. Exhibit
EC-77 does not suggest that a similar request was made in the context of the procedure under Directive 90/220.

Delays at member State level

7.766 In support of their assertion that the European Communities applied a general moratorium on
approvals the Complaining Parties have pointed to a number of approval procedures in which they say
the member State to which the application was subm itted – the lead CA – either did not complete its
assessment of the relevant application or completed it with considerable delay. We consider these
approval procedures below, recalling that Article 12(2) of Directive 90/220 provides that " [a]t the
latest 90 days after receipt of the [application], the competent authority shall either: a) forward the
dossier to the Commission with a favourable opinion, or b) inform the [applicant] that the proposed
release does not fulfil the conditions of this Directiv e and that it is therefore rejected". Article 12(5)
of Directive 90/220 further provides that "[f]or th e purpose of calculating the 90-day period referred
to in paragraph 2, any periods of time during which the competent authority is awaiting further
information which it may have requested from the applicant shall not be taken into account".
7.767 Since some of the relevant lead CA assessment s were made after the entry into force of
Directive 2001/18, we further recall that Article 14(2) of Directive 2001/18 similarly provides in
relevant part that "[w]ithin 90 days after receipt of the [application], the competent authority shall […]
prepare an assessment report and send it to the [applicant]". Article 14(2) further provides that where
the assessment report indicates that the product in question may be placed on the market, the
competent authority shall "send its report […] to the Commission which shall, within 30 days of its
receipt, forward it to the competent authorities of th e other Member States". Article 12(4) provides in
relevant part that "[f]or the purpose of calculati ng the 90 day period referred to in paragraph 2, any
periods of time during which the competent author ity is awaiting further information which it may
have requested from the [applicant] shall not be taken into account".
Bt-531 cotton (EC-65)
7.768 In the approval procedure concerning Bt-531 cotton, the applicant submitted an updated
application to the Spanish CA (lead CA) on 16 Janua ry 2003, in accordance with the requirements of
Directive 2001/18. When the Panel was established on 29 August 2003, the lead CA had not yet
forwarded the application to the Commission.
7.769 Argentina argues that although the applicant in January 2003 submitted an updated
application in accordance with the requirement s of Directive 2001/18, the application did not
progress. Argentina submits that, as a result, as of the date of its first written submission – April 2004
– the application concerning Bt-531 cotton had been inactive for an additional period of 1 year and 3
months.
7.770 The European Communities submits that the application contained an incomplete
monitoring plan. According to the European Co mmunities, the lead CA is awaiting additional
information on the post-marketing monitoring plan that it has requested with letters of August and
October 2003. The European Communities argues th at it cannot be responsible for the lack of
diligence or failings of an individual applicant.
7.771 The Unites States responds that the argument by th e European Communities that the
applicant failed to provide an ad equate monitoring plan under Directive 2001/18 is flatly wrong. The
applicant had submitted an Insect Resistance Ma nagement (IRM) plan as part of its product
stewardship, which was deemed "adequate" by the EC's own SCP back in 1998. According to the
Unites States, that the application is being discussed at the "staff-level" under Directive 2001/18 – in
this case at an arguably delayed pace and on questi onable grounds – is entirely consistent with a
moratorium adopted on a political level.

7.772 The Panel notes that the updated application was submitted to the lead CA in January 2003,
and that more than seven months later, in August 2003, i.e., when this Panel was established, the lead
CA had not completed its initial assessment.
7.773 We recall that in accordance with Article 14( 2) of Directive 2001/18, the lead CA should
have prepared an assessment report within 90 days. The 90 days do not include any periods of time
during which the lead CA is awaiting further inform ation which it requested from the applicant. In
the present case, the lead CA requested additional information in relation to the monitoring plan at the
beginning of August 2003
823. Before forwarding this request, the lead CA spent six and a half months
evaluating the application without finishing its asse ssment report. As of the end of August 2003, the
applicant had not provided the requested information.
7.774 The European Communities provides no explana tion for the time taken by the lead CA in
excess of the 90-day period, other than the asserti on that the monitoring plan submitted by the
applicant was incomplete. Moreover, the Europ ean Communities does not suggest that the alleged
incompleteness somehow prevented the lead CA fro m evaluating other aspects of the application.
Thus, the alleged incompleteness of the monitori ng plan does not in any event explain why the
evaluation of these other aspects led the lead CA to exceed the 90-day period.
7.775 As an additional matter, it must be kept in mind that the lead CA in this case was not
examining the application concerning Bt-531 cotton for the first time. In November 1997, the lead
CA forwarded the application to the Commission with a favourable assessment.
824 Moreover, in July
1998, the SCP provided its own assessment of the application. 825 While it is true that the lead CA in
2003 had to undertake an assessment in accordan ce with the partly new requirements of
Directive 2001/18, it seems equally clear that the prior assessments rendered the lead CA's task
considerably less complex than it would have been if the lead CA had had to undertake an assessment
for the first time. Notwithstanding this fact, the lead CA in this case failed to complete its assessment
within the prescribed 90-day period.
7.776 Furthermore, while there is no indication that Spain in 2003 was actively supporting a general
moratorium on final approvals, we consider that the fact that by August 2003 the Spanish CA had
already exceeded the 90-day period to complete its assessment under Directiv e 2001/18 is consistent
with the existence of a moratorium on final appr ovals. Following the June 1999 declaration by the
Group of Five countries, Spain had reason to belie ve that these countries would act as a "blocking
minority" in the Regulatory Committee and the Counc il at least pending the adoption of new EC rules
on labelling and traceability 826, and that, as in the case of some of the previously discussed approval
procedures, the Commission might not complete the approval procedure in the face of systematic
opposition by the Group of Five countries.
7.777 In the light of the above considerations, we conclude that the time taken by the Spanish CA to
assess the application concerning Bt-531 cotton unde r Directive 2001/18 is consistent with the
contention of the Complaining Parties that the Eu ropean Communities applied a general moratorium
during the relevant time period.

823 Exhibit EC-65/At. 64.
824 Exhibit EC-65/At. 4.
825 Exhibit EC-65/At. 47.
826 We note that Exhibit US-80, which contains an internal Commission note, suggests that several
Group of Five countries in Octobe r 2001 expressed the view that ne w EC rules on labelling and traceability
needed to enter into force before new biotech products could be approved. We note that Exhibit US-80 was also
referred to by Argentina.

RR-1445 cotton (EC-66)
7.778 In the approval procedure concerning RR-1445 co tton, the applicant submitted an updated
application to the Spanish CA (lead CA) on 16 Janua ry 2003, in accordance with the requirements of
Directive 2001/18. When the Panel was established on 29 August 2003, the lead CA had not yet
forwarded the application to the Commission.
7.779 Argentina argues that although the applicant in January 2003 submitted an updated
application in accordance with the requirement s of Directive 2001/18, the application did not
progress. Argentina submits that, as a result, as of the date of its first written submission – April 2004
– the application concerning RR-1445 cotton had been inactive for an additional period of 1 year and
3 months.
7.780 The European Communities submits that the application contained an incomplete
monitoring plan. According to the European Co mmunities, the lead CA is awaiting additional
information on the post-marketing monitoring plan that it has requested with letters of August and
October 2003. The European Communities argues th at it cannot be responsible for the lack of
diligence or failings of an individual applicant.
7.781 The Panel notes that the updated application was submitted to the lead CA in January 2003,
and that more than seven months later, in August 2003, i.e., when this Panel was established, the lead
CA had not completed its initial assessment.
7.782 We recall that in accordance with Article 14( 2) of Directive 2001/18, the lead CA should
have prepared an assessment report within 90 days. The 90 days do not include any periods of time
during which the lead CA is awaiting further inform ation which it requested from the applicant. In
the present case, the lead CA requested additional information in relation to the monitoring plan at the
beginning of August 2003.
827 Before forwarding this request, the lead CA spent six and a half months
evaluating the application without finishing its assessment report. As of 29 August 2003, i.e. less than
a month after that request, the applicant had not provided the requested information.
7.783 The European Communities provides no explana tion for the time taken by the lead CA in
excess of the 90-day period, other than the asserti on that the monitoring plan submitted by the
applicant was incomplete. Moreover, the Europ ean Communities does not suggest that the alleged
incompleteness somehow prevented the lead CA fro m evaluating other aspects of the application.
Thus, the alleged incompleteness of the monitori ng plan does not in any event explain why the
evaluation of these other aspects led the lead CA to exceed the 90-day period.
7.784 As an additional matter, it must be kept in mind that the lead CA in this case was not
examining the application concerning RR-1445 cotton for the first time. In November 1997, the lead
CA forwarded the application to the Commission with a favourable assessment.
828 Moreover, in July
1998, the SCP provided its own assessment of the application. 829 While it is true that the lead CA in
2003 had to undertake an assessment in accordan ce with the partly new requirements of
Directive 2001/18, it seems equally clear that the prior assessments rendered the lead CA's task
considerably less complex than it would have been if the lead CA had had to undertake an assessment
for the first time. Notwithstanding this fact, the lead CA in this case failed to complete its assessment
within the prescribed 90-day period.

827 Exhibit EC-66/At. 64.
828 Exhibit EC-66/At. 3.
829 Exhibit EC-66/At. 43.

7.785 Furthermore, while there is no indication that Spain in 2003 was actively supporting a general
moratorium on final approvals, we consider that the fact that by August 2003 the Spanish CA had
already exceeded the 90-day period to complete its assessment under Directiv e 2001/18 is consistent
with the existence of a moratorium on final appr ovals. Following the June 1999 declaration by the
Group of Five countries, Spain had reason to belie ve that these countries would act as a "blocking
minority" in the Regulatory Committee and the Counc il at least pending the adoption of new EC rules
on labelling and traceability
830, and that, as in the case of some of the previously discussed approval
procedures, the Commission might not complete the approval procedure in the face of systematic
opposition by the Group of Five countries.
7.786 In the light of the above considerations, we conclude that the time taken by Spain to assess
the application concerning RR-1445 cotton under Dir ective 2001/18 is consistent with the contention
of the Complaining Parties that the European Co mmunities applied a general moratorium during the
relevant time period.
RR oilseed rape (EC-79)
7.787 In the approval procedure concerning RR oil seed rape (EC-79), the applicant submitted an
application to France (lead CA) on 21 May 1995. When Directive 90/220 was repealed on 17
October 2002, the lead CA had not yet forwarded the dossier to the Commission. The application was
withdrawn on 15 January 2003.
7.788 The United States argues that this application was delayed at the member State level for
more than 100 months. The United States submits that although the applicant in this procedure
provided answers to all of the questions raised by the lead CA, the lead CA failed to approve the
product under Directive 90/220. More specifically, the United States argues, based on the applicant's
letter of withdrawal, that the lead CA refused to c onsider the application after February 1996, the date
of the lead CA's last request for information.
7.789 Canada asserts that after responding to three ite rations of questions, the applicant was
informally advised that the lead CA would not be proceeding further with the assessment of the
application. More particularly, Canada argues that since 1996, the lead CA has taken no further
action to complete the approval procedure, meaning that this application was delayed at the member
State level for more than 100 months. Canada acknowledges that some of the delays occurred prior to
October 1998. Canada submits in this respect that whatever the motivation of France prior to October
1998, RR oilseed rape was the victim of the morato rium after October 1998. Canada further asserts
that it was due to the inaction of the lead CA that the applicant on 7 July 1998 submitted a second
application, this time to the Netherlands (app lication concerning RR oilseed rape (EC-70)).
According to Canada, this demonstrates that if the delay caused by a particular lead CA is long
enough, it has the effect of discouraging applicants from continuing with their applications.
7.790 The European Communities notes that the applicant in 2003 gave two reasons for the
withdrawal of its application in January 2003: the prolonged inaction by the lead CA with respect to
this application and the applicant's consequent focus on commercial activities outside of the European
Communities. The European Communities also co nfirms, however, that a second application was
filed in the Netherlands in 1998.

830 We note that Exhibit US-80, which contains an internal Commission note, suggests that several
Group of Five countries in Octobe r 2001 expressed the view that ne w EC rules on labelling and traceability
needed to enter into force before new biotech products could be approved.

7.791 The Panel notes that in August 1996 the appli cant provided additional information in
response to a request of February 1996 from th e French "Commission du génie biomoléculaire"
(hereafter CGB).
831 The CGB apparently delivered a favourable opinion at the end of 1996. 832 There
is no indication that after receiving the CGB's opinion at the end of 1996 the lead CA was waiting for
further scientific advice or for additional informatio n from the applicant. In fact, in mid-1997, the
applicant wrote to the lead CA to inquire about the progress of the procedure, the modalities of
transmission of the dossier to the Commission and th e advisability of supplementing the dossier with
further information prior to its forwarding to the Commission. 833 It appears that the lead CA never
provided a formal response to the applicant's inquiry.834
7.792 The United States and Canada argue that the lead CA's failure to complete its assessment of
RR oilseed rape (EC-79) is consistent with th eir view that as of October 1998 the European
Communities applied a general moratorium, that is to say, a decision not to allow any application to
proceed to final approval. The Panel considers th at as of June 1999 the unexplained failure by the
lead CA to complete its assessment supports the view of the United States and Canada. It is important
to recall in this context that France is one of the Group of Five countries. The countries making up
the Group of Five in June 1999 declared that they would use their powers under Directive 90/220 to
prevent the approval of applications, pending the adoption of new EC legislation on labelling and
traceability. The fact that France as the lead CA in this procedure delayed the completion of the
assessment at member State level for several years is in accordance with the June 1999 declaration.
835
7.793 In the light of the above considerations, we conclude that the failure by France to complete its
assessment of RR oilseed rape (EC-79) is consistent with the Complaining Parties' assertion that
during the relevant time period the European Co mmunities applied a general moratorium on final
approvals.
RR oilseed rape (EC-70)
7.794 In the approval procedure concerning RR oilseed rape (EC-70 – incidentally the same product
as in EC-79 where the lead CA is the French CGB) , the applicant submitted an application to the
Netherlands ((lead CA) on 7 July 1998. When Directive 90/220 was repealed on 17 October 2002,
the lead CA had not yet forwarded the dossier to the Commission. The dossier was forwarded to the
Commission with a favourable assessment report on 16 January 2003, after the applicant had provided
an updated application in accordance with Directive 2001/18.
7.795 The United States argues that this application was delayed at the member State level for
more than four years. The United States submits that although the applicant in this procedure
provided answers to all of the questions raised by the lead CA, the lead CA failed to approve the
product under Directive 90/220. More specifically, the United States argues that the total time taken
at the member State level for the initial review w as 54 months (7 July 1998 to 22 January 2003), of

831 Exhibit EC-79/At. 15.
832 Exhibit EC-79/At. 30.
833 Exhibit EC-79/At. 28.
834 Exhibit EC-79/At. 30.
835 In the approval procedure concerning Bt-11 mai ze (EC-69), France was also the lead CA. In that
procedure, which was initiated in June 1996, France completed its assessment and forwarded the application to
the Commission in early April 1999. Thus, that application was forwarded before the June 1999 declaration by
the Group of Five countries. France was also the lead CA in the case of two other oilseed rape applications
under Directive 90/220 – MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape. These applications were
approved at Community level, but France subsequently withheld its consent to the placing on the market of the
two products concerned.

which 12 months were taken by the applicant to r espond to questions. The United States asserts that
an additional 10 months of the total time taken were spent resolving confidentiality issues in relation
to detection methods. Thus, according to the United States, the lead CA in this procedure took 32
months for its review instead of the 90 days referred to in Article 12 of Directive 90/220.
7.796 Canada notes that in February 2000, the Dutch State Institute for Quality Control of
Agricultural Products (hereafter RIKILT-DLO), resp onsible for providing scientific opinions relating
to feed safety, issued a favourable assessment of RR oilseed rape (EC-70). On 10 January 2001, the
Dutch Committee on Genetic Modification (COGEM), responsible for providing scientific advice
relating to human health and the environment, concluded its assessment with a favourable conclusion.
In January 2003, the Netherla nds CA published a favourable ove rall assessment report. Canada
submits that the two-year delay by the Netherlands CA in completing its overall assessment report and
forwarding it to the Commission is unjustified.
7.797 Canada further argues that the total time taken by the Netherlands to revi ew this file was 54
months (7 July 1998 to 22 January 2003). Out of these 54 months, the applicant took a total of 12
months to respond to questions. Another 10 months were used for discussions of the confidentiality
status of certain information submitted by the app licant beyond the legal requirements of the approval
legislation then in force. Canada submits that ev en if the latter period of time were not taken into
account in this calculation, the remaining 32 months are in stark contrast to the 90 days foreseen in
Directive 90/220 for this procedural step. In Canada's view, it is reasonable to infer from this that in
the light of the moratorium, the Dutch authorities were taking a decidedly go-slow approach.
7.798 The European Communities argues that in this procedure there was a continuous exchange
of correspondence between the lead CA and the a pplicant until December 2002, when the applicant
updated its application in accordance with the re quirements of Directive 2001/18. The lead CA
requested additional information on molecular charact erization and on certain feed safety aspects, and
exchanges regarding these issu es continued until the year 2000. After the adoption of
Directive 2001/18 in March 2001, the lead CA aske d the applicant to provide information on a
detection method as required under the new legislation. The applicant requested confidentiality status
for the information to be provided. The lead CA initially did not accept the reasons provided for
requesting that status and several letters were exch anged on the issue. The lead CA also requested
reference material which again triggered a deba te on confidentiality. The European Communities
notes that these issues were only settled in the autu mn of 2002. By that time, Directive 2001/18 had
entered into force and the lead CA and applican t worked on up-dating the application according to
Directive 2001/18. The European Communities points out that once the applicant had provided an
update, the application moved immediately to the Comm unity level. This indicates that all relevant
steps had already been completed, and is inconsistent with the notion that a moratorium was in place.
7.799 The Panel understands from the record that in evaluating applications for placing on the
market at the time in question, the Netherlands generally took into consid eration the application
submitted by the applicant, the advice from the CO GEM, the opinion of the RIKILT-DLO, where
applicable, and comments from other relevant parties. Based on this evaluation, a draft assessment
report was then published and was open for pub lic comments for a period of four weeks.
836 In the
procedure concerning RR oilseed rape (EC-70), the RIKILT-DLO submitted its favourable opinion in
February 2000 837; the applicant was advised in March 2000 in an e-mail that no further technical

836 Exhibit EC-70/At. 66, Summary of the evaluation carried out by the Netherlands Competent
Authority (GT73), p. 3; see also Exhibit CDA-57.
837 Exhibit EC-70/At. 66, Summary of the evaluation carried out by the Netherlands Competent
Authority (GT73), p. 5; see also Exhibit CDA-57.

information for the risk assessment needed to be supplied
838; and the COGEM provided its favourable
advice on 10 January 2001.839
7.800 By January 2001 the Netherlands had spent ove r seven months evaluating RR oilseed rape
(EC-70).840 In other words, the Netherlands had alr eady exceeded the 90 day time-period envisaged
for this process in Directive 90/220. The Europ ean Communities suggests that all of the time taken
until December 2002 when the applicant compleme nted its application in accordance with the
requirements of Directive 2001/18 was necessary to resolve scientific and technical issues. 841
However, there is no indication that the COGEM provided its advice only in January 2001 because it
needed to resolve scientific or technical issues. The COGEM met in September 1998 to discuss the
application in question. This led to a request for additional information on molecular characterization,
which was transmitted to the applicant also in September 1998. 842 The applicant provided the
requested information in December 1998. 843 Yet the COGEM did not meet again to discuss the
application and the additional information for anothe r two years. The relevant meeting took place in
December 2000, a month before the COGEM provided its final advice.844
7.801 In the light of the foregoing, the Panel consider s that at the latest in March 2000, when the
Netherlands CA confirmed to the applicant by e-mail that no further technical information needed to
be submitted, the Netherlands CA c ould have had all the elements to complete its assessment report.
The European Communities notes that the applican t submitted additional information in April and
May 2000. It is correct that in the aforementi oned e-mail of March 2000, the Dutch CA also noted
that the legal name and registration of the applicant would need to be confirmed, and that the original
application would need to be modified to take into account the additional information submitted in the
course of the assessment process. 845 However, the Panel does not consider that the March 2000 e-
mail from the Netherlands CA constituted a formal request for information which triggered a clock-
stop.846 In any event, in April 2000, the applican t did confirm its legal name and registration. 847 And
in mid-May 2000, the applicant sent a draft docum ent to the Netherlands CA to indicate how it
intended to modify the original applicati on and to ask for comments and suggestions. 848 T h e

838 Exhibit EC-70/At. 18; Exhibit CDA-132.
839 Exhibit EC-70/At. 66, Summary of the evaluation carried out by the Netherlands Competent
Authority (GT73), p. 5; see also Exhibit CDA-57.
840 The evidence on the record does not permit a precise determination of the period during which the
clock was stopped. Nevertheless, it is clear from Exhib it EC-70 that the lead CA was assessing the application
between 13 August 1998 and 25 September 1999; between 2 April 1999 and 17 August 1999; and between 18
November 1999 and 21 January 2000 when the RIKILT-DLO appears to have requested additional information
(Exhibit EC-70/At. 17). These periods of time alone during which the clock was not stopped and which are but
examples already add up to more than seven months.
842 Exhibit EC-70/At. 7.
843 Exhibit EC-70/Ats. 9 and 10.
844 Exhibit EC-70/At. 17, p. 2 (in Dutch), Letter of 10 January 2001 by the COGEM to the Netherlands
CA, p. 2. See also Exhibit EC-70/At. 66, Summary of the evaluation carried out by the Netherlands Competent
Authority (GT73), p. 5.
845 Exhibit EC-70/At. 18.
846 Indeed, the chronology provided to the Panel by the European Communities does not describe the
communication as such, which is in contrast to other entries in the chronology. Exhibit EC-70/At. 18.
847 Exhibit EC-70/At. 19. In addition, the applicant sent some information which the European
Communities acknowledges had already been transmitted to the lead CA. EC reply to Panel question No. 152.
848 Exhibit EC-70/At. 21. The Panel fails to see a basis for the European Communities' contention that
the relevant draft document was "a new element in the authorization process because it change[d] the terms of
the application". Nor does the Panel think that Exhibit EC-70/At. 23 supports the conclusion that the lead CA
was still "analys[ing] the update" in November 2000. EC reply to Panel question No. 152.

Netherlands CA replied that it would communicate it s "findings" as soon as possible, probably within
less than a fortnight.
849 This estimate demonstrates that the document submitted in mid-May 2000 did
not call for a lengthy analysis by the Netherlands CA. Thus, it cannot be said that the additional
information submitted in April and May 2000 prec luded the Netherlands CA from proceeding to
finalize its assessment report as from March 2000.
7.802 Even assuming that the COGEM could not have provided its advice before January 2001,
once the COGEM had done so, the Netherlands CA ha d all the elements to complete its assessment
report. Notwithstanding this, the Netherlands CA di d not finalize its report at that point. Instead, on
12 March 2001 – on the day Directive 2001/18 was adopted – the Netherlands CA wrote to the
applicant saying that in accordance with Directiv e 2001/18 a detection method "should be provided"
to complete the dossier, "to be able to fo rward the dossier to the EU member states". 850 Although
Directive 2001/18 was not to enter into force until October 2002, the applicant provided a detection
method on 16 March 2001. 851 The applicant requested, however, that the detection method be treated
as confidential. In May 2001, the lead CA asked the applicant to reconsider its request or else provide
further substantiation. The lead CA also stated th at in the absence of further substantiation by June
2001, it would take a decision with respect to the request. 852 In September 2001, after providing
further clarification at the request of the lead CA and "in order to keep the approval process moving
forward", the applicant agreed to disclose the protocol for the detection of RR oilseed rape (EC-70).
But the applicant requested that the primer sequences in the protocol remain confidential until the first
patent application was published. 853 In response, the lead CA agai n sought further substantiation.
After receiving additional substan tiation, the lead CA in January 2002 granted the request that the
primer sequences should be treated as confidential. As is clear from the foregoing, 8 months were
spent clarifying the confidentiality status of the detection method and primer sequences. While the
applicant took a total of 3 and a half months to re ply to the several requests for further substantiation,
it must also be noted that in June 2001 the lead CA waited for more than a month after receiving
further substantiation before it followed up w ith a request for yet more substantiation. 854 A similar
situation arose in September 2001 when the lead CA waited for more than two months before
following up with another request.855
7.803 In January 2002, the lead CA made a request , "according to the conditions as laid down in
Directive 2001/18/EC", that the applicant should provi de reference material to verify the primer
sequences and detection method. 856 Two weeks later, the applicant informed the lead CA that it was
sending the requested materials. 857 According to a statement by the Netherlands, the assessment
report was completed before 17 October 2002 but was not forwarded to the Commission due to a
change of government following general elections.858
7.804 It is clear from the foregoing that there are a number of elements which support the
conclusion that the Netherlands could have complete d its assessment much earlier than it did: (i) the
COGEM apparently did not review information subm itted at its request for more than two years,
which delayed the finalization of the lead CA's as sessment report since the lead CA as of March 2000

849 Exhibit EC-70/At. 22.
850 Exhibit EC-70/At. 23.
851 Exhibit EC-70/At. 24.
852 Exhibit EC-70/At. 26.
853 Exhibit EC-70/At. 30.
854 Exhibit EC-70/At. 28.
855 Exhibit EC-70/At. 33.
856 Exhibit EC-70/At. 35.
857 Exhibit EC-70/At. 36
858 Exhibit EC-70/At. 66, Statement of the Competent Authority of the Netherlands.

had all other technical information needed for its risk assessment; (ii) when the COGEM finally
provided its advice in January 2001, the lead CA di d not complete its assessment report but requested
additional information based on the provisions of Directive 2001/18, even though the Directive had
not yet entered into force; and (iii) during th e eight-month exchange with the applicant over
confidentiality issues, the lead CA caused delays by not following up promptly with its additional
requests for clarification.
7.805 The United States and Canada do not assert that the Netherlands itself was an active
participant in the alleged morato rium on approvals and that the ti me taken by the Netherlands to
complete its assessment is a reflection of the Neth erlands' support for the moratorium. Rather, their
assertion is that the time taken by the Netherlands re flects the impact of the moratorium. The United
States and Canada contend that the Netherlands was placed in a position of having to recognize the
moratorium as a reality and that this affected the speed with which it conducted its assessment. In the
view of the United States and Canada, the Nether lands knew that because of the alleged moratorium
the speed of its assessment would have little impact on the eventual date of approval.
859
7.806 Following the June 1999 declaration by the Gr oup of Five countries, the Netherlands had
reason to believe that the Group of Five countries would act as a "blocking minority" both in the
Regulatory Committee and in the Council. It is r easonable to assume that the Netherlands was also
aware that in the approval procedures concer ning Bt-531 cotton and RR-1445 cotton the Commission
after May 1999 failed to discharge its responsibility inasmuch as it did not submit a draft measure to
the Council. Consequently, the Netherlands could in our view have come to the conclusion that there
was no realistic prospect that RR oilseed rape (E C-70) could be approved under Directive 90/220 in
1999 or at any point thereafter until the date of repe al of the Directive. The Netherlands' conduct is
consistent with such a view. The COGEM did not provide its advice until shortly before the adoption
of Directive 2001/18. Instead of completing its assessment report at that point, the Netherlands on the
day of adoption of Directive 2001/18 requested th e applicant to provide a detection method, even
though the Directive would not enter into force for another 19 months. During the subsequent
exchange with the applicant over the confidentialit y of the detection method and primer sequences,
there were further delays attributable to the l ead CA. And even when the applicant provided the
requested reference material in early February 2002, the assessment report was not promptly
completed and forwarded to the Commission so that the application might still have been approved in
the event of no objections within 60 days from other member States.
7.807 The European Communities correctly points ou t that once the applicant had provided an
updated application in December 2002, the appli cation was quickly forwarded to the Commission
together with the lead CA's fa vourable assessment report. We also agree with the European
Communities that this indicates that the assessment report was up-to-date in terms of the requirements
of Directive 2001/18. But we do not agree that this undermines the claim that a moratorium on
approvals was in place. In our view, the fact th at under Directive 2001/18 the application promptly
moved to the Community level rather supports th e opposite view. This is the view that the
Netherlands considered that for as long as Directive 2001/18 was not in force, the Group of Five
countries and the Commission would prevent the fi nal approval of the application in question,
whereas after the entry into force of the new Direc tive, the application might eventually be approved,
after the adoption of new EC rules on labelling and traceability.
7.808 In the light of the above considerations, we conclude that the time taken by the Netherlands to
complete its assessment of RR oilseed rape (EC-70 ) is consistent with the Complaining Parties'

859 US reply to Panel question Nos. 193-195; Canada's reply to Panel question No. 189.

assertion that during the relevant time period the European Communities applied a general
moratorium on final approvals.
LL soybeans (EC-71)
7.809 In the approval procedure concerning LL so ybeans (EC-71), the applicant submitted an
application to Belgium (lead CA) on 28 September 1998. In September 1999, the applicant submitted
an application for this same product to Portugal. We will discuss the latter application separately
below. When Directive 90/220 was repealed on 17 October 2002, Belgium as the lead CA in the
procedure here at issue had not yet forwarded the dossier to the Commission. The applicant updated
the application on 15 January 2003. The applicant withdrew the application to Portugal in January
2003. The application to Belgium was withdrawn by the applicant on 29 June 2004. It is important to
note as well that in November 1998 the applicant su bmitted to Belgium an application concerning LL
soybeans (EC-93) for approval as a novel food under Regulation 258/97.
7.810 The United States submits that although the applicant in this procedure provided answers to
all of the questions raised by the lead CA, the lead CA failed to approve the product under
Directive 90/220.
7.811 Argentina claims that the application was delayed at the member State level for 68 months
without a final decision on its approval. Argentin a asserts that the Eur opean Communities neither
processed the application nor conducted the required ri sk assessment. Argentin a argues that there is
no scientific justification for the suspension of the approval procedures, as the "initial reports" were
not prepared, and considers this to be a "failure to consider" the application for LL soybeans (EC-71).
7.812 The European Communities provides three explanations for the delay at the member State
level: (1) requests by the lead CA for further information during the period from September 1998 to
2001; (2) procedural problems arising from the fact that the applicant submitted an application for the
same product in Portugal; and (3) delays caused by the applicant's lack of response to requests for
additional information on 25 February 2003.
7.813 The Panel considers that in relation to Belgium' s assessment of LL soybeans (EC-71) three
separate time periods can be usefully distinguished : (1) the time period between the submission of
the application to the Belgian CA and the concu rrent submission in Portugal; (2) the time period
between the submission of the concurrent application in Portugal and the repeal of Directive 90/220;
and (3) the time period between the submission of the application under Directive 2001/18 and the
applicant's withdrawal of the application.
7.814 In considering the first time period, we understa nd that in evaluating applications for placing
on the market at the time in question, Belgium generally took into consideration the application
submitted by the applicant and the advice from th e Biosafety Council. Two months after the
application was first submitted to the Belgian CA , the Biosafety Council requested a substantial
amount of information
860 and the Belgian CA indicated that the approval process would be suspended
until the requested information was provided. 861 In a response to this request the applicant noted that
some information which was being requested by th e Biosafety Council had already been submitted to
the Ministry of Public Health. 862 In a later letter dated Marc h 1999, the Biosafety Council
acknowledged that the applicant had apparently submitted much of the requested information

860 Exhibit EC-71/At. 4.
861 Exhibit EC-71/At. 5.
862 Exhibit EC-71/At. 12.

regarding herbicides and stated that the Belgian CA had passed this information directly to the High
Health Council for evaluation.
863 In this same letter, the Biosaf ety Council stated that it was "of the
opinion that the file [concerning the application s ubmitted under Directive 90/220] in its present form
(with addition of molecular data and after minor corrections) can be passed on to the European
Commission with a positive opinion". Based on the advice by the Biosafety Council the Belgian CA
in May 1999 asked for more information, includ ing information on molecular characterization,
nutritional analysis (concerning the approval proc edure for LL soybeans (EC-93)) and herbicide
aspects.864 The applicant did not respond to the May 1999 request until July 2001.
7.815 The second time period begins with the submissi on by the applicant of a second application
concerning LL soybeans (EC-81) to Portugal in September 1999. We note that in a communication to
Belgium dated 1 December 2000, the applicant explic itly indicated its intention of maintaining dual
applications.865 In this letter the applicant also stated it would take all necessary measures to ensure
that only one application would circulate at the Community level. On 5 December 2000, the
Biosafety Advisory Council of the Belgian CA conf irmed the continuation of the evaluation process
in Belgium and requested that the applicant forwar d the questions posed by the Portuguese CA in the
approval procedure concerning LL soybeans (EC-81) in order to complete the application dossier in
Belgium.866 On 5 September 2001, ten months after c onfirming the continuation of the evaluation
process in Belgium, the lead CA (Belgium) indicated to the applicant that further evaluation of the
application would be suspended until the applicant specified a single country to handle the
application.867 The applicant responded by asserting the maintenance of double concurrent
applications.868 No further exchanges appear to have o ccurred between the applicant and the lead CA
until January 2003, when the applicant update d the application submitted to Belgium under
Directive 2001/18. While there is no evidence on the reco rd to confirm this, it appears that in view of
the applicant's response the lead CA did not fu rther assess the application concerning LL soybeans
(EC-71) between October 2001 and January 2003.
7.816 In relation to the third time period, we note that after the applicant updated its application
under Directive 2001/18 (15 January 2003) and wit hdrew its application in Portugal (27 January
2003), the Belgian CA acknowledged receipt of the updated appli cation and requested further
information regarding molecular characterization, detection methods and reference materials. The
applicant provided preliminary informal answers regarding information for labelling requirements and
detection methods in March 2003. There is no record of further exchanges between the applicant and
the lead CA until the applicant withdrew the application in July 2004.
7.817 It is clear from the foregoing that the progress of this application was adversely affected
notably by two elements. First, the applicant took more than two years to provide the information
requested by the lead CA in May 1999. Secondly, the consideration of the application appears to have
been suspended as from September 2001 as a result of th e applicant's refusal to discontinue one of the
two applications submitted under Directive 90/220.
7.818 Regarding the first element, we note that the United States and Argentina do not assert that at
the time of the May 1999 request for additional inform ation, Belgium was an active participant in the
alleged moratorium on approvals. Indeed, we recall that in June 1999 Belgium was one of the Group

863 Exhibit EC-71/At. 16.
864 Exhibit EC-71/Ats. 17 and 22.
865 Exhibit EC-71/At. 23.
866 Exhibit EC-71/At. 24.
867 Exhibit EC-71/At. 28.
868 Exhibit EC-71/At. 29.

of Seven countries which declared, not that they wo uld take steps to suspend further approvals, but
that they would take a thoroughly precautionary appro ach in dealing with applications for the placing
on the market of biotech products. We consider that Belgium's May 1999 request for additional
information could be a reflection of the precau tionary approach referred to in the June 1999
declaration of the Group of Seven countries.
7.819 Regarding the second element, we note that the applicant was of the view that
Directive 90/220 did not prevent it from filing identical applications to different lead CAs. It
nevertheless acknowledged that this approach could give rise to procedural problems, and it therefore
indicated that it would withdraw one of the two a pplications as soon as one of the applications was
ready for transmission to the Commission. The Be lgian CA appears to have considered that the
approach followed by the applicant was either not permitted by Directiv e 90/220 or otherwise
inappropriate. From the information before us it is not apparent that Belgium's position on this issue,
which appears to have led it to suspend considera tion of the application concerning LL soybeans (EC-
71) under Directive 90/220, was a mere pretext for dela ying the consideration of the application. We
recall in this regard that Belgium indicated to th e applicant that it would continue considering the
relevant application if the applicant decided to di scontinue the application submitted to Portugal. At
the same time, it must be noted that a similar issue of parallel applications arose in the approval
procedure concerning Bt-11 maize (EC-80). In that procedure, however, the lead CA (Spanish CA)
did not appear to consider this a problem.
869
7.820 Taking account of the foregoing, we consider th at the aforementioned two elements do not in
themselves provide direct confirmation of the existe nce of a general moratori um on final approvals.
However, we note that the application concerning LL soybeans (EC-71) did not reach the Community
level phase of the EC approval process prior to its w ithdrawal in April 2004. In other words, it never
reached the procedural stage where the Group of Five countries and/or the Commission could have
taken action to delay or prevent its final approval. Therefore, while it is recognized that the two
above-mentioned elements which affected the pr ogress of the application concerning LL soybeans
(EC-71) at the member State level do not directly confirm that a general moratorium was in effect, the
record on this case does not demonstrate that no mo ratorium on final approvals was in effect during
the relevant time period.
7.821 In the light of the above considerations, we c onclude that Belgium's failure to complete its
assessment of the application concerning LL soybean s (EC-71) prior to August 2003 is consistent
with the Complaining Parties' assertion that during the relevant time period the European
Communities applied a general moratorium on final approvals.
LL soybeans (EC-81)
7.822 The application concerning LL soybeans (EC-81) was introduced in Portugal (lead CA) in
1999. The applicant withdrew the application on 27 January 2003. As already discussed, an
application for the approval of LL soybeans under Di rective 90/220 had been previously submitted to
Belgium (EC-71, see above) and the evaluation of th at application by Belgium was ongoing when the
application in Portugal was withdrawn.
7.823 The United States claims that this application was delayed at the member State level.
7.824 Argentina asserts that in this case, the European Communities blocked the marketing of the
product, given the suspension of, or failure to consid er, the application. Argentina further notes that

869 Exhibit EC-80/At. 12.

in the case of this product the European Communitie s neither processed the application nor conducted
the required risk assessment. Argentina asserts th at there is no scientific justification for the
suspension of the approval procedures, as the "initial reports" were not prepared, and considers this to
be a "failure to consider" the application for LL soybeans (EC-81).
7.825 The European Communities notes that after discussions between the lead CA and
 the
applicant, the application was withdrawn by the ap plicant's letter of 27 January 2003. The product
had been previously notified in Belgium, and th e evaluation of that application in Belgium was
ongoing.
7.826 The Panel notes that no dossier was submitted as eviden ce for this application with regard to
the approval procedure in Portugal. We understand fro m the record that in evaluating applications for
placing on the market at the time in question, Port ugal's CA generally took into consideration the
application submitted by the applicant and the advice from the Ministry of Agriculture, the Ministry
of Health and the Institute for Experimental and Technological Biology (IBET).
7.827 In a December 1999 opinion on the application concerning LL soybeans (EC-81), the
Ministry of Agriculture noted lack of informa tion on environmental impacts and lack of region-
specific studies.
870 In January 2000, the Ministry of Health noted that the application was not clear
about whether there was an intention to cultivate this product, and that the molecular characterization
provided was insufficient.871 The Ministry of Health also noted the need to have a toxicological study
of the associated herbicide. The Ministry of Health asked Portugal's CA to obtain clarification, and so
in January 2000 Portugal's CA requested additional information from the applicant. In May 2000, the
IBET, in the opinion it provided to Portugal's CA, noted several areas in which the analyses presented
were somewhat incomplete and concluded that "hav ing due regard to the grounds for caution and the
need to clarify the abovementioned points in doubt, there do not, however, appear to be any objective
reasons for regarding these soybeans as 'unsafe' to us e, at least when compared with other equivalent
products currently on the market". 872 Following IBET's advice, the Portuguese CA sought further
clarification from the applicant in May 2000.
7.828 After a 16-month delay, in September 2001, th e applicant responded to questions from the
Ministry of Health and IBET, providing additio nal information on nutritional composition and
molecular characterization. 873 In October 2001, the Portuguese CA acknowledged receipt of the
information and indicated that the information w ould be assessed by the Ministry of Health and
IBET.874
7.829 In November 2001, the Portuguese CA proposed to the applicant that it updates the
application under Directive 2001/18, which had b een adopted in March 2001. The Portuguese CA
pointed out that its initiative was in accordance with a July 2000 proposal by the Commission whose
aim it was "to allow the different Member States to vote on and approve, where appropriate, the
Commission's proposals for decisions authorizing the placing on the market of notified products
before the new Directive enters into force." The Portuguese CA's letter further notes that "although
the requested reformulation of the application is voluntary, given the complex situation currently
prevailing in Europe with regard to authorizati ons for the placing on the market of new genetically
modified products we consider it to be absolutely necessary" in order to present the application for

870 Exhibit EC-81/At. 2.
871 Exhibit EC-81/At. 3.
872 Exhibit EC-81/At. 6
873 Exhibit EC-81/Ats. 7 and 8.
874 Exhibit EC-81/At. 9

assessment by the member States.
875 The letter asked the applicant to let the Portuguese CA know
whether it accepted the CA's proposal. The appli cant responded that it would be providing the
requested documentation as soon as possible.876. However, the applicant does not appear to have done
so.
7.830 In January 2002, the Ministry of Health rai sed further questions particularly related to
molecular characterization. 877 There is no record of a res ponse from the applicant addressing this
request for information. In January 2003, one year after the last request for information from the lead
CA, the applicant withdrew the application citing "various reasons" for the withdrawal.878
7.831 It is clear from the foregoing that the progress of this application was adversely affected
notably by two elements: (i) the time taken by the applicant to respond to the January and May 2000
requests for information and (ii) the failure of the applicant to update the application under
Directive 2001/18, as proposed by the Portuguese CA in November 2001.
7.832 In considering Portugal's conduct, we note th at the United States and Argentina do not assert
that at the time of the January and May 2000 requ ests for additional information or in November
2001, Portugal was an active participant in the a lleged moratorium on appr ovals. Indeed, Portugal
was not one of the Group of Five countries. We also note that Portugal was not part of the Group of
Seven countries which declared that they would ta ke a thoroughly precautionary approach in dealing
with applications for the placing on the market of biotech products.
7.833 Concerning Portugal's 2001 proposal that the a pplicant update its application in accordance
with the requirements of Directive 2001/18, the first thing to be noted is that Portugal made it clear
that doing so was voluntary. However, Portugal also indicated its view that, in view of the "complex
situation currently prevailing in Europe", the update was "absol utely necessary" in order for the
application to be approved at Community level. The reference to a "complex situation currently
prevailing in Europe" could be a reference to a general moratorium on final approvals. Indeed,
Portugal suggested that complia nce with certain Directive 2001/ 18 requirements was a necessary
condition for approval; it did not suggest that this w ould lead to approval. But the reference to a
"complex situation" could also be a reference to the fact that there was opposition among member
States to approving under Directive 90/220 applicati ons which did not meet the main requirements of
Directive 2001/18. We recall in this regard that already before Directive 2001/18 had been adopted,
in June 1999, the Group of Seven countries stated that to the extent legally possible they wished to see
applied the principles, especially regarding traceab ility and labelling, laid down in the Council's
Common Position of June 1999 concerning the revision of Directive 90/220. Therefore, we consider
that the November 2001 proposal of the Portuguese CA does not provide confirmation of the asserted
fact that the European Communities at the time a pplied a general moratori um on final approvals.
However, it is consistent with that assertion.
7.834 It should be added that as of January 2003, wh en it was withdrawn by the applicant, the
application concerning LL soybeans (EC-81) had not reached the Community level phase of the
approval procedure under Directive 90/220. In othe r words, it had not yet reached the procedural
stage where the Group of Five countries and/or the Commission could have taken action to delay or
prevent its final approval.

875 Exhibit EC-81/At. 11.
876 Exhibit EC-81/At. 12.
877 Exhibit EC-81/At. 13.
878 Exhibit EC-81/At. 15.

7.835 In the light of the above considerations, we conc lude that the failure of Portugal to complete
its assessment of the application concerning LL so ybeans (EC-81) prior to January 2003, when the
application was withdrawn, is consistent with th e contention of the Complaining Parties that the
European Communities applied a general moratorium on final approvals during the relevant period of
time.
LL oilseed rape (EC-72)
7.836 The application concerning LL oilseed rape was submitted to the United Kingdom (lead CA)
on 28 January 1999. When Directive 90/220 w as repealed on 17 October 2002, the United Kingdom
had not yet forwarded the dossier to the Commission. The applicant submitted an updated application
on 13 January 2003 in accordance with Directive 2001/ 18. The application was still pending at the
time of establishment of the Panel. It was withdrawn by the applicant on 26 March 2004.
7.837 The United States argues that this application was delayed at the member State level for
more than four years. The Un ited States submits that although the applicant provided answers to all
of the questions raised by the lead CA, the l ead CA nonetheless delayed and ultimately suspended
consideration or failed to approve the product.
7.838 The European Communities argues that the lead CA request ed some additional information
after having initially received the application. Afte r having received that information, the lead CA
forwarded the dossier for a preliminary view to its scientific committee, the Advisory Committee on
Releases to the Environment (hereafter ACRE). Th e ACRE found that the dossier not only showed
inconsistent data on molecular characterization but was also generally "rather impenetrable". In
December 1999, the dossier was sent back to the applicant for "substantial revision and clarification".
7.839 According to the European Communities, the applicant did not get back to the lead CA on this
dossier for almost two years. Contact was only re-established towards the end of 2002 when the
applicant inquired about what was needed to up- date the dossier under the new Directive 2001/18.
The applicant sent some up-dated documents in January 2003, but not the full dossier. The lead CA
requested completion of the up-dated application and the applicant provided further data, which
required further clarifications and led the lead CA to suggest that the full dossier should be re-
submitted. In March 2004, the applicant withdr ew the pending application and submitted a new
application a few days later. According to the Euro pean Communities, at the time of establishment of
the Panel the new dossier was in the course of being assessed by the lead CA. The European
Communities maintains that it cannot be responsible for delays arising at the instigation of the
applicant.
7.840 The Panel understands from the record that the lead CA made some preliminary requests for
additional information in the months following receipt of the application. Some, but not all, of the
additional requests from the lead CA are included in the information provided to the Panel. For
example, a letter from the lead CA dated 20 July 1999 requests that the applicant provide further
information and clarification on points raised in an annex to the letter; however the annex has not
been provided.
879 There is, moreover, no record of a response from the applicant to this request.
7.841 In November 1999, the lead CA apparently re quested the ACRE to provide guidance to the
lead CA as to where the application needed impr ovement and noted that the ACRE would be asked
for formal advice only at a later stage. The prel iminary advice by ACRE was that there were a
number of inconsistencies in the molecular data pr ovided, some deficiencies in the molecular studies

879 Exhibit EC-72/At. 11.

and too much important material was in annexes rath er than being in the core dossier. It was noted
that the appropriate experimental data may have been supplied some where in the application dossier
but it was not immediately obvious where it might be.
880 As advised by ACRE, the lead CA in
December 1999 requested that the applicant undertake substantial revision and clarification of the
dossier. The lead CA suggested a meeting with the applicant later in the same month to provide the
applicant with some guidance. There is no evidence in the information before the Panel that such a
meeting took place, and that the applicant provided what was requested in December 1999.
7.842 On 16 January 2003, the applicant submitted an updated application under Directive 2001/18
to the lead CA. 881 In acknowledging receipt of the updated application, the lead CA indicated, on 27
January 2003, that the dossier was still incomplete and information requested in July and December
1999 was still missing. 882 Further requests for clarifications or modification of the application were
made by the lead CA in the first half of 2003, with responses apparently provided by the applicant in
May 2003. 883 On 13 June 2003, the lead CA requested fu rther clarifications and suggested that a
complete version of the application be re-submitted.884 On 26 March 2004, the applicant withdrew the
application, saying that certain elements of that application were incomplete or out-of-date, and
submitted a new one (C/GB/04/M5/4). 885 No information was provided to the Panel regarding the
assessment of the new application.
7.843 It is clear from the foregoing that the consideration of the application concerning LL oilseed
rape was delayed for almost two years between 2 December 1999 and the repeal of Directive 90/220
in October 2002, following a letter from the lead CA advising the applicant that the dossier required
substantial revision and clarification. Based on the information submitted to us, we understand that
this gap was caused by the failure of the app licant to provide the additional information and
clarification requested in July and December 1999. However, the precise reasons for the failure of the
applicant to respond to the information solicited by the lead CA in July and December 1999 are
unclear.
7.844 We asked the experts advising us whether the in formation requested by the lead CA up to and
in December 1999 was necessary to ensure that conclusions of th e safety assessment were valid. 886
Dr. Nutti, the only expert who responded to this qu estion, concurred that the deficiencies in the
application as identified by the ACRE were such that the requested information was necessary for the
safety assessment.887
7.845 Nonetheless, the circumstance that the applican t apparently never responded to the July and
December 1999 requests for additional information is consistent with the existence of a moratorium
on final approvals. Following the June 1999 declar ation by the Group of Five countries and the
failure by the Commission to complete some of the previously discussed approval procedures, we
think the applicant could have believed that the a pplication concerning LL oil seed rape would not be
approved while Directive 90/220 was still in force.
7.846 Taking account of the aforementioned elements, we consider that the gap between December
1999 and October 2002 does not in itself provide di rect confirmation of the existence of a general

880 Exhibit EC-72/At. 12.
881 Exhibit EC-72/At. 15.
882 Exhibit EC-72/At. 16.
883 Exhibit EC-72/Ats. 18 and 19.
884 Exhibit EC-72/At. 28.
885 Exhibit EC-72/At. 29.
886 Annex H, Panel Question 29.
887 Annex H, para. 600.

moratorium on final approvals. But in our view th e gap is consistent with the contention that a
general moratorium was in effect at the time.
7.847 Regarding the assessment of the application concerning LL oilseed rape under
Directive 2001/18, we recall our earlier summary of re levant facts. These facts do not lead us to
believe that the lead CA was deliberately delaying the consideration of this application. We also note
in this respect that the United States does not assert that the United Kingdom was an active participant
in the alleged moratorium on approvals. Indeed, the United Kingdom was not part of the Group of
Five countries. However, as of August 2003, when this Panel was established, the application
concerning LL oilseed rape had not reached the Community level phase of the approval procedure
under Directive 2001/18. In other words, it had not yet reached the procedural stage where the Group
of Five countries and/or the Commission could have taken action to delay or prevent its final
approval.
7.848 In the light of the above considerations, we conclude that the failure of the United Kingdom
to complete its assessment of the application c oncerning LL oilseed rape prior to August 2003 is
consistent with the contention of the Complaini ng Parties that the European Communities applied a
general moratorium on final approvals during the relevant time period.
BXN cotton (EC-73)
7.849 The application concerning BXN cotton was subm itted to the Spanish CA (lead CA) in April
1999. When Directive 90/220 was repealed on 17 Oc tober 2002, the lead CA had not yet forwarded
the dossier to the Commission. An updated application was submitte d on 16 January 2003, in
accordance with Directive 2001/18. According to the European Communities, the application was
withdrawn after the establishment of the Panel.
888
7.850 The United States argues that this application was delayed at the member State level for
more than four years. The Un ited States submits that although the applicant provided answers to all
of the questions raised by the lead CA, the l ead CA nonetheless delayed and ultimately suspended
consideration or failed to approve the product.
7.851 The European Communities argues that the lead CA forwar ded the dossier to its scientific
committee, the National Biosafety Committee, which f ound that the dossier needed to be improved.
A considerable amount of information was mi ssing on issues such as compositional analysis,
environmental impact, toxicity, nutritional analys is, and a number of points, such as scope, labelling
proposal, etc., had to be clarified. The lead CA forwarded these comments to the applicant in July
1999.
7.852 According to the European Communities, afte r a first exchange of correspondence, the
applicant did not respond to the lead CA for three years, until January 2003, when the company which
produced the herbicide to which the cotton is tolera nt informed the lead CA that it had assigned this
pending application to anothe r company. The new applicant company submitted an up-dated
application in accordance with Directive 2001/18 on 16 January 2003.
7.853 The European Communities mainta ins that the lead CA forwarded the new dossier to the
National Biosafety Committee, which found that there were deficiencies in the molecular
characterization of the product. The lead CA fo rwarded these comments to the applicant in October
2003. In November 2003, the lead CA was asked by another company to clarify its request for

888 There is nothing in the record to confirm this EC assertion.

additional information. The lead CA has provided th ese clarifications and asked for an explanation of
the identity of the applicant. The European Communities notes that a response is still awaited.
7.854 The Panel begins its analysis by noting that despite its request in June 2004 that the European
Communities provide complete documentation re lating to the scientific assessments of all
applications, the documentation provide d in relation to this applicati on is incomplete. None of the
substantive information provided by the applicant, e ither with respect to the original application in
May 1999 or with the resubmission of the application in January 2003, has been made available. This
makes it very difficult to put into context the requ ests for clarification and for further information
from the lead CA.
7.855 We note that the application was first submitted in May 1999, and in July 1999 the lead CA
submitted questions and requested further information from the applicant. The applicant responded in
September 1999, clarifying, inter alia, that the application was both for the import and processing of
seeds of BXN cotton as well as for the cultivation of BXN cotton. Following the further examination
of the application in January 2000 by the Span ish National Biosafety Committee, the lead CA
requested further clarifications on some of th e same issues in a communication dated 2 February
2000.
889 The applicant did not respond to this request before an updated application was submitted in
January 2003 under Directive 2001/18.890
7.856 The communication from the lead CA in February 2000 made five points. One was to note
that the National Biosafety Committee saw fit to requ est the Ministry of Agriculture to register the
associated herbicide for use on this cotton product. Another was to instruct that references to the
OECD in relation to the certification of varieties be deleted as not relevant . Two of the remaining
points appeared to be related to food and feed safety concerns: that new analyses be conducted
regarding the nitrilase level in cottonseed oil, and that the studies proposed on animals fed on feed
derived from this product be c onducted under normal livestock feedi ng conditions in Spain. The
remaining point was to request rewording of the te xt with reference to gentamicine resistance.
Although this would appear to be a concern about po tential risks to human or animal health arising
from antibiotic resistan ce, without the text of the application it is not possible to confirm that this is
indeed a food safety issue.
7.857 The Panel asked the experts advising it whether the information requested by the lead CA up
to and in February 2000 was necessary to ensure that conclusions of the safety assessment were
valid.891 The experts noted that only the table of cont ents of the actual submission by the applicant
had been provided, and the response from the applican t. On the basis of this limited information,
Dr. Nutti was of the view that the responses provide d by the applicant in September 1999 appeared to
be satisfactory as far as food safety was concerned. These responses provided clarification or
explanations of information that presumably was contained in the original application.
892 Dr. Andow
noted that the information previously requested by the lead CA was normally necessary to assess
environmental risks, particularly those related to the cultivation of the plant. However, without the
application itself, he could not determine to what extent relevant information may have already been
provided by the applicant, or how much additi onal information might be necessary. Dr. Andow
further observed that, according to the table of conten ts, only two pages of the text of the application
were devoted to issues relating to environmental im pact studies, herbicide or residue toxicity or

889 Exhibit EC-73/At. 6.
890 This is confirmed by Exhibit EC-73/At. 12.
891 Annex H, Panel Questions 30 and 31.
892 Annex H, para. 601.

ecotoxicity tests or proposals to manage, monitor an d handle the crop to reduce the risk of herbicide
resistance in weeds.
893
7.858 An updated application was submitted in January 2003 under Directive 2001/18 and
completed in March 2003. Again, the application itsel f has not been provided to the Panel. It seems
that the application now concerned the importa tion of seed for processing, but not cultivation. 894 In
August 2003, when this Panel was established, the ap plication appears to have been under review by
the National Biosafety Committee.895
7.859 It is clear from the foregoing that in this procedure a delay of more than two and a half years
occurred between February 2000, when the lead CA requested clarifications, and October 2002, when
Directive 90/220 was repealed. Based on the information submitted to us, we understand that this gap
was caused by the failure of the applicant to pr ovide the requested clarifications. However, the
precise reasons for the failure of the applicant to respond to the lead CA's February 2000 request are
unclear.
7.860 We recall that, due to incomplete information, the experts advising us were unable to express
definitive views on whether the clarifications requ ested by the lead CA in February 2000 were
necessary to ensure that conclusions of the safety assessment were valid. Nonetheless, the
circumstance that the applicant did not respond to the February 2000 request is consistent with the
existence of a moratorium on final approvals. Fo llowing the June 1999 declaration by the Group of
Five countries and the failure by the Commission to complete some of the previously discussed
approval procedures, we think the applicant could have believed that the application would not be
approved while Directive 90/220 was still in force.
7.861 The European Communities has surmised that th e failure to pursue this application may be
due to the numerous changes in the ownership of the producing company as well as in the rights on
the pending application. From information provid ed by the European Communities it appears that in
1999 and 2001, the applicant from the EU was merged with or taken over by other EU companies.
Subsequently, in 2003, the lead CA was informed that the rights to the application had been
transferred to a US company. It is unclear wh en the application was assigned to the relevant US
company. Based on the information before us, we think it is conceivable that the aforementioned
changes in ownership had an impact on the efforts made by the applicant in pursuit of its application.
7.862 Taking account of the aforementioned elements, we consider that the gap between February
2000 and October 2002 does not in itself provide di rect confirmation of the existence of a general
moratorium on final approvals. But in our view th e gap is consistent with the contention that a
general moratorium was in effect at the time.
7.863 Turning to Spain's assessment of the application concerning BXN cotton under
Directive 2001/18, we note that the updated notif ication was submitted to Spain on 16 January
2003.896 It was not until 14 February 2003, i.e., almost one month later, that the lead CA requested
the applicant to submit a summary of the application as required by Directive 2001/18. 897 T h e
applicant provided such a summary on 19 March 2003, and thus the updated application appears to

893 Annex H, paras. 604-612.
894 Exhibit EC-73/At. 12.
895 There is no information about when the application was submitted to the National Biosafety
Committee.
896 Exhibit EC-73/At. 8.
897 Exhibit EC-73/At. 9.

have been complete as of that date.
898 The application was apparently forwarded to the National
Biosafety Committee for an assessment, but as of August 2003 that assessment had not yet been
completed. The record shows that the assessment was completed in September 2003. 899 From the
record of the consideration of this application by the National Biosafety Committee, it is clear that the
Committee had also been reviewing the applica tions concerning Bt-531 cotton and RR-1445 cotton,
for which Spain was also the lead CA. However, we recall that pursuant to Directive 2001/18, the
lead CA is to prepare an assessment report within 90 days after receipt of an application. It should
also be noted in this connection that the Nati onal Biosafety Committee's assessment concerning BXN
cotton is quite short i.e., there is no indication that the preparation of the report itself required much
time.
7.864 While there is no indication that Spain in 2003 was actively supporting a general moratorium
on final approvals, we consider that the fact th at by August 2003 Spain had already exceeded the 90-
day period to complete its assessm ent under Directive 2001/18 is consistent with the existence of a
moratorium on final approvals. 900 Following the June 1999 declaration by the Group of Five
countries, Spain had reason to believe that these co untries would act as a "blocking minority" in the
Regulatory Committee and the Council at least pending the adoption of new EC rules on labelling and
traceability901, and that, as in the case of some of the pr eviously discussed approval procedures, the
Commission would not complete the approval proce dure in the face of systematic opposition by the
Group of Five countries.
7.865 In the light of the above considerations, we c onclude that the failure of the Spanish CA to
complete its assessment of the application c oncerning BXN cotton under Directive 90/220 is
consistent with the contention of the Complaini ng Parties that the European Communities applied a
general moratorium during the relevant time period. We further conclude that the time taken by Spain
to assess the application concerning BXN cotton unde r Directive 2001/18 is consistent with the
contention of the Complaining Parties that the Eu ropean Communities applied a general moratorium
during the relevant time period.
Bt-1507 maize (EC-74)
7.866 The application concerning Bt-1507 maize (EC-74) was first submitted to the Netherlands CA
(lead CA) in November 2000. The scope of the application was for import of maize for processing
and for use as food and feed. A separate appli cation was submitted to the Spanish CA for the
cultivation of the product, which we hereafter re fer to as the application concerning Bt-1507 maize
(EC-75). We will discuss that application separatel y below. When Directive 90/220 was repealed on
17 October 2002, the Netherlands CA had not yet fo rwarded the dossier to the Commission. An
updated application was submitted in November 2002 under Directive 2001/18. The lead CA
completed its initial assessment of the application and submitted the application to the Commission on
15 August 2003.
7.867 The United States argues that this application was delayed at the member State level for
several years, and was not submitted for a decision by the Regulatory Committee. The United States

898 Exhibit EC-73/At. 10.
899 Exhibit EC-73/At. 12.
900 Since the application was not complete until March 2003, it would appear that the 90-day period
started to run as of that time.
901 We note that Exhibit US-80, which contains an internal Commission note, suggests that several
Group of Five countries in Octobe r 2001 expressed the view that ne w EC rules on labelling and traceability
needed to enter into force before new biotech products could be approved.

submits that although the applicant provided answers to all of the questions, the lead CA nonetheless
delayed consideration of the product. The United St ates explicitly contests the justifiability of one of
the information requests by the lead CA, as well as of a number of the objections raised by other
member States following the circulation of the application by the Commission.
7.868 The European Communities argues that following receipt of this application, the lead CA
requested additional information on molecular charact erization, allergenicity and toxicity of CRY1F,
and on labelling. Exchanges with the applicant on these issues went on until almost the end of 2002.
In two instances, the applicant requ ested an extension of the time granted by the lead CA to submit
further data or information. The applicant updated the application just after the entry into force of
Directive 2001/18. After a further exchange on compositional data, a monitoring plan, and
confidentiality of the detection method, the lead CA submitted the full application and its assessment
report to the Commission in August 2003. Once th e application reached the Community level, a
considerable number of objections were raised by member States, including on environmental effects,
the monitoring plan, molecular characterisation, sampling and detection methods, allergenicity and
toxicity. The Commission forwarded the dossier to EFSA for an opinion in February 2004, together
with a summary of the remaining objections from se ven member States. The European Communities
argues that the facts demonstrate that there was neith er a suspension of consideration nor a failure to
approve this product.
7.869 The Panel notes that there was frequent communication between the lead CA and the
applicant on this application from the time the application was initially submitted under
Directive 90/220 until the lead CA sent its assessme nt report to the Commission on 15 August 2003.
Although extensive documentation was provided to us, it was presented in a manner which did not
facilitate its consideration (som e documents were reproduced up-s ide down or sideways, others
mislabelled or duplicated, for others only the tables of content were provided).
7.870 The United States explicitly questions the jus tifiability of only one of the requests for
additional information made by the lead CA, a re quest of 13 December 2001 for additional field trial
data. Other US arguments concern objections and requests for additional information from other
member States which were made subsequent to the establishment of the Panel and hence are not
specifically taken into account.
7.871 We note that in response to the March 2001 re quest from the lead CA the applicant on 16
October 2001 provided field trials from Chile, France and Italy, which it considered representative for
the cultivation areas exporting maize to the European Communities.
902 On 13 December 2001, the
lead CA indicated that it was not convinced by th e response and maintained its request. Specifically,
the lead CA indicated that it was not convinced that these locations would be representative of
locations exporting maize to the European Communiti es. It therefore requested that the applicant
conduct additional field trials and provide compositional data for two consecutive growing seasons.903
The applicant addressed this further request for additional field trials in its responses of 21
November 2002. It provided arguments as to why the results of the field trials for 1998/1999 from
Chile, France and Italy should be considered to be sufficient, and also submitted the results of field
trials for 1999/2000 from Bulgaria, France and Italy.
904 On 10 February 2003, the lead CA indicated
that it accepted this response, but requested that th e data provided from the field trials in Chile be

902 Exhibit EC-74/At. 33.
903 Exhibit EC-74/At. 52.
904 Exhibit EC-74/At. 65, response to Panel Question 3.

presented in the same detail and manner as for France and Italy, and suggested a format.
905 This was
apparently done by the applicant on 24 March 2003.906
7.872 The United States argues that when the lead CA on 13 December 2001 rejected the applicant's
compositional data from field trials that had been conducted in France, Italy and Chile, on the grounds
that these locations were insuffici ently representative of locations exporting maize to the European
Communities, the lead CA provided no explanati on for its conclusion that the locations were
"insufficiently representative." The United States ar gues that the data provided by the applicant in
October 2001 would generally be c onsidered "representative" and re levant for evaluating maize that
might be imported into the European Communities. The United States maintain s that, in the absence
of some further explanation, such as an anomaly in the submitted data, the only explanation for the
lead CA's request for additional field trials of 13 December 2001 appeared to be the resulting two-
year delay caused by the time it would take for the applicant to generate the data.
7.873 We sought advice from the experts advising us as to whether the field trials in France, Italy
and Chile would provide compositional data on maize kernels that would be relevant to evaluating
cultivation areas exporting maize to the European Co mmunities. Dr. Nutti drew attention to the
Codex Alimentarius Guidelines for the Conduct of Food Safety Assessment of Foods Derived from
Recombinant-DNA Plants907 which state that the location of the trials sites should be representative of
the range of environmental conditions under which the plant varieties would be expected to be grown.
The number of trial sites should be sufficient to allow accurate asse ssment of compositional
characteristics over this range. Similarly, trials should be conducted over a sufficient number of
generations to allow adequate exposure to the variety of conditions met in nature.
7.874 Dr. Nutti considered that the field tests in Fr ance, Italy and Chile could be considered as
supplementary information to previous tests carri ed out by the applicant, although she did not
consider that they were necessary, in particular since the maize in question was for importation and
processing and not for cultivation. 908 Dr. Andow noted that it was likely that for some industrial uses
of maize, e.g., as biofuel, there was little need to dis tinguish among regional sources. However,
without data supporting this lack of need to distinguish geographic sources, it was not possible, in his
view, to determine if maize from Chile would in f act be representative of maize from other regions of
the world. He further observed that the scientific rationale for the request for compositional data was
not evident from the written record. He consider ed it essential that the lead CA provide such a
rationale concomitant with the request for inform ation, because many of the possible reasons for
requesting such information were not necessary for completing a scientific risk assessment.909
7.875 In considering the December 2001 request by the l ead CA for further field trials, we note that
the United States does not assert that, at that time, the Netherlands was an active participant in the
alleged moratorium on approvals. However, the United States contends that the Netherlands was
placed in a position of having to recognize the morato rium as a reality and that this affected how it
assessed applications.
7.876 We consider that following the June 1999 d eclaration by the Group of Five countries, the
Netherlands had reason to believe that the Group of Five countries would act as a "blocking minority"
both in the Regulatory Committee and in the Counc il pending the adoption of new EC rules on

905 Exhibit EC-74/At. 84.
906 Exhibit EC-74/Ats. 87-88.
907 CAC/GL 45-2003, para. 45.
908 Annex H, para. 626.
909 Annex H, para. 635

labelling and traceability. The Commission made a proposal for such rules in July 2001. In our view,
the Netherlands also had reason to believe that, as in the case of some of the previously discussed
approval procedures, the Commission would not co mplete the approval procedure in the face of
systematic opposition by the Group of Five countries. Consequently, the Netherlands could in our
view have come to the conclusion in 2001 that th ere was no realistic prospect that the application
concerning Bt-1507 maize (EC-74) could be approved prior to the repeal of Directive 90/220.
7.877 Against this background, we accept that it is possible that the lead CA's December 2001
request for further field trials could, as the Un ited States argues, be explained as a way to delay
consideration of the application concerning Bt-1507 (EC-74) so that it would not be forwarded to the
Commission and the other member States until the en try into force of Directive 2001/18, under which
the application might eventually be approved, af ter the adoption of new EC rules on labelling and
traceability. The fact that the applicant's response to the December 2001 request did not come until
after the repeal of Directive 90/220 is consistent with this explanation. However, the applicant's
response was provided together with responses to a request of March 2002 for other additional
information which has not been questioned by the Un ited States. It is therefore not clear that the
resulting delay is attributable solely to the request for additional field trials.
7.878 It must also be noted that the Netherlands was part of the Group of Seven countries which
declared in June 1999 that they would take a thoroughly precautionary appr oach in dealing with
applications for the placing on the market of biotech products. In our view, the December 2001
request for additional field trials could also reflect a precautionary approach to evaluating
applications. The views expressed by the experts advising us do not appear to rule out this possibility.
7.879 Taking account of the aforementioned elements, we consider that the December 2001 request
by the Netherlands for additional field trials does not in itself provide direct confirmation of the
existence of a general moratorium on final approvals. But in our view the request is consistent with
the contention that a general moratorium was in effect at the time.
7.880 We note that after the applicant had provided an updated application in November 2002, the
lead CA requested further information from the a pplicant on 10 February 2003 with respect to a
surveillance plan and the confidentiality of the propo sed detection method. Furthermore, as noted, in
February 2003 the lead CA dropped its request for the additional field trials, but requested that the
data be presented in a uniform manner. The responses to these requests were provided by the
applicant on 24 March 2003, and on 28 May 2003 the applicant withdrew the request for
confidentiality with respect to the detection method.
7.881 In the light of the foregoing, we consider that by the end of March 2003 the lead CA had all
the elements to complete its safety assessment. The outstanding clarification of the confidentiality
issue should not have delayed the completion of the safety assessment itself. In any event, as we have
noted, the confidentiality issue was resolved in May 2003. Notwithstanding this, the lead CA did not
send its completed assessment report to the Commission until 15 August 2003.
7.882 We recall that in accordance with the require ments of Directive 2001/18 the lead CA was to
have transmitted its completed assessment report at the latest 90 days after receipt of the updated
application. As we have already pointed out, fo llowing the receipt of the application in November
2002, the lead CA reviewed the application for more than two and a half months before forwarding its
request for additional information. After receivi ng the applicant's response in March 2003, the lead
CA took an additional period of time of more than f our and a half months to complete its assessment
report and transmit it to the Commission. Thus, by the time the lead CA sent its assessment report to

the Commission it had taken more than seven months to evaluate the updated application instead of
the 90 days envisaged in Directive 2001/18.
7.883 We have observed earlier in respect of the 90-day deadline stipulated in Directive 2001/18
that that deadline provides a useful indicator for determining how much time might be needed to
complete an assessment. As we have said, in the case of the application concerning Bt-1507 maize
(EC-74), by the end of March 2003 the lead CA ha d all the elements to complete its safety
assessment. Even if the lead CA at that point in time had taken a full 90-day period to complete its
assessment, it would have completed its assessment befo re the end of June 2003. By that time, as
noted, the confidentiality issue had also been resolved.
7.884 While there is no indication that the Netherla nds in 2003 was actively supporting a general
moratorium on final approvals, we consider that th e fact that the Netherlands exceeded the 90-day
period even after it had received all necessary inform ation is consistent with the existence of a
moratorium on final approvals. Following the June 1999 declaration by the Group of Five countries,
the Netherlands had reason to believe that these coun tries would act as a "blocking minority" in the
Regulatory Committee and the Council at least pending the adoption of new EC rules on labelling and
traceability
910, and that, as in the case of some of the pr eviously discussed approval procedures, the
Commission would not complete the approval proce dure in the face of systematic opposition by the
Group of Five countries.
7.885 Moreover, we note that it was not until 15 August 2003 that the application concerning
Bt-1507 (EC-74) reached the Community level phase of the approval procedure under
Directive 2001/18. As we have said before, it is onl y at the Community level that the Group of Five
countries and/or the Commission could take action to delay or prevent the final approval of this
application.
7.886 In the light of the above considerations, we c onclude that the failure of the Netherlands to
complete its assessment of the application concer ning Bt-1507 maize (EC-74) earlier than in August
2003 is consistent with the contention of the Co mplaining Parties that the European Communities
applied a general moratorium during the relevant time period.
Bt-1507 maize (EC-75)
7.887 Neither the date of the initial submission of the application concerning Bt-1507 maize
(EC-75) to the Spanish CA (lead CA), nor the appl ication itself, have been made available to the
Panel. However, the lead CA acknowledged receipt of the application in a letter dated 11 July 2001.
The application was for all uses including cultiva tion. When Directive 90/220 was repealed on
17 October 2002, the lead CA had not yet forwarded the dossier to the Commission. The application
was updated in December 2002 under Directive 2001/18. On 5 August 2003, the lead CA submitted
the application and its assessment report to the Commission; it was circulated to all member States on
20 August 2003.
7.888 The United States argues that this application was delayed at the member State level for
several years, and was not submitted for a decision by the Regulatory Committee. The United States
submits that although the applicant provided answers to all of the questions, the lead CA nonetheless
delayed consideration of the product. The United St ates contests the justifiability of some of the

910 We note that Exhibit US-80, which contains an internal Commission note, suggests that several
Group of Five countries in Octobe r 2001 expressed the view that ne w EC rules on labelling and traceability
needed to enter into force before new biotech products could be approved.

information requested by the lead CA, and particularly of a number of the objections raised by other
member States following circulation of the lead CAs' assessment report by the Commission.
7.889 The European Communities argues that following a preliminary assessment of this
application by the Spanish National Biosafety Comm ittee, the lead CA requested further additional
information on molecular characterization, allerg enicity and toxicity of CRY1F, environmental
impact and a monitoring plan. These requests were dealt with by the applicant during the following
12 months, until 17 July 2002.
911 After the entry into force of Directive 2001/18, the applicant
updated the application in line with the requirements of the new legislation. Exchanges between the
applicant and the lead CA continued until the 28 May 2003. The lead CA submitted the full
application and its assessment report to the Commission on 5 August 2003.
7.890 The European Communities notes that the Commi ssion circulated the application to the
member States and received comments and objections from ten of them. These concern issues such as
molecular characterization, detection methods, non target organisms, monitoring plans, toxicity,
allergenicity and agricultural practices.
7.891 The Panel notes that there appeared to be at least two exchanges between the applicant and
the lead CA regarding requests for further inform ation before the repeal of Directive 90/220.
Unfortunately, although a considerable amount of documentation was provided to us, it was presented
in a manner which did not facilitate its considerati on. Many of the documen ts were mislabelled or
misrepresented in the chronologies provided by the European Communities; or they did not
correspond to the requests for information identified but rather to requests that occurred considerably
later.
7.892 As far as we have been able to determine, fo llowing the receipt of the application in July
2001, the lead CA consulted with its Nati onal Biosafety Committee and on 30 October 2001
requested additional information from the applicant based on the advice received from the Committee.
This request was apparently repeated in a comm unication of 28 November 2001. First and foremost,
the lead CA requested that field studies of Bt- 1507 maize (EC-75) be conducted in Spain. Other
requests concerned molecular characterization, pr otein expression, effects on target and non-target
species, and monitoring of resistance. A response was provided by the applicant on 14 February
2002, including information on field studies undertaken in Spain. Following further advice from the
National Biosafety Committee of 13 May 2002, on 17 June 2002, the lead CA submitted requests for
additional field studies and other additional informat ion about molecular characterization and protein
expression to the applicant. The applicant responded to these requests on 17 December 2002,
providing, inter alia, information on additional field studies undertaken in Spain. This was after the
date of repeal of Directive 90/220.
7.893 The application was apparently updated and re-submitted under Directive 2001/18 on 13
February 2003. The lead CA requested a specifi c recalculation on the molecular characterization,
additional information regarding toxicity studies, and information on herbicide use on 17 February
2003. Following a meeting between the applicant a nd lead CA on 28 February 2003, the applicant
provided the requested information on 7 April 2003. Following another meeting between the
applicant and lead CA, the applicant submitted a re vised updated application on 28 May 2003. The
updated application was forwarded along with a positive assessment by the lead CA to the
Commission on 5 August 2003. It was circulated by the Commission to member States on 20 August
2003, with a deadline for comments of 19 October 2003. On the date of estab lishment of the Panel,
the application was thus being reviewed by the member States.

911 Exhibit EC-75/Ats. 1-3.

7.894 It is clear from the foregoing that the assessment of the application concerning Bt-1507 maize
(EC-75) under Directive 90/220 was delayed as a consequence of two requests for information from
the lead CA in November 2001 and June 2002, respec tively. We sought advice from the experts as to
whether the information requested by the lead CA in November 2001 on molecular characterization,
allergenicity, toxicity and environmental impact were necessary to ensure that the conclusions of the
safety assessment were valid.
912 The experts were unable to assess the original application as it was
not provided to the Panel. Dr. Nutti noted, however, that the subsequent explanations and information
provided by the applicant with regard to protein to xicity and allergenicity were correct, very well
detailed and comprehensive. 913 Dr. Andow opined that the requests for further information on
toxicity, including the toxicity of degradation pr oducts of Cry1F or PAT proteins, were necessary to
ensure that the conclusions of the safety assessment were valid. He also considered that there could
be a legitimate basis for requesting studies on non-target species of particular concern to Spain. He
noted that there was no scientific consensus regarding the need for field trials to be conducted in the
actual location of concern, but he considered th e question from the lead CA to be insufficiently
specific to guide the applicant in providing a resp onse and therefore concluded that the particular
question which was put forward by the lead CA was not necessary to ensure th at the conclusions of
the safety assessment were valid .914
7.895 In connection with the November 2001 and June 2002 requests for information, we further
note that on both occasions the lead CA waited for more than one month before forwarding the
questions suggested by the National Biosafety Co mmittee. This contrasts with other approval
procedures where Spain was also the lead CA a nd where the Spanish CA forwarded requests for
information from the National Biosafety Committee more promptly.915
7.896 In examining the lead CA's November 2001 and June 2002 requests for information, we note
that the United States does not assert that, at that tim e, Spain was an active participant in the alleged
moratorium on approvals. However, the United States contends that Spain was placed in a position of
having to recognize the moratorium as a reality and that this affected how it assessed applications.
7.897 We consider that following the June 1999 declaration by the Group of Five countries, Spain
had reason to believe that the Group of Five countri es would act as a "blocking minority" both in the
Regulatory Committee and in the Council pending th e adoption of new EC rules on labelling and
traceability. The Commission made a proposal for such rules in July 2001. In our view, Spain also
had reason to believe that, as in the case of some of the previously discussed approval procedures, the
Commission would not complete the approval proce dure in the face of systematic opposition by the
Group of Five countries. Consequently, Spain could in our view have come to the conclusion in 2001
that there was no realistic prospect that the app lication concerning Bt-1507 maize (EC-75) could be
approved prior to the repeal of Directive 90/220. Spain's conduct, notably the time taken by the lead
CA to forward questions from the National Biosafety Committee, is consistent with such a view, in
that it contributed to the application not being fo rwarded to the Commission and the other member
States until after the entry into force of Directive 2001/18.
7.898 We recognize that the application in this case was submitted and acknowledged just fifteen
months before the date of repeal of Directive 90/22 0. However, we do not consider that in September
2001, when the lead CA received the suggested qu estions from the National Biosafety Committee, the
lead CA could have legitimately concluded that it was impossible to complete the required steps and

912 Annex H, Questions No. 36 and 36(a).
913 Annex H, paras. 636-637.
914 Ibid, paras. 639-651.
915 See, e.g., the approval procedure concerning BXN cotton. Exhibit EC-73/Ats. 2-3 and 5 and 6.

have the application approved or rejected while Dire ctive 90/220 was still in force. It should also be
noted that Spain was part of the Group of Seven countries which declared in June 1999 that they
would take a thoroughly precautionary approach in dealing with applications for the placing on the
market of biotech products. However, even if we were to accept, taking account of the views
expressed by the experts advising us, that the Nove mber 2001 request for information might reflect a
precautionary approach to evaluating applications, th e delayed transmission of that request cannot, in
our view, be said to reflect such an approach.
7.899 We note that under Directive 2001/18, in Februa ry 2003, the lead CA requested further
information in response to the applicant's replies to the lead CA's request for information of June
2002. The applicant provided a response in April 2003 and a revised updated application in May
2003. The updated application was then forwarded to the Commission together with the lead CA's
favourable assessment report within three months, as required by Directive 2001/18. The fact that
after obtaining yet further information, the a pplication under Directive 2001/18 appears to have
moved promptly to the Community level in our view does not disprove the claim that a moratorium
on approvals was in place. As we have said, Spain could have considered that while Directive 90/220
was still in force, the Group of Five countries and the Commission would prevent the final approval
of the application in question, whereas after the en try into force of Directive 2001/18, the application
might eventually be approved, after the adoption of new EC rules on labelling and traceability.
7.900 In the light of the above considerations, we c onclude that Spain's failure to complete its
assessment of the application concerning Bt-15 07 maize (EC-75) earlier than in August 2003 is
consistent with the contention of the Complaini ng Parties that the European Communities applied a
general moratorium during the relevant time period.
Bt-11 maize (EC-80)
7.901 The application concerning Bt-11 maize (EC-80) was first submitted to the CA of Spain (lead
CA) on 29 May 1998. On 30 April 1999, the lead CA forwarded the application with a positive
assessment to the Commission. The application w as withdrawn by the applicant on 20 May 1999. In
withdrawing the application, the applicant refe rred to the parallel application which had been
submitted to France on 28 May 1996 (Bt-11 maize (EC- 69)), and which had been forwarded by the
French CA to the Commission on 4 April 1999 with a positive assessment.
7.902 The application concerning Bt-11 maize (EC-80) was for approval of the cultivation of this
product. It should be noted that Bt-11 maiz e (EC-163) had been approved in the European
Communities as of 22 April 1998 under Directive 90/220 for import and for processing.
7.903 The United States argues that this application was delayed at the member State level and was
not forwarded for consideration at the Community le vel. The United States submits that although the
applicant provided answers to all of the qu estions, the member State nonetheless delayed and
ultimately suspended consideration or failed to approve the product. The United States considers that
the delays in the consideration by the lead CA are evidence of the existence of a moratorium.
7.904 The European Communities argues that after discussions between the lead CA and the
applicant, this application was withdrawn on 20 May 1999. The applicant gave as the reason for its
withdrawal the existence of a parallel application made in France.
7.905 The United States argues that the companies had a st rong incentive to maintain cordial
relations with EC regulators and saw no advantage of complaining to EC regulators about the length
of the delays, which the United States maintains results from the moratorium.

7.906 The Panel begins by noting the United States' argument that the application concerning Bt-11
maize (EC-80) was not forwarded for consideration at the Community level. This is incorrect. This
application was submitted by the lead CA to th e Commission in April 1999 and thus did reach the
Community level; however, the applicant withdrew the application within a month of this referral.
7.907 The United States further argues that the delays in the consideration by the lead CA are
evidence of the existence of a moratorium. In consid ering this argument, we first recall that it is the
United States' contention that the European Communi ties applied a general moratorium as of October
1998. From the information provided to us, it a ppears that between October 1998 and April 1999 the
application was under assessment by Spain's Nati onal Biosafety Committee and by the Spanish CA.
There is no indication that in the period from October 1998 to April 1999 further information was to
be submitted by the applicant in response to requ ests for information. This period exceeds the 90-day
assessment period provided for in Directive 90/220. We therefore agree with the United States that
between October 1998 and April 1999 there were de lays in the consideration of the application
concerning Bt-11 maize (EC-80).
7.908 No explanation has been offered by the Europ ean Communities of the failure of the lead CA
to consider this application within the period of time foreseen in Directive 90/220. The United States
does not assert that Spain itself was an active partic ipant in the alleged moratorium on approvals and
that the time taken by Spain to complete its as sessment is a reflection of Spain's support for the
moratorium. Rather, its assertion is that the time taken by Spain reflects the impact of the
moratorium.
7.909 We note that the relevant delay in the consid eration of this application occurred between
October 1998 and April 1999, i.e., before the June 1999 declaration by the Group of Five countries.
Spain was not a part of the Group of Five countries. Spain was part of the Group of Seven countries
which declared in June 1999 that they would ta ke a thoroughly precautionary approach in dealing
with applications for the placing on the market of biotech products. Taking into account these
elements, we consider that the delay which occu rred between October 1998 and April 1999 neither
contradicts nor confirms the existence of a moratori um on final approvals as of October 1998. In our
view, a general EC moratorium on final approvals as of October 1998 could explain Spain's conduct
after 1998. Spain could have considered that strict compliance with the 90-day deadline was
effectively not necessary since in any event a final approval of the application concerning Bt-11 maize
(EC-80) would not be granted while the alleged mora torium was in effect. On the other hand, since
Spain in June 1999 formally declared that it w ould take a thoroughly precautionary approach, we
think it is also possible that Spain reviewed the appl ication particularly carefully and that this resulted
in unintended delays.
7.910 In our view, the fact that the applicant did no t specifically cite a general EC moratorium on
approvals as a reason for the withdrawal of the appli cation is not inconsistent with the United States'
assertion that the European Communities was applying a general moratorium on approvals as from
October 1998. As was pointed out by the Complaining Parties, if a moratorium was in effect, there
are plausible explanations for why the applicant di d not specifically cite the alleged moratorium or
resulting delays as a reason for withdrawing the application concerning Bt-11 maize (EC-80).
7.911 In the light of the above considerations, we conc lude that the failure by Spain to complete its
assessment of the application concerning Bt-11 maiz e (EC-80) earlier than in April 1999 is consistent
with the Complaining Parties' assertion that during the relevant time period the European
Communities applied a general moratorium on final approvals.

NK603 maize (EC-76)
7.912 In the approval procedure concerning NK603 maize, the applicant submitted an application to
Spain (lead CA) in August 2000. When Directive 90/220 was repealed on 17 October 2002, the lead
CA had not yet forwarded the dossier to the Co mmission. The application was forwarded with a
positive assessment to the Commission on 14 January 2003. The scope of the application covered
import and industrial use, including use as animal feed.
7.913 The United States argues that the application was delayed at the first stage of the approval
process under 90/220 because the lead CA declined to forward the application to the Commission.
Although the applicant provided answers to all of the questions raised by the lead CA, the lead CA
nonetheless delayed this product under Directive 90/220. The application remained at member State
level for a period of 25 months. This product was resubmitted under Directive 2001/18, and received
favourable initial assessments from the Spanish CA.
7.914 Canada argues that the total time taken by the lead CA for its review was 25 months, and that
only 13 of the 25 months were taken by the applican t to respond to questions. The difference of 12
months exceeds the 3-month period provided for in Directive 90/220.
7.915 Argentina notes that a risk assessment of NK603 maize was initiated under Directive 90/220
and re-initiated under Directive 2001/18. This wa s concluded with a favor able opinion from the
scientific panel. Argentina notes that, as of April 2004, the approval procedure concerning NK603
maize, which was initiated on 4 August 2000, had last ed 3 years and 8 months and no final decision
had been reached on the application for approval.
7.916 The European Communities claims that the only delays in the application for NK603 maize
arose due to questions on additional information; otherwise the application process has proceeded
smoothly. In addition, the European Communities asserts that the application submitted in August
2000 was incomplete and therefore not considered as received until January 2001. The European
Communities further claims that 44 days after th e application was submitted, the clock was stopped
because the scientific committee of the lead CA re quested additional information on issues such as
molecular characterization, nutritional composition, and environmental impact.
916
7.917 The United States notes that using the January 2001 date of receipt suggested by the
European Communities, and taking account of the "clock stop" when requested information was
awaited from the applicant, out of the total 25 months for which the application was at the CA level,
the European Communities had delayed action on the application for NK603 maize under
Directive 90/220 for 12 months.
7.918 The European Communities responds that, given that the applicant had taken 13 months to
gather additional information, it was not unreasonable that the lead CA required 12 months to digest
and process that information.
7.919 The Panel understands from the record that the app licant sent the first application to the
Spanish CA on 4 August 2000. Four months later, on 20 December 2000, the applicant resubmitted
the application in Spanish and apparently w ith additional studies added to the application. 917 We note
that there is no record of these additional studi es. The Spanish CA subsequently acknowledged
receipt of the letter on 2 January 2001.

916 Exhibit EC-76/At. 1.
917 Exhibit EC-76/At. 3.

7.920 It is clear from the record that the progress of this application was adversely affected notably
by two elements. First, the applicant took more than six months to provide information requested by
the lead CA in February 2001. Secondly, the applicant took more than five months to provide
information requested by the lead CA in October 2001.
7.921 Regarding the February 2001 request for information, we note that the lead CA requested
additional information concerning mo lecular characterization, nutriti onal analysis and environmental
impact of the product in question. We asked the experts advising us whether the information
requested by the lead CA in February 2001 was n ecessary to ensure that conclusions of the product's
safety assessment were valid.
7.922 Given that the application was for import and industrial use in the European Communities and
not for cultivation, Dr. Andow indicated that "some information is necessary to consider how gene
escape can occur either during processing, storage or transport, but detailed information is not
necessary." Thus, he concluded that requests for additional detailed enviro nmental studies were not
justified.
918
7.923 Dr. Nutti noted that the food safety information available to the lead CA seemed sufficient
given that substantial equivalence had been demonstrated in several feeding studies. 919 Dr. Nutti
stated that "whatever studies were further requested by the lead CA [...] were not necessary to ensure
that conclusions of the safety assessment were vali d since all the relevant information had already
been provided."
7.924 Regarding the October 2001 request for informa tion, we understand from the record that one
month after the applicant had submitted new informa tion in response to the request of February 2001,
in October 2001, the Spanish CA requested that a Polymerase Chain Reaction (PCR) be conducted,
and sought additional informati on on molecular characterization and details of the potential
environmental impact of accidental dissemination or germination. 920 More than five months passed
before the applicant responded with additional info rmation. After the applicant had submitted new
information in March 2002, the Spanish CA communicated persistent doubts.921
7.925 The United States notes that the Spanish CA had stressed that PCR should be used to detect
small DNA insertions because PCR provi des a greater degree of sensitivity. 922 The United States
argues that the use of some PCR-based method to de tect additional fragments potentially too small to
be seen by a Southern blot analysis was scientifically unjustified.
7.926 The European Communities claims that the re quest from the lead CA was scientifically
valid.923 According to the European Communities, th e additional data provided by the applicant
indicates that the use of PCR improved the sensitivity of the molecular characterization in comparison
to the data previously provided in the application. Therefore, although the applicant stressed that the
conclusion in relation to safety provided in th e application was not altered, the European
Communities maintains that the lead CA's request fo r additional information w as necessary to ensure
that conclusions of the safety assessment were valid.

918 Annex H, Dr. Andow's response to Panel Question 37.
919 Annex H, Dr. Nutti's response to Panel Question 37.
920 Exhibit EC-76/At. 10.
921 Exhibit EC-76/At. 14.
922 Exhibit EC-76/At. 10.
923 EC Comments on the experts replies, para. 462.

7.927 In relation to PCR, the Panel recalls that Dr. Nutti expressed the view that the initial
information regarding food safety seemed sufficient.
924 The Panel understands from the record,
however, that the Spanish CA emphasized that th e PCR is also considered "essential for product
traceability".925
7.928 In relation to the additional October 2001 requ ests for environmental information, Dr. Andow
noted that the applicant had not addressed this que stion of potential environmental impact of any
accidental dissemination or germination. He co mmented that the applicant "believes, probably
rightly, that the likelihood of accidental disseminati on and germination (exposure to the environment)
is small. If this is true, the applicant is arguing that when exposure is small, risk is small.
Consequently, the applicant may believe that it was not necessary to address this question." 926
However, Dr. Andow noted that the lead CA coul d believe that the potential risk associated with
accidental dissemination and germination could be la rge. Dr. Andow therefore concluded that this
request for information to be provided by the applicant was justified.
7.929 In considering the lead CA's February 2001 and October 2001 requests for information, we
note that the United States and Argentina do not assert that, at the time of these requests, Spain was an
active participant in the alleged moratorium on appr ovals. Indeed, Spain was not part of the Group of
Five countries. However, following the June 1999 d eclaration by the Group of Five countries, Spain
had reason to believe that the Group of Five countri es would act as a "blocking minority" both in the
Regulatory Committee and in the Council pending th e adoption of new EC rules on labelling and
traceability.927 In our view, Spain also had reason to be lieve that, as in the case of some of the
previously discussed approval procedures, the Commission would not complete the approval
procedure in the face of systematic opposition by th e Group of Five countries. Consequently, Spain
could in our view have come to the conclusion in 2001 that there was no realistic prospect that the
application concerning NK603 maize could be approved prior to the repeal of Directive 90/220.
7.930 Against this background, we consider that Spain could have been requesting information
which it would not otherwise have requested, and th at it was not concerned about any delays such
requests would entail, as it saw no possibility of the application being approved while
Directive 90/220 was still in force. The views expressed by the experts advising us are not
inconsistent with this possibility. As indicated previously, notably in the case of the February 2001
request the experts questioned the need for the information that was requested.
7.931 It must also be remembered, however, that Sp ain was part of the Group of Seven countries
which declared in June 1999 that they would ta ke a thoroughly precautionary approach in dealing
with applications for the placing on the market of bi otech products. In our view, the fact that the
experts questioned the need for the information that was requested in February 2001 does not rule out
the possibility that Spain was taking a precautionary a pproach to evaluating applications. Therefore,
we think the February 2001 and October 2001 request s for additional information could also be a
reflection of the June 1999 declaration by the Group of Seven countries.
7.932 Taking account of the aforementioned elements, we consider that Spain's February 2001 and
October 2001 requests for additional information do not in themselves provide direct confirmation of
the existence of a general moratorium on final approvals. But in our view these requests are
consistent with the contention that a general moratorium was in effect at the time.

924 Annex H, Dr. Nutti's response to Panel Question 37.
925 Exhibit EC-76/At. 10.
926 Annex H, Dr. Andow's response to Panel Question 38.
927 We recall that the Commission made a proposal for such rules in July 2001.

7.933 We note that at a very early stage, in August 2002, the applicant submitted an updated
application to satisfy the new requirements of Dir ective 2001/18. The applicant appears to have done
so at its own initiative.
928 In August 2002, it was already clear, however, that the approval procedure
concerning NK603 maize could not be completed under Directive 90/220. Consistent with the fact
that the update was submitted early on, the update d application was promptly forwarded to the
Commission with the lead CA's favourab le assessment report on 14 January 2003. 929 However, the
fact that under Directive 2001/18 the application m oved to the Community level very quickly in our
view does not disprove the claim that a moratorium on approvals was in effect. As we have said,
Spain could have considered that while Directiv e 90/220 was still in force, the Group of Five
countries and the Commission would prevent the fi nal approval of the application in question,
whereas after the entry into force of Directive 2001/ 18, the application might eventually be approved,
after the adoption of new EC rules on labelling and traceability.
7.934 In the light of the above considerations, we conc lude that the failure of Spain to complete its
assessment of NK603 maize earlier than in January 2003 is consistent with the contention of the
Complaining Parties that the European Communities applied a general moratorium during the relevant
time period.
GA21 maize (EC-85)
7.935 The application concerning GA21 maize (EC-85) was initially submitted to the United
Kingdom (lead CA) on 12 December 1997, for the import of grain and of derived products for animal
feed and processing. On 15 October 1999, the l ead CA submitted the application to the Commission
with its favourable assessment.930 The application was withdrawn on 27 June 2001.
7.936 The United States argues that this application was delayed at the member State level for
seven months. In February 1999, the Advisory Committee on Release into the Environment (ACRE)
notified the applicant that it would forward th e application to the Commission following some
amendments to the application. 931 On 23 March 1999 the applicant submitted the final and complete
amended application, as agreed between the app licant and the lead CA, which was ready to be
forwarded to the Commission as of that date. 932 The application, however, was delayed for more than
seven months for no discernible reason before it was finally sent to the Commission on 15 October
1999. More than four months after the positive ACRE opinion, the applicant explicitly inquired about
this delay in a letter dated 8 July 1999 to the Minister of the Environment, only to receive a reply back
four months later, on 2 November 1999, noting, without explanation, that the application "had
recently been forwarded" to the Commission.933
7.937 The United States observes that the chronology provided by the European Communities gives
the false impression that activity actually occurred on this application after April 1999 by referencing
an ACRE meeting on 16 September 1999. 934 As the minutes of that meeting show, however, GA21
maize (EC-85) was not on the agenda and was not discussed. There was no activity during this time
period on the side of the lead CA. The United Stat es maintains that these seven months of inaction
following the lead CA's positive risk assessment we re politically motivated. The exact application as

928 Exhibit EC-76/At. 18.
929 Exhibit EC-76/At. 27.
930 We recall that an application for the same product was submitted to Spain on 29 May 1998 (EC-78).
931 EC Exhibit 78 + 85/At. 22.
932 Exhibit US-145.
933 Exhibit US-146.
934 Exhibit EC-78 + 85/At. 24.

submitted by the applicant on 23 March 1999 was fi nally forwarded to the Commission without
further discussion or amendment.
7.938 Canada argues that the lead CA failed to submit the application to the Commission until
November 1999, well after the applicant had made cert ain amendments to the original application in
March 1999 in accordance with the agreement with the lead CA made in February 1999. That is, the
lead CA failed to forward the application to the Commission for 7.5 months. Canada argues that this
should be considered together with the fact that the lead CA had already spent 15.5 months for its
review with regard to the application since th e application was submitted by the applicant in
November 1997.
7.939 The European Communities argues that the delays at the me mber State level relating to this
application were due to the numerous requests for additional information. Furthermore, when the
application was withdrawn, the applicant cited as reasons for its withdrawal "unexpected commercial
constraints" and the parallel application in Spain.
7.940 The United States argues that the application was withdrawn because of the European
Communities' excessive delay in carrying out the ap proval process. The United States maintains that
although a company may not have cited undue delays in its withdrawal letter, over time, as the delays
mounted, in some cases the commercial incentive for seeking approval changed. Furthermore,
according to the United States, the companies had a st rong incentive to maintain cordial relations with
EC regulators and saw no advantage of complaining to EC regulators about the length of the delays,
which the United States maintains results from the moratorium.
7.941 The Panel notes that on 16 February 1999 the lead CA informed the applicant that, in light of
some of the new data provided by the applicant in response to requests from the lead CA, ACRE had
re-reviewed the application, and requested some am endments in order to permit the dossier to be
forwarded to the Commission. ACRE indicated that subject to these amendments being made, it was
content for the dossier to be forwarded to the Commission with a favourable opinion.
935 The
applicant provided an amended appli cation to the lead CA in March 1999. 936 The chronology
provided by the European Communities indicates that a meeting of ACRE was held on 16 September
1999. However, as correctly noted by the Unite d States, the minutes of this meeting make no
reference to any discussion of the GA21 maize (EC-85) application.
937 The EC chronology shows no
further action on this application until it was forw arded to the Commission with a positive assessment
report on 15 October 1999. Eviden ce submitted by the United States shows, however, that on 8 July
1999, the applicant inquired with the lead CA why the application was not being forwarded. 938 The
lead CA replied on 2 November 1999, almost four m onths later, indicating only that the application
had meanwhile been forwarded to the Commission.939
7.942 The United States does not assert that the United Kingdom itself was an active participant in
the alleged moratorium on approvals and that the delay in question is a reflection of the United
Kingdom's support for the moratorium. Nevertheless, th e United States contends that the fact that the
lead CA did not forward the application to the Commission for almost seven months after receiving
an amended version was politically motivated. In response to a request for elaboration from the

935 Exhibit EC78+85/At. 22.
936 Exhibit EC-78+85/At. 26. Evidence submitted by the United States confirms that the revised
application was submitted on 23 March 1999. Exhibit US-145.
937 Exhibit EC-78+85/At. 24.
938 Exhibit US-146.
939 Ibid.

Panel, the United States observed that many EC member States, including the United Kingdom, were
divided internally on their position related to bi otechnology. On the one hand, elements of the UK
government have, in the United States' view, been supportive of agricultural biotechnology. On the
other hand, the United States argues that certain political figures were not supportive, including the
UK Environment Minister at the time of the delay in question. According to the United States, the
conduct of the United Kingdom shows that count ries other than the Group of Five countries
recognized the political reality of the moratorium, and that this reality at times affected the manner in
which they conducted their assessments of biotech applications.
7.943 In considering the United States' arguments, we note that it is reasonable to assume that the
lead CA needed some time to review the ame nded application submitted in March 1999 before it
could be forwarded to the Commission with a favour able opinion. Nevertheless, the lead CA had
previously indicated that there were no other ou tstanding issues, and so we agree with the United
States that a delay did occur between March 1999 and October 1999. Indeed, this period alone
resulted in the consideration of this application at the member State level far exceeding the 90-day
assessment period allowed under Directive 90/220.
7.944 The precise reasons for the lead CA's temporary inaction are unclear. We note that during the
period from March to October 1999, in June, the Environment Council agreed on a Common Position
in relation to the revision of Directive 90/220 and the Group of Five countries made their declarations.
It may be that the United Kingdom considered that it was not appropriate to forward the application
concerning GA21 maize (EC-85) to the Commission and the other member St ates with a favourable
opinion shortly before this important Council meeting, and that after the meeting the United Kingdom
took time to evaluate the impact of the Council meeting on the EC approval process, and to see the
reaction of the Commission. It may also be that the delay reflects an internal UK policy debate, as
suggested by the United States.
7.945 What is clear, though, is that the United Kingdom completed its assessment and in October
1999 forwarded the application to the Commission with a favourable opinion. This is consistent with
the circumstance that the United Kingdom was not part of the Group of Five countries which stated
that they would take steps to suspend further a pprovals. The fact that the United Kingdom completed
its assessment does not, however, contradict the cl aim that a general moratorium on final approvals
was in effect in October 1999. If a moratorium was in effect, it was only after the application
concerning GA21 maize (EC-85) reached the Community level that the Group of Five countries
and/or the Commission could take steps to prevent the final approval of the application concerning
GA21 maize (EC-85).
7.946 In our view, the fact that the applicant did no t specifically cite a general EC moratorium on
approvals as a reason for the withdrawal of the appli cation in 2001 is not inconsistent with the United
States' assertion that the European Communities was applying a general moratorium on approvals. As
was pointed out by the United States, if a moratorium was in effect, there are plausible explanations
for why the applicant did not specifically cite the alleged moratorium or resulting delays as a reason
for withdrawing the application concerning GA21 maize (EC-85).
7.947 In the light of the above considerations, we conclude that the time taken by the United
Kingdom to complete its assessment of the applica tion concerning GA21 maize (EC-85) is consistent
with the Complaining Parties' assertion that during the relevant time period the European
Communities applied a general moratorium on final approvals.

MON810 x GA21 maize (EC-82)
7.948 The application concerning MON810 x GA21 maize was initially submitted to Spain (lead
CA) on 4 August 1999. This maize is produced by conventionally hybridizing two "parental" biotech
products, MON810 maize and GA21 maize. This app lication was withdrawn by the applicant on 15
September 2003. At that time, the lead CA had not yet submitted the application to the Commission.
7.949 The United States argues that this application never reached the Community level stage of
review due to the moratorium. On 30 November 1999, the lead CA requested that the applicant
provide several additional studies to support the application for this product.
940 The applicant
responded in August 2001 to all requests, exce pt for a scientifically unjustified study on the
nutritional composition of milk from dairy cows fed this product.941 Given the demonstrated safety of
maize in feed generally, as well as the substantial data submitted to support the feed safety of both
transgenic parents, there is no scientific basis to suggest a concern. One of the parental lines
(MON810 maize) was approved by the European Commun ities several years prior to this application,
and the feed safety was established as part of that process. 942 In addition, as part of its original
submission, the applicant had relie d on substantial compositional anal yses of the other parent (GA21
maize), as well as feeding studies.943 None of these studies identified anything that would provide any
basis for the concern raised by the member State.
7.950 The United States notes that the lead CA also requested additional studies of the hybrid in
order to verify the stability of both events jointly. In the view of the United States, there was no
logical basis for this request, which implies some interaction between the MON810 and GA21 events.
The United States submits that the applicant had already shown the stability of these transformation
events in each parental line. The insertions, having been shown to be stable in the parental lines,
would be no more likely to be affected by cro ssing than any other gene already present in either
parent.
7.951 The United States notes that the applicant provide d translations in January 2002 of various
studies it had previously submitted. Following that, the only activity by the lead CA was a meeting
held in April 2002.
944 No further action was taken on this application for over 18 months, until the
applicant volunteered to update the applica tion under Directive 2001/18 on 16 January 2003. 945 The
applicant, however, subsequently withdrew the application on 15 September 2003, at the same time it
withdrew the application for GA21 maize (EC-78) , as the delays caused by the moratorium had
rendered the applications for GA21 maize (E C-78) and MON810 x GA21 maize commercially
obsolescent.946

940 Exhibit EC-82/At. 8.
941 Exhibit EC-82/ Ats. 9, 10 and 11. According to the United States, conducting the dairy cattle
feeding study would have involved considerable cost and delay to the applicant. Such a test would require the
applicant to obtain approval for further experimental plantings to generate sufficient maize for the feeding study;
employ external consultants to undertake the required study; grow maize for the feeding study in the 2000
season; harvest, transport and ensile the maize unde r rigorous experimental conditions; undertake the cow-
feeding phase; analyse the milk samples; and produce all reports to the Standards of Good Laboratory Practice.
942 Commission Decision concerning th e placing on the market of ge netically modified maize (zea
mays L. line MON810) pursuant to Council Directive 90/220/EEC, (98/294/EC), April 22, 1998, Official
Journal of the European Communities, L 131/32, May 5, 1998 (Exhibit US-131).
943 Exhibit EC-82/Ats. 2 and 5.
944 Exhibit EC-82/At. 18.
945 Exhibit EC-82/At. 20.
946 Exhibit EC-82/At. 21.

7.952 The European Communities argues that the delays identifie d by the United States can be
explained by the fact that the safety of one of the parental lines of this hybrid product, GA 21 maize,
had not yet been assessed. The lead CA was aw aiting that assessment. The European Communities
maintains that it is obvious that the assessment of a hybrid cannot be concluded as long as the
assessment of one of its parental lines is still ope n. Furthermore, according to the European
Communities, the United States acknowledges that the delays were caused by the applicant when it
stated in response to a question from the Panel that "the applicant was unable to devote resources to
respond to the questions posed by the [lead CA] in a timely fashion".
947
7.953 The European Communities further observes that after discussions between the lead CA and
the applicant, the application was withdrawn with a letter of 15 September 2003. The applicant gave
three reasons for the withdrawal: first, the prog ress in the procedure of NK603 maize to a more
advanced stage than the GA21 maize (EC-78) a pplication; second, the introduction of the new
regulations concerning commercialisat ion of GM products in the European Communities; and third,
the change of the company's commercial priorities.
7.954 The United States denies acknowledging that the delays we re caused by the applicant. The
summary table of the US response to question 47 fro m the Panel was not intended to indicate that
delay was the fault of the applicant. Rather, the applicant recognized that the application for
MON810 x GA21 maize would not move forward as l ong as consideration of the application for the
single trait parent GA21 maize (EC-78) remained suspended under the moratorium. The United
States contends that it was pointless for the applican t to devote resources to pursue the application for
MON810 x GA21 maize when the approval of GA21 ma ize (EC-78) had been stalled for years under
the moratorium. Thus, the delay in the app lication for MON810 x GA 21 maize was a direct
consequence of the delay in the application for GA21 maize (EC-78) under the moratorium.
7.955 The United States points out that because of th e delay in the approval procedure concerning
GA21 maize (EC-78), that product, as well as MON810 x GA21 maize, have been superseded by a
second generation Roundup Ready ma ize product (NK603 maize and NK603 × MON810 maize,
respectively). The United States main tains that the applicant may not have cited undue delays in its
withdrawal letter because it had a strong incentive to maintain cordial relati ons with EC regulators
and saw no advantage of complaining to EC regulators about the length of the delays.
7.956 The Panel begins by noting that much of the info rmation provided to it has been incorrectly
identified. In particular, translations into Spanish of information previously submitted in English have
been identified as "additional data", and at times the same document was included as several different
attachments. Furthermore, it should be recalled at the outset that the Spanish CA in May 1999 had
given a favourable assessment to the application concerning GA21 maize (EC-78) and forwarded that
application to the Commission. When the ap plication concerning MON810 x GA21 maize was
submitted, the application concerning GA21 maiz e (EC-78) was under assessment at Community
level.948
7.957 Turning now to Spain's assessment of the application concerning MON810 x GA21 maize
under Directive 90/220, we note that the most significan t delay in the consideration of this application
appears to be due to the time taken by the applicant to provide information in response to a request for
additional information from the Spanish CA in N ovember 1999. The applicant did not provide the

947 The European Communities refers to the United States' response to question 47 of the Panel, table in
Annex I.
948 We recall that the application concerning GA21 maize (EC-78) was withdrawn by the applicant in
2003.

information requested until August 2001, and a translation into Spanish of the documents submitted in
the August 2001 response was provided to the Spanish CA in January 2002. The United States has
pointed out that the applicant did not comply with the Spanish CA's request that it provide a study on
the nutritional composition of milk from dairy cows which had been fed the product in question.
7.958 In April 2002, the Spanish National Biosafety Committee reviewed the January 2002 Spanish
translation of the applicant's documents. The Na tional Biosafety Commission concluded that it still
needed the results of feeding studies on cows, and other information.
949 However, there is no
indication in the record that a further request for information was ever sent to the applicant prior to the
repeal of Directive 90/220 in October 2002.
7.959 We note that after receiving the additional info rmation requested from the applicant, it was
incumbent on the Spanish CA either to seek further cl arifications or to complete its assessment within
the 90-day period provided for in Directive 90/220 . As indicated, there is no evidence that the
Spanish CA requested additional or missing information once the National Biosafety Commission had
reviewed the Spanish version of the applicant's documents of August 2001. Nor did the Spanish CA
complete its assessment after receiving further advice from the National Biosafety Commission in
April 2002. From the information before us, it woul d appear that the 90-day period had already been
exceeded by April 2002.
7.960 According to the European Communities, the failure of the lead CA to forward the application
concerning MON810 x GA21 maize to the Commission in 2002 can be explained by the fact that the
lead CA was waiting for the result of the Community level assessment of one of the parental lines of
this hybrid product, GA 21 maize (EC-78). The European Communities maintains that it is obvious
that the assessment of a hybrid cannot be concluded as long as the assessment of one of its parental
lines is still open. We are not convinced by this explanation.
7.961 To begin with, as previously noted, the Span ish CA had already favourably assessed the
application concerning GA21 maize (EC-78). Furthermore, the SCP in September 2000 had issued a
favourable opinion on the applicati on concerning GA21 maize (EC-78). 950 It is not clear, therefore,
why the same Spanish CA would not be in a position to reach a conclusion also with regard to the
application concerning the hybrid product, i.e., MON810 x GA21 maize. Indeed, the record does not
indicate that the Spanish CA ever indicated to the applicant that it was unabl e to proceed due to the
failure of the European Communities to approve the GA21 maize (EC-78) parent. As a general
matter, it may be correct that "the assessment of a hybrid cannot be concluded as long as the
assessment of one of its parental lines is still open" . However, it would seem that the assessment of
the parental lines could also be made in the contex t of the assessment of the hybrid. At any rate, the
Spanish CA could not "conclude" the assessment of the application concerning MON810 x GA21
maize completely on its own. If other member States had concerns with Spain's assessment of GA21
maize (EC-78), even though that assessment appears to have been confirmed by the SCP, they could
have raised an objection and the assessment would then have been "concluded" at Community level.
Thus, it is not apparent to us that the Spanish CA needed to keep the application at the member State
level in order to avoid the possibility of conflicting assessments of GA21 maize.
7.962 The United States argues that this application never reached the Community level stage due to
the alleged general moratorium on fi nal approvals. More particularly , the United States contends that
the delay in the application for MON810 x GA21 maiz e was a direct consequence of the delay in the
application for GA21 maize (EC-78) under the moratorium. We recall that the United States does not

949 Exhibit EC-82/At. 18.
950 Exhibit EC-78+85/At. 90.

assert that Spain itself was an active participant in the alleged moratorium on approvals or that the
time taken by Spain in its assessment is a reflection of Spain's support for the moratorium. Rather, it
asserts that Spain was placed in a position of having to recognize the moratorium as a reality, and that
this affected the speed with which it conducted its assessment.
7.963 We consider that following the June 1999 declaration by the Group of Five countries, Spain
had reason to believe that the Group of Five countri es would act as a "blocking minority" both in the
Regulatory Committee and in the Council pending th e adoption of new EC rules on labelling and
traceability.
951 In our view, Spain also had reason to be lieve that, as in the case of some of the
previously discussed approval procedures, the Commission would not complete the approval
procedure in the face of systematic opposition by the Group of Five countries. We note in this regard
that the single trait parent application concerning GA21 maize (EC-78) did not progress at
Community level after the SCP had issued its favourable opinion in September 2000.
952 In relation to
that application, we have prev iously concluded that the Commission's failure to submit a draft
measure concerning GA21 maize (EC-78) to the Regulatory Committee following the issuance in
September 2000 of the SCP's opinion is consistent with the United States' assertion that during the
relevant time period the European Communities applied a general moratorium on final approvals.
7.964 Against this background, and in particular in vi ew of the situation with regard to the single
trait parent application concerning GA21 maize (EC-78) , we consider that Spain could have come to
the conclusion in 2002 that there was no realistic prospect that the application concerning MON810 x
GA21 maize could be approved prior to the repeal of Directive 90/220. In our view, Spain's failure to
complete its assessment prior to the repeal of Dire ctive 90/220 is therefore consistent with the view
that a general moratorium on approvals was in effect at the time.
7.965 We note that Spain was part of the Group of Seven countries which declared in June 1999 that
they would take a thoroughly pr ecautionary approach in dealing w ith applications for the placing on
the market of biotech products. However, in this instance, it is not apparent that the Spanish CA's
conduct as of April 2002 reflects a precautionary approach. Indeed, the Spanish CA did not follow up
with the applicant to seek more information or add itional clarifications after receiving further advice
from the National Biosafety Commission in April 2002. We recognize that, by that time, the date of
repeal of Directive 90/220 was approaching. Howe ver, we note that in another approval procedure,
the Spanish CA forwarded questions from the National Biosafety Commission as late as mid-June
2002.
953
7.966 Furthermore, the fact that the applicant did no t specifically cite a general EC moratorium on
approvals as a reason for the withdrawal of the appli cation in 2003 is not inconsistent with the United
States' assertion that the European Communities was applying a general moratorium on approvals. As
was pointed out by the United States, if a moratorium was in effect, there are plausible explanations
for why the applicant did not specifically cite the alleged moratorium or resulting delays as a reason
for withdrawing the application concerning MON810 x GA21 maize.
7.967 Regarding Spain's assessment of the app lication concerning MON810 x GA21 maize under
Directive 2001/18, we note that the applicant on 16 Ja nuary 2003 indicated its intention to submit an
updated application in accordance with Directive 2001/18. The European Communities has indicated,
however, that the updated application was never receiv ed by the lead CA. We have seen no evidence

951 We recall that the Commission made a proposal for such rules in July 2001.
952 It is reasonable to assume that as the lead CA in the approval procedure concerning GA21 maize
(EC-78), Spain was aware of this situation.
953 Exhibit EC-75/At. 13.

to the contrary. The only other information regarding this application relates to its withdrawal by the
applicant on 15 September 2003. Thus, it appears that the application was never considered by the
lead CA under Directive 2001/18. This said, without an updated application, the lead CA could not
have done so.
7.968 In the light of the above considerations, we conc lude that the failure of Spain to complete its
assessment of the application concerning MO N810 x GA21 maize prior to the repeal of
Directive 90/220 in October 2002 is consistent with th e contention of the Complaining Parties that the
European Communities applied a general moratorium during the relevant time period.
High-oleic soybeans (EC-87)
7.969 The application concerning High-oleic soybean s was submitted to the Netherlands (lead CA)
on 19 June 1998. Following several requests for additional information from the lead CA and
responses by the applicant, the application was withdrawn by the applicant on 12 December 2002.
7.970 The United States argues that the application for High-oleic soybeans was withdrawn
because of the European Communities' excessive de lay in carrying out the approval process. The
United States maintains that this delay was a manifestation of the moratorium on approvals.
7.971 The European Communities argues that when the application was withdrawn by the
applicant in December 2002, the justification gi ven for the withdrawal pointed to "entirely
commercial reasons".
7.972 The United States argues that in many cases the withdrawal of applications resulted from the
applicant's frustration with the European Communi ties' suspension of its approval process, although
the applicant may not have explicitly so indicated in its reasons for withdrawal. Over time, as the
delays mounted, in some cases the commercial incen tive for seeking approval changed. Second, the
companies have a strong incentive to maintain co rdial relations with EC regulators, and saw no
advantage of complaining to EC regulators a bout the length of the delays resulting from the
moratorium.
7.973 The Panel notes that in a communication dated 7 D ecember 1998, the Netherlands Institute
for Food Safety (RIKILT), one of the advisory sci entific bodies considering the application, informed
the lead CA that not enough information was ava ilable to assess the safety of livestock feed made
from High-oleic soybeans.
954 The applicant was formally informed of the request for further data in a
letter dated 8 January 1999. However, it appear s that the RIKILT's questions had been made
available to the applicant by e-mail already on 4 December 1998. 955 On 1 July 1999, the applicant
provided responses to the RIKILT's questions "from 4 December 1998". The applicant submitted
almost 270 pages of replies and studies.
956 The new information was apparently reviewed by the
RIKILT, and on 27 October 1999, the Dutch CA on behalf of the RIKILT requested the applicant to
provide further substantiation of the compositional analysis it had submitted.
957 The applicant did not
provide the requested substantiation, however. There is no indication of any further communications
on this application until it was withdrawn by the applicant more than three years later, on 12
December 2002, i.e., after the repeal of Directive 90/220.

954 Exhibit EC-87/At. 11.
955 Exhibit EC-87/Ats. 13 and 14.
956 Exhibit EC-87/At. 14.
957 Exhibit EC-87/At. 15.

7.974 It is clear from the foregoing that the progress of this application was adversely affected
notably by two elements. First, the lead CA's request for additional information of December
1998/January 1999 and the time taken by the lead CA to review the additional information once it had
been received. Secondly, the applicant's failure, over a period of more than three years, to respond to
a follow-up request for additional information.
7.975 Regarding the first element, we have asked th e experts advising us whether the information
requested in December 1998/January 1999 and Oc tober 1999 on the composition of the product and
the alteration in the protein profile were necessary to ensure that conclusions of the safety assessment
were valid. Dr. Nutti considered that the data re quested in December 1998/January 1999 on the lectin
content and composition data for at least two seasons was necessary to ensure that conclusions of the
safety assessment concerning human use were valid. She also noted, however, that the changes in the
fatty acid composition would not be expected to have an impact on livestock feed safety.
958
7.976 In considering the requests of December 1998/Jan uary 1999, it must also be noted, however,
that a few months later, in June 1999, the Neth erlands formally declared that it would take a
thoroughly precautionary approach in dealing with applications for the placing on the market of
biotech products. In our view, the December 1998/January 1999 requests might reflect a
precautionary approach to evaluating applications.
7.977 On 1 July 1999, the applicant provided the in formation requested in December 1998/January
1999. Almost four months late r, on 27 October 1999, the Dutch CA forwarded additional questions
from the RIKILT to the applicant. This means that during that period alone, the Netherlands
exceeded the 90 days available to it under Directiv e 90/220 to assess the application. On the one
hand, it should be recalled in this context that the applicant's technical response consisted of a 270-
page document. In comparison, the or iginal application contained 170 pages.
959 On the other hand,
we consider that following the June 1999 declara tion by the Group of Five countries, the Netherlands
had reason to believe that the Group of Five countri es would act as a "blocking minority" both in the
Regulatory Committee and in the Council pending th e adoption of new EC rules on labelling and
traceability. It is also reasonable to assume that the Netherlands was aware that after May 1999, in
the approval procedures concerning Bt-531 cotton and RR-1445 cotton, the Commission failed to
discharge its responsibility inasmuch as it did not submit a draft measure to the Council.
Consequently, it is possible, in our view, that the Netherlands considered that the application
concerning High-oleic soybeans could not be promptly approved at Community level, and that this
affected the speed of its own assessment at the member State level. Hence, we think the Netherlands'
conduct is consistent with the view that a general moratorium on approvals was in effect at the time.
7.978 Regarding the second element which contributed to a delay in the completion of this
procedure, we note that the reasons for the applic ant's failure to provide further substantiation are
unclear. In its December 2002 letter of withdrawal, the applicant indicated that there was no safety
concern relating to High-oleic soybeans and that the withdrawal was related entirely to commercial
reasons.960 In our view, the fact that the applicant di d not specifically cite a general EC moratorium
on approvals as a reason for the withdrawal of the a pplication in 2002 is not inconsistent with the
United States' assertion that the European Comm unities was applying a general moratorium on
approvals. As was pointed out by the United States, if a moratorium was in effect, there are plausible
explanations for why the applicant did not specifically cite the alleged moratorium or resulting delays
as a reason for withdrawing the application concerning High-oleic soybeans.

958 Annex H, paras. 673-674.
959 Exhibit EC-87/At. 1.
960 Exhibit EC-87/At. 16.

7.979 In the light of the above considerations, we c onclude that the failure by the Netherlands to
complete its assessment of the application concer ning High-oleic soybeans prior to December 2002,
when it was withdrawn by the applicant, is consiste nt with the Complaining Parties' assertion that
during the relevant time period the European Co mmunities applied a general moratorium on final
approvals.
RR sugar beet (EC-88)
7.980 The application concerning RR sugar beet wa s submitted for approval in Belgium (lead CA)
in December 1998 under Directive 90/220. Followi ng the entry into force of Directive 2001/18, an
updated application was submitted by the applicant on 16 January 2003. At the time of establishment
of the Panel, the lead CA had not yet submitted its assessment to the Commission. On 16 April 2004,
the application was withdrawn by the applicant.
7.981 The United States claims that the application for RR sugar beet was delayed at the first stage
of the approval process under 90/220 because the member State declined to forward the application to
the Commission. Although the applicant provided answ ers to all of the questions raised by the lead
CA, the member States nonetheless delayed and ultim ately suspended consideration or failed to
approve this product under Directive 90/220. This product was resubmitted under Directive 2001/18.
7.982 Canada argues that the lead CA failed to complete its review with regard to the application,
and thus exceeded the 90-day limit provided for by Directive 90/220 by several years. Canada argues
that during the review process, the lead CA re quested three times (April 1999, November 2000 and
January 2001) the applicant to "voluntarily" comply with the requirements provided for by
Directive 2001/18, even though Directive 2001/18 would not be in force until October 2002.
7.983 The European Communities notes that after discussions between the lead CA and the
applicant, the application was withdrawn by the companies producing the product on 16 April 2004.
As the reason for the withdrawal, the applicant point ed to a decision to stop any further development
of the RR sugar beet derived from event T9100152.
7.984 The United States argues that in many cases the withdrawal of applications resulted from the
applicant's frustration with the European Comm unities’ suspension of its approval process, although
the applicant may not have explicitly so indicated in its reasons for withdrawal. Over time, as the
delays mounted, in some cases the commercial incen tive for seeking approval changed. Second, the
companies have a strong incentive to maintain co rdial relations with EC regulators, and saw no
advantage of complaining to EC regulators a bout the length of the delays resulting from the
moratorium.
7.985 The Panel observes that the application was appare ntly sent to the lead CA in December
1998, however no record of this application is avai lable to us. Also, the lead CA considered the
application to be incomplete. After the applican t submitted further information, the lead CA on 1
March 1999 acknowledged receipt of a complete application.
961 Apparently, the application was
considered at a meeting of the Belgian Biosafety Advisory Council held on 26 April 1999. The
questions which were generated by this meeting were transmitted to the applicant in June 1999 and
included questions on agricultural practices, molecula r characterization, toxicology, allergenicity, and

961 Exhibit EC-88/At. 3.

food/feed equivalence.
962 The applicant provided responses to some of these questions in July
1999.963 Other questions were answered in December 1999.964
7.986 In October 1999 the lead CA requested additional information on gene tr ansfer in digestive
tracts.965 The applicant provided such information in January 2000. 966 We asked the experts advising
us whether the information regarding allergenicity, molecular characterization and gene transfer in
digestive tracts requested by the lead CA was n ecessary to ensure that conclusions of the safety
assessment were valid. Dr. Nutti stated that th e information provided by the applicant prior to
October 1999 on these three topics was adequate to en sure that the conclusions of the assessment
were valid.967
7.987 In February 2000, the lead CA requested missi ng bibliographical references. The applicant
provided the relevant referenc es in February and March 2000. 968 According to the chronology
provided to us, in April 2000 the applicant met wi th the CA to discuss issues relating to identity
preservation, Good Agricultural Practices, post-mark et monitoring, traceability, public information,
line-specific detection methods and primers. The r ecord of this meeting was not provided to us,
however. In July 2000, the applicant at its own initiative provided additional information on the
characterization of a protein and detection protocols. The applicant noted that this data did not change
the conclusions of the safety assessment.969
7.988 In November 2000, the lead CA requested fu rther clarifications regarding molecular
characterization and allergenicity of "event '77'".970 We asked the experts if the information regarding
molecular characterization and allergenicity of "event '77'" requested by the lead CA was necessary to
ensure that conclusions of the safety assessment were valid. Dr. Nutti emphasized that the
information "for allergenicity was not necessary to ensure that the conclusions of the safety
assessment were valid", as the initial application had satisfactorily established the safety of this
product in this respect.971 The applicant apparently did not provide the requested information.
7.989 In January 2001 the lead CA "invited" the a pplicant to provide a proposal for labelling and
traceability as well as a proposal for a monitoring plan and Good Agricultural Practices in accordance
with the principles of the Common Position of the Council on the amendment of Directive 90/220.
The lead CA indicated that in the absence of voluntary compliance with these principles, it seemed
that the Commission and the other member States would oppose the approval of the application even
if the lead CA forwarded it with a positive assessment.
972 The applicant apparently did not reply to
the lead CA's invitation. In June 2001, the lead CA sent the applicant some comments on its
application, asking the applicant to make corresponding corrections. 973 After the June 2001
communication from the lead CA there appear to ha ve been no further exchanges between the lead
CA and the applicant until the repeal of Directive 90/220 in October 2002.

962 Exhibit EC-88/Ats. 8 and 9.
963 Exhibit EC-88/At. 10.
964 Exhibit EC-88/At. 13.
965 Exhibit EC-88/At. 12.
966 Exhibit EC-88/At. 15.
967 Annex H, Dr. Nutti's response to Panel Question 42.
968 Exhibit EC-88/Ats. 17-21.
969 Exhibit EC-88/At. 22.
970 Exhibit EC-88/At. 27.
971 Annex H, Dr. Nutti's response to Panel Question 43.
972 Exhibit EC-88/At. 29.
973 Exhibit EC-88/At. 30.

7.990 In January 2003, the applicant submitted an updated application under Directive 2001/18.
There was an acknowledgement by the lead CA in February 2003 that the applicant had provided
updates and a request for further information.
974 The applicant apparently did not provide the
requested information. Instead, in April 2004 the applicant submitted a letter of withdrawal.
7.991 We begin our examination of the lead CA's assessment of the application concerning RR
sugar beet by recalling that the applicant did not r espond to the lead CA's November 2000 request for
additional information. 975 It would therefore appear that after November 2000 the lack of progress
under Directive 90/220 is attributable to the applican t. The question to be examined, then, is why the
lead CA did not complete its assessment prior to No vember 2000. We note in this respect that by the
end of March 2000 the applicant had provided all additional information requested by the lead CA.
Notwithstanding this, the lead CA did not complete it s assessment in the next several weeks. Instead,
more than seven months later, in November 2000, the lead CA requested further clarification on
molecular characterization and allergenicity issu es previously addressed by the applicant. The
European Communities did not provide an explanation for why the Belgian CA could not have sought
these clarifications much earlier, given that the applicant had provided additional information on these
issues before the end of 1999. We note in this connection that by November 2000, Belgium had
already far exceeded the 90-day period provided fo r in Directive 90/220 for the assessment to be
made by a lead CA.
7.992 We also recall that in June 1999 Belgium w as one of the Group of Seven countries which
declared, not that they would take steps to susp end further approvals, but that they would take a
thoroughly precautionary approach in dealing with applications for the placing on the market of
biotech products. However, in view of the timi ng of Belgium's November 2000 request for additional
information – it was forwarded more than seven mo nths after the applicant had submitted additional
information in March 2000 – we are not convinced that that request was a reflection of the
precautionary approach referred to in the June 1999 declaration of the Group of Seven countries.
7.993 We consider that following the June 1999 declaration by the Group of Five countries,
Belgium had reason to believe that the Group of Five countries would act as a "blocking minority"
both in the Regulatory Committee and in the Counc il pending the adoption of new EC rules on
labelling and traceability. The Commission made a proposal for such rules in July 2001. In our view,
Belgium also had reason to believe that, as in the case of some of the previously discussed approval
procedures, the Commission would not complete th e approval procedure in the face of systematic
opposition by the Group of Five countries. Consequen tly, it is possible, in our view, that Belgium
considered that the application concerning RR su gar beet could not be promptly approved at
Community level, and that this affected the sp eed of its own assessment and led it to request
information which it might not otherwise have requested. 976 As indicated previously, notably in the
case of the clarifications sought concerning alle rgenicity, Dr. Nutti questioned the need for the
information that was requested. The circumstance that the applicant did not respond to the November
2000 request is also consistent with this possibilit y, for it may indicate that the applicant had lost
confidence that its application would be forwarded to the Commission by Belgium while
Directive 90/220 was still in force.

974 Exhibit EC-88/At. 34.
975 The lead CA in January 2001 reminded the applicant of its November 2000 request for information.
Exhibit EC-88/At. 29.
976 In fact, as noted earlier, in January 2001 Belgium itself indicated to the a pplicant that it expected
opposition to the approval of the application concerning RR sugar beet if the applicant did not voluntarily
comply with certain principles set out in the Common Position on the revision of Directive 90/220.

7.994 Taking account of the aforementioned elements, we consider that Belgium's failure to
complete its assessment prior to its November 2000 request for additional info rmation is consistent
with the existence of a general moratorium on approval s. This view is not contradicted by the fact
that the applicant did not specifically cite a gene ral EC moratorium on approvals as a reason for the
withdrawal of the application in 2004. As was poi nted out by the United States, if a moratorium was
in effect, there are plausible explanations for why the applicant did not specifically cite the alleged
moratorium or resulting delays as a reason for withdrawing the application concerning RR sugar beet.
7.995 In the light of the above considerations, we c onclude that the time taken by Belgium for its
assessment of RR sugar beet is consistent with the Complaining Parties' assertion that during the
relevant time period the European Communities applied a general moratorium on final approvals.
Transgenic green-hearted chicory (EC-110)
7.996 The application concerning Transgenic green -hearted chicory was submitted for approval in
the Netherlands (lead CA) on 11 March 1996 under Directive 90/220. On 15 April 2003, the
application was withdrawn.
7.997 The European Communities has indicated that, after assessment at both national and
European Community level, the notification was wi thdrawn by the applicant on 15 April 2003. The
applicant gave two reasons for the withdrawal: firs t, the absence of a market for these products; and
second, the fact that the company preferred not to be associated with GMOs any longer.
7.998 The United States argues that in many cases the withdrawal of applications resulted from the
applicant's frustration with the European Comm unities’ suspension of its approval process, although
the applicant may not have explicitly so indicated in it reasons for withdrawal. Over time, as the
delays mounted and new products were developed, in some cases the commercial incentive for
seeking approval changed. Second, the companie s have a strong incentive to maintain cordial
relations with EC regulators, and saw no advantage of complaining to EC regulators about the length
of the delays resulting from the moratorium.
7.999 The Panel notes that a draft of a favourable opinion prepared for submission to the European
Commission was provided to the applicant for comments on 8 July 1996.
977 Six months later, in
January 1997, the applicant submitted a letter requesting that the application not be forwarded to the
Commission until there was greater clarity regardi ng the authorization of Transgenic red-hearted
chicory (EC-77).978
7.1000 More than two years later, on 25 March 1999, the Dutch advisory body for feed safety, the
RIKILT, submitted an assessment report to the Dutch CA. Contrary to the description of this report
given by the European Communities, the RIKILT did not request additional information. Rather, the
RIKILT stated that given the conclusions of th e Provisional Committee For Safety Evaluation of
Novel Foods and/or the SCP, there were no indications that occasional use of the modified green-
hearted chicory as feed would not be safe. The repo rt did indicate that by current EU standards the
data provided on the composition of the modified green-hearted chicory was insufficient to comment
on its comparability with non-modified green-hearted chic ory. It went on to state, however, that as
green-hearted chicory was not a normal ingredient of feed, and in light of the opinion of the
Provisional Committee on the Safety of Novel Foods regarding its safety for human consumption,

977 Exhibit EC-110/At. 4.
978 Exhibit EC-110/At. 5.

there was no indication that the product would not be safe for both animals and consumers of animal
products if occasionally used as feed.
979
7.1001 On 19 May 1999, the applicant voluntarily provid ed some supplementary data on food safety
aspects "in response to requests by different Member States" in the context of the discussion of the
application concerning the same product submitte d under Regulation 258/97. The application
provided the information, although the applicati on concerning Transgenic green-hearted chicory
concerned feed use, not food use. 980 No information was provided to us regarding any further
exchanges concerning this application after this date. The application was not re-submitted under
Directive 2001/18 and formally withdrawn on 15 April 2003. The withdrawal letters submitted to us
are in Dutch and no translation was provided.
7.1002 It is evident from the foregoing that the consid eration of this application by the lead CA was
not completed within the 90 days foreseen under Directive 90/220. Unfortunately, however, based on
the information that was provided to us we are una ble to ascertain to what extent any delays which
occurred after May 1999, when th e applicant voluntarily submitted further information, were
attributable to the lead CA. As noted, the evidence seems to suggest that in July 1996, the application
was deemed sufficient for the relevant scientific co mmittees within the Netherlands to conclude that
the Transgenic green-hearted chicory presented no risk to human or animal health or the environment.
But in January 1997, the applicant requested that the application not be forwarded until there was
greater clarity about the approval of Transgenic red- hearted chicory. From the evidence before us, it
is not clear whether in May 1999, the lead CA w as still waiting for the applicant to withdraw its
holding request. If that was the case, the failure of the lead CA to complete its assessment after May
1999 and forward the application to the Commission would be the result of the applicant's own
request.
7.1003 Even assuming, however, that the lead CA was waiting for the applicant to give it the go-
ahead, this would not demonstrate that no moratori um on final approvals was in effect during the
relevant time period. As of October 2002, wh en Directive 90/220 was repealed, the application
concerning Transgenic green-hearted chicory had not reached the Community level phase of the
approval procedure under Directive 90/220. In othe r words, it had not yet reached the procedural
stage where the Group of Five countries and/or the Commission could have taken action to delay or
prevent its final approval.
7.1004 In the light of the above considerations, we c onclude that the failure by the Netherlands to
complete its assessment of Transgenic green-h earted chicory prior to October 2002, when
Directive 90/220 was repealed, is consistent with the Complaining Parties' assertion that during the
relevant time period the European Communities applied a general moratorium on final approvals.
Member State failure to give consent to placing on the market
7.1005 In support of their assertion that the European Communities applied a general moratorium on
approvals the United States and Ca nada have pointed to approval procedures in which the member
State to which the application was submitted – the l ead CA – failed to give its written consent to the
placing on the market of a biotech product, after that biotech product had been approved by
Commission decision. We consider these approval procedures below, recalling that Article 13(4)
provides in relevant part that "[w]here the Commission has taken a favourable decision, the competent
authority that received the original notification shall give consent in writing to the notification so that

979 Exhibit EC-110/At. 7.
980 Exhibit EC-110/At. 8.

the product may be placed on the market". Article 13(5) further provides that "[o]nce a product has
received a written consent, it may be used without further notification throughout the Community in
so far as the specific conditions of use and the envi ronments and/or geographical areas stipulated in
these conditions are strictly adhered to".
MS1/RF1 oilseed rape (EC-89)
MS1/RF2 oilseed rape (EC-90)
7.1006 The applications for both MS1/RF1 oilseed ra pe (EC-89) and MS1/RF2 oilseed rape were
submitted to France (lead CA) in April 1995 fo r cultivation, import and marketing. After
consideration by the lead CA and subsequently at Community level, these applications were approved
by the Commission on 6 June 1997.
981
7.1007 The United States argues that numerous applicati ons that were blocked under
Directive 90/220 were not resubmitted under Direc tive 2001/18, including MS1/RF1 oilseed rape
(EC-89) and MS1/RF2 oilseed rape. These applicati ons languished at the final stage of the process
for more than five years because the lead CA withheld its final approval. 982 Both applications were
submitted to France in April 1995, which forwarded them with favourable opinions to the European
Commission on 27 July 1995. The Commission review ed the applications and found "no reason to
believe that there will be any adverse effect on human health and the environment" from placing
MS1/RF1 oilseed rape (EC-89) and MS 1/RF2 oilseed rape on the market. 983 Accordingly, the
Commission approved both products on 6 June 1997, 984 consistent with the favourable opinion of the
Regulatory Committee. 985 Despite the favourable decision of the Commission, France refused to
complete the process by giving its final consent so that MS1/RF1 oilseed rape (EC-89) and MS1/RF2
oilseed rape could be placed on the market.986
7.1008 Canada argues that MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape have been
affected by the moratorium, as these products have been prevented from receiving the approval
necessary for the product to be legally marketed in the European Communities. Canada submits that
although these products were approved prior to Oct ober 1998, these products are the victims of the
moratorium after October 1998 as much as any products.
7.1009 Canada notes that the EC decisions approving the placing on the market of MS1/RF1 oilseed
rape (EC-89) and MS1/RF2 oilseed rape in July 1997 stated that "consent shall be given by the
competent authority of France to the placing on the market" of the products in question 987, on the
basis, in part, that there was no reason to believe that there would be any adverse effects on human
health and the environment. However, the lead CA failed to give its consent for either product
contrary to this stipulation and Article 13(4) of Directive 90/220 and despite the fact that the same
competent authority originally provided a favourable opinion.

981 Commission Decision 97/392/EC of 06/06/1997 in OJ L164 of 21/06/1997, p. 38 (Exhibit EC-89)
and Commission Decision 97/393/EC of 06/06/1997 in OJ L164 of 21/06/1997, p. 40 (Exhibit EC-90).
982 Questions and Answers on the Regulation of GMOs in the EU, at Annex 1 (Exhibit US-107).
983 Commission Decision 97/392/EC, O.J. 21.6.1997 L164, preamble, fifth recital (Exhibit US-43);
Commission Decision 97/393/EC, O.J. 21.6.1997 L164, preamble, fifth recital (Exhibit US-44).
984 Commission Decision 97/392 (Exhibit US-43); Commission Decision 97/393 (Exhibit US-44).
985 Commission Decision 97/392, preamble, eighth recital (Exhibit US-43); Commission Decision
97/393, preamble, eighth recital (Exhibit US-44).
986 Questions and Answers on the Regulation of GMOs in the EU, at Annex 1 (Exhibit US-107).
987 Canada refers to Article 1(1) of each Commission Decision, respectively.

7.1010 Canada further notes that on 7 July 1999, the Commission sent a "reasoned opinion" to France
in relation to the withholding of consent for these pr oducts. This procedural step necessarily precedes
any legal proceedings by the Commission against a member State for infringement of EC law before
the European Court of Justice.
988 However, the Commission did not pursue this matter any further; it
did not bring an infringement procedure. Althoug h Canada requested additional information from the
European Communities during consultations, the European Communities has yet to provide any
additional information on what steps were actua lly taken. Furthermore, in a judgment dated 4
November 2000, the French Conseil d'Etat, followi ng the decision of an earlier European Court of
Justice ruling in relation to Article 13(4) of Direc tive 90/220, concluded that without new information
concerning the risks associated with MS1/RF1 oil seed rape (EC-89) and MS1/RF2 oilseed rape, the
French Ministry could not call into question the decision taken by the Commission.989
7.1011 Canada argues that despite the Commission's decisions to place both products on the market
over 6 years ago (and the completion of the mo st recent favourable risk assessment by an EC
scientific body on a closely related use of the same product at least 5 years ago), France has continued
to withhold consent to the placement of these products on the market. Accordingly, the applicant has
been unable to place either plant variety on the EU market.990
7.1012 The European Communities argues that from a legal point of view, the absence of the final
consent does not mean that the applicant is not entitled to place MS1/RF1 oilseed rape (EC-89) and/or
MS1/RF2 oilseed rape on the market. These products have obtained marketing approval by virtue of
Commission decisions of 6 June 1997. While tho se decisions were addressed to France and placed an
obligation upon France to grant final consent, th ey could nevertheless develop a direct effect vis-à-vis
the applicant as well.
7.1013 According to the European Communities, in th e case law of the European Court of Justice,
EC member States cannot prevail themselves of the f act that they have not implemented (or refuse to
implement) Community obligations addressed to them in order to deny an individual a right granted
through those same Community provisions. 991 The individual, therefore, can assert this right by
directly relying on the Community law in question. These principles form the so-called doctrine of
"direct effect." The Court has based this doctrin e on a teleological interpretation of Community law,
and in particular, on the so-called "effet utile" principle.
7.1014 The European Communities confirms that the Commission initiated infringement proceedings
against France in 1998, however it decided not to ta ke the case to the Court. This was because the
very legislation on the basis of which the approv al had been granted had been identified to be
insufficient and was being revised. Furthermore, France had raised the same environmental risk

988 European Communities, GMOs: Commission move s against Luxembourg and France, Commission
Press Release, IP/99/438, Brussels, 7 July 1999 (Exhibit CDA-52). See also European Communities,
Commission, Seventeenth Annual Report on Monitoring the Application of Community Law (1999), COM
(2000) 92 final, Brussels, 23 June 2000 (Sector on Chemicals and Biotechnology), p. 80 (Exhibit CDA-53).
989 European Communities, Commission, Eighteenth Annual Report on Monitoring the Application of
Community Law (2000), COM (2001) 309 final, Brussels, 16 July 2001 (Sector on Chemicals and
Biotechnology), p. 67 (Exhibit CDA-50); see also, European Court of Justice, Association Greenpeace France
v. Ministère de l'Agriculture et de la Pêche, C-6/99, [2000] E.C.R. I-01651 (Exhibit CDA-51).
990 Canada notes that the processed oil from canola/oilseed rape hybrid MS1/RF1 was approved for
placing on the market pursuant to the simplified procedures of Article 5 of Regulation 258/97 as of 24 June
1997 (see the summary of Article 5 applications received in 1997, product number 2, contained in Exhibit CDA-
25). The application was submitted to the Commission by the United Kingdom following a scientific
assessment conducted by its Advisory Committee on Novel Foods and Processes.
991 See only European Court of Justice, Leberpfennig, C-9/70 [1970] ECR 825.

concerns regarding these two products as it had for the products for which it subsequently adopted
safeguard measures ( i.e. the identical product MS1/RF1 oilseed rape which had been approved for
breeding activities in 1996).
7.1015 The approvals of MS1/RF1 and MS1/RF2 oilseed rape for import, processing and cultivation
in 1996 and 1997 did not provide for any reporting or monitoring of marketing in the European
Communities. Accordingly, the European Comm unities claims it is unable to say whether these
products have been sold in the European Communiti es. According to the European Communities, no
oilseed rape varieties derived from MS1/RF1 or MS 1/RF2 oilseed rape have been registered in
member States' national catalogues or in the Common Catalogue of varieties of agricultural plant
species – which is a prerequisite for allowing th eir commercial cultivation – because there has been
no application from companies to do so.
7.1016 The United States maintains that under Directive 90/220, the "Community level" approval is
not effective unless and until the member State that initially received the application takes the final
step of placing the product on the market. In this case, the lead CA never allowed the product to be
placed on the market. Thus, these products in fact were never approved for cultivation, import, and
marketing in the European Communities. This is an example of how in certain circumstances a single
member State can block a product approval, and is furthermore an example of the existence of the
general moratorium. Neither of these products is in fact on the market in the European Communities
and EC Customs officials would not admit either of these products without the final step (the French
consent) in the approval process. The European Communities has failed to explain how a product can
be considered approved if additional legal proceedi ngs are required to allow the product to be placed
on the market.
7.1017 Canada argues that one cannot reasonably conclude that an approval procedure has been
brought to an end if an applicant must undergo pot entially expensive and time-consuming litigation to
enforce its rights.
7.1018 The Panel notes that although the two applications concerning MS1/RF1 oilseed rape (EC-
89) and MS1/RF2 oilseed rape were formally approved by the Commission for placing on the market
in June 1997, the lead CA subsequently failed to take the final step of the approval procedure
provided for in Article 13(4) of Directive 90/220, wh ich is to grant written consent to the placing on
the market of a product. The relevant Commission decisions, which are addressed to the member
States, also provide in their Article 1(1) that "c onsent shall be given by the competent authority of
France to the placing on the market" of the oilseed rape products in question.
992
7.1019 Neither Article 13(4) of Directive 90/220 nor the relevant Commission decisions lay down
specific time periods within which the lead CA had to give consent. However, it is clear to us that
this does not mean that the lead CA could take any am ount of time to complete the step required of it.
If it were otherwise, the deadlines stipulated in Di rective 90/220 for the completion of other steps of
the approval procedure, such as the 90-day member State assessment period set out in Article 12, the
60-day objection period set out in Article 13 and the three-month action period set out in Article 21,
could easily be nullified and rendered meaningless. We recall that in the case of the two applications
at issue, the approval for both applications was given by the Commission on 6 June 1997. As of
October 2002, when Directive 90/220 was repealed, France had not granted its consent to the placing

992 Exhibits US-43 and -44; CDA-48 and -49.

on the market of the products at issue. Thus, Fr ance did not grant its consent for more than five
years.
993
7.1020 The European Communiti es has suggested that France's inaction after June 1997 was due to
concerns about environmental risks, and that these same risks led France in November 1998 to adopt a
safeguard measure on MS1/RF1 oilseed rape (EC-161). The application concerning MS1/RF1 oilseed
rape (EC-161) had been submitted to the United Kingdom and was approved for breeding activities in
1996. In considering this assertion, we note that we have been provided very little information on the
approval procedures concerning MS1/RF1 oilseed ra pe (EC-89) and MS1/RF2 oilseed rape. In
particular, we have seen no evidence which points to the alleged environmental concerns by France.
To the contrary, the Commission decisions approving the applications concerning MS1/RF1 oilseed
rape (EC-89) and MS1/RF2 oilseed rape make clear that France forwarded the application to the
Commission with a favourable opinion.
7.1021 Furthermore, there is no indication that France after June 1997 sought additional information
from the applicant, or proposed to the applicant voluntarily to accept stricter conditions to meet
France's alleged environmental concerns. More over, the Commission decisions approving the two
products specify that Directive 90/220 provides for additional safeguards if new information on risks
of the products in question became available. In the light of this, even if France considered that by
June 1997 there were justifiable r easons for it to consider that th e products in question constituted a
risk to the environment, it could have taken a saf eguard measure, as it did for MS1/RF1 oilseed rape
(EC-161), after giving its written consent to the placing on the market of the two products in
question.
994 The concerns underlying France's safeguard measure would then have been examined by
the SCP, and a decision on the validity of France's concerns would then have had to be taken at
Community level.
7.1022 For all these reasons, we are not persuaded that there were outstanding environmental issues
which were specific to the products in question, and which France was trying to have the applicant
address prior to giving its written consent to the placing on the market of these products.
7.1023 We recall that in June 1999 France was one of the Group of Five countries which declared
that they would take steps to suspend further approvals under Directive 90/220 pending the adoption
of new EC rules on labelling and traceability. As previously noted, the Complaining Parties argue
that one of the steps which the Group of Five countri es could take to prevent further approvals was to
withhold written consent to the placing on the ma rket of the product to be approved in cases where
they were acting as the lead CA. We consider that France's conduct is consistent with the June 1999
declaration by the Group of Five countries. Indeed , despite a clear legal obligation to give written
consent to the placing on the market of MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape,
France withheld its consent and thus did what wa s within its power to prevent these products from
being approved.
7.1024 Therefore, we consider that at least as from June 1999, France's failure to give its written
consent supports the Complaining Parties' asserti on that the European Communities was applying a

993 We note, by way of example, that in the approval procedure concerning the Red-hearted chicory,
which was also conducted under Directive 90/220, the l ead CA gave its written consent two-and-a-half months
after the Commission approved the application for breeding activities. Exhibit EC-77/At. 42.
994 There is nothing in Directive 90/220 which says th at a lead CA forwarding an application with a
positive opinion and giving written consent to the placing on the market of a product may not subsequently take
a safeguard measure in respect of that product.

general moratorium on final approvals. France's c onduct is not inconsistent with the Complaining
Parties' assertion that a general EC moratorium was in effect already as from October 1998.
However, the fact that France withheld its con sent already as from June 1997 could also support the
view that although France, for its part, opposed further approvals and used its powers to prevent
approvals, no general EC-wide moratorium was in effect in October 1998.
7.1025 We should note that there is uncertainty as to the status of the applications concerning
MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape after the repeal of Directive 90/220.
Article 35 of Directive 2001/18 provides that applications submitted under Directive 90/220 in respect
of which the approval procedures under Directive 90/ 220 have not been completed by 17 October
2002 are subject to Directive 2001/18. It further provides that by 17 January 2003 applicants had to
complement their applications in accordance with Di rective 2001/18. There is no indication that the
applications concerning MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape were
complemented in accordance with Directive 2001/18.
7.1026 The European Communities appears to argue, however, that the approval procedures
concerning MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape were completed under
Directive 90/220. The European Communities contends that in accordance with the jurisprudence of
the European Court of Justice the absence of the fi nal consent from the lead CA does not mean that
the applicant is not legally entitle d to place MS1/RF1 oilseed rape (EC-89) and/or MS1/RF2 oilseed
rape on the market. According to the European Communities, the applicant could invoke before
French courts the obligation imposed by the above-n oted Commission decisions on France to give its
consent to the placing on the market of the products in question. The United States and Canada did
not contest that the applicant would have this right under EC law. In these circumstances, and in the
absence of evidence to the contrary, we see no grounds for rejecting the European Communities'
contention regarding the position under its own law.
7.1027 Accepting the European Communities' contention m eans that as of the date of establishment
of this Panel, the above-noted Commission decisions were still legally binding, and that as of that date
the applicant could still invoke the above-noted Co mmission decisions against France, since France
had not given its written consent by then. This does not mean, however, that either before or after the
repeal of Directive 90/220 France itself was no lo nger required to comply with the Commission
decisions and was not obliged to grant its written consent. Therefore, the European Communities'
contention does not detract from our view that at least as from June 1999 France's continued failure to
give its written consent supports the Complaining Parties' assertion that the European Communities
was applying a general moratorium on final approvals.
7.1028 In the light of the above considerations, we conclude that at least as from June 1999 the
failure of France to give its written consent to the placing on the market of MS1/RF1 oilseed rape
(EC-89) and MS1/RF2 oilseed rape supports the contention of the Complaining Parties that the
European Communities applied a general moratorium on approvals.
Delays due to changes in the legislative framework

7.1029 As we have noted at the outset, the Eur opean Communities acknowledges that delays
occurred in some approval procedures which were pe nding under Directive 90/220. According to the
European Communities, these delays occurred as a r esult of legislative changes which were being
made at the time. Specifically, th e European Communities refers to the revision of Directive 90/220
which led to the adoption of Directive 2001/18. The European Communities observes that while
Directive 90/220 continued to be the basis for the processing of applications, pending applications
presented a problem in that they did not generally contain the data/information necessary to address

the concerns which led to the adoption of Direc tive 2001/18. The European Communities says that it
therefore had to find ways to ensure that the a pplicant provided the necessar y data/information. The
European Communities points out that most applicants agreed to do so on a voluntary basis. The
European Communities submits that with the adoption and entry into force of the new legislation, all
relevant concerns have been addressed. The Eur opean Communities asserts that, as a consequence,
under Directive 2001/18 all approval procedures have been proceeding normally.
7.1030 Thus, the European Communities essentially argues that to the extent there were delays in the
processing of Directive 90/220 applications, they we re linked to legislative changes which were
completed in October 2002 with the entry into force of Directive 2001/18. They were not linked to
legislative changes sought by the Group of Five countries and obtained in September 2003 with the
adoption of new EC rules on labelling and traceabilit y. In support of this assertion, the European
Communities submits that there were delays before the entry into force of Directive 2001/18, but not
after.
7.1031 It is apparent from the above review of indi vidual approval procedures that delays occurred
which were linked to the adoption of Directive 2001/ 18 or to its more or less imminent entry into
force. In our view, however, these delays are enti rely consistent with the Complaining Parties'
contention that a general moratorium on approvals w as in effect until at least August 2003. We recall
in this respect that in June 1999 the Group of Five countries declared that "pending the adoption of
[new EC rules ensuring labelling and traceab ility of GMOs and GMO-derived products]"
995, they
would take steps to have any new authorizations for growing and placing on the market suspended.
By October 2002, when Directive 2001/18 entered in to force, the new EC rules on labelling and
traceability had not been adopted.996 Thus, it is clear from the June 1999 declaration that the Group of
Five countries would oppose approvals until the adoption of the new rules, that is to say, until after
the entry into force of Directive 2001/18. We also recall the Complaining Parties' assertion that the
Commission was instrumental in the adoption and a pplication of the alleged general moratorium on
approvals and that it decided no t to discharge its responsibility u nder Directive 90/220 to complete
approval procedures, in view of opposition to fi nal approvals by the Group of Five countries.
Accordingly, if a general moratorium on approvals was in effect until at least August 2003, it was to
be expected that the Group of Five countries (acting as lead CA or through the Regulatory
Committee/Council) and/or the Commission woul d cause delays prior to the repeal of
Directive 90/220 so as to prevent applications from being approved while that Directive was still in
force.
7.1032 The European Communities claims that after the entry into force of Directive 2001/18, there
were no further delays, except for delays which were the result of a clock-stop while further
information was awaited. However, as our preceding an alysis has shown, there were in fact delays in
the processing of applications under Directive 2001/18 which are consistent with the existence of a
moratorium on approvals. Such delays occurred at the member State level in the approval procedures
concerning Bt-531 cotton, RR-1445 cotton, BXN cott on and Bt-1507 maize (EC-74). Our analysis
also showed that in a number of instances, app lications moved to the Community level relatively
promptly.997 However, we have said that, in our view, th is does not disprove the Complaining Parties'
claim that a moratorium on approvals was in effect during the relevant time period. We observed that
the lead CA in the relevant cases could have consid ered that while Directive 90/220 was still in force,
the Group of Five countries and the Commission woul d prevent the final approval of the application

995 Exhibits US-76 and -77; CDA-3; ARG-12.
996 The Commission did not propose such rules until July 2001.
997 See, e.g., the approval procedures concerning RR oilseed rape (EC-70), Bt-1507 maize (EC-74),
Bt-1507 maize (EC-75) and NK603 maize.

in question, whereas after the entry into force of Directive 2001/18, the application might eventually
be approved, after the adoption of new EC rules on labelling and traceability. In other words, the lead
CAs had reason to believe that under Directive 2001/18 any delays caused by them at member State
level might have an impact on when the relevant applications would be approved.
7.1033 The European Communities' contention that ther e were and should have been no delays after
the entry into force of Directive 2001/18 is also inconsistent with the June 1999 declaration by the
Group of Five countries. As noted earlier, the Gr oup of Five countries announced that they would
take steps to prevent approvals pending the adoption of the new EC rules on labelling and traceability.
Such rules were adopted in September 2003, i.e., after the entry into force of Directive 2001/18. The
record shows that Group of Five countries conti nued to oppose the approval of applications even
though they had been updated in accordance with the requirements of Directive 2001/18.
998
7.1034 Furthermore, we note that, as of August 2003, there had been no case where an approval
procedure conducted under Directive 2001/18 reached the stage where the Commission had to submit
a draft measure to the Regulatory Committee/Council or adopt a draft measure not adopted by the
Council. In other words, there was no proce dure which reached the stage where the Commission
could have taken action to delay or prevent the final approval of an application. Moreover, the first
Commission approval of an application under Directiv e 2001/18 occurred only in July 2004, that is to
say, after the establishment of the Panel and after th e entry into force of the new EC rules on labelling
and traceability. Hence, as far as the Commission's conduct is concerned, the record does not
disprove the Complaining Parties' claim that th e Commission had decided not to complete approval
procedures for as long as the new EC rules had not been adopted.
7.1035 In the light of the above considerations, we are not persuaded by the European Communities'
contention that to the extent there were delays in the processing of applications for deliberate release
into the environment, they were attributable in pa rt to legislative changes which were completed in
October 2002 with the entry into force of Directive 2001/18, but not to legislative changes sought by
the Group of Five countries. We consider that the delays which occurred prior to the entry into force
of Directive 2001/18 are entirely consistent with the contention of the Complaining Parties that the
European Communities was applying a general morato rium on approvals at least until August 2003.
We also consider that the record does not s upport the European Communities' assertion that under
Directive 2001/18 there were no delays or at least n one which are consistent with the existence of a
moratorium on approvals.
(ii) Novel Foods – Applications submitted under Regulation 258/97
7.1036 The Panel now turns to address those of the re levant applications wh ich were submitted and
dealt with under the provisions of Regulation 258/97 concerning novel foods and novel food
ingredients. From the information provided to us , it appears that all of the biotech products which
were the subject of the relevant Regulation 258/97 applications had also been submitted for approval
under Directive 90/220.
999 It is also noteworthy that all Regulation 258/97 applications were
submitted after the corresponding Di rective 90/220 applications. 1000 Furthermore, the two biotech
food products which were approved by the Co mmission in 2004, Bt-11 sweet maize (food) and

998 See, e.g., the approval procedures concerning RR oilseed rape (EC-70) (Exhibit EC-70/At. 71) and
NK603 maize (Exhibit EC-76/At. 46).
999 In some cases, the Directive 90/220 and Regulation 258/97 applications were submitted to the same
lead CA. In most cases, they were submitted to different lead CAs.
1000 In some cases, the Regulation 258/97 applications were submitted a few days later, in other cases
more than a year later.

NK603 maize (food), were approved after having been approved under Directive 90/220 (Bt-11 maize
(EC-163)) and Directive 2001/18 (NK603 maize).
7.1037 Some of the approval procedures we address be low are for applications covering foods or
food ingredients which contain or consist of GMOs.
1001 It should be noted in this respect that
according to Regulation 258/97 "risks to the envir onment may be associated with novel foods or food
ingredients which contain or consist of [GMOs]". 1002 Article 9(1) of Regulation 258/97 therefore
requires that applications concerning such foods or food ingredients be accompanied by the technical
dossier supplying the relevant information requi red under Article 11 of Directive 90/220 and the
environmental risk assessment based on this in formation or, where appropriate, the decision
approving the placing on the market of the relevant product under Directive 90/220. Article 9(2)
provides that the decision approving the placing on the market under Regulation 258/97 must "respect
the environmental safety requirements laid down by [Directive 90/220] to ensure that all appropriate
measures are taken to prevent the adverse effects on human health and the environment which might
arise from the deliberate release of [GMOs]". It would seem to follow from Article 9 that if the
applicant did not submit an environmental risk ass essment, a Regulation 258/97 application could not
be approved by the Commission unless the corresponding Directive 90/220 application had previously
been approved.
7.1038 The Complaining Parties assert that the facts and histories of the relevant approval procedures
support their view that the European Communities ap plied a general moratorium on final approvals of
biotech products, including biotech food products. We recall in this respect that in June 1999 the
Group of Five countries declared that "in exercising the powers vested in them regarding the growing
and placing on the market of genetically modified organisms (GMOs)", "pending the adoption of [EC
rules ensuring labelling and traceability of GMOs a nd GMO-derived products], in accordance with
preventive and precautionary principles, they will ta ke steps to have any new authorizations for
growing and placing on the market suspended".
1003 This declaration was made in the context of the
revision of Directive 90/220. However, by its te rms, the declaration does not exclude from its scope
GMOs which are directly used as foods or food i ngredients, GMOs contained in foods or food
ingredients, or GMOs from which foods or food ingredients are produced, but which do not contain
the relevant GMOs.
7.1039 Furthermore, we note that the new EC rules on labelling and traceability of GMOs and GMO-
derived products referred to in the June 1999 declaration by the Group of Five countries clearly
include those which were adopted in September 2003 as Regulation 1830/2003. That Regulation, as
its title makes clear, concerns "the traceability and labelling of [GMOs] and the traceability of food
and feed products produced from [GMOs] " (emphasis added). The preamble to
Regulation 1830/2003 notes that traceability requir ements for food and feed produced from GMOs
should be established to facilitate accurate la belling of such products in accordance with the
requirements of Regulation 1829/2003 on genetically modified food and feed, which was also adopted
in September 2003. In the light of this link between the two Regulations, and above all in view of the
reference in the Group of Five declaration to ne w EC rules on "labelling [...] of GMOs and GMO-
derived products", it is plausible that the Group of Five declaration was intended to cover also
Regulation 1829/2003. That Regul ation lays down additional labelling requirements for genetically
modified food and feed. In particular, unlike Regulation 258/97, it requires labelling of GMO-derived

1001 In some cases, from the information provided to us, we could not determine whether an application
covered foods or food ingredients containing or consisting of GMOs.
1002 Fifth preambular paragraph of Regulation 258/97.
1003 Exhibits US-76 and -77; CDA-3; ARG-12.

food products also in cases where the DNA or protein of GM origin is not detectable in the final food
products.
7.1040 In relation to Regulation 1829/ 2003, we should add that Cana da and Argentina submitted to
us a Council document which indicates that on the issue of "authorization of new GMO food
products" Denmark, supported by France, Italy, Au stria, Portugal and Luxembourg, in January 2003
pointed to "the conditions for further approval of [GMOs] since a political agreement had been
reached at the Council on 28 November 2002 [...] on the proposal for a Regulation on [GM food and
feed]". The document further states that "[s]om e of these delegations" considered that "no new
procedure of authorization for placing on the market new GMOs should be granted as long as this
Regulation had not yet entered into force".
1004 However, we cannot give much weight to this
document as it is not clear what is meant by "the conditions for further approval", nor is it clear how
many and which of these delegations were against further approvals pending the entry into force of
the new Regulation 1829/2003 on GM food and feed.
7.1041 Finally, we note that if the Group of Five countries considered it appropriate, pending the
adoption of new EC rules on labelling and traceability, to take steps to prevent the approval under
Directives 90/220 or 2001/18 of biotech products which are for cultivation and/or feed use, it would
be surprising if they did not oppose on the same grounds the approval under Regulation 258/97 of the
identical products for food use, at least where tho se products contain or consist of GMOs. To recall,
Regulation 258/97 indicates that environmental risk s may also be associated with the food use of
biotech products and requires that food products containing or consisting of GMOs satisfy the
environmental safety requirements of Directives 90/220 and 2001/18. In fact, the record shows that
Denmark and France have invoked the June 1999 decl aration by the Group of Five countries in the
context of approval procedures c onducted under Regulation 258/97, when raising objections to
favourable lead CA assessments of specific applications.
1005
7.1042 With these observations in mind, we now turn to review the approval procedures conducted
for the relevant Regulation 258/97 applications. As with our review of the procedures conducted for
the Directive 90/220 applications, we will firs t focus on the Commission's conduct. Then, we
consider the conduct of the SCF. Finally, we examine the conduct of individual member States acting
as lead CAs.
Failure by the Commission to submit a draft measure to the Regulatory Committee
7.1043 In support of their assertion that the European Communities applied a general moratorium on
approvals the Complaining Parties have pointed to a number of approval procedures in which the
Commission failed to submit to the Regulatory Committee 1006 a draft measure on the relevant
applications. We consider these approval proc edures below, recalling that Article 13(3) of
Regulation 258/97 provides in relevant part that " [t]he representative of the Commission shall submit
to the Committee a draft of the measures to be taken".

1004 Press Office of the Council, 2481 st Council meeting – Agriculture and Fisheries, Brussels, 27 and
28 January 2003, p. 23 (Exhibit ARG-52). See also Exhibit CDA-118.
1005 Exhibits EC-91/At. 32 (food containing or consisting of GMOs and food produced from, but not
containing GMOs); EC-92/Ats. 23 and 27 (food containing or consisting of GMOs); EC-96/At. 27 (food
containing or consisting of GMOs and food produced from, but not containing GMOs).
1006 We recall that the Regulatory Committee establis hed under Article 13 of Regulation 258/97 was
the Standing Committee on Foodstuffs.

GA21 maize (food) (EC-91)
7.1044 The application for GA21 maize (food) was subm itted to the Dutch CA (lead CA) on 24 July
1998. The initial assessment of the lead CA was provided to the Commission on 21 January 2000,
and circulated by the Commission to member States on 18 February 2000. On 18 May 2000, the
Commission requested the SCF to evaluate the application; the opinion of the SCF was issued on 27
February 2002. At the time the Panel was estab lished, the Commission had not submitted a draft
measure on the application to the Regulatory Committee.
7.1045 The United States argues that the Commission asked the SCF for an opinion on 18 May
2000. However, it was eleven months later that th e SCF contacted the applicant for the first time,
asking for additional information.
1007 Within less than one month, the applicant provided answers to
all questions.1008 It took a further 11 months for the SCF to issue an opinion on 27 February 2002. 1009
Hence the application was delayed for 17 months at the Community level before the SCF rendered its
positive opinion on 27 February 2002. In its opi nion, the SCF concluded th at the data submitted,
including the two whole food studies, were "sufficient for evaluation" 1010 and cited these studies in
support of its ultimate conclusion that "from the point of view of consumer health, maize grain from
maize line GA21 and derived products [ …] are as safe as grain a nd derived products from
conventional maize lines."1011
7.1046 According to the United States, almost two months passed after the positive SCF opinion with
no activity on this application. On 23 April 2002, the applicant offered to reduce the scope of the
application to include only processed grain and de rived ingredients, but not unprocessed grains, in
order to enable the authorization procedur e under Regulation 258/97 to proceed immediately. 1012 The
applicant explained that the reason for this proposal was because the food use of unprocessed grains is
also subject to Directive 90/220 and that "progress under this Directive has been suspended for some
time, with the result that GA21 maize grain has not yet been considered for consent."1013
7.1047 The United States argues that despite the effort s of the applicant to remove any possible
impediments, the Commission still failed to forw ard the application to the Regulatory Committee
after the positive SCF opinion. Instead, as reflected in the minutes of a meeting on 5 June 2002
between the Commission and the applicant, the Commi ssion 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 legislative developments w ith respect to the authorization of GM food and
feed as well as the labelling of GM products".
1014 The United States maintains that the European
Communities simply halted the processing of this application in anticipation of possible upcoming
changes to its regulations, an action entirely cons istent with the moratorium which the European
Communities and member State officials had anno unced. Although both the new food and feed and
traceability and labelling legislations would not enter into force until 2004, and although the applicant
stated its preference to apply the labelling require ments currently in effect under Regulation 258/97,
the Commission noted that "it is clear that it would be more difficult to obtain a favourable opinion by

1007 Exhibit EC-91/At. 39.
1008 Exhibit EC-91/At. 40.
1009 The United States observes that the current revi sed regulatory framework recognizes that a period
of six months is an achievable timeframe for the European Communities' scientific authority (EFSA GMO
Panel) to come to an opinion. Regulation (EC) No. 1829/2003, Article 6.1.
1010 Exhibit EC-91/At. 43, pp. 11-12.
1011 Exhibit EC-91/At. 43.
1012 Exhibit EC-91/At. 44.
1013 Exhibit EC-91/At. 44.
1014 Exhibit EC-91/At. 45, p. 1.

a majority of Member States in the Comitology pr ocedure" if the applicant were not required to
anticipate the new labelling requirements be fore the new legislation was adopted.
1015 In other words,
the applicant was required to wait until the require ments for labelling under pending legislation were
finalized. Thus 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 Food and
Feed regulation was passed in September 2003.
7.1048 Canada notes that after GA21 maize received a favourable assessment by the lead CA, other
member States raised objections. The SCF was then requested to conduct its own independent risk
assessment and specifically "to focus its deliberatio ns on the issues raised in the comments made by
member States’ authorities."1016 The risk assessment, taking into consideration the objections raised
by member States, concluded that the product in question was as safe as conventional maize.
Specifically, the SCF concluded in February 2002:
"Having reviewed all the information provided by the petitioner and in the light of
current published scientific information it is concluded that from the point of view of
consumer health maize grain from maize lin e GA21 and derived products that are the
subject of this application are as safe as grain and derived products from conventional
maize lines."1017
7.1049 Canada notes, however, that GA-21 maize is among those products where no decision has
been taken despite having received a favourable opinion from the relevant scientific committee. Since
1998, the Regulatory Committee has not delivered a single favourable opinion in relation to the
authorization of biotech products under Regula tion 258/97. Canada rejects the European
Communities' attempt to rationalize the "delay" in ap proving this product on the basis that legislative
change was required to enable regulators to adopt "risk management". The risk assessment of GA21
maize under Regulation 258/97 did not identify any ri sks for which risk management measures would
be justified. Therefore there is no justificati on for imposing "risk management" measures, be they
labelling, post market monitoring or tools to fac ilitate the implementation and enforcement of such
risk management measures ( e.g. product tracing or detection). Ca nada maintains, rather, that the
"delays" in approving GA21 maize under Regulation 258/97 are a result of the moratorium on the
approval of biotech products.
7.1050 Argentina argues that for GA21 maize (food), the risk assessment required by
Regulation 258/97 has been completed. However, since 27 February 2002, the date on which the SCF
expressed its favourable opinion, there has been no further progress in the approval process.
Argentina indicates that the application was withdrawn in September 2003 because no progress had
been made since 27 February 2002. This means that the process dragged on for a total of 5 years and
2 months since the initial submission of the application without a definitive response.
7.1051 The European Communities recalls that in May 2000, the Commission requested the
opinion of the SCF. The SCF issued its opinion in February 2002, finding that the application did not
contain sufficient information concerning substantia l equivalence and toxicity testing, and requested
additional information from the applicant.
1018

1015 Exhibit EC-91/At. 45, p. 2.
1016 Exhibit CDA-35-J, p. 2; Exhibit CDA-35-K, p. 2; Exhibit CDA-35-M, p. 11.
1017 Exhibit CDA-35-K, pp. 11-12; Exhibit EC-91/at.43.
1018 Exhibit EC-91/At. 17.

7.1052 The European Communities notes the difference between risk assessment and risk
management and argues that the former is the task of the scientific committees, while the latter is the
function of the Regulatory Committee. Since the Regulatory Committee fulfils risk management
functions, it has to take into account all re levant factors, including risk assessment stricto sensu. The
European Communities argues that the draft me asures forwarded by the Commission to the
Regulatory Committee are therefore supported by scientific assessments, but also address other
legitimate issues, including risk management i ssues, which are not addressed by a scientific
committee.
7.1053 Specifically in relation to the application concerning GA21 maize (food), the European
Communities submits that the SCF's opinion did not address sufficiently all relevant elements. The
elements which determined the insufficiency of th e SCF's opinion related to the issues of detection
and validation methods, which were requirements to be included in the new legislation on "Food and
Feed" and on whose importance the applicant agreed. More partic ularly, the European Communities
notes that in view of the pending legislative proposal for "Food and Feed", in June 2002 the applicant
committed on a voluntary basis to providing det ection and validation met hods for its product in
collaboration with the Joint Research Centre of the Commission (hereafter the "JRC").
7.1054 The European Communities notes that agreement on the amount of data and material and the
circumstances of their submission to the JRC took a considerable amount of time. All the necessary
data were received in proper condition in mid-September 2003. The pre-validation study was initiated
in October and was concluded after the applicant de livered the full data set at the end of November
2003. Some additional testing on the method and ma terials was carried out in early 2004. The
collaborative study of method validation was launched in April 2004 and was expected to be finished
by the end of June 2004.
7.1055 The Panel notes that the lead CA forwarded the application with its positive assessment to the
Commission on 21 January 2000. After the circulation of this assessment report to all member States
three weeks later, a number of member States submitted comments, requested further data, or raised
objections within the 60-day period provided under Regulation 258/97. On 18 May 2000, the
Commission requested the SCF to give an opinion regarding potential health concerns related to
GA21 maize (food), and to focus specifically on the issues raised in the comments by member States.
7.1056 Shortly after the application was submitted to the SCF, the applicant provided responses to
questions from two member States and submitted a re vised labelling proposal; all of this possibly
new information was, however, available by th e end of August 2000. In April 2001, the SCF
requested further information from the applicant. The applicant apparently provided the data
requested by the SCF within two months. Howeve r, another eight months elapsed before the SCF
issued its favourable opinion on 27 February 2002.
7.1057 On 23 April 2002, the applicant informed th e Commission that it was no longer seeking to
obtain approval to place on the market unprocessed GA21 maize grain for food use. The applicant
explained that this food use would be subject to Directive 90/220
1019, and noted that the progress of
the application concerning GA21 maize (EC-78) under Directive 90/220 had been suspended for some

1019 Pursuant to Article 9 of Regulation 258/97, in the case of foods or food ingredients containing or
consisting of GMOs, the approval decision to be taken must "respect the environmental safety requirements laid
down by Directive 90/220 to ensure that all appropri ate measures are taken to prevent the adverse effects on
human health and the environment which might arise from the deliberate release of [GMOs]".

time. The applicant was hoping that this move w ould enable the application under Regulation 258/97
to proceed immediately.
1020
7.1058 More than a month later, on 5 June 2002, the Commission services met with the applicant.
The Commission in its report of the meeting states that "it would be desirable that a [draft measure on
the application] would take into account in an a ppropriate manner the legislative developments with
respect to the authorization of GM food and feed as well as the labelling of GM products".1021
7.1059 The report first addresses the issue of the labelling of foods and food ingredients derived from
GA21 maize. It states that the applicant preferred to comply only with the labelling requirements set
out in Article 8 of Regulation 258/97, which requi res labelling only of foodstuffs where detectable
traces of modified DNA or the resulting protein are present ( i.e., GM-maize oil was not required to be
labelled). According to the report, the applicant be lieved that this was the sc heme which would be in
force at the time a decision would be made on this application, and would also avoid that GA21 maize
would be treated differently from foods derived from other varieties of GM maize already on the EC
market. The report notes that the applicant cons idered that if and when the labelling scheme was
changed, those changes would automatically become obligatory for all authorized foodstuffs derived
from any GM-maize variety. However, the Commi ssion observed that it was clear that it would be
more difficult to obtain a favourable opinion by a majority of member States if not all foods and food
ingredients derived from GA21 maize had to be labelled, recognizing that anticipating the new
labelling requirements (before the new legislation wa s adopted) would require re-consideration of the
labelling of foods derived from GM maize already on the market. It was agreed that the Commission
and the applicant would meet again to discuss the labelling issue once the European Parliament had
debated the proposal for the new legislation in July 2002. There is nothing in the record to indicate
that such a meeting took place in July 2002, or that the labelling issue was otherwise pursued further.
7.1060 The report of the meeting then goes on to address the issue of " [d]etection methods,
traceability, reference materials [and] identification". The report indi cates that the applicant "agreed
to provide" the necessary information and materials to the JRC in a timely manner. There is nothing
in the record which indicates that this "agreement" from the applicant was not voluntary. The report
of the meeting indicates that there should be "no par ticular problem with respect to the validation.
However, the availability of referen ce material has not been discussed."
1022 The report notes that a
draft measure might be presented to the Regulatory Committee in November 2002, provided that a
validated detection method was available by then.
7.1061 In September 2002, another meeting took place between the Commission and the applicant.
The report of the meeting indicates that little progress ha d been made with regard to the validation of
a detection method. This was because of a deadlo ck resulting from a request by the applicant that the
method be kept confidential until the date of approval of the application. The report further notes that
once a material transfer agreement was reached and a detection method and the necessary materials
were available, the validation would take three months.
1023 Apparently, a material transfer agreement
was finally signed in late February 2003, but a detection method was not provided until the end of
March 2003. 1024 At the time of establishment of the Panel, the question of the validation of the
detection method had not yet been resolved by the JRC, and so by August 2003 no draft measure had
been forwarded to the Regulatory Committee.

1020 Exhibit EC-91/At. 44.
1021 Exhibit EC-91/At. 45.
1022 Exhibit EC-91/At. 45.
1023 Exhibit EC-91/At. 46.
1024 Exhibit EC-91/At. 50.

7.1062 It is clear from the foregoing that after th e SCF opinion was issued, the progress of the
application was adversely affected by the fact that the Commission waited for more than three months
before seeking voluntary commitments from the applicant. As well, the applicant agreed to provide
additional information and materials so as to provi de a basis for traceability, as envisaged in the new
EC rules proposed by the Commission. This in turn resulted in further delays, due to the need for
validation of a detection method.
7.1063 The Complaining Parties consider that the Commission's failure promptly to submit a draft
measure to the Regulatory Committee, without seek ing additional commitments from the applicant,
reflects the adoption by the European Communities of a general moratorium, that is, a decision not to
allow any application to proceed to final approval. We recall in this regard the June 1999 declaration
by the Group of Five countries in which these countri es stated that they would take steps to suspend
approvals pending the adoption of new EC rules ensuring the labelling and traceability of GMOs and
GMO-derived products. Thus, in April 2002, following the issuance of the SCF opinion, the
Commission had reason to believe that the Group of Five countries would act as a "blocking
minority" in the Regulatory Committee and the Counc il, and that the Commission would then have to
adopt the draft measure submitted to the Regul atory Committee and Council, as required under
Regulation 258/97. It is the Complaining Parties' contention, however, that the Commission decided
not to discharge its responsibility under Regulation 258/97 to complete approval procedures, in view
of opposition to final approvals by the Group of Five countries and that the Commission was therefore
instrumental in the adoption and application of the alleged general moratorium.
7.1064 In considering the Complaining Parties' contention, we note, first of all, that the Commission
could have forwarded a draft measure based on th e requirements of Regulation 258/97 only. It did
not do so. Instead, the Commissi on sought voluntary commitments fro m the applicant with regard to
labelling and traceability. The commitments sought we re based on legislative proposals for new EC
rules on labelling and traceability. In relation to labelling, the Commission specifically pointed out
that it would be difficult to obtain a majority without additional commitments. These elements
suggest that the Commission wanted to prepare and forward a draft measu re which could obtain
qualified majority support in the Regulatory Comm ittee or the Council. As pointed out earlier,
however, in view of the June 1999 declaration by the Group of Five countries, the Commission had
reason to believe that no qualified majority could be achieved before the new EC rules on labelling
and traceability of GMOs and GMO-derived products were adopted.
1025 It should also be noted in this
connection that the record contains no example of an approval procedure, whether it be one conducted
under Directives 90/220 and 2001/18 or one c onducted under Regulation 258/97, where the
Commission adopted its own draft measure prior to the adoption of the new EC rules on labelling and
traceability. For these reasons, we consider that th e Commission's conduct in the approval procedure
concerning GA21 maize (food) is cons istent with the Complaining Parties' contention that at least
until August 2003 the Commission followed a decision not to discharge its responsibility under
Regulation 258/97 to prevent the Group of Five countries from blocking the approval of applications.
7.1065 In the light of the above considerations, we c onclude that the Commission's failure to submit
a draft measure concerning GA21 maize (food) to the Regulatory Committee prior to August 2003 is
consistent with the Complaining Parties' assertion that during the relevant time period the European
Communities applied a general moratorium on final approvals.

1025 This view is supported by the fact that Denmark invoked the June 1999 declaration by the Group of
Five countries in the approval procedures concerning GA21 maize (food), when raising objections to the lead
CA's favourable assessment of the application. Exhibit EC-91/At. 32.

Bt-11 sweet maize (food) (EC-92)
7.1066 A request for the approval of products process ed from Bt-11 sweet maize (food) was initially
submitted to the Netherlands (lead CA) on 6 April 1998. An amendment submitted on 24 November
1998 extended the scope of the request to cover also the consumption of fresh Bt-11 sweet maize.
The documentation for these two requests was joined in a single document, which was submitted to
the Commission on 11 February 1999 in accordance with Regulation 258/97. On 12 May 2000, the
lead CA forwarded its initial assessment report to the Commission who circulated it to all member
States on 15 June 2000. The Commission requested the opinion of the SCF in December 2000; the
SCF issued its opinion in April 2002. At the time the Panel was established, the Commission had not
submitted a draft measure on the application to the Regulatory Committee.
7.1067 Subsequent to the establishment of the Panel, on 10 November 2003, the Regulatory
Committee failed to vote on the draft measure subm itted by the Commission. On 8 December 2003,
the Regulatory Committee voted on the draft measure but failed to reach a qualified majority. On 24
April 2004, the Council failed to reach a qualified majority on the draft measure submitted by the
Commission. On 19 May 2004, the Commission adopt ed its draft measure concerning Bt-11 sweet
maize (food).
7.1068 The United States notes that Bt-11 sweet maize (food) application was for marketing the
maize as a fresh vegetable or after processing, not for cultivation. Moreover, the maize line was
derived from an already reviewed and approved version of Bt-11 field maize.
1026 On 10 February
1998, the SCF published an opinion in which it concluded that the use of seed carrying the Bt-11
event was as safe as the use of seed from conventional maize varieties.1027
7.1069 The United States argues that following the positi ve assessment of the SCF in April 2002,
there were delays in the processing of this appli cation. The United States notes that the European
Communities attempts to justify delays in the pro cessing of the Bt-11 sweet maize (food) application
by claiming that "[b]etween October and early December 2003 [after the SCF positive opinion], three
new risk assessment were issued by the Member States, all of which conflicted with the SCF
opinion".
1028 These risk assessments were supposedly provided by Austria, Belgium and France. The
United States maintains that the EC contention is unsupported by the reco rd. No risk assessments
were in its view submitted during that time peri od. According to the European Communities' own
chronology, the only events that occurred between October to December 2003 we re: the finalization
of a method validation by the JRC on 2 October 2003; 1029 the applicant's agreement to making public
the validation method on 20 October 2003 1030; a meeting of the Standing Committee on the Food
Chain and Animal Health on 10 November 2003; 1031 a comment from France on 27 November
2003;1032 the vote at the Regulatory Committee on 8 D ecember 2003 (which did not reach a qualified
majority);1033 and a 20 November 2003 letter from the applicant to the Commission releasing
technical data. 1034 None of these documents contain any purported risk asse ssments conducted by

1026 According to the United States, the key diffe rence between sweet and field maize is that,
irrespective of whether it is genetically modified or not, sweet maize has a higher amount of natural sugars.
1027 Exhibit EC-92/At. 17, p. 1 (referring back to the February 1998 SCP Opinion).
1028 Responses by the European Communities to the questions posed by the Panel on the 3 rd of June,
2004, Response to Question 1.
1029 Exhibit EC-92/At. 66.
1030 No document available per the European Communities' chronology.
1031 Exhibit EC-92/At. 67 (misdated in the EC chronology as November 8).
1032 Exhibit EC-92/At. 69.
1033 Exhibit EC-92/At. 70.
1034 Exhibit EC-92/At. 68.

France, Austria, or Belgium. At the 10 Nove mber 2003 meeting of the Standing Committee on the
Food Chain and Animal Health,
1035 only a comment was provided by France, not a risk
assessment.1036 At the Regulatory Committee meeting on 8 December 2003, Austria 1037, Belgium1038
and France1039 submitted written declarations to their votes. But none of these was a risk assessment.
Rather, when the Regulatory Committee failed to obtain a qualified majority in December 2003 it was
because certain member States objected due to th e proposed new traceability and labelling regulations
(which did not become effective until April 2004).1040
7.1070 In May 2004, the novel food application for Bt -11 sweet maize was finally approved. The
United States contends that the history of this application confirms the delays resulting from the
moratorium, and its ultimate approval does not indi cate that the moratorium has finally ended.
Rather, in the view of the United States, the Bt- 11 approval in May 2004 is entirely consistent with,
and in fact supports, the existence of a general moratorium during the period covered within the
Panel's terms of reference. Both the Commission and the Council have stated that the entry into force
of the new traceability and labelling rules for biotech products might finally allow for the lifting of the
moratorium. Those new rules went into effect on 19 April 2004. The United States considers that the
fact that the Commission then approved the appli cation concerning Bt-11 sweet maize (food) just one
month later is not mere coincidence. To the c ontrary, this timing indicates that the EC approval
system was held up not by any problems with particul ar applications, but by events outside the scope
of its approval legislation. Moreover, the United States emphasizes that the Council itself
acknowledged the existence of the "m oratorium" – using this very word – in a statement concerning
the scheduled approval of the application concerning Bt-11 sweet maize (food).1041
7.1071 Canada argues that Bt-11 sweet maize is one of six products whose approval was delayed for
as long as five years, despite having received a fa vourable assessment from the lead CA, and, in the
case of this product, having also received a positiv e assessment from the SCF. Canada notes that the
Regulatory Committee held a vote on the applica tion concerning Bt-11 sweet maize (food) on 8
December 2003, after the establishment of the Pane l. However, the Regulatory Committee failed to
obtain the qualified majority necessary for approva l, despite having received a favourable opinion
from the SCF.
7.1072 Canada further argues that it is unjustif iable to fail to approve products under
Regulation 258/97 on the basis that the existing le gislation does not provide for risk management

1035 Exhibit EC-92/At. 67.
1036 The French comment does not "evaluate the pote ntial for adverse effects on human or animal
health" posed by the sweet corn's different sugar metabolism from field corn. The comment is concerned with
unintended effects, theoretical risks not identified by any of the existing protein toxicity or animal studies
conducted. As the Commission stated in its Proposal for a Council Decision of 28 January 2004, "[t]he
concerns raised in the opinion of the 'Agence française de sécurité sanitaire des aliments' (AFSSA) of 26
November 2003 do not bring any new scientific elements in addition to the initial assessment of sweet maize
Bt-11 carried out by the competent authorities of the Nether lands". In fact, these conc erns were also expressed
in two AFSSA opinions of 21 July 2000 and 20 March 2001 and were duly considered by the SCF in its opinion
of 17 April 2002, which confirmed the findings of the initial assessment that Bt-11 sweet maize is as safe for
human food use as conventional maize. Exhibit EC-92/At. 77.
1037 Exhibit EC-92/At. 71.
1038 Exhibit EC-92/At. 73.
1039 Exhibit EC-92/At. 72.
1040 Exhibit EC-92/Ats. 67 (noting that "[f]inally, se veral Member States questioned the opportunity to
proceed with the authorization of this product in anticipation of the coming into application of Regulation (EC)
1829/2003 and 1830/2003."), 71, 74, 75 and 76.

measures, where the risk assessments for those product s have not identified any risks that need to be
managed. The SCF concluded in April 2002 that Bt -11 sweet maize (food) is as safe for human food
use as its conventional counterparts.
1042
7.1073 In relation to the Commission's decision of May 2004 to approve the placing on the market of
Bt-11 sweet maize (food), Canada observes that the Commission has been forced to adopt a decision
authorizing Bt-11 sweet maize (food) only after resort to the exceptional Regulatory Committee
procedure. Despite favourable opinions of EFSA and despite the entry into force of the new
legislative regime,1043 member States voted against the Commissi on's proposal for the approval of the
product in question at the Regulatory Committee stage. Moreover, the Council failed to act. Far from
demonstrating that the moratorium has been lifted, the fact that approval is granted only at the last
possible step is another indication of the existence of the moratorium.
7.1074 Argentina argues that although some products, including Bt-11 sweet maize (food), received
positive scientific opinions under Regulation 258/97, approval of these products was nonetheless
stalled, both before reaching the Regulatory Committee stage and within that stage.
7.1075 The European Communities notes that following the submission of this application to the
Netherlands in 1999, the lead CA requested additi onal information relating mainly to the antibiotic
resistance marker used (PAT protein) and to the toxi city studies done in relation to this protein. After
the lead CA sent its initia l assessment report to the Commission in May 2000, four member States
raised objections and several more requested add itional information, relating mainly to the above
issues as well as to molecular characterization. The Commission requested an opinion of the SCF in
December 2000. The SCF requested further data whic h the applicant only supplied in February 2002.
The SCF issued its opinion in April 2002, stating th at on the basis of the information supplied in the
application and further material supplied by the ap plicant in response to queries raised by member
States and in the light of the published literature, it was to be concluded that Bt-11 sweet maize (food)
was as safe for human food use as its conventional counterparts.
7.1076 According to the European Communities, in view of the pending legislative proposal on
"Food and Feed", the applicant, on a voluntary basi s agreed to provide detection and validation
methods for its product in collaboration with the JRC. The amount of data and material and the
circumstances of their submission to the JRC we re agreed upon in a planning meeting in October
2002. The first set of material sent at the be ginning of 2003 was inadequate in terms of necessary
amounts of information, and the method provided by the applicant performed very poorly in a pre-
validation study. The applicant delivered a prope r method and all the necessary materials only by
July 2003. The JRC finalized the validation met hod in October 2003. Following the finalization of
the validation method, the Commission prepared a pr oposal for a decision on a market authorization.
The proposal did not obtain a qualified majority in the Regulatory Committee or in the Council and
was adopted by the Commission on 19 May 2004.
7.1077 The European Communities argues that the histor y of the application concerning Bt-11 sweet
maize (food) is an illustration of the fact that th e approval process has been steadily proceeding over
the past years. The marketing authorization of Bt-11 sweet maize (food) did not occur because of a
sudden change in the European Communities' polic y on GMOs, but as the result of a normal process
of assessment, which has known no suspension a nd has been conducted taking into account the

1042 Exhibit CDA-35-J, pp. 9-10.
1043Regulation 1829/2003 (GM food and feed) (Exhibit CDA-20) and Regulation 1830/2003
(traceability and labelling) (Exhibit CDA-30) entered into force on 18 April 2004.

reactions of the applicants, the constant evoluti on of the scientific and regulatory debate concerning
GMOs and the entry into force of new legislation resulting from this debate.
7.1078 The Panel notes that the lead CA forwarded the application with its positive assessment to the
Commission on 12 May 2000. After the circulation of this assessment report to all member States, a
number of member States submitted comments, requested further data, or raised objections within the
60-day period provided under Regulation 258/97 . On 13 December 2000, the Commission requested
the SCF to give an opinion regarding potential h ealth concerns related to Bt-11 sweet maize (food),
and to focus specifically on the issues raised in th e comments by member States. The SCF apparently
considered the application for four months before requesting further information from the applicant on
15 April 2001. It appears that no response was fo rthcoming from the applicant, and on 12 November
2001 the SCF reminded the applicant that it was aw aiting information requested in April. The
applicant apparently replied that it expected to pr ovide the requested data in January 2002. On 17
April 2002, the SCF issued its report with the conclusion that Bt-11 sweet maize (food) is as safe for
human food use as its conventional counterparts.
7.1079 More than a month and a half later, on 5 June 2002, the Commission services met with the
applicant. The Commission in its report of the meet ing states that "it would be desirable that a [draft
measure on the application] would take into a ccount in an appropriate manner the legislative
developments with respect to the authorization of GM food and feed as well as the labelling of GM
products".
1044
7.1080 The report of the meeting addresses the issue of " [d]etection methods, traceability, reference
materials [and] identification". The report indicates that the applicant "agree[d] to provide" the
necessary information and materials to the JRC in a timely manner. 1045 There is nothing in the record
which indicates that this "agreement" from the a pplicant was not voluntary. The report notes that a
draft measure might be presented to the Regulatory Committee in November 2002, provided that a
validated detection method was available by then.
7.1081 Apparently, the applicant did not transfer any material until late January 2003. Following
unsatisfactory results of the detection methods valid ation, and further provision of materials for the
validation, in January 2003 the JRC indicated that it would provide a template protocol for the
validation for use by the applicant.
1046 The JRC continued to find the results unacceptable, and in July
2003 the applicant accepted to use the method pr oposed by the JRC and submitted materials. 1047 The
JRC finalized its method va lidation in October 2003. 1048 Thus, at the time of establishment of the
Panel, the question of the validation of the detec tion method had not yet been resolved by the JRC,
and so by August 2003 no draft measure had been forwarded to the Regulatory Committee.
7.1082 It is clear from the foregoing that after the SCF opinion was issued the progress of the
application was adversely affected by the fact th at the Commission waited for more than a month and
a half before seeking voluntary commitments from the applicant. As well, the applicant agreed to
provide additional information and materials so as to provide a basis for traceability, as envisaged in
the new EC rules proposed by the Commission. This in turn resulted in further delays, due to the need
for validation of a detection method.

1044 Exhibit EC-92/At. 54.
1045 Ibid.
1046 Exhibit EC-92/Ats. 56 and 57.
1047 Exhibit EC-92/Ats. 59 and 63.
1048 Exhibit EC-92/At. 66.

7.1083 In its responses to questions by the Panel, the European Communities submits that another
reason for the delay in the forwarding of a dr aft measure to the Regulatory Committee was the
circumstance that between October and early De cember 2003 new risk assessme nts were issued by
Austria, Belgium and France, all of which, accord ing to the European Communities, conflicted with
the SCF opinion. We note that this explanation conc erns a period of time that post-dates the date of
establishment of this Panel, and we will therefore not consider this explanation.
7.1084 The Complaining Parties consider that the fact that the Commission did not promptly submit
a draft measure to the Regulatory Committee, without seeking additional commitments from the
applicant, reflects the adoption by the European Communities of a general moratorium, that is, a
decision not to allow any application to proceed to fi nal approval. We recall in this regard the June
1999 declaration by the Group of Five countries in which these countries stated that they would take
steps to suspend approvals pending the adoptio n of new EC rules ensuring the labelling and
traceability of GMOs and GMO-derived products. T hus, in April 2002, following the issuance of the
SCF opinion, the Commission had reason to believe that the Group of Five countries would act as a
"blocking minority" in the Regulatory Committee and the Council, and that the Commission would
then have to adopt the draft measure submitted to the Regulatory Committee and Council, as required
under Regulation 258/97. It is the Complaining Pa rties' contention, however, that the Commission
decided not to discharge its responsibility under Regul ation 258/97 to complete approval procedures,
in view of opposition to final approvals by the Gr oup of Five countries and that the Commission was
therefore instrumental in the adoption and application of the alleged general moratorium.
7.1085 In considering the Complaining Parties' contention, we note, first of all, that the Commission
could have forwarded a draft measure based on th e requirements of Regulation 258/97 only. It did
not do so. Instead, the Commission sought vo luntary commitments from the applicant. The
commitments sought were based on legislativ e proposals for new EC rules on labelling and
traceability of GMOs and GMO-derived products. These elements suggest that the Commission
wanted to prepare and forward a draft measure whic h could obtain qualified ma jority support in the
Regulatory Committee or in the Council. As pointed out earlier, however, in view of the June 1999
declaration by the Group of Five countries, the Commission had reason to believe that no qualified
majority could be achieved before the new EC rules on labelling and traceability of GMOs and GMO-
derived products were adopted.
1049 It should also be noted in this connection that the record contains
no example of an approval procedure, whether it be one conducted under Directives 90/220 and
2001/18 or one conducted under Regulation 258/97, where the Commission adopted its own draft
measure prior to the adoption of the new EC rule s on labelling and traceability. We recall that in the
case of the application concerning Bt-11 sweet maize (food), the Commission adopted its own draft
measure only after the entry into force of the new EC rules. For these reasons, we consider that the
Commission's conduct in the approval procedure con cerning Bt-11 sweet maize (food) is consistent
with the Complaining Parties' contention that at least until August 2003 the Commission followed a
decision not to discharge its responsibility under Regulation 258/97 to prevent the Group of Five
countries from blocking the approval of applications.
7.1086 We note the European Communities' argument that the approval of the application concerning
Bt-11 sweet maize (food) did not occur because of a sudden change in the European Communities'

1049 This view is supported by the fact that Denmark and France invoked the June 1999 declaration by
the Group of Five countries in the approval procedures concerning Bt-11 sweet maize (food), when raising
objections to the lead CA's favourable assessment of the application. Exhibit EC-92/Ats. 23 and 27. We also
note that even after the adoption of the new EC rules in September 2003, neither the Regulatory Committee in
its December 2003 vote nor the Council in its April 2004 vote achieved a qu alified majority in favour of the
application concerning Bt-11 sweet maize (food).

policy on GMOs, but as the result of a normal process of assessment, which steadily proceeded and
knew no suspension. We recall that the Complain ing Parties' contention is that the European
Communities was applying a general moratorium on fi nal approvals. Thus, "steady progress" of an
application short of final approval is not inconsistent with the Complain ing Parties' contention. As of
August 2003, the application concerning Bt-11 sweet maize (food) had not yet been approved by the
Commission. The application was only approved afte r the entry into force of the new EC rules on
labelling and traceability in April 2004, and then only after every procedural step had been exhausted.
Neither the Regulatory Committee nor the Council ach ieved a qualified majority in favour of the
application.
7.1087 In the light of the above considerations, we c onclude that the Commission's failure to submit
a draft measure concerning Bt-11 sweet maize (f ood) to the Regulatory Committee prior to August
2003 is consistent with the Complaining Parties' assertion that during the relevant time period the
European Communities applied a general moratorium on final approvals.
Transgenic tomato (food) (EC-100)
7.1088 The application concerning the
Transgenic tomato (food) was initially submitted to the United
Kingdom (lead CA) and to the Commission on 2 Marc h 1998. The lead CA forwarded its initial
assessment to the Commission on 4 June 1998, and th is was circulated to all member States on 22
June 1998. On 23 December 1998, the SCF was requested to evaluate the application; the opinion of
the SCF was given on 7 September 2000. The app lication was withdrawn by the applicant on 24
September 2001.
7.1089 The United States argues that after this application received a positive assessment from the
SCF, the application was withdrawn because of th e excessive delay in carrying out the approval
process.
7.1090 The European Communities contends that after assessment at the national level, the request
was withdrawn by the applicant. As the reas on for its withdrawal, the applicant pointed to
"commercial re-positioning" following a merger.
7.1091 The United States argues that in many cases the withdrawal of applications resulted from the
applicant's frustration with the European Communi ties' suspension of its approval process, although
the applicant may not have explicitly so indicated in it reasons for withdrawal. Over time, as the
delays mounted, in some cases the commercial incen tive for seeking approval changed. Second, the
companies have a strong incentive to maintain co rdial relations with EC regulators, and saw no
advantage of complaining to EC regulators a bout the length of the delays resulting from the
moratorium.
7.1092 The Panel notes that the initial assess ment by the lead CA was completed well within the 90-
day time period established in Regulation 258/97. Following the circulation of the initial positive
assessment to member States, a number of member States submitted comments and objections. On 23
December 1998, after further comments from other member States had been submitted, and responses
provided by the applicant, the Commission requested an opinion of the SCF.
7.1093 On 23 September 1999, the SCF gave its opinion and concluded that from the human health
point of view, processed tomato products derived from these tomatoes were as safe as products from
conventional fruit.1050 The next step in the procedure was for the Commission to prepare and submit a

1050 Exhibit EC-100/At. 48.

draft measure on the application to the Regulatory Co mmittee. However, there is no evidence of this
step being completed during the eleven months following the SCF opinion.
7.1094 On 7 September 2000, the SCF issued another opinion on the application concerning the
Transgenic tomato (food).
1051 Apparently, the Commission had requested this further opinion to
obtain the SCF's comments on the relevance of particular studies undertaken in the United States on
transgenic tomatoes for fresh consumption. This request was apparently prompted by a question to
the Commission from a member of the European Pa rliament. The SCF concludes that these results
have no relevance for the assessment of the safety of the processed tomato products which were to be
approved in accordance with the application concerning the Transgenic tomato (food).
7.1095 Even after this second positive assessment by the SCF, the Commission did not forward a
draft measure to the Regulatory Committee before the application was withdrawn by the applicant
more than one year after the second positive opini on by the SCF. As noted by the European
Communities, in the letter of withdrawal the appli cant made reference to recent mergers and to its
commercial re-positioning.
1052
7.1096 It is clear from the foregoing that the application concerning the Transgenic tomato (food) did
not progress because the Commission did not forward a draft measure to the Regulatory Committee.
The SCF gave a favourable opinion of the applica tion on two separate occasions, and no reasons for
the lack of progress were provided to us.
7.1097 The United States considers that the Commission's failure, over a period of more than two
years, to submit a draft measure to the Regulator y Committee reflects the adoption by the European
Communities of a general moratorium on approvals, that is to say, of a decision not to allow any
application to proceed to final approval. We reca ll in this regard the June 1999 declaration by the
Group of Five countries in which these countries st ated that they would take steps to prevent
approvals pending the adoption of new EC rules ensuring the labelling and traceability of GMOs and
GMO-derived products. Thus, in September 1999, following the issuance of the first SCF opinion,
the Commission had reason to believe that the Group of Five countries would act as a "blocking
minority" in the Regulatory Committee and the Counc il, and that the Commission would then have to
adopt the draft measure submitted to the Regul atory Committee and Council, as required under
Regulation 258/97. It is the United States' cont ention, however, that the Commission decided not to
discharge its responsibility under Regulation 258/97 to complete approval procedures, in view of
opposition to final approvals by the Group of Five countries and that the Commission was therefore
instrumental in the adoption and application of the alleged general moratorium.
7.1098 We consider that the Commission's conduct in the approval procedure concerning the
Transgenic tomato (food) is consistent with the contention that the Commission followed a decision
not to discharge its responsibility under Regulati on 258/97 to prevent the Group of Five countries
from blocking the approval of applications. In our view, the fact that the applicant did not specifically
cite a general EC moratorium on approvals as a reas on for the withdrawal of the application is not
inconsistent with the United States' assertion th at the European Communities was applying a general
moratorium on approvals at the time. As was pointed out by the United States, if a moratorium was in
effect, there are plausible explanations for why th e applicant did not specifically cite the alleged
moratorium or resulting delays as a reason for wit hdrawing the application concerning the Transgenic
tomato (food).

1051 Exhibit EC-100/At. 49.
1052 Exhibit EC-100/At. 50.

7.1099 In the light of the above considerations, we c onclude that the Commission's failure to submit
a draft measure concerning the Tr ansgenic tomato (food) to the Regulatory Committee prior to the
withdrawal of the application in September 2001 is consistent with the Complaining Parties' assertion
that during the relevant time period the European Communities applied a general moratorium on final
approvals.
Failure by the Scientific Committee on Food to complete its review

7.1100 In support of its assertion that the European Communities applied a general moratorium on
approvals, the United States has pointed to two a pproval procedures in which it says the Scientific
Committee for Food (SCF) which the Commission consulte d with regard to these applications did not
complete its review. We consider these approva l procedures below, recalling that Article 11 of
Regulation 258/97 provides that " [t]he Scientific Committee for Food shall be consulted on any
matter failing within the scope of this Regulation likely to have an effect on public health".
Transgenic red-hearted chicory (food) (EC-97)
Transgenic green-hearted chicory (food) (EC-98)
7.1101 The applications concerning Transgenic red- hearted chicory (food) and Transgenic green-
hearted chicory (food) for human consumption were initially submitted to the Netherlands (lead CA)
in April 1998. The lead CA provided initia l positive assessments for both products to the
Commission on 23 April 1998, which was circulated to member States as drafts on 13 May 1998. On
27 October 1998, the Commission informed member St ates that the initial assessments were not draft
texts, and that the lead CA was not undertaking any further assessment. A large number of member
States submitted comments or objections on these applications, and on 29 April 1999 the Commission
requested the SCF to give an opinion. The SCF c onsidered both products at the same time in its
evaluation. No opinion had been issued by the SCF at the time these applications were withdrawn on
27 May 2003.
7.1102 The United States argues that although these products received favourable initial assessments
by the lead CA, as of May 2003, when the applicati on for both was withdrawn, the products had been
"under assessment" by the SCF for more than five years. The United States contends that these
withdrawn applications are direct evidence of the existence of a general moratorium, and that the
withdrawal evinces the applicant's frustration with the suspension of the EC approval process.
7.1103 The European Communities notes that after assessment of these products by the lead CA,
the request was withdrawn by the applicant with th e indication that the applicant preferred to no
longer be associated with genetically modified products because of the negative response from the
market.
7.1104 The Panel notes that the initial assessments by the lead CA were made within the 90-day
period foreseen for this purpose under Regulation 25 8/97. Delays in the consideration of the
applications for these two products occurred primarily in the course of the evaluation by the SCF. For
example, more than four months went by afte r the SCF received the request by the Commission to
evaluate these products before the SCF requested better quality images of certain analytical results
from the applicant. The information provided does not indicate when or if the applicant provided the
requested data, but only that, two months later, th e SCF requested additional information, and after a
7-month delay, the SCF requested that the app licant provide studies covering two growing seasons
and at least six locations. The applicant apparent ly instead offered to provide data from previous
growing seasons, which the SCF indicated might be acceptable.

7.1105 In a communication to the SCF of 14 November 2000, the applicant expressed very apparent
frustration with the progress of evaluation of these two products.
1053 The applicant noted that much
information had been provided to permit the dete rmination of substantial equivalence between the
transgenic chicory and conventiona l chicory, and expressed the view that "it does not make sense to
continue year after year with experiments without having any indication that there is no substantial
equivalence".1054 The applicant also expressed concern th at since the SCF had not indicated whether
it would accept the new experiments as proposed by th e applicant, "this might be a new reason for the
SCF to ask the company to do new experiment s after the proposed experiments have been
finished".1055 The alternative suggested by the SCF would require the applicant to apply for additional
field trials in several countries, and the applicant indi cated that it would take at least one year to get
permission from all competent authorities. The tota l process would thus take at least three additional
years, and the applicant indicated that this would have negative financial imp lications. The applicant
indicated that it had reached the conclusion that the applications for the Transgenic red-hearted
chicory (food) and the Transgenic green-hearted chicory (food) were a kind of "never ending story",
and that "the procedure, time energy and costs are disproportionate compared to conventional
breeding programs. This may lead to the conclusi on that development and marketing of transgenic
vegetable crops in the European Union do not have any opportunity."
1056 The applicant nevertheless
provided additional information from various years of fi eld introductions to substantiate its claims of
substantial equivalence, and requested that the SC F extract its conclusions and take decisions based
on the information now available to it.
7.1106 Five months after the November 2000 communication from the applicant, the SCF informed
the applicant that it would accept th e data provided regarding field studies, and requested additional
information regarding nutritional composition.1057 The applicant indicated, in response, that it had not
yet decided whether to execute additional experi ments. It expressed concern that the question
regarding antibiotic resistance markers would need to be resolved before new experiments were
started, and requested clarification regarding whether products containing antibiotic resistance
markers would be permitted to enter the EC market after the entry into force of Directive 2001/18. 1058
In a response dated 24 July 2001, the Commission indicated that the provisions of Directive 2001/18
did not include a general legal ban on antibiotic r esistance marker genes as such but linked their
phasing out to certain qualifiers. The Commissi on also indicated that consideration of the
applications for the Transgenic red-hearted chicory (food) and the Transgenic green-hearted chicory
(food) was suspended until the requested info rmation on nutritional composition had been
provided.
1059 The record does not include any further response from the applic ant until the formal
withdrawal of the applications on 27 May 2003. 1060 However, the European Communities asserts that
the SCF was requested as early as 24 September 2001 to suspend its consideration of the applications
concerned.
7.1107 We sought the views of the experts advising us regarding the necessity of the information
requested by the SCF on substantial equivalence, mo lecular characterization and antibiotic resistance
marker genes to ensure that the safety assessment was valid. 1061 The only expert who provided a

1053 Exhibits EC-97/At. 25 and EC-98/At. 35.
1054 Ibid.
1055 Ibid.
1056 Ibid.
1057 Exhibits EC-97/At. 28 and EC-98/At. 38.
1058 Exhibits EC-97/At. 29 and EC-98/At. 39.
1059 Exhibits EC-97/At. 31 and EC-98/At. 41.
1060 Exhibits EC-97/At. 32 and EC-98/At. 42.
1061 Annex H, Question 55 and 56.

response to this question, Dr. Nutti, considered that the information requested regarding the
establishment of substantial equivalence was nece ssary, and that the information requested on
nutritional composition was also required.
1062
7.1108 The United States considers that the SCF's failure , for more than two years, to complete its
assessment of the applications in question reflect s the adoption by the European Communities of a
general moratorium, that is, a decision not to allow any application to proceed to final approval. We
note that the United States does not assert that the SCF was an active participant in the alleged
moratorium on approvals and that the time taken by the SCF for its assessment is a reflection of the
SCF's support for the moratorium. We understand the United States to argue instead that the alleged
general moratorium on approvals affected the manne r in which, and the speed with which, the SCF
conducted its assessments of the applications in question.
7.1109 It is reasonable to assume that the SCF was aware of the June 1999 declaration by the Group
of Five countries, and thus of their declared in tention to act as a "blocking minority" both in the
Regulatory Committee and in the Council pending th e adoption of new EC rules on labelling and
traceability.1063 In our view, it can further be assumed that the SCF was aware of the failure by the
Commission in the approval procedure concerning the Transgenic tomato (food) to submit a draft
measure to the Regulatory Committee following the two positive SCF opinions. Against this
background, it is conceivable that the SCF could have been requesting more information than it would
otherwise have requested, notwithstanding the fact th at such requests could be expected to result in
delays.
7.1110 The November 2000 communication from the applican t, referring to a "never ending story",
clearly documents the applicant's frustration w ith the long delays and repeated requests for
information. This communication is therefore cons istent with the possibility that the progress of the
SCF's assessment was affected by the alleged genera l moratorium on approvals. In our view, the fact
that the applicant did not specifically cite a gene ral EC moratorium on approvals as a reason for the
withdrawal of the application is not inconsistent with the United States' assertion that the European
Communities was applying a general moratorium on appr ovals at the time. As was pointed out by the
United States, if a moratorium was in effect, there are plausible explanations for why the applicant did
not specifically cite the alleged moratorium or resulting delays as a reason for withdrawing the
applications concerning the Transgenic red-hearte d chicory (food) and the Transgenic green-hearted
chicory (food).
7.1111 On the other hand, the record shows that in other approval procedures, and during the relevant
time period, the SCF completed its assessment of applications within a shorter timeframe. 1064
Furthermore, we recall the advice of Dr. Nutti that the information requested by the SCF may be
considered necessary to ensure that the conclusions of the safety assessment of the Transgenic red-
hearted chicory (food) and the Transgenic green-hearte d chicory (food) were valid. However, even if
it is accepted that the time taken by the SCF may be explained by the need for valid conclusions, this
would not contradict the United States' assertion that the European Communities applied a general
moratorium on approvals. In June 1999, the Group of Five countries indicated that they would act as
a "blocking minority" in the Regulatory Committee and in the Council, and we recall that in the
approval procedure concerning the Transgenic toma to (food), the Commission failed to discharge its

1062 Annex H, paras. 759-760.
1063 We recall that the Commission made a proposal for such rules in July 2001.
1064 See, e.g, the approval procedure concerning Bt-11 sweet maize (food), where an SCF opinion was
requested in December 2000 and provided in April 2002. During that period, the clock was stopped for several
months. Exhibit EC-92/Ats. 47-53.

responsibility inasmuch as it did not submit a draft measure to the Regulatory Committee. These acts
and omissions affect and concern stages of th e approval procedure subsequent to the SCF's
involvement. The applications concerning the Transgenic red-hearted chicory (food) and the
Transgenic green-hearted chicory (food) had not reached these stages as of September 2001, when the
SCF was apparently requested to suspend its work.
7.1112 In the light of the above considerations, we conc lude that the failure of the SCF to complete
its assessment of the applications concerning th e Transgenic red-hearte d chicory (food) and the
Transgenic green-hearted chicory (food) prior to September 2001, when the SCF was apparently
requested by the applicant to suspend its work, is consistent with the contention of the Complaining
Parties that the European Communities applied a general moratorium during the relevant time period.
Delays at member State level

7.1113 In support of their assertion that the European Communities applied a general moratorium on
approvals the Complaining Parties have pointed to a number of approval procedures in which they say
the member State to which the application was subm itted – the lead CA – either did not complete its
assessment of the relevant application or completed it with considerable delay. We consider these
approval procedures below, recalling that Article 6(3) of Regulation 258/97 provides that "[t]he initial
assessment report [by the lead CA] shall be drawn up within a period of three months from receipt of
[the application]". Article 6(4) further provides that the lead CA "shall without delay forward the
[initial assessment report] to the Commission, which shall forward it to the other Member States."
GA21 maize (food) (EC-91)
7.1114 The application for GA21 maize (food) was submitted to the Netherlands CA (lead CA) on 24
July 1998. The initial assessment of the lead CA was provided to the Commission on 21 January
2000, and circulated to member States on 18 February 2000. At the time the Panel was established,
the Commission had not submitted a draft measure on the application to the Regulatory Committee.
7.1115 The United States argues that the application for GA21 maize (food) under
Regulation 257/98 was delayed at the member State level for 18 months while the lead CA completed
its risk assessment. The lead CA requested the applicant to perform a further study on compositional
analysis. The request was made on 24 February 19 99, and the applicant provided its response by 26
October 1999.1065 Thus, the total time between the first submission, 24 July 1998, and the lead CA's
opinion, 17 January 2000, was 18 months. Of tho se 18 months, 8 were used by the applicant to
answer questions.
7.1116 Canada argues that the total time taken by the lead CA for its review was 18 months, and that
only 8 of the 18 months were taken by the applican t to respond to questions. The difference of 10
months exceeds the 3-month period provided for in Regulation 258/97.
7.1117 The European Communities argues that this application was pending at the member State
level for about a year and a half due to requests by the lead CA for completion of the dossier and for
additional scientific data. The United States ignores the fact that the 18 months spent at member State
level were due to the incompleteness of the dossier initially submitted by the applicant and to the need
for additional scientific data.1066

1065 Exhibit EC-91/Ats. 11 and 14.
1066 The European Communities refers to Exhibit EC-91/Ats. 1-6.

7.1118 The Panel notes from the record that this application was submitted to the Netherlands in July
1998. A month and a half later, the applicant was a pparently requested to complete the dossier. The
applicant seems to have provided the missing information in December 1998, although some
references were provided only in January 1999. In February 1999, the Dutch Health Council put
forward its first substantive request for inform ation. The applicant provided the requested
information in March 1999. In June 1999, the Hea lth Council informed the applicant that it needed
more data than that provided by the applicant in March. The applicant provided the data in October
1999. The Health Council completed its assessment in December 1999, and the Dutch CA forwarded
its initial assessment report in January 2000.
7.1119 We note that the record for this approval pr ocedure is incomplete, but it appears that the
Dutch CA did not have a reasonably complete file until December 1998. We also note, however, that
the Dutch CA then waited for almost three mo nths before forwarding an initial request for
information. After receiving the requested informat ion, the Dutch CA again waited for almost three
months before making a follow-up request for more data. Finally, after obtaining the necessary data,
the lead CA spent another period of almost three months finalizing its assessment. It is clear,
therefore, that the lead CA ex ceeded the three-month period for eseen in Regulation 258/97 for an
initial assessment.
7.1120 The United States and Canada do not assert that the time taken by the Netherlands to
complete its assessment is a reflection of Dutch su pport for the moratorium. Rather, their assertion is
that the time taken by the Netherlands reflects the impact of the alleged moratorium. According to the
United States and Canada, the Netherlands was placed in a position of having to recognize the
moratorium as a reality and that this affected the speed with which it conducted its assessment.
7.1121 We consider that following the June 1999 d eclaration by the Group of Five countries, the
Netherlands had reason to believe that the Group of Five countries would act as a "blocking minority"
both in the Regulatory Committee and in the Counc il pending the adoption of new EC rules on
labelling and traceability. In our view, the Netherland s also had reason to believe that, as in the case
of some of the previously discussed approval pr ocedures, the Commission might not complete the
approval procedure in the face of systematic opposition by the Group of Five countries. We note,
however, that the lead CA's initial request for ad ditional information and its follow-up request for
more data were made in February and early June 1999, respectively, and thus pre-date the June 1999
declaration of the Group of Five countries. On th e other hand, it was after the June 1999 declaration
that the lead CA spent an additional three months finalizing its initial assessment report.
7.1122 We also note, however, that the Netherlands was part of the Group of Seven countries which
declared in June 1999 that they would take a thoroughly precautionary appr oach in dealing with
applications for the placing on the market of biotech products. However, in this instance, we are not
convinced that the Dutch CA's conduct reflects a pr ecautionary approach. In particular, we are not
convinced that the Dutch CA could not forward its June 1999 follow-up request for more data sooner
than it did even while following a precautionary appr oach, or that after receiving the applicant's
response it could not finalize its initial assessment earlier than in January 2000.
7.1123 It is pertinent to note in this regard that th e applicant had submitted two other applications
concerning the same product under Directive 90/220, one to the United Kingdom (GA21 maize
(EC-85)) and one to Spain (GA21 maize (EC-78)). By the time the Dutch CA was finalizing its
assessment report, the two Directive 90/220 applicati ons were under assessment at Community level.
As we have noted, following the June 1999 declara tion by the Group of Five countries, the Dutch CA
in our view had reason to believe that at Comm unity level the Group of Five countries and/or the
Commission could take action to delay or prevent the final approval of these applications. Since a

special environmental safety assessment was necessary for the application concerning GA21 maize
(food) to be approved under Regulation 258/97
1067, we think it could also be that the time taken by the
Dutch CA before forwarding its initial assessment report in January 2000 reflects a view on the part of
the Dutch CA that the Directive 90/220 applica tions concerning GA21 maize would be delayed at
Community level.
7.1124 In the light of the above considerations, we c onclude that the time taken by the Netherlands
for its initial assessment of the application concer ning GA21 maize (food), and in particular the time
taken by the lead CA as from October 1999 to finali ze its initial assessment repor t, is consistent with
the contention of the Complaining Parties that during the relevant time period the European
Communities applied a general moratorium on final approvals.
LL soybeans (food) (EC-93)
7.1125 The application concerning LL soybeans (food) was submitted to Belgium on 30 November
1998. The application was sent to the Commission on 2 February 1999. At the time of establishment
of the Panel, the lead CA had not completed its assessment of the application. In July 2004, the
applicant withdrew the application.
7.1126 The United States submits that Belgium refused to fo rward the application for LL soybeans
(food) for consideration at the Community level.
7.1127 Argentina argues that there was an overall delay of 5 years and 8 months since the
application was submitted.
7.1128 The European Communities notes that the application for LL soybean (food) was with the
Belgian CA only as of February 1999. The Commissi on gave notice of the Belgian application to all
other member States in March 1999. In Apr il 1999, the Belgium Biosafety Council requested
additional information from the applicant in order to proceed with the initial assessment. The request
touched upon the issues of subs tantial equivalence and presence of transgenic PAT DNA and PAT
protein.1068 The applicant did not fully respond to this request for additional information. Greece
(June 1999) and Italy (July 1999) also asked for additional information on various points such as
nutritional and biochemical characteri zation and toxicity of the transg enic plant, but did not receive
any answer. 1069 In April 2004, the lead CA reminded the applicant to respond to the requests for
additional information so that it would be able to finalize the pending assessment report.
7.1129 The European Communities submits that the Complaining Parties choose to ignore the fact
that the applicant failed to provide the additional in formation that was requested by the lead CA in
April 1999, and by Greece and Italy in June and Ju ly 1999. According to the European Communities,
all three requests for additional information re mained mostly unansw ered. The European
Communities points out that on 6 July 2004, the applicant withdrew its application.
7.1130 The Panel notes that contrary to what the Eur opean Communities asserts, the application
concerning LL soybeans (food) was with the Belgia n CA as of early December 1998, and not only as

1067 We note that the application concerning GA21 maize (food) as submitted to the Dutch CA inter
alia concerned foods or food ingredients containing or consisting of GMOs and as such would appear to be
subject to the provisions of Article 9 of Regulation 258/ 97. To recall, Article 9 requires that approval decisions
concerning foods or food ingredients containing or consisting of GMOs must respect the environmental safety
requirements laid down in Directive 90/220.
1068 Exhibit EC-93/At. 11.
1069 Exhibit EC-93/Ats. 16 and 17.

of February 1999.
1070 On 8 December 1998, the Belgian Ge neral Food Inspectorate requested the
Belgian Biosafety Council to prepare a first evaluation report within 90 days of referral of the file.
7.1131 The record indicates that the Biosafety Counc il met on the application on 17 December 1998.
At that meeting, concerns were raised that while the application focused on animal nutrition, a number
of tests concerning possible human consumption impact s were absent. The applicant apparently gave
a written undertaking to address these concerns re lating to substantial equivalence following
instructions from a Belgian expert.1071
7.1132 In March 1999, the Commission circulated the application for information to all member
States. The chronology provided by the Europ ean Communities indicates that Denmark requested
further information from the applicant at that tim e, however this correspondence was not provided to
us.
7.1133 Towards the end of April 1999, the Belgian Bi osafety Council responded to a query from the
Belgian General Food Inspectorate. The letter not es that the applicant had still not addressed the
Biosafety Council's concerns relating to substantial equivalence. The letter further states that the
applicant needed to provide add itional information regarding the implementation of labelling and,
more specifically, the presence of PAT DNA and PAT protein in derived soya products. 1072 The letter
of the Biosafety Council concludes by saying that due to the absence of data and information on
substantial equivalence and the presence of transg enic PAT DNA and PAT protein it was not possible
for the Biosafety Council to issue a final evaluation report with regard to the application concerning
LL soybeans (food). We asked the experts advising us whether information regarding substantial
equivalence and the presence of transgenic PAT DNA and PAT protein was necessary to ensure that
conclusions of the safety assessment were valid . Dr. Nutti responded that these requests were
valid.
1073
7.1134 In May 1999, the lead CA sent a reminder to the applicant informing it that it had yet to reply
to the two requests for additional information from April 1999. 1074 The lead CA also informed the
Commission that the deadline for evaluation of this application would not be met due to the lack of
response from the applicant to the aforementi oned two requests for additional information. 1075 The
record indicates that as of August 2003, the applican t had still not fully replied to the first request
relating to substantial equivalence. 1076 It appears that the applicant responded to the first request
concerning the presence of PAT DNA and PAT protein in derived soya products, but it is not clear
when.1077
7.1135 Greece (June 1999) and Italy (July 1999) also requested additional information regarding
nutritional and biochemical characterization and toxicity of the transgenic plants. We again asked the
experts advising us whether the additional information requested by Greece and Italy was necessary to
ensure that conclusions of the safety assessment were valid. Dr. Nutti responded that the application
did not provide all the information which would be expected in order to comply with the
recommended Codex evaluation procedure, and theref ore the requests for some of this information

1070 Exhibit EC-93/Ats. 1 and 3.
1071 Exhibit EC-93/At. 11.
1072 Ibid.
1073 Annex H, Dr. Nutti's response to Panel Question 48.
1074 Exhibit EC-93/At. 14.
1075 Exhibit EC-93/At. 13.
1076 Exhibit EC-93/At. 25.
1077 Ibid.

were justified.
1078 In December 2000 and again in July 2001, the applicant apparently provided
additional information to the lead CA regarding in sert characterization, however this information was
not provided to us. In the same correspondence, the applicant indicated that information on
compositional analyses would be forthcoming at a later date. 1079 Seven months later, in
correspondence dated July 2001, the applicant appa rently provided information to satisfy these
requests, although this information was not included in the evidence provided to us.1080
7.1136 In August 2001, the lead CA requested clarifi cation regarding nutritional composition, stating
that the data provided by the applicant in July 2001 had not adequately addressed the lead CA's
request of April 1999. We again asked the experts whether this clarification was necessary to ensure
that conclusions of the safety assessment were valid. Dr. Nutti noted that the information requested
would normally be necessary to judge the safety of the product, however given the incompleteness of
the record, it was impossible for her to determine whet her or not this information had previously been
provided to the lead CA. 1081 The lead CA also inquired about a broiler chicken growth performance
study which the applicant had said was already includ ed in the dossier, but which the lead CA could
not find. Finally, the lead CA indicated that in accordance with new recommendations by the
Biosafety Council on molecular characterization, th e lead CA would be requesting some additional
information on molecular characterization.
7.1137 The record suggests that the applicant neve r replied to the August 2001 request for
clarification. Indeed, in June 2003, in intern al e-mail correspondence concerning a request from the
Commission for an update on this dossier, the lead CA highlighted the fact that the applicant had not
provided the requested broiler chicken growth st udy. The lead CA also indicated that it had
requested, but not received, additional informati on on molecular characterization. However, the
record does not indicate that such a request was forwarded to the applicant.1082
7.1138 It is unfortunate that the evidence provided on this application is incomplete. While the
experts indicated that much of the information requ ested by the lead CA and by other member States
was necessary to ensure a valid safety assessment, it was not possible to determine to what extent
such information may already have been provided by the applicant. It is also very difficult to
determine from the information before us whether pa rticular requests for information were met by the
applicant.
7.1139 This said, as noted earlier, it appears that the a pplicant never fully replied to the lead CA's
April 1999 request for additional information. It also seems that the responses which were given were
not provided in a timely manner. Furthermore, th e record suggests that the applicant never responded
to the August 2001 request for clarification. In fact , there does not appear to have been any further
communication from the applicant until it withdrew its application in July 2004.
7.1140 In considering the applicant's conduct, and in pa rticular its failure to respond to the August
2001 request for clarification, it is important to recall that the applicant had submitted an application
concerning the same product under Directive 90/220. That application was also being evaluated by
Belgium. As we have noted earlier, however, the c onsideration of that application – the application
concerning LL soybeans (EC-71) – appears to ha ve been suspended as from September 2001 as a
result of the applicant's refusal to discontinue another Directive 90/220 application concerning the

1078 Annex H, Dr. Nutti's response to Panel Question 49.
1079 Exhibit EC-93/At. 21.
1080 Exhibit EC-93/At. 22.
1081 Annex H, Dr Nutti's responses to Panel Question 50.
1082 Exhibit EC-93/At. 25.

same product, which had been submitted to Portugal. Directive 90/220 was repealed in October 2002.
The applicant withdrew its application from Po rtugal and submitted an updated application to
Belgium. Belgium then continued its considera tion of the application under Directive 2001/18 as of
February 2003.
7.1141 We further recall that Article 9(2) of Regula tion 258/97 provides that decisions approving the
placing on the market of foods or food ingredients containing or consisting of GMOs must "respect
the environmental safety requirements laid down by [Directive 90/220] to ensure that all appropriate
measures are taken to prevent the adverse effects on human health and the environment which might
arise from the deliberate release of [GMOs]". As noted, the environmental safety assessment under
Directive 90/220 was suspended as of September 2001. Since a specific environmental safety
assessment was necessary for the application concerning LL so ybeans (food) to be approved under
Regulation 258/97, it seems plausible that the appl icant did not see much use in seeking progress in
the Regulation 258/97 procedure as long as the Directive 90/220 procedure was suspended. In
relation to the application concerning LL soybeans (E C-71), we said earlier that the fact that Belgium
suspended consideration of that application – in r esponse to the applicant's refusal to discontinue one
of the two Directive 90/220 applications – does not di rectly confirm that a general moratorium was in
effect in the European Communities.
7.1142 Nevertheless, we consider that the history of the approval procedure concerning LL soybeans
(food) at the member State level is consistent with the Complaining Parties' assertion that the
European Communities applied a general moratorium on approvals. We recall in this regard that in
June 1999, the Group of Five countries indicated that they would act as a "blocking minority" in the
Regulatory Committee and in the Council, and th at in the approval procedure concerning the
Transgenic tomato (food), the Commission after Oc tober 1999 failed to discharge its responsibility
inasmuch as it did not submit a draft measure to the Regulatory Committee following the first SCF
opinion of September 1999. These acts and omissions affect and concern the Community level phase
of the approval procedure under Regulation 258/ 97. However, the application concerning LL
soybeans (food) as of August 2003 had not reached the Community level.
7.1143 In the light of the above considerations, we c onclude that the record of the progress of the
application concerning LL soybeans (food) at the memb er State level is consistent with the contention
of the Complaining Parties that the European Co mmunities applied a general moratorium during the
relevant time period.
MON810 x GA21 maize (food) (EC-94)
7.1144 The application concerning MON810 x GA21 ma ize (food) was submitted to the Netherlands
(lead CA) on 29 February 2000. A summary of the file was circulated by the Commission to all
member States on 29 March 2000. At the time of est ablishment of the Panel, the lead CA had not
completed its initial assessment.
7.1145 The United States argues that approval for MON810 x GA21 maize (food), which is
produced by conventionally hybridizing two "par ental" biotech products, MON810 maize and GA21
maize, has been delayed by the failure of the le ad CA to complete its initial assessment. More
specifically, the United States argues that at the time of establishment of the Panel, the application had
already been under consideration by the lead CA for three and a half years. The United States
contends that this lag had two distinct causes.
7.1146 According to the United States, one cause for the lag was the undue delay in the EC approval
of GA21 maize under Regulation 258/97. The a pplication for approval of MON810 x GA21 maize

(food) submitted under Regulation 258/ 97 referenced the detailed risk assessments undertaken on the
parental biotech products, complemented with conf irmatory safety and characterization data on the
MON810 x GA21 hybrid. One parent, MON810 maiz e, was approved under Directive 90/220 in
1998
1083 and was notified in 1998 on the basis of an opi nion of substantial equivalence as required
under Regulation 258/97 in 1998.1084 However, the application for the single trait parent GA21 maize
(food) under Regulation 258/97 stalled at the Co mmission level after the Commission requested an
opinion from the SCF in May 2000 and then again after the final SCF opinion in February 2002.
Therefore, progress on GA21 maize (food) was a limiting step on the progress of the application
concerning MON810 x GA21 maize (food) in the regulatory process. In fact, in its comments on the
application for MON810 x GA21 maize (food), Italy stated that "examination of the documentation
relating to authorization [of MON810 x GA21 maize] should only be carried out after the marketing
of GA21 has been authorized [under Regulation 258/97]."
1085 At the time of establishment of the
Panel, the approval of GA21 maize (food) under Regulation 258/97 had not yet been granted.
7.1147 The United States contends that the other cause of the lag reflected, in part, the need for the
applicant to respond to requests for information that were scientifically unjustified. The United States
points out that the lead CA insisted on mol ecular characterization of the MON810 x GA21 line
without regard to the previous data that had been submitted on the parental lines. In particular, the
lead CA requested an additional whole food study in mice. 1086 The rationale offered for this request
was the need to address hypothetical concerns th at unknown pieces of DNA could be scattered over
the genome. The impact of any such insertions can be determined by evaluating the compositional
analyses of the plant as well as its agronomic pe rformance. If both analyses indicate no unexpected
changes, the United States argues, there is no basis on which to hypothesize a food safety concern for
food from the plant. In this case, such assessments had been perfor med on each of the parental lines
and no unexpected changes were observed. At no ti me did the lead CA provide any explanation of
the reason it believed that the compositional analyses or feeding studies previously submitted on both
the parent lines, as well as the compositional an alyses submitted on the hybrid, did not adequately
address this issue.
7.1148 The United States notes that, nonetheless, the a pplicant analysed the composition of the
MON810 x GA21 maize, which was found to be compar able to that of the parental lines and other
commercial maize varieties. 1087 The applicant also had previously submitted several whole food
feeding studies, including a 90-day feeding study in rats using MON810 maize or GA21 maize, and a
broiler chicken feeding study using grain from MON810 x GA21 maize. None of these studies
revealed any adverse effects.
7.1149 Furthermore, the United States notes, the lead CA requested further information on the levels
of EPSPS protein expressed in the hybrid lines, although such information is not relevant to assessing
the risks given the known safety information about the EPSPS protein. 1088 The lead CA also

1083 Commission Decision concerning the placing on the market of genetically modified maize (zea
mays L. line MON810) pursuant to Council Directive 90/220/EEC, (98/294/EC), April 22, 1998, Official
Journal of the European Communities, L 131/32, May 5, 1998 (Exhibit US-131).
1084 Exhibit US-132.
1085 Exhibit EC-94/At. 11.
1086 Exhibit EC-94/At. 12.
1087 Exhibit EC-82/At. 9.
1088 The United States refers to LA Harrison, MR Bailey, MR Naylor, JE Ream, BG Hammond, DL
Nida, BL Burnette, TE Nickson, TA Mitsky, ML Taylor, RL Fuchs, and SR Padgette, "The Expressed Protein in
Glyphosate-Tolerant Soybean, 5-Enolypyruvylshikimate-3-Phosphate Synthase from Agrobacterium sp. Strain
CP4, Is Rapidly Digested in Vitro and Is Not Toxic to Acutely Gavaged Mice", Journal of Nutrition 126:728-
740 (1996) (Exhibit US-143).

requested unnecessary comparisons of compositional data between the new hybrid and non-transgenic
control lines. The data submitted in the applica tion analysed the new hybrid in comparison to the
transgenic parental lines.
1089 The transgenic parental lines had al ready been shown to be substantially
equivalent to non-genetically modified maize except for the introduced traits. Given all of the data
that had been submitted on both parental lines, the United States argues that the requests for yet
further studies lacked any scientific basis.
7.1150 According to the United States, the United Kingdom also insisted that the applicant provide
extensive characterization of the new hybrid, rather than rely on the analyses previously carried out on
the transgenic parental lines. 1090 As part of this request, the United Kingdom requested molecular
characterization to "confirm[] the absence of antib iotic resistance markers and have details regarding
the homology between the two constructs introduced as a result of the crosses." 1091 Given that neither
parent contained an antibiotic marker gene, there is absolutely no scientific basis, in the United States'
view, for theorizing that cross-breeding between the two products would somehow introduce such a
gene.
7.1151 Under these circumstances, the United States argue s that it was pointless for the applicant to
devote resources to pursue the application for MON810 x GA21 maize (food) as long as consideration
of the applications for the single trait parent GA 21 maize remained suspended under the moratorium.
The United States contends that the delay in the application for MON810 x GA21 maize (food) and
GA21 maize (food) is thus a direct consequence of the delays in the application for GA21 maize
under the moratorium. The United States further point s out that because of the delay in the approval
procedure concerning GA21 maize (food), that pr oduct, as well as MON810 x GA21 maize, have
been superseded by a second generation Roundup Ready maize product (NK603 maize and
NK603 × MON810 maize, respectively). Nonetheless, the applicant has continued to pursue the
necessary regulatory clearance for MON810 x GA21 maize (food).
7.1152 Canada argues that the application is still pending with the lead CA.
7.1153 The European Communities argues that the lead CA requested additional information from
the applicant in July 2000, however the request was only partly answered in February 2002. Contrary
to the United States, the European Communities main tains that the lead CA request for a whole food
study in mice was necessary to assess unintende d effects caused by possible additional DNA
fragments. Since the request was made on valid gro unds, the delay caused by it cannot be considered
"undue." Furthermore, issues such as molecula r characterization of inserted DNA from transgenic
parent lines, the determination of flanking DNA or compositional analysis still remain unanswered.
Finally, the European Communities considers that it is obvious that the assessment of a hybrid cannot
be concluded as long as the assessment of one of its parental lines is still open.
7.1154 The Panel notes that under Regulation 258/97 the init ial assessment report is to be drawn up
by the lead CA within a period of three months fro m receipt of an application meeting the applicable
conditions. When the Commission circulated notice of this application to all member States on
29 March 2000, it indicated that the initial assessm ent was to be completed by 16 June 2000 at the
latest.
1092 However, the lead CA's assessment ha d not been completed by the time of the
establishment of the Panel, that is, three and a half years after submission of the application.

1089 Exhibit EC-94/At. 2.
1090 Exhibit EC-94/At. 10.
1091 Ibid.
1092 Exhibit EC-94/At. 5.

7.1155 The first indication of any contact from the lead CA was a request for additional data sent to
the applicant on 17 July 2000.
1093 No specific explanation has been provided as to why this
information was not requested much sooner, rath er than one month after the normal deadline for
completion of the assessment. The response to th e July 2000 request was provided by the applicant
only on 15 February 2002. Subsequently, there w as a five-month delay before the lead CA followed
up with the applicant to request additional inform ation on 2 July 2002. No specific explanation has
been provided for this further delay. Furthermor e, no information has been provided regarding any
action on this application between July 2002 and August 2003. It appears that during that period the
applicant did not respond to the lead CA's July 2002 request for information.
7.1156 We sought the views of the experts advising us regarding the necessity of the information
requested by the lead CA in July 2000 to ensure that the conclu sions of the safety assessment were
valid.1094 Dr. Nutti addressed the lead CA's requests regarding the EPSPS protein, the effect of
glyphosate treatment on the composition of maize plants, the additional information on the
composition of the hybrid, and the additional toxicolo gical feeding study. Dr. Nutti did not consider
that any of this requested information was necessary to ensure the validity of the safety assessment, in
light of the information already provided in the application and already known about the parental
lines. In her view, the responses provided by the applicant in February 2002 confirmed the data
previously submitted.
1095 Dr. Andow addressed the requests regarding the effect of glyphosate
treatment and toxicology. In his view, the request regarding the glyphfosate treatment was necessary,
as he believes the applicant had provided an incorr ect statistical analysis. With regard to the
toxicology request, Dr. Andow considered that the underlying concern was valid, but he considered
that the applicant should have been able to addr ess this concern through other means, and the request
for toxicity testing was not necessary to ensure th at the conclusions of the safety assessment were
valid for MON810 x GA21 maize.1096
7.1157 We are cognizant of the fact that the Europ ean Communities disagrees with some of the
responses by the experts. The European Communiti es notes that the results of the additional studies
were required to confirm the information provided in the application, and that there are different
regulatory approaches regarding the comparisons of a GM hybrid and the data requirements needed to
assess the safety of these hybrids. In particular, th e European Communities argues that the fact that
the approach of the lead CA differs from the one pr eferred by the Panel's experts does not mean it is
not valid. Furthermore, the European Communities submits that the lead CA requested information
on additional substances in light of the information that had just become available regarding the
presence of unintended DNA fragments in a genetically modified glyphosate-resistant soybean.
7.1158 We accept that different regulatory practices may result in differences in perceptions as to
what information is necessary to a safety assessment. However, even accepting that contrary to the
views of the experts the information requested by the lead CA in July 2000 was necessary to ensure
the validity of the safety assessment, this still woul d not explain the long dela ys in responses by the
lead CA both before and after the July 2000 request.
7.1159 The United States argues that these delays reflect the alleged general moratorium on final
approvals. More particularly, the United States c ontends that the delay in the application for
MON810 x GA21 maize (food) was a direct consequen ce of the delays in the applications for GA21
maize (EC-78) and GA21 maize (food) under the mora torium. We recall that the United States does

1093 Exhibit EC-94/At. 12.
1094 Annex H, question 44.
1095 Annex H, paras. 682-687.
1096 Annex H, para. 700.

not assert that the time taken by the Netherlands in its assessment of the application concerning
MON810 x GA21 maize (food) is a reflection of its support for the alleged moratorium. Rather, the
United States asserts that the Netherlands was placed in a position of having to recognize the
moratorium as a reality, and that this affected the speed with which it conducted its assessment.
7.1160 We consider that following the June 1999 d eclaration by the Group of Five countries, the
Netherlands had reason to believe that the Group of Five countries would act as a "blocking minority"
both in the Regulatory Committee and in the Counc il pending the adoption of new EC rules on
labelling and traceability. In our view, the Netherland s also had reason to believe that, as in the case
of some of the previously discussed approval procedures, the Commission would not complete the
approval procedure in the face of systematic oppos ition by the Group of Five countries. We note in
this regard that in 2000, when the appli cation concerning MON810 x GA21 maize (food) was
submitted, the single trait parent applications concerning GA21 maize (EC-78) and GA21 maize
(food) were both under assessment at Community leve l. In relation to these single trait parent
applications, we have previously noted that th e Commission in both procedures failed to submit a
draft measure concerning these applications to the Regulatory Committee prior to August 2003, and
that this is consistent with the assertion that th e European Communities applied a general moratorium
on final approvals.
7.1161 Against this background, and in particular in vi ew of the situation with regard to the single
trait parent applications concerning GA21 maize (EC-78) and GA21 maize (food)
1097, we consider
that the Netherlands could have come to the conclu sion that there was no realistic prospect that the
single trait parent applications concerning GA21 mai ze would be approved prior to the date of repeal
of Directive 90/220, and that as long as they were not approved the hybrid application concerning
MON810 x GA21 maize (food) would likewise not be approved.
1098 In our view, the time taken by
the Netherlands both before and after its July 2000 re quest for information is therefore consistent with
the existence of a general moratorium on approvals.
7.1162 We note that the Netherlands was part of th e Group of Seven countries which declared in
June 1999 that they would take a thoroughly precauti onary approach in dealin g with applications for
the placing on the market of biotech products. Howeve r, in this instance, we are not convinced that
the Dutch CA's conduct reflects a precautionary appr oach. Indeed, we are not convinced that the
Dutch CA could not forward its July 2000 and July 2002 requests to the applicant sooner than it did
even while following a precautionary approach.
7.1163 Regarding the fact that the applicant took more than a year and a half to provide its response
to the lead CA's July 2000 request, and that it did not respond to the July 2002 request for
information, we consider this is consistent w ith the United States' suggestion that the applicant
thought that the single trait parent applicati ons concerning GA21 maize (EC-78) and GA21 maize
(food) were being delayed at Community level as a result of the alleged moratorium and that the
applicant therefore saw little va lue in actively pursuing the hybrid application for MON810 x GA21
maize (food).
7.1164 In the light of the above considerations, we c onclude that the time taken by the Netherlands
for its assessment of the application concerning M ON810 x GA21 maize (food) is consistent with the

1097 Since these applications were at Community level, it is reasonable to assume that the Dutch CA
was aware of the relevant situation.
1098 We note that the application concerning MON810 x GA21 maize (food) referenced Article 9 of
Regulation 258/97 which applies to foods or food ingredients containing or consisting of GMOs and which
requires that the approval decision respect the environmental safety requirements laid down in Directive 90/220.

Complaining Parties' assertion that during the relevant time period the European Communities applied
a general moratorium on final approvals.
Bt-1507 maize (food) (EC-95)
7.1165 The application concerning Bt-1507 maize (food)
 was submitted to the Netherlands (lead CA)
on 15 February 2001. At the time of establishment of the Panel, the lead CA had not completed its
initial assessment. This assessment was completed on 4 November 2003, and the report circulated to
all member States by the Commission on 10 December 2003.
7.1166 The United States argues that the lead CA refused to forward this application to the
Commission.
7.1167 The European Communities observes that after receiving the application in February 2001,
the lead CA asked for additional information in June 2001. This information was finally provided in
February 2003. Between February 2003 and Ju ly 2003, there was ongoing correspondence between
the applicant and the lead CA on additional informati on to be submitted by the applicant, in particular
on labelling, monitoring, molecular characterisation, and event-specific detection methods. The lead
CA finalized the initial assessment report in Nove mber 2003, and concluded th at the consumption of
Bt-1507 maize as well as foods and food ingredient s derived from it were as safe for humans as the
consumption of the non-genetically modified counterparts.
7.1168 The European Communities further notes th at the Commission forwarded the initial
assessment report to member States for comment s in December 2003, and received comments and
reasoned objections against the initial assessmen t. On 26 March 2004, the complete dossier
(including responses to the objections and comments raised by member States) was forwarded to
EFSA for consideration under Regulation 1829/2003. In parallel, the applicant undertook the steps to
ensure the production of certified reference material and for the validation of a detection method by
the JRC.
7.1169 The Panel recalls that according to Regulation 258/ 97, an initial assessment report is to be
drawn up by the lead CA within a period of three months from receipt of an application meeting the
applicable conditions. In this case, this initial assessment was not completed until 4 November 2003,
that is, almost three years after receipt of the application. We note, however, that an initial request for
additional data was made by the lead CA on 28 June 2001, that is four months following receipt of the
application.
1099 The applicant apparently provided some information in November 2001, although this
was not given to us, but did not provide all of the information requested until 12 February 2003.1100 In
March 2003, the lead CA requested further clar ifications, which were provided in May 2003. 1101 In
June 2003, the lead CA posed questions in relation to the applicant's May 2003 reply. 1102 T h e
applicant provided answers by 9 July 2003. 1103 The information as provided by 9 July 2003 was
apparently deemed sufficient by the lead CA to conclude its assessment. As noted, a positive
assessment was reported on 4 November 2003.
7.1170 It is clear from the foregoing that the major delay in the assessment of this application is
attributable to the time taken by the applicant to pr ovide the information requested in June 2001. We

1099 Exhibit EC-95/At. 8.
1100 Exhibit EC-95/At. 12.
1101 Exhibit EC-95/Ats. 13 and 14.
1102 Exhibit EC-95/At. 15.
1103 Exhibit EC-95/At. 16.

asked the experts advising us for their views on the necessity of the information requested by the lead
CA in June 2001 to ensure that the conc lusions of the safety assessment were valid.
1104 Dr. Nutti
responded to this question and commented specifi cally on the lead CA's requests related to
compositional and toxicological analyses. She consid ers that some of the information requested, such
as three seasons of field tests (as opposed to two seasons as provided in th e application), was not
necessary to ensure the safety assessment. On the other hand, the request for compositional data
regarding certain substances and the oral toxicity study to rule out unintended change in Bt-1507
maize were necessary in her view. 1105 All of this information was provided by the applicant in
February 2002, except for the results of the oral t oxicity study which was submitted only in February
2003.
7.1171 Even accepting that the information requested by the lead CA in June 2001 was necessary to
ensure the validity of the safety assessment, it s hould be noted that the application concerning
Bt-1507 maize (food) had been under review in the Netherlands for almost four and a half months
before the Dutch CA forwarded its June 2001 request for information. Similarly, the lead CA on two
occasions took a month to analyse responses provided by the applicant and forward follow-up
requests for information. And once the applicant had provided information in response to the Dutch
CA's last request for informati on, the lead CA still took several months to complete its initial
assessment report.
7.1172 The United States does not assert that the time ta ken by the Netherlands to complete its
assessment is a reflection of Dutch support for the moratorium. Rather, its assertion is that the time
taken by the Netherlands reflects the impact of th e moratorium. The United States contends that the
Netherlands was placed in a position of having to re cognize the moratorium as a reality and that this
affected the speed with which it conducted its assessment.
7.1173 We consider that following the June 1999 d eclaration by the Group of Five countries, the
Netherlands had reason to believe that the Group of Five countries would act as a "blocking minority"
both in the Regulatory Committee and in the Counc il pending the adoption of new EC rules on
labelling and traceability. In our view, the Netherland s also had reason to believe that, as in the case
of some of the previously discussed approval procedures, the Commission would not complete the
approval procedure in the face of systematic opposition by the Group of Five countries.
7.1174 We also note, however, that the Netherlands was part of the Group of Seven countries which
declared in June 1999 that they would take a thoroughly precautionary appr oach in dealing with
applications for the placing on the market of biotech products. However, in this instance, we are not
convinced that the Dutch CA's conduct reflects a pr ecautionary approach. In particular, we are not
convinced that the Dutch CA could not forward its June 2001 request for information to the applicant
sooner than it did even while following a precautiona ry approach, or that it could not complete its
assessment report earlier than in November 2003.
7.1175 It is pertinent to note in this regard that th e applicant had submitted an application concerning
the same product under Directive 90/220. That a pplication was also under assessment by the Dutch
CA. The Dutch CA did not complete its assessme nt of the application concerning Bt-1507 maize
(EC-74) until August 2003. We have previously c oncluded in this respect that the failure of the
Netherlands to complete its assessment of the a pplication concerning Bt-1507 maize (EC-74) earlier
than in August 2003 is not inconsistent with the contention that the European Communities applied a
general moratorium during the relevant time period. Since a special environmental safety assessment

1104 Annex H, Question 51.
1105 Annex H, Dr. Nutti's responses to Question 51.

was necessary for the application concerni ng Bt-1507 maize (food) to be approved under
Regulation 258/97
1106, we think it could also be that the time taken by the Dutch CA before
forwarding its June 2001 request or before comple ting its initial assessment report in November 2003
reflects the delays in the approval procedure concerning Bt-1507 maize (EC-74).
7.1176 Taking account of the aforementioned elements, we consider that the Dutch CA's conduct in
the approval procedure concerning Bt-1507 maize (food) is consistent with the United States' view
that a general moratorium on final approvals was in effect in the European Communities at the time.
It should be recalled, in addition, that the a pplication concerning Bt-1507 maize (food) as of August
2003 had not reached the Community level. In other words, it had not yet reached the procedural
stage where the Group of Five countries and/or the Commission could have taken actions to delay or
prevent its final approval.
7.1177 In the light of the above, we conclude that the failure of the Netherlands to complete the
initial assessment of the application concerning Bt- 1507 maize (food) by Augus t 2003 is consistent
with the contention of the Complaining Parties th at during the relevant time period the European
Communities applied a general moratorium on final approvals.
NK603 maize (food) (EC-96)
7.1178 The application for NK603 maize (food) was subm itted to the Netherlands (lead CA) in April
2001. The lead CA forwarded its initial assessment report to the Commission in November 2002. In
January 2003, the Commission forwarded the initial assessment report by the lead CA to member
States for comments and objections.
7.1179 The United States argues that although the application concerning NK603 maize (food)
eventually received a positive assess ment from the lead CA, this pr oduct was at the member State
level for almost 19 months, instead of the 90 days foreseen by Regulation 258/97. Of this period of
time, only 3½ months were used by the applicant to provide additional information; the lead CA used
the remaining 14½ months.
7.1180 The United States questions certain requests fo r additional information from the lead CA,
arguing they were scientifically unnecessary. For example, the lead CA requested an additional
whole food feeding study in mice or rats, to a ddress concerns about the presence of unintended DNA
fragments that the applicant had identified as pa rt of their molecular characterization data.
1107 T h e
lead CA stated that "the presence of additional unintended modifications cannot be excluded with
sufficient certainty". The United St ates argues that the mere fact th at an additional insert is present
does not necessarily mean that the product presents an additional risk. Rather, the determination turns
on the results of all of the other data and informa tion provided by the applicant, which the lead CA
failed to take into consideration in making this request. If the results of those tests raise questions,
then further examination would be warranted. But in this case, the applicant had conducted
compositional analysis and a broiler chicken w hole food study with the product containing the
additional insert, and in these circumstances would ha ve detected any resulting changes relevant to

1106 We note that the application concerning Bt-1507 maize (food) applies to foods or food ingredients
containing or consisting of GMOs and as such would appear to be subject to the provisions of Article 9 of
Regulation 258/97. To recall, Article 9 requires that approval decisions concerni ng foods or food ingredients
containing or consisting of GMOs must respect the environmental safety requirements laid down in
Directive 90/220.
1107 Exhibit EC-96/At. 7.

food safety. The United States observes that the ap plicant nevertheless conducted the requested test,
which identified no adverse effects.
7.1181 Canada argues that the total time taken by the lead CA for its review was 18 months, and that
only 3.5 of the 18 months were taken by the applican t to respond to questions. The difference of 14.5
months exceeds the 3-month period provided for in Regulation 258/97.
7.1182 Argentina argues that the assessments performed by the lead CA and subsequently the EFSA
concluded that there was no evidence of risk to human health or life. Therefore, the delays by the lead
CA to complete its initial assessment and forwar d this application to the Commission were not
justified.
7.1183 The European Communities notes that the application for food use of the NK603 maize was
submitted to the Netherlands in 2001. After the a pplicant submitted additional information requested
by the lead CA, the lead CA completed its evaluation in November 2002 and sent its initial
assessment report to the Commission. The 18 months spent at member State level were due to the
incompleteness of the dossier initially submitted by the applicant and the need for further data on
molecular characterization and compositional analysis.
7.1184 The Panel understands from the record that the appl icant first submitted the application to the
lead CA in April 2001. Two months later the lead CA requested copies of cited literature and data in
order to facilitate the lead CA's work. The applicant provided these documents in July 2001.
7.1185 There were two separate requests for additional in formation before the lead CA forwarded its
initial assessment report to the Commission in November 2002. First, the lead CA requested further
information in December 2001 on the sequen ce of the inserted DNA fragment as well as further
information on the flanking sequences, semi-chronic toxicity study, and further information on
compositional data from the field trials.
1108 A cover letter indicates that the applicant provided this
information three months later, however the record does not include the details from the applicant's
response.
7.1186 We asked the experts advising us whethe r the information regarding molecular
characterization, toxicity effects of unintended ch anges and compositional data requested by the lead
CA was necessary to ensure that conclusions of the safety assessment were valid. Dr. Nutti noted that
the applicant had provided all the information us ually requested for the food safety assessment, and
had also confirmed that the GM maize in question was equivalent in composition and nutrition to the
conventional counterpart. She emphasized that "t here was no need for requesting a semi chronic
toxicity study in mice or rats, using maize grain or meal, in order to rule out possible undesired effects
of additional, unidentified changes". 1109 The European Communities contests Dr. Nutti's conclusion
that the additional 90-day toxicity study was not necessary. The European Communities indicates that
the lead CA provided as rationale for its request fo r the 90-day study that it would provide additional
reassurance of no unintended undesired effects. 1110 The European Communities argues that Dr.
Nutti's conclusion should be dismissed on the basi s of the available scientific evidence on the
relevance of such studies.
7.1187 The second request for information came from Italy in January 2002 in a letter to the
Commission. This request asked for further inform ation on the evaluation of substantial equivalence,

1108 Exhibit EC-96/At. 7.
1109 Annex H, Dr. Nutti's responses to question 53.
1110 Exhibit EC-96/At. 7.

molecular characterization, and detection analysis. Italy noted that the request was particularly
important as "in the Community context, it has been shown that the simplified procedure needs to be
suspended for GMOs".
1111
7.1188 We again asked the experts whether the inform ation requested by Italy was necessary to
ensure that the conclusions of the safety assessme nt were valid. Dr. Nutti noted that "additional
animal feeding studies may be warranted for GM f oods if changes in the bioavailability of the
nutrients are expected or if the composition of the GM food is not comparable to conventional
food".
1112 She considered that the applicant had adequa tely established the substantial equivalence of
the NK603 maize with its conventional counterpart, a nd that the request from Italy for more animal
feeding studies was therefore not necessary to ensure that conclusions of the safety assessment were
valid. In any event, there is no evidence on the record th at the applicant was ev er requested by the
lead CA to provide the information sought by Ital y. Nor is there any ev idence that the applicant
submitted information to address the requests made by Italy.
7.1189 In August 2002, five months after the applicant supplied the information requested by the lead
CA, the lead CA's advisory body, the Dutch Hea lth Council's Committee on the Safety Assessment of
Novel Foods, finished its assessment report. Th e Committee concluded that "the consumption of
NK603 maize and food and food ingredients derive d from this is just as safe for humans as the
consumption of non-genetically m odified maize and maize products". 1113 It was not until November
2002 that the lead CA forwarded its assessment report to the Commission.1114
7.1190 In considering the foregoing, we note that this application was under assessment at the
member State level for eighteen m onths. The lead CA's December 2001 request for information led
to a delay, inasmuch as the applicant took three mo nths and a half to respond to the request. We
recall the view expressed by one of the experts th at the request in question was not necessary to
ensure the validity of the safety assessment. Howe ver, even accepting that th e information requested
by the lead CA in December 2001 was appropriate to ensure the validity of the safety assessment, it
should be noted that the Netherla nds took considerably more time for its assessment than the three
months foreseen under Regulation 258/97. Notably, the application concerning NK603 maize (food)
had been under review in the Netherlands for more than seven months before the Dutch CA
forwarded its December 2001 request for information. 1115 Moreover, once the applicant had provided
information in response to the Dutch CA's Dece mber 2001 request for information, the Health
Council's Committee on the Safety Assessment of Nove l Foods still took more than four months to
complete its initial assessment report. While this report needed to be adopted by the Dutch CA, the
report was not forwarded to the Commission for another two and a half months.
7.1191 The United States does not assert that the time ta ken by the Netherlands to complete its
assessment is a reflection of Dutch support for the moratorium. Rather, its assertion is that the time
taken by the Netherlands reflects the impact of th e moratorium. The United States contends that the
Netherlands was placed in a position of having to re cognize the moratorium as a reality and that this
affected the speed with which it conducted its assessment.

1111 Exhibit EC-96/At. 9.
1112 Annex H, Dr. Nutti's responses to question 54.
1113 Exhibit EC-96/At. 7.
1114 Exhibit EC-96/At. 12.
1115 The application had been under review for more than four and a half months after receipt of copies
of the cited literature and data. These copies were reque sted by the lead CA two months after receipt of the
application.

7.1192 We consider that following the June 1999 d eclaration by the Group of Five countries, the
Netherlands had reason to believe that the Group of Five countries would act as a "blocking minority"
both in the Regulatory Committee and in the Counc il pending the adoption of new EC rules on
labelling and traceability. In our view, the Netherland s also had reason to believe that, as in the case
of some of the previously discussed approval procedures, the Commission would not complete the
approval procedure in the face of systematic opposition by the Group of Five countries.
7.1193 We also note, however, that the Netherlands was part of the Group of Seven countries which
declared in June 1999 that they would take a thoroughly precautionary appr oach in dealing with
applications for the placing on the market of biotech products. However, in this instance, we are not
convinced that the Dutch CA's conduct reflects a pr ecautionary approach. In particular, we are not
convinced that the Dutch CA could not forward its December 2001 request for information to the
applicant sooner than it did even while following a precautionary approach, or that it could not
forward its completed assessment report earlier than in November 2002.
7.1194 It is pertinent to note in this regard that th e applicant had submitted an application concerning
the same product under Directive 90/220. That application was under assessment by the Spanish CA
during the same time period. The Spanish CA did not complete its assessment while Directive 90/220
was still in force. Under Directive 2001/18, the Spanish CA forwarded its positive assessment report
concerning NK603 maize to the Commission on 14 January 2003. We have previously concluded in
this respect that Spain's failure to complete its assessment of NK603 maize earlier than in January
2003 is not inconsistent with the contention of the Complaining Parties that the European
Communities applied a general moratorium during the relevant time period. Since a special
environmental safety assessment was necessary for the application concerning NK603 maize (food) to
be approved under Regulation 258/97
1116, we think it could also be that the time taken by the Dutch
CA before forwarding its December 2001 request or before forwarding its initial assessment report in
November 2003 reflects a view on the part of the Dutch CA that the Spanish CA would not forward
the application concerning NK603 maize to the Commission and the other member States until after
the entry into force of Directive 2001/18.
7.1195 Taking account of the aforementioned elements, we consider that the Dutch CA's conduct in
the approval procedure concerning NK603 maize (food) is consistent with the Complaining Parties'
view that a general moratorium on final approvals was in effect in the European Communities at the
time. It should also be recalled in this regard that the applica tion concerning NK603 maize (food) as
of August 2003 had not reached the Community level. In other words, it had not yet reached the
procedural stage where the Group of Five countries and/or the Commission could have taken action to
delay or prevent its final approval.
7.1196 In the light of the above considerations, we conclude that the time taken by the Netherlands to
complete its initial assessment of the application concerning NK603 ma ize (food) is consistent with
the contention of the Complaining Parties that the European Communities applied a general
moratorium during the relevant time period.

1116 We note that the application concerning NK603 maize (food) concerns foods or food ingredients
containing or consisting of GMOs and as such would appear to be subject to the provisions of Article 9 of
Regulation 258/97. To recall, Article 9 requires that approval decisions concerni ng foods or food ingredients
containing or consisting of GMOs must respect the environmental safety requirements laid down in
Directive 90/220.

High-oleic soybeans (food) (EC-99)
7.1197 The application concerning High-oleic soyb eans (food) was submitted to the Netherlands
(lead CA) on 24 July 1998. The application was withdrawn by the applicant on 12 December 2002.
At that time, the lead CA had not yet issued its initial assessment of the application.
7.1198 The United States argues that the application for High-oleic soybeans (food) was withdrawn
because of the European Communities' excessive delay in carrying out the approval process.
7.1199 The European Communities argues that after discussions between the lead CA and the
applicant, the applicant in December 2002 withdrew its application. The applicant gave as the reason
for its withdrawal "entirely commercial reasons."
7.1200 The United States argues that in many cases the withdrawal of applications resulted from the
applicant's frustration with the European Communi ties' suspension of its approval process, although
the applicant may not have explicitly so indicated in it reasons for withdrawal. Over time, as the
delays mounted, in some cases the commercial incen tive for seeking approval changed. Second, the
companies have a strong incentive to maintain co rdial relations with EC regulators, and saw no
advantage of complaining to EC regulators a bout the length of the delays resulting from the
moratorium.
7.1201 The Panel observes that in circulating notice of this application to all member States, the
Commission indicated that the initial assessment by the lead CA would be available by 5 November
1999 at the latest. In contrast, at the time this application was withdrawn in December 2002, this
initial assessment had not yet been completed.
7.1202 It appears that the lead CA requested furthe r references from the applicant sometime before
mid-October 1998, which was when these were provide d. The information provided is incomplete
and does not permit identification of when these re ferences had been requested. Furthermore, in
March 1999, the lead CA contacted the applicant to request explanations regarding certain results
reported in the initial application.
1117 This was more than seven months after its receipt of the
application. No explanation has been provide d for this delay. The applicant provided the
explanations and information requested in May 1999. 1118 More than three months later, in September
1999, the lead CA requested further clar ification of the information provided. 1119 The applicant
responded within three weeks, on 22 September 1999. 1120 It appears that the applicant's response
addressed all questions asked by the lead CA. Ther e is no indication that subsequent to September
1999 the lead CA sought further information or t ook any further action on this application until the
application was withdrawn more than three years later on 12 December 2002.
7.1203 We note that no explanation has been provided to us for why the lead CA did not complete its
assessment during the three years following the appl icant's September 1999 response to a request for
clarification. The United States argues that this de lay was due to the alleged general moratorium on
approvals. The United States does not assert that the time taken by the Netherlands to complete its
assessment is a reflection of Dutch support for the moratorium. Rather, its assertion is that the time
taken by the Netherlands reflects the impact of th e moratorium. The United States contends that the

1117 Exhibit EC-99/At. 11.
1118 Exhibit EC-99/At. 14.
1119 Exhibit EC-99/At. 15.
1120 Exhibit EC-99/At. 16.

Netherlands was placed in a position of having to re cognize the moratorium as a reality and that this
affected the speed with which it conducted its assessment.
7.1204 We consider that following the June 1999 d eclaration by the Group of Five countries, the
Netherlands had reason to believe that the Group of Five countries would act as a "blocking minority"
both in the Regulatory Committee and in the Counc il pending the adoption of new EC rules on
labelling and traceability. In our view, the Netherland s at the time also had reason to believe that, as
in the case of some of the previously discussed approval procedures, the Commission would not
complete the approval procedure in the face of systematic opposition by the Group of Five countries.
7.1205 We also note, however, that the Netherlands was part of the Group of Seven countries which
declared in June 1999 that they would take a thoroughly precautionary appr oach in dealing with
applications for the placing on the market of biotech products. However, in this instance, we are not
convinced that the Dutch CA's conduct reflects a pr ecautionary approach. In particular, we are not
convinced that it was not possible for the Dutch CA to complete its assessment before December 2002
even while following a precautionary approach.
7.1206 It is pertinent to note in this context th at the applicant had submitted an application
concerning the same product under Directive 90/220. That application was also under assessment by
the Dutch CA. In the procedure conducted under Directive 90/220, the Dutch CA requested
additional information in October 1999.
1121 However, the applicant did not provide a response to that
request until it withdrew its application in Decemb er 2002. Since a special environmental safety
assessment was necessary fo r the application concerning High-oleic soybeans (food) to be approved
under Regulation 258/97 1122, we think it could be that the time taken by the Dutch CA after the
September 1999 response by the applicant reflects th e delays in the approval procedure concerning
High-oleic soybeans. We have previously conclu ded that the record of the member State level
assessment of that application is not inconsistent with the contention of the Complaining Parties that
the European Communities applied a general moratorium during the relevant time period.
7.1207 Taking account of the aforementioned elements, we consider that the unexplained failure by
the lead CA to complete its assessment of the ap plication concerning High-oleic soybeans (food) after
September 1999 is consistent with the United St ates' view that a general moratorium on final
approvals was in effect in the Euro pean Communities at that time. It should also be recalled in this
regard that the application concerning High-olei c soybeans (food) as of August 2003 had not reached
the Community level. In other words, it had not yet reached the procedural stage where the Group of
Five countries and/or the Commission could have taken action to delay or prevent its final approval.
7.1208 In our view, the fact that the applicant did no t specifically cite a general EC moratorium on
approvals as a reason for the withdrawal of the app lication in December 2002 is not inconsistent with
the United States' assertion that the European Communities was applying a general moratorium on
approvals at the time. As was pointed out by the United States, if a moratorium was in effect, there
are plausible explanations for why the applicant di d not specifically cite the alleged moratorium or
resulting delays as a reason for withdrawing the application concerning High-oleic soybeans (food).

1121 Exhibit EC-87/At. 15.
1122 We note that the application concerning High-oleic soybeans (food) concerns foods or food
ingredients containing or consisting of GMOs and as such would appear to be subject to the provisions of
Article 9 of Regulation 258/97. To recall, Article 9 requires that approval decisions concerning foods or food
ingredients containing or consisting of GMOs must respect the environmental safety requirements laid down in
Directive 90/220.

7.1209 In the light of the above considerations, we c onclude that the failure by the Netherlands to
complete its assessment of the application concer ning High-oleic soybeans (food) prior to December
2002, when it was withdrawn by the applicant, is c onsistent with the Complaining Parties' assertion
that during the relevant time period the European Communities applied a general moratorium on final
approvals.
T25 x MON810 maize (food) (EC-101)
7.1210 The application concerning T25 x MON810 maiz e (food) was submitted to the Netherlands
(lead CA) on 20 April 2000. The application was wi thdrawn on 12 December 2002. At that time, the
lead CA had not completed its initial assessment. (An application for approva l of this product under
Regulation 90/220 was also submitted; see EC-86 above.)
7.1211 The United States argues that the application for T25 x MON810 maize (food) was
withdrawn because of the European Communities' excessive delay in carrying out the approval
process.
7.1212 The European Communities maintains that after discussions between the lead CA and the
applicant, in its letter withdrawing the applica tion the applicant pointed to "entirely commercial
reasons."
7.1213 The United States argues that in many cases the withdrawal of applications resulted from the
applicant's frustration with the European Communi ties' suspension of its approval process, although
the applicant may not have explicitly so indicated in it reasons for withdrawal. Over time, as the
delays mounted, in some cases the commercial incen tive for seeking approval changed. Second, the
companies have a strong incentive to maintain co rdial relations with EC regulators, and saw no
advantage of complaining to EC regulators a bout the length of the delays resulting from the
moratorium.
7.1214 The Panel notes that in bringing the application to the attention of all member States on
3 May 2000, the Commission stated that the initial assessment was to be concluded by 28 July 2000 at
the latest.
1123 However, it was apparently only on 17 July 2000 that the lead CA first contacted the
applicant to request additional information. 1124 After the applicant responded on 22 November 2000,
another five months lapsed before the lead CA requested further information on 23 April 2001.1125
7.1215 In responding to the April 2001 request from the lead CA, on 21 November 2001 the
applicant noted that not only had both parental lines been previously approved, but the same hybrid
T25 x MON810 maize product had been reviewed under Directive 90/220 and had received a
favourable assessment from the Dutch CA and from the SCP in June 2000. Given these
circumstances, the applicant qu estioned the need for providing additional information on molecular
characterization. It also noted that the request for a semi-chronic toxicity study was "an unexpected
requirement".1126 Nonetheless, the applicant indicated its intention to provide the information
requested by mid-2002, and asked that the Dutch He alth Council allow the applicant the opportunity
to provide the additional informa tion before completing its safety assessment. It appears from the
applicant's November 2001 response th at the Health Council had previously indicated its intention to
finalize its safety assessment before the end of 2001.

1123 Exhibit EC-101/At. 4.
1124 Exhibit EC-101/At. 11.
1125 Exhibit EC-101/Ats. 13 and 14.
1126 Exhibit EC-101/At. 15.

7.1216 No evidence has been provided of further correspondence on this application until the letter of
12 December 2002 from the applicant withdrawing the application. We can only presume that the
applicant did not provide the information as indicated in its letter of 21 November 2001, and that the
lead CA did not explain to the applicant the reasons for its "unexpected requirement" nor otherwise
further seek information requested from the applicant.
7.1217 We sought the advice of the experts assisting us as to whether the additional information
regarding molecular characterization, field trials, secondary plant metabolites, and toxicological tests
requested by the lead CA in April 2001 were necess ary to ensure that conclusions of the safety
assessment were valid.
1127 Dr. Nutti did not consider that the requests regarding compositional and
toxicological analysis were necessary, in light of the information available on the parental lines. She
characterized the likelihood of fortuitous cha nges in the plant metabolism as a result of the
conventional cross-breeding of two GMO maizes as being "vanishingly small".1128
7.1218 Dr. Andow considered that there is a scientif ic justification for requiring comparison of T25
maize with and without the pestic ide treatment with conventional and untreated maize, although he
indicates that there is a scientific debate as to wh ether all three comparisons are necessary to ensure
the safety assessment. With respect to the secondary plant metabolites, Dr. Andow also considers that
the likelihood of a change in the plant metabolism may be very small, but that it is difficult to argue
how small, and since a potential human health risk could arise from such changes, he considered the
requested information to be necessary to ensure a valid safety assessment. Dr. Andow, however,
agreed that the requested toxicology study was not necessary for the safety assessment.1129
7.1219 Dr. Squire considered that the requests by the l ead CA were arguably consistent with the type
of information required in the Codex Guideline fo r the conduct of food safety assessment of food
derived from recombinant-DNA plants.1130
7.1220 We are cognizant of the European Communities' disagreement with the views of Drs. Andow
and Nutti regarding the need for the toxicology st udy, and with Dr. Nutti regarding the data on
herbicide treatment and on secondary compounds. Ev en accepting that the information requested by
the Health Council in April 2001 was necessary to ensure the validity of the safety assessment, this
would not explain the time taken by the lead CA before initially requesting additional information in
July 2000 (three months), and the time taken to review the information received in November 2000
(five months).
7.1221 The United States does not assert that the time ta ken by the Netherlands to complete its
assessment is a reflection of Dutch support for the moratorium. Rather, its assertion is that the time
taken by the Netherlands reflects the impact of th e alleged moratorium. The United States contends
that the Netherlands was placed in a position of ha ving to recognize the moratorium as a reality and
that this affected the speed with which it conducted its assessment.
7.1222 We consider that following the June 1999 d eclaration by the Group of Five countries, the
Netherlands had reason to believe that the Group of Five countries would act as a "blocking minority"
both in the Regulatory Committee and in the Counc il pending the adoption of new EC rules on
labelling and traceability. In our view, the Netherland s also had reason to believe that, as in the case

1127 Annex H, Question 57.
1128 Annex H, para.766.
1129 Annex H, para. 772.
1130 Annex H, para. 774.

of some of the previously discussed approval procedures, the Commission would not complete the
approval procedure in the face of systematic opposition by the Group of Five countries.
7.1223 We also note, however, that the Netherlands was part of the Group of Seven countries which
declared in June 1999 that they would take a thoroughly precautionary appr oach in dealing with
applications for the placing on the market of biotech products. However, in this instance, we are not
convinced that the Dutch CA's conduct reflects a pr ecautionary approach. In particular, we are not
convinced that the Dutch CA could not forward its July 2000 request for information to the applicant
sooner than it did even while following a precautionary approach, or that after receiving the
applicant's response it could not identify the need fo r more detailed information earlier than in April
2001.
7.1224 It is pertinent to note, furthermore, that the applicant had submitted an application concerning
the same product under Directive 90/220. That appli cation had also been assessed by the Dutch CA.
At the time the application concerning T25 x M ON810 maize (food) was submitted to the Dutch CA,
the application concerning T25 x MON810 maize w as being assessed at Community level. In June
2000, the SCP issued a favourable opinion, but the Commission subsequently did not forward a draft
measure to the Regulatory Committee prior to the w ithdrawal of the application in December 2002.
We have previously concluded in this respect that the Commission's failure to submit a draft measure
concerning T25 x MON810 maize to the Regulatory Committee is consistent with the Complaining
Parties' assertion that the European Communities applied a general moratorium on final approvals.
7.1225 Taking account of the aforementioned elements, we consider that the time taken by the lead
CA before initially requesting additional information in July 2000, and the tim e taken to review the
information received in November 2000, is consiste nt with the United States' view that a general
moratorium on final approvals was in effect in the European Communities at that time. It should also
be recalled in this regard that the application concerning T25 x MON810 maize (food) as of the date
of its withdrawal had not reached the Community level. In other words, it had not yet reached the
procedural stage where the Group of Five countries and/or the Commission could have taken action to
delay or prevent its final approval.
7.1226 Furthermore, in our view, the fact that the applicant did not specifically cite a general EC
moratorium on approvals as a reason for the withdraw al of the application in December 2002 is not
inconsistent with the assertion that the European Communities was applying a general moratorium on
approvals at the time. As was pointed out by the United States, if a moratorium was in effect, there
are plausible explanations for why the applicant di d not specifically cite the alleged moratorium or
resulting delays as a reason for withdrawing the application concerning T25 x MON810 maize (food).
7.1227 In the light of the above, we conclude that th e time taken by the Netherlands for its initial
assessment of the application for T25 x MON810 maize (food) is consistent with the contention of the
Complaining Parties that during the relevant time period the European Communities applied a general
moratorium on final approvals.
RR sugar beet (food) (EC-102)
7.1228 The application concerning RR sugar beet (food) was submitted to the Netherlands (lead CA)
in November 1999. At the time of establishment of the Panel, the lead CA had not yet completed its
initial assessment. The application was withdrawn by the applicant on 16 April 2004.
7.1229 The United States argues that the lead CA refused to forward this application to the
Commission.

7.1230 The European Communities argues that after discussions between the Dutch CA and the
applicant, the request was withdrawn on 16 April 2004. As the reason for its withdrawal the applicant
pointed to a decision to stop any further development of the RR sugar beet.
7.1231 The United States argues that in many cases the withdrawal of applications resulted from the
applicant's frustration with the European Communi ties' suspension of its approval process, although
the applicant may not have explicitly indicated so in it reasons for withdrawal. Over time, as the
delays mounted, in some cases the commercial incen tive for seeking approval changed. Second, the
companies have a strong incentive to maintain co rdial relations with EC regulators, and saw no
advantage of complaining to EC regulators a bout the length of the delays resulting from the
moratorium.
7.1232 The Panel notes from the record that this applica tion was submitted to the Netherlands in
November 1999. Four months later, in March 2000, the Health Council of the Netherlands requested
information from the applicant regarding missi ng and illegible references and a request for
information on the nutritional value of glyphosate-treated RR sugar beet.
1131 The applicant responded
one month later and indicated that further studi es on DNA and protein detection from sugar produced
from RR sugar beet were in process. 1132 In May 2000, the lead CA requested further information on
protein toxicity. 1133 The applicant provided a response in December 2000, which included new
scientific reports and data.1134
7.1233 In January 2001, Denmark requested further in formation regarding compositional analysis of
RR sugar beet treated with herbicide, as well as non-treated, and field management for RR and
conventional sugar beet. The Danish CA also requ ested information on the level of amino acid in
treated sugar beet as well as a series of technical repor ts which were cited in the application, but not
provided, by the applicant. 1135 There is no indication on record that the applicant responded to the
request from Denmark.
7.1234 In May 2001, after reviewing the additional information provided by the applicant in
December 2000, the lead CA reque sted further information on protein analysis. The lead CA
indicated that it was not yet fully satisfied with th e information provided by the applicant concerning
the likelihood of specific protein formation. In addition, mentioning recent studies which had shown
that "unintended effects on GMOs" were possibly caused by transformation of plant cells, the lead CA
also requested a semi-chronic oral toxicity study on rats in order to "to rule out possible undesirable
effects [...] with sufficient certainty".1136 No specific study was cited in this regard.
7.1235 There is no indication in the evidence before us that the applicant responded to the requests
from the lead CA for further information. A lthough the European Communities indicates in the
chronology it provided on this application that the applicant sent a message regarding the status of the
application in November 2001, there is no such document in the record. The next item in the
chronology is the withdrawal of the application by the applicant in April 2004.
7.1236 We sought the advice of the experts assisting us as to whether the additional information
requested by the lead CA in May 2001 was necessar y to ensure that the conclusions of the safety

1131 Exhibit EC-102/At. 21.
1132 Exhibit EC-102/At. 22.
1133 Exhibit EC-102/At. 23.
1134 Exhibit EC-102/At. 26.
1135 Exhibit EC-102/At. 31.
1136 Exhibit EC-102/At. 32.

assessment were valid. Dr. Nutti expressed the view th at "the information requested by the lead CA
regarding the derived proteins and the request for a semi-chronic oral toxicity test on mice or rats with
edible parts of sugar beet was not necessary to en sure that the conclusions of the safety assessment
were valid". She emphasized that the applicant had already completed an acute toxicity test on rats
and conducted studies which confirmed that RR s ugar beet "was equivalent in composition and
nutrition to the conventional counterpart".
1137
7.1237 Even accepting that contrary to the views of Dr. Nutti the information requested by the Health
Council in May 2001 was necessary to ensure the va lidity of the safety assessment, this would not
explain the time taken by the lead CA before in itially requesting additiona l information in March
2000 (almost five months), and th e time taken to review the inform ation received in December 2000
(five months).
7.1238 The United States does not assert that the time ta ken by the Netherlands to complete its
assessment is a reflection of Dutch support for the moratorium. Rather, its assertion is that the time
taken by the Netherlands reflects the impact of th e alleged moratorium. The United States contends
that the Netherlands was placed in a position of ha ving to recognize the moratorium as a reality and
that this affected the speed with which it conducted its assessment.
7.1239 We consider that following the June 1999 d eclaration by the Group of Five countries, the
Netherlands had reason to believe that the Group of Five countries would act as a "blocking minority"
both in the Regulatory Committee and in the Counc il pending the adoption of new EC rules on
labelling and traceability. In our view, the Netherland s also had reason to believe that, as in the case
of some of the previously discussed approval procedures, the Commission would not complete the
approval procedure in the face of systematic opposition by the Group of Five countries.
7.1240 We also note, however, that the Netherlands was part of the Group of Seven countries which
declared in June 1999 that they would take a thoroughly precautionary appr oach in dealing with
applications for the placing on the market of biotech products. However, in this instance, we are not
convinced that the Dutch CA's conduct reflects a pr ecautionary approach. In particular, we are not
convinced that the Dutch CA could not forwar d its March 2000 request for information to the
applicant sooner than it did even while following a precautionary approach, or that after receiving the
applicant's response it could not identify the need fo r more detailed information earlier than in May
2001.
7.1241 It is pertinent to note, furthermore, that the applicant drew the Dutch CA's attention to an
application concerning the same product which the applicant had previously submitted to Belgium
under Directive 90/220.
1138 Belgium did not complete its assessment of that application, and the
applicant withdrew it in April 2004. We have previo usly concluded in relation to that application that
the time taken by Belgium for its assessment of RR sugar beet is consistent with the Complaining
Parties' assertion that during the relevant time pe riod the European Communities applied a general
moratorium on final approvals.
7.1242 Taking account of the aforementioned elements, we consider that the time taken by the lead
CA before initially requesting additional information in March 2000, and the time taken to review the
information received in December 2000, is consiste nt with the United States' view that a general
moratorium on final approvals was in effect in the European Communities at that time. It should also
be recalled in this regard that the application c oncerning RR sugar beet (food) as of the date of its

1137 Annex H, para. 775.
1138 Exhibit EC-102/At. 20.

withdrawal had not reached the Community level. In other words, it had not yet reached the
procedural stage where the Group of Five countries and/or the Commission could have taken action to
delay or prevent its final approval.
7.1243 Furthermore, in our view, the fact that the applicant did not specifically cite a general EC
moratorium on approvals as a reason for the withdr awal of the application in April 2004 is not
inconsistent with the assertion that the European Communities was applying a general moratorium on
approvals at the time. As was pointed out by the United States, if a moratorium was in effect, there
are plausible explanations for why the applicant di d not specifically cite the alleged moratorium or
resulting delays as a reason for withdrawing the application concerning RR sugar beet (food).
7.1244 In the light of the above, we conclude that th e time taken by the Netherlands for its initial
assessment of the application concerning RR sugar beet (food) is consistent with the contention of the
Complaining Parties that during the relevant time period the European Communities applied a general
moratorium on final approvals.
(iii) Conduct of Group of Five countries generally
7.1245 In the preceding analysis, the Panel has addressed certain conduct of one particular Group of
Five country, France, in its capacity as lead CA in individual approval procedures.
1139 In what
follows, the Panel focuses on the conduct of Group of Five countries in approval procedures in which
they were not acting as the lead CA. In particul ar, the Panel considers how Group of Five countries
voted in the Regulatory Committee or Council and whether they raised objections to favourable
assessments circulated by the lead CA.
Voting behaviour by Group of Five countries in the Regulatory Committee or Council
7.1246 We begin by considering the voting behaviour by Group of Five countries in the Regulatory
Committee or Council. The record makes clear th at there was no vote on any application in the
Regulatory Committee or the Council between June 1999, when the Group of Five countries made
their joint declaration, and August 2003. It is th erefore not possible to establish whether, consistent
with their June 1999 declaration, the Group of Five countries cast their votes in the Regulatory
Committee or the Council in such a way as to pr event the necessary qualified majority from being
reached.
7.1247 In response to a question from the Panel, the European Communities pointed out that between
October 1998 and June 1999 four votes took place in the Regulatory Committee and that during that
time period two Group of Five countri es voted in favour of applications.
1140 Specifically, the
European Communities mentions that Italy cast a favourable vote in the Regulatory Committee on
four applications submitted under Directive 90/220 1141 and that Denmark did the same in relation to
one application submitted under Directive 90/2201142.

1139 See the approval procedures concerning RR oilseed rape (EC-79) and MS1/RF1 oilseed rape
(EC-89) as well as MS1/RF2 oilseed rape.
1140 EC reply to Panel question No. 87.
1141 The applications in question are those concerning Bt-531 cotton, RR-1445 cotton, MON809 maize
and the Transgenic tomato.
1142 The application in question is that concerning the Transgenic tomato. It should be noted that
Denmark voted against the applications concerning Bt-531 cotton and RR-1445 cotton. Exhibits EC-65/At. 59
and EC-66/At. 57. Regarding the application concerning MON809 maize, Denmark abstained. Exhibit
EC-83/At. 65.

7.1248 In the Panel's view, the fact that Italy and Denmark voted in favour of a number of
applications between October 1998 and June 1999 does not support the inference that if there had
been votes between June 1999 and August 2003, these two member States would have voted in favour
of additional applications. To be gin with, in June 1999 Italy and De nmark declared that they would
take steps to prevent new applications from bei ng approved. In addition, between June 1999 and
August 2003, Italy and Denmark repeatedly objected to the placing on the market of biotech products
which had received a favourable initial assessment from the lead CA.
1143
7.1249 The European Communities also points out that in February 2004, Italy and France in the
Regulatory Committee voted in favour of a Comm ission draft measure approving the application
concerning NK603 maize.1144 The Panel notes that the vote referred to by the European Communities
occurred well after 29 August 2003, the date of est ablishment of this Panel. As these votes may have
been influenced by the establishment of this Panel, it would be inappropriate to infer from these votes
that if votes had been held prior to August 2003, Italy and France would have voted in favour of
applications.1145 Also, the voting behaviour by Italy and France in the procedure concerning NK603
maize is consistent with the June 1999 declaration of the Group of Five, in that the new EC rules on
labelling and traceability were adopted in September 2003.
Objections by Group of Five countries to favourable assessments by lead CAs
7.1250 We now turn to consider whether the Group of Five countries raised any objections to
favourable assessments by lead CAs in the period between June 1999, when the Group of Five
countries made their joint declaration, and August 2003 . In considering this issue, we first of all
recall that under the approval procedures set out in Directives 90/220 and 2001/18 as well as
Regulation 258/97, when the lead CA circulates a favourable assessment report, the other member
States have 60 days within which to raise objections to the placing on the market of the biotech
product in question. If such objections are main tained, the decision on whether to approve the
relevant biotech product must be made at Community level.
7.1251 The record indicates that there were relativel y few individual approval procedures in which
the 60-day period for objections ended between June 1999 and August 2003. More specifically, it is
possible to identify a total of nine applications wh ich fall within this category. They include six
applications which were being assesse d under Directives 90/220 and/or 2001/18
1146 and three
applications which were being assessed under Regulation 258/971147.
7.1252 We note that in the case of each of the nine app lications in question, there was at least one
Group of Five country which raised and maintained an objection to the placing on the market of the
biotech product in question. The nine applications include three in which Group of Five country

1143 E.g., in the approval procedures concerning Bt-11 maize (EC-69) (Denmark and Italy), RR oilseed
rape (Denmark and Italy), GA21 ma ize (EC-85) (Denmark and Italy), T25 x MON810 maize (Denmark and
Italy), GA21 maize (food) (Italy) and Bt-11 sweet maize (food) (Denmark and Italy.
1144 EC first written submission, para. 565; EC reply to Panel question No. 87. It should be noted that
other Group of Five countr ies – Greece, Luxembourg and Denmark – vote d against approving the application.
Exhibit EC-114.
1145 For completeness, it should be noted that in February 1999, France in the Regulatory Committee
voted against approving Bt-531 cotton and RR-1445 cotton. Exhibits EC-65/At. 59 and EC-66/At. 57.
1146 The six approval procedures are the approval procedures concerni ng (i) Bt-11 maize (EC-69), (ii)
RR oilseed rape (EC-70), (iii) NK603 maize, (iv) GA21 maize (EC-78), (v) GA21 maize (EC-85) and (vi) T25 x
MON810 maize.
1147 The three approval procedures are the approval procedures concerning (i) GA21 maize (food), (ii)
Bt-11 sweet maize (food) and (iii) NK603 maize (food).

objections were raised and maintained under the provisions of Directive 2001/18. We further note
that in none of the nine cases did all Group of Five countries raise objections.
1148 It should, however,
be recalled in this connection that under Dir ectives 90/220 and 2001/18 as well as Regulation 258/97
an objection from a single Group of Five country was sufficient to force a decision at Community
level and hence for the Group of Five countries to obtain the opportunity to use their "blocking
minority" in the Regulatory Committee and Council.
7.1253 The fact that at least one Group of Five country raised and maintained an objection in the case
of each of the nine relevant applications does not necessarily mean that all of these objections were
maintained for the reasons underlying the June 199 9 declaration by the Group of Five countries.
1149
Nonetheless, the existence of an objection from at le ast one Group of Five country in each of the nine
cases is consistent with the Complaining Parties' assertion that certain member States intentionally
delayed or prevented the final approval of applica tions. Even if the reason presented by a Group of
Five country for its objection differed from the reasons underlying the June 1999 declaration, this fact
alone would not contradict the Complaining Parties' assertion. Since this particular Group of Five
country raised an objection, it cannot simply be ass umed that if the reason offered for the objection
had not existed, the country in question would have refrained from objecting on the basis of the June
1999 declaration.1150
(iv) Commission conduct prior to the June 1999 declaration by the Group of Five countries
7.1254 We note that Argentina has commented on the conduct of the Commission prior to the
issuance of the June 1999 declaration by the Group of Five countries. The conduct in question
affected the progress in the approval process of a number of applications which had been submitted
under Directive 90/220. In Argentina's view, the Commission's conduct in respect of these
applications confirms the existence of a general moratorium on approvals as from October 1998.
7.1255 Argentina argues that all applications which had received positive opinions from EC
scientific committees in 1998 were prevented by the Commission from progressing in the approval
process. The Commission did so by holding leng thy inter-service consulta tions in September 1998
and May 1999. According to Argentina, a first group of these applications – those concerning Falcon
oilseed rape, MS8/RF3 oilseed rape and RR fodder b eet – was delayed by inter-service consultations
which began in September 1998. The relevant a pplications did not reach the Regulatory Committee
stage until June or October 1999. A second group of applications – those concerning Bt-531 cotton
and RR-1445 cotton – reached the Regulatory Comm ittee stage, but failed to achieve a qualified
majority vote in the Regulatory Committee in February 1999. The Commission launched inter-
service consultations in May 1999 on draft meas ures to be submitted to the Council, but the
Commission did not submit any draft measures, and so the applications in question made no progress

1148 In three approval procedures there were three Group of Five countries which raised and maintained
objections, and in another three approval procedures there were two Group of Five countries which did so.
1149 In relation to DS291 and DS292, we note that the United States and Canada have demonstrated that
in some of the nine relevant approval procedures objec tions by Group of Five countries were based on reasons
which explicitly included those underlying the June 1999 declaration.
1150 Indeed, if a Group of Five country opposed the placing on the market of a biotech product and it
considered there existed, in its view , clear product- or application-specific reasons for doing so, then there was
no need for it to fall back on the more general reasons underlying the June 1999 declaration. In other cases,
however, the relevant Group of Five country might well have wished to base its opposition to the product in
question on the June 1999 declaration. Cases in point are Denmark's first objection concerning Bt-11 maize
(EC-69), which was based on product- and application-specific reasons (Exhibit EC-69/At. 66), and Denmark's
objection concerning Bt-11 sweet maize (food), which was based on the June 1999 declaration (Exhibit
EC-92/At. 27).

until they had to be updated under Directive 2001/18 in January 2003. For Argentina, the September
1998 and May 1999 inter-service c onsultations undertaken by the Commission are evidence of the
existence of a general de facto moratorium. Argentina finds further support for this view in the
circumstance that the "inter-service consultation" phase was not provided for in Directive 90/220.
7.1256 The Panel has already addressed the delays that occurred as from May 1999 as a result of the
Commission's inter-service consultations on the applications concerning Bt-531 cotton and RR-1445
cotton. Accordingly, the Panel need only address the inter-service consultations on the applications
concerning Falcon oilseed rape, MS8/RF3 oilseed rape and RR fodder beet. These consultations were
all launched in September 1998. The Panel cons iders that in addition to these three approval
procedures mentioned by Argentina, the appr oval procedures concerning MON809 maize, the
Transgenic tomato, Bt-531 cotton and RR-1445 cotton are also relevant. These additional
applications also received favourable opini ons from EC scientific committees in 1998
1151, and the
Commission launched inter-service consultations on them in or before September 1998 1152. The
following table summarizes the factual situation.

Application
Commission inter-
service consultations
on draft measure to
be submitted to
Regulatory
Committee
Launch by
Commission
of vote in
Regulatory
Committee
Vote in Regulatory
Committee
Commission
inter-service
consultations on
draft measure to
be submitted to
Council
MON809 maize 12/06/1998 04/09/1998 23/10/1998 (absence
of qualified majority)
01/02/1999
Transgenic
tomato
05/10/1998 26/11/1998 18/12/1998 (absence
of qualified majority)
16/02/1999
Bt-531 cotton 04/09/1998 26/11/1998 22/02/1999 (absence
of qualified majority)
07/05/1999
RR-1445 cotton 04/09/1998 26/11/1998 22/02/1999 (absence
of qualified majority)
07/05/1999
Falcon oilseed
rape
04/09/1998 29/06/1999 29/10/1999 (no vote)
09/03/2000 (no vote)

MS8/RF3 oilseed
rape
04/09/1998 30/06/1999 29/10/1999 (no vote)
09/03/2000 (no vote)

RR fodder beet 04/09/1998 29/10/1999 (no vote)

7.1257 The above table shows that the Commissi on on 4 September 1998 began inter-service
consultations on five different applications. Wh ile in the approval procedures concerning Falcon
oilseed rape, MS8/RF3 oilseed rape and RR fodder beet, these consultations apparently went on for
almost ten months (or more in the case of RR fodd er beet), in the approval procedures concerning
Bt-531 and RR-1445 cotton, the consultations were completed much sooner, in less than three
months. In considering this discrepancy, account s hould be taken of the four votes which took place
in the Regulatory Committee after 4 September 1998. As is clear from the table, the application
concerning MON809 maize was voted on in October 1998, the application concerning the Transgenic
tomato in December 1998, and the applications concerning Bt-531 cotton and RR-1445 cotton in
February 1999. In each case, the Commission's dr aft measure approving the relevant application
failed to obtain the necessary qualified majority. It may well be that in view of these four successive
"defeats" in the Regulatory Committee, the Commission did not find it opportune quickly to launch

1151 Exhibits EC-83/At. 54; EC-84/At. 42; EC-65/At. 47; EC-66/At. 43.
1152 Exhibits EC-83/At. 55; EC-84/At. 43; EC-65/At. 48; EC-66/At. 44.

further votes on other applications submitted under Directive 90/220. Th e timing of the launch of the
next votes – 29 June 1999 for Falcon oilseed rape and 30 June 1999 for MS8/RF3 oilseed rape – tends
to suggest that the Commission preferred to wait until after the Environment Council meeting of
24/25 June 1999 at which a Common Position was adopted on the proposal to amend
Directive 90/220.
1153
7.1258 The Panel is not convinced that the Commissi on's conduct in respect of the applications
concerning Falcon oilseed rape, MS8/RF3 oilseed ra pe and RR fodder beet supports Argentina's and
the other Complaining Parties' assertion that a gene ral moratorium on approvals was in effect already
as from October 1998. It was not until June 1999 th at the Group of Five countries announced that
they would take steps to suspend new approvals. Moreover, the record of the above-mentioned four
votes shows that only some of the five member States which later issued the June 1999 joint
declaration voted against the Commission's draft measures. 1154 In the absence of evidence of
systematic member State opposition to final ap provals, comparable to the kind of opposition
announced in June 1999 by the Group of Five countries, there is no apparent reason to believe that the
Commission's conduct reflects a decision to prevent the final approval of applications.
7.1259 It might be argued that the Commission's four successive "defeats" in the Regulatory
Committee could be evidence of reluctance on the part of certain member States to approve
applications under Directive 90/220 which was cons idered to require amendment. Even accepting
this argument, the circumstance that the Commissi on could have found it increasingly difficult to get
member States to vote in favour of applications submitted under Directive 90/220 might provide a
rationale for not precipitating further votes. But it does not provide a plausible rationale for the
Commission deciding not to make full use of its powers under Directive 90/220 and not to complete
approval procedures on its own, if necessary. It is noteworthy in this respect that the Commission
eventually did call votes on the applications con cerning Falcon oilseed rape, MS8/RF3 oilseed rape
and RR fodder beet. The Commission did not do so in the case of applications which had obtained
favourable opinions from EC scientific committees after the June 1999 declaration by the Group of
Five countries. The view that a moratorium on a pprovals was not already in effect as from October
1998 draws further support from the explanation offered by Greece for abstaining from voting on the
Transgenic tomato in December 1998. Greece stated that "we support the idea of a 'moratorium' for
G.M.O., as presented by some Member-States".
1155 This statement suggests that a moratorium was an
idea entertained by some member States at the time, but not that it was a reality.
7.1260 The Panel does not agree with Argentina that the very fact that th e Commission launched
inter-service consultations is evidence of a de facto moratorium on approvals. 1156 I t i s c o r r e c t t h a t
Commission inter-service consultations were not pr ovided for in Directive 90/220 as a distinct stage
in the approval process. 1157 However, as the European Comm unities explained in response to a
question from the Panel, inter-service consultation is a process internal to the Commission, designed

1153 Particularly in relation to MS8/RF3 oilseed rape and RR fodder beet, some of the delay may also be
attributable to additional information supplied by the applicant.
1154 Regarding MON809 maize, only Greece voted agai nst, with Denmark, France and Luxembourg
abstaining. Exhibit EC-83/At. 65. Regarding the Transgenic tomato, no Group of Five country voted against.
Greece and Luxembourg abstained. Exhibit EC-84/At. 45. Regarding Bt-531 cotton, Denmark, France and
Greece voted against, with Luxem bourg abstaining. Exhibit EC-65/At . 59. Regarding RR-1445 cotton,
Denmark, France and Greece voted against, with Luxembourg abstaining. Exhibit EC-66/At. 57.
1155 Exhibit EC-84/At. 45 (emphasis added).
1156 The United States makes a similar argument about the inter-service consultations launched in May
1999 on the applications concerning Bt-531 cotton and RR-1445 cotton. US second written submission,
paras. 56-57; US first oral statement, para. 30.
1157 En passant, the Panel notes that the same is true for Directive 2001/18 and Regulation 258/97.

to ensure that the Commission services with a legitimate interest in the matter on which a
Commission decision is being prepared, work in close co-operation and in co-ordinated fashion.
1158
As the European Communities also pointed out, inter-service consultation is mandated by the
Commission's rules of procedure for the preparation and implementation of each Commission
decision.1159 It is clear to the Panel, therefore, that the inter-service consultations of September 1998
were not an additional procedural stage devised by the Commission to prevent the approval of biotech
products.
7.1261 In the light of the above considerations, the Panel concludes that the time taken by the
Commission to submit to the Regulatory Committee draft measures on the applications concerning
Falcon oilseed rape, MS8/RF3 oilseed rape and RR fodder beet does not support Argentina's and the
other Complaining Parties' assertion that the European Communities applied a general moratorium on
final approvals already as from October 1998.
(v) Concluding observations
7.1262 The Panel notes that the Complaining Parties did not present detailed arguments in respect of
each of the individual approval procedures discussed above. In fact, Canada and Argentina did not
present any arguments in respect of some of th ese approval procedures. The European Communities
argues in this regard that addressing only a limited selection of individual approval procedures is not
sufficient to prove the existence of an across-the-board moratorium, i.e., of a moratorium which
applies to any and all applications which were pending during the relevant time period.
1160 In other
words, according to the European Communities, the Complaining Parties cannot sustain their burden
of establishing a prima facie case of the existence of a general moratorium on approvals unless they
provide detailed evidence and arguments in resp ect of each and every of the above-mentioned
individual approval procedures. In response to a question from the Panel, the Complaining Parties
dispute this EC argument.1161
7.1263 The Panel agrees with the European Communiti es that the Complaining Parties could have
sought to establish a prima facie case of the existence of a general, or across-the-board, moratorium
by offering evidence and argumentation in respect of each and every of the individual approval
procedures which were pending between October 1998 and August 2003. But the Panel cannot accept
the European Communities' suggestion that this w as the only way in which the Complaining Parties
could discharge their burden of demonstrating prima facie that the alleged moratorium applied to all
pending applications.
7.1264 As is clear from the Panel's preceding analys is, the Complaining Parties have provided other
relevant evidence and argumentation to demonstrate the generality of the alleged moratorium. First
and foremost, the Complaining Parties demonstrat ed that not a single biotech application under
consideration between October 1998 and August 2003 was approved on or before the date of
establishment of this Panel. Moreover, the Comp laining Parties relied on the June 1999 declaration
by the Group of Five countries, which states that the Group of Five countries "will take steps to have
any new authorizations for growing and placing on the market suspended" (emphasis added). Finally,
the Complaining Parties submitted numerous EC doc uments and statements by EC or member State

1158 EC reply to Panel question No. 94. In response to a question from Argentina, the European
Communities defined "inter-service consultation" as the process by which the lead service(s) consults with other
interested services. EC reply to Argentina's question Nos. 9 and 10.
1159 Ibid.
1160 EC second written submission, footnote 212.
1161 Complaining Parties' replies to Panel question No. 179.

officials. The Panel found that these documents and statements support the Complaining Parties'
assertion that the European Communities applied a general moratorium during the relevant time
period. In the specific circumstances of this case, these elements of proof taken together are
sufficient, in the Panel's view, to establish a pr ima facie case of the generality of the alleged
moratorium.
7.1265 Having regard to the individual approval pr ocedures which the Complaining Parties did
address, the Panel notes that, according to the Co mplaining Parties, these approval procedures
confirm that certain member States and/or the Commission did cause delays or prevent the final
approval of applications in the manner alleged by the Complaining Parties. The relevant approval
procedures support this contention. To illustrate th is, the Panel recalls below its findings on member
States' and the Commission's ability to delay or prevent the final approval of applications and
indicates whether it has been established that me mber States and/or the Commission actually did
delay or prevent the approval of applications in th is manner. The Panel begins with the relevant
member State actions and/or omissions:
(a) The Panel found that the lead CA could delay the completion and circulation of its
initial assessment. The United States and Canada have established that a Group of
Five country delayed the completion and circulation of its initial assessment, so much
so that the applicant withdrew the application.
1162 The European Communities has
correctly pointed out, however, that the same Group of Five country in another
approval procedure 1163 in April 1999 transmitted to the Commission a favourable
initial assessment and that it confirmed that assessment in June 2003, after the
application had been updated in acco rdance with the requirements of
Directive 2001/18.
1164 To the extent this is viewed as inconsistent behaviour 1165, it
suggests that in situations where the releva nt Group of Five country acted as the lead
CA, it was not in all cases prepared to assume the possible consequences of delaying
or blocking action1166.

1162 The approval procedure in question is that concerning RR oilseed rape (EC-79).
1163 The approval procedure in question is that concerning Bt-11 maize (EC-69).
1164 EC reply to Panel question No. 87.
1165 A special circumstance which should be pointed out is the previously mentioned fact that the
biotech product at issue – Bt-11 maize – had already been approved for marketing in the European Communities
in April 1998, although not for cultivation (Bt-11 maize (EC-163)), which was the use at issue in the approval
procedure concerning Bt-11 maize (EC-69).
1166 By failing to complete its initial assessment, a lead CA exposes itself to the risk of legal action
being instituted against it under its own domestic law. EC first written submission, para. 186. There is no such
risk, or less of a risk, where a Group of Five country avails itself of its right to object to an initial assessment
prepared by a lead CA, or exercises its right to vot e against a draft measure submitted by the Commission to the
Regulatory Committee or to the Council. For this reason, the Panel does not consider that the fact that France in
April 1999 and June 2003 transmitted a favourable initial assessment of Bt-11 maize (EC-69) to the
Commission is necessarily inconsistent with the June 1999 declaration by the Group of Five countries. France
may have considered that other Group of Five countries, and even the Commission, would take the necessary
steps to delay or prevent Bt-11 maize (EC-69) from being approved at member State level or at Community
level.
With reference to DS291, the Panel notes that the United States submitted a July 1999 news report
which is consistent with the view that Group of Five countries which acted as lead CAs might not always have
been willing to face the possible legal c onsequences of delaying or blocking action. The news report states that
"the Commission pointed out on 15 July 1999 that France and Denmark have GMO applications pending, even
though they were the leading proponents of GMO moratorium in June". The news report then reports the
spokesman for then-Environment Commissioner Ritt Bjerregard to have said that "[w]e cannot understand why

(b) The Panel found that member States other than the lead CA could object to the
placing on the market of a biotech product following a favourable assessment by the
lead CA. The record establishes that one or more Group of Five countries raised and
maintained an objection in each of the a pproval procedures in which the deadline for
raising objections expired in the period be tween June 1999, when the Group of Five
countries made their joint declaration, and August 2003.
(c) The Panel found that a group of member St ates that constituted a blocking minority
could prevent the appropriate Regulatory Committee or the Council from reaching the
qualified majority necessary to adopt a draft measure proposing approval of an
application. The Panel also found that the Group of Five countries constitute such a
group of member States and that the formation of that group was announced in June
1999 in a joint declaration. In this respect , the record makes clear that there was no
vote on any application in the Regulator y Committee or the Council between June
1999 and August 2003. It is therefore not po ssible to establish that consistent with
their June 1999 joint declaration, the Group of Five countries cast their votes in the
Regulatory Committee or the Council in such a way as to prevent the necessary
qualified majority from being reached.
(d) The Panel found that the lead CA could refuse to give its consent to the placement on
the market of a biotech product after the Commission has approved an application.
The United States and Canada have establis hed that one Group of Five country
refused to give its consent to the placement of a biotech product after the Commission
had approved the application.
1167
7.1266 The Panel now turns to relevant Commission actions and/or omissions:
(a) The Panel found that the Commission could delay the submission of a draft measure
to the appropriate Regulatory Committee, or it could fail to convene the Regulatory
Committee for a vote on a draft measure which has been submitted. The United
States, Canada and Argentina have establis hed that the Commission failed to submit
draft measures to the appropriate Regulatory Committee.
1168 The United States and
Canada have further established that the Commission failed to re-convene the
Regulatory Committee for a vote on a draft measure which had been previously
submitted, but on which no vote was held.1169
(b) The Panel found that the Commission could delay the submission of a draft measure
to the Council where the Regulatory Co mmittee was unable to reach the qualified

these countries do not withdraw their applications after all the statements they made at the Council of Ministers.
[...] It is one thing to make all th ese grand declarations and go before the press and assert their desire for a
moratorium. But it seems to be another to take the step of withdrawing their applications. Until these
applications are withdrawn, the Commission has a clear lega l obligation to pursue the procedures set out in the
EEC/90/220 directive". The news report also quotes the spokesman as saying that "[w]e are basically asking the
member states to put their money where their mout h is". "EU Official Calls on Members to Pull GMO
Applications in Light of 'Moratorium'", International Trade Reporter, 21 July 1999, p. 1214 (Exhibit US-96).
1167 See the Panel's earlier analysis of the approval procedures concerning MS1/RF1 oilseed rape
(EC-89) and MS1/RF2 oilseed rape.
1168 See the Panel's earlier analysis of various approval procedures under the sub- headings "Failure by
the Commission to submit a draft measure to the Regulatory Committee".
1169 See the Panel's earlier analysis of various approval procedures under the sub-heading "Failure by
the Commission to re-convene the Regulatory Committee for a vote on a draft".

majority necessary to deliver an opinion. The United States, Canada and Argentina
have established that the Commission failed to submit draft measures to the Council
in a situation where the Regulatory Committee was unable to reach the qualified
majority necessary to deliver an opinion.
1170
7.1267 As a final matter, the Panel recalls the European Communities' assertion that the Complaining
Parties' claims in respect of the general moratori um would collapse when the facts and history of each
approval procedure are considered. The European Communities contended that an analysis of the
relevant facts would show that during the releva nt time period there were no acts and/or omissions
which stalled applications at key decision-making st ages in the approval process. In the alternative,
the European Communities argued that even if the delays that occu rred could be viewed as the result
of a moratorium, that moratorium ended w ith the entry into force in January 2003 of
Directive 2001/18.
7.1268 The Panel has undertaken an extensive analys is of each individual application discussed by
the European Communities as well as of those app lications which were withdrawn during the time
period in question. As is clear from the above analysis, the facts and histories of the relevant approval
procedures do not demonstrate that there were no act s and/or omissions which stalled applications at
key decision-making stages in the approval process. To the contrary, for the time period from June
1999 to August 2003, the facts and histories of all approval procedures which have been examined are
consistent with the Complaining Parties' assertion that during that time period Group of Five countries
and/or the Commission were delaying or preventing the final approval of applications.
7.1269 Moreover, the Panel's analysis does not bear out the European Co mmunities' alternative
contention that any acts and/or omissions which mi ght have served to prevent the final approval of
applications prior to the entry into force of Dire ctive 2001/18 ended when that Directive entered into
force in January 2003. The Panel found in this rega rd (i) that at the member State level there were
delays in the processing of applications under Directive 2001/18 which are consistent with the
existence of a moratorium on final approvals, (ii) that Group of Five countries continued to oppose the
approval of applications even though they had b een updated in accordance wi th the requirements of
Directive 2001/18; and (iii) that, as of August 2003, no procedure had reached the stage where the
Commission could have taken action to delay or prevent the final approval of an application.1171
7.1270 It follows from the foregoing that the Panel's analysis of individual approval procedures does
not lead to the "collapse" of the Complaining Par ties' claim that the European Communities applied a
general de facto moratorium on approvals. Nevertheless, wh ile the Panel considers that the facts and
histories of individual approval procedures are cons istent with the Complaining Parties' contention
that a general moratorium was in effect in August 2003, the Panel was not persuaded that the facts and
histories of these procedures support the Complaining Pa rties' claim that a general moratorium was in
effect already before June 1999, and, more specifically, as from October 1998.
(f) Overall conclusions
7.1271 The Panel has now completed its considerati on of the various elements it said it would
address. To determine to what conclusion these elemen ts lead, it is useful to recall the Panel's main
findings:

1170 See the Panel's earlier analysis of various approval procedures under the sub-heading "Failure by
the Commission to submit a draft measure to the Council".
1171 See supra, paras. 7.1032-7.1034.

(a) The Panel found that during the relevant time period (October 1998 to August 2003)
member States and the Commission had the ability and opportunity to prevent or
delay the approval of applications in the manner identified by the Complaining
Parties.
(b) The Panel found that the June 1999 joint decl aration by the Group of Five countries
constitutes direct evidence of an intention on the part of the relevant five member
States (Denmark, Italy, France, Greece and Luxembourg) to do what was within their
power to prevent the approval of further applications, pending the adoption of EC
rules concerning labelling and traceability of biotech products. The Panel also found
that because of the June 1999 declaration by the Group of Five countries, the
Commission had reason to believe that it c ould no longer approve applications with
the (qualified majority) support of the member States. The Panel found it plausible
that the systematic opposition by the Group of Five countries was an issue for the
Commission, and that this situation, while it continued, could have affected the
Commission's readiness to make full use of the relevant procedures to complete the
approval process.
(c) The Panel found that no applications were approved between October 1998 and
August 2003. This is despite the fact th at a large number of applications were
pending and that many of these had received one or more favourable scientific
assessments. The Panel also noted that before October 1998 ten agricultural biotech
products had been approved and that af ter August 2003 three applications were
approved. The Panel highlighted the fact that the post-August 2003 approvals were
granted when the present panel proceedings were already under way.
(d) The Panel found that each of the Comp laining Parties had submitted numerous
official and internal EC documents and statements by high-ranking officials which
explicitly state that the reason for the absence of approvals was a general de facto
moratorium on approvals. The Panel also found that the documents and statements
submitted by each Complaining Party permit th e inference that a general moratorium
was in effect between June 1999 and August 2003. The Panel was not convinced that
they warrant the inference that a general moratorium was in effect already as from
October 1998, or that it ended in January 2003, when Directive 2001/18 entered into
force.
(e) The Panel found that the facts and histories of individual approval procedures
confirm that Group of Five countries and/or the Commission did cause delays or
prevent final approvals in the manner alleged by the Complaining Parties.
(f) The Panel found that for the time period from June 1999 to August 2003 the facts and
histories of all approval procedures examin ed by the Panel are consistent with the
Complaining Parties' assertion that th e final approval of applications was
intentionally being prevented by Group of Five countries and/or the Commission.
The Panel was not persuaded that it can be in ferred from the facts and histories of the
relevant approval procedures that a general de facto moratorium was in effect already
as from October 1998, or that it ended in January 2003, when Directive 2001/18
entered into force.
7.1272 The Panel considers that all of these findings ta ken together lead logically to the following
conclusion:

(i) that a moratorium on approvals was in effect in the European Communities
between June 1999 and August 2003, when this Panel was established;
(ii) that this moratorium was generally applicable, i.e., to all applications for
approval which were pending betw een June 1999 and August 2003 under
Directives 90/220 and/or 2001/18 or under Regulation 258/97; and
(iii) that this moratorium was applied de facto, i.e., without having been adopted
through a formal EC rule- or decision-making process, and, more
particularly, that the final approval of applications was prevented by the
Group of Five countries
1172 and/or the Commission through their actions
and/or omissions.
7.1273 The Panel also considers that the record s upports the inference that the Group of Five
countries and the Commission prevented the final a pproval of applications pursuant to decisions
which were intended to be generally applicable. In the case of the Group of Five countries, it can be
inferred from their June 1999 joint declaration that they decided to use their powers in the approval
process so as to prevent any and all new applica tions from being approved, until new EC rules on
labelling and traceability were adopted. The actual conduct of these countries in the context of
individual approval procedures is consistent with the existence of such decisions. During the relevant
time period (June 1999 to Augus t 2003), numerous applications received favourable initial
assessments from the lead CA. But in each case, one or more Group of Five countries objected to the
placing on the market of the relevant biotech product, sometimes explicitly invoking the Group of
Five declaration as a reason for their objection. This meant that no application was approved at
member State level. At Community level, the Regulatory Committee or the Council did not proceed
to a vote on any application between June 1999 an d August 2003. There thus exists no information
about the voting behaviour of the Group of Five countries during that time period.
7.1274 Regarding the Commission, the Panel made th e point that the Commission was faced with
highly exceptional circumstances when in June 1999 the Group of Five countries formally signalled
its systematic opposition to final approvals. In the Panel's view, it is plausible that the Commission in
those circumstances effectively decided not to make full use of the relevant procedures to complete
the approval process. In fact, during the relevant time period there was no case where the
Commission completed the approval process. Moreover, the Panel's analysis of the facts and histories
of individual approval procedures reveals a clear and repeated pattern of inaction, or delayed action,
by the Commission at certain stages of the EC a pproval processes. It shows that the Commission
repeatedly failed to forward draft measures to the Council in situations where the Regulatory
Committee did not reach the required qualified majo rity. It also shows that the Commission
repeatedly failed to submit a draft measure to the Regulatory Committee, or failed to call a vote in the
Regulatory Committee. In the Panel's assessment , the aforementioned elements – the exceptional
circumstances presented by the formation of the Group of Five, the fact that the Commission did not
approve a single application during the relevant ti me period, and the fact that during the same time
period there was an observable pattern of inaction by the Commission – warrant the inference that the

1172 The Panel's reference to the Group of Five countr ies is not intended to suggest that there were no
member States other than the Group of Five countries which took steps, during part of the relevant time period
(June 1999 to August 2003), with a view to delaying or preventing the final approval of any and all applications.
It should be recalled in this respect that Canada submitted evidence which shows that in February 2001 Austria
formally expressed its support for the June 1999 declaration by the Group of Five countries, and that the United
States submitted a document which suggests that Belg ium as of December 2001 al so supported the June 1999
declaration by the Group of Five countries.

Commission's conduct was the result of an effective decision not to ma ke full use of the relevant
procedures to complete the approval process.
1173
7.1275 The European Communities appear s to argue that the described pattern of inaction by the
Commission should rather be considered as a practice in the sense of a pattern of similar responses to
a similar set of circumstances. 1174 The European Communities' concept of practice implies that the
Commission was engaged in case-by-case decision-maki ng to formulate and develop policy, and that
the Commission's conduct in specifi c cases was subsequently repeated in similar cases, with the
consequence that this conduct crystallized into a practice.
7.1276 The Panel is not persuaded that the Comm ission's conduct reflects nothing more than a
practice as that term is understood by the European Communities. True enough, a pattern of inaction
could point to the existence of a Commission practi ce. But it may equally be the consequence of a
generally applicable decision by the Commission. Furt hermore, the mere fact that the record contains
no document embodying such a Commission decision does not imply that no such decision existed
and that the described pattern of inaction amounted to a practice. It is important to bear in mind in
this regard that the Commission had to respond to decisions of the Group of Five countries which
were applicable to all pending an d new applications. In these circumstances, the most logical course
of action was for the Commission to define and establish a policy which was likewise applicable to all
pending and new applications. This was not a s ituation where the Commission lacked the necessary
information to make a general decision and where it was therefore advisable to proceed on a case-by-
case basis. The June 1999 declaration by the Group of Five countries provided the Commission with
a clear and predictable scenario of how the Group of Five countries would exercise their powers in the
context of the EC approval process.
7.1277 Without prejudice to the preceding remarks, the Panel would accept that, in one sense, the
Commission's conduct might be considered to reflect a practice. The practice the Panel is referring to
relates to the implementation of the Commission's effective decision not to make full use of the
relevant procedures to complete the approval process. It is reasonable to assume that there was no
predetermined general policy with regard to im plementation, as implementation necessarily had to
take account of attendant circumstances, including , most notably, the stage in the relevant EC
approval procedure to which particular applications had progressed. Indeed, the record shows that the
Commission's conduct varied according to the pro cedural stage reached by a given application. 1175
Another indicator that there was no predetermined general policy with regard to implementation is the
circumstance that at one point the Commission changed its conduct in relation to applications which

1173 For present purposes, it matters little whether the Commission's effective decision was intended to
establish Commission policy for several years or whether the decision was tacitly renewed from time to time.
Regarding the 2004 approvals of Bt-11 maize (food), NK603 maize and NK603 maize (food), it should be noted
that there is no evidence on record which would demonstrate that the Commission decided before 29 August
2003 to complete the approval process in respect of the aforementioned applications. In the case of Bt-11 sweet
maize (food), a draft measure was on the agenda of the relevant Regulatory Committee on 8 November 2003.
The record does not indicate when the Commission forwarded the draft measure. Exhibit EC-92/At. 67. In the
case of NK603 maize, the Commission launched inter-serv ice consultations on a draft measure only on 8
December 2003. Exhibit EC-76/At. 71. Finally, in the case of NK603 maize (food), a draft measure was
presented to the Regulatory Committee on 30 April 2004. Here again, the record does not indicate when the
Commission forwarded the draft measure. Exhibit EC-96/At. 42. In the light of the evidence on record, there is
therefore no reason to doubt that a general de facto moratorium was still in effect on 29 August 2003.
1174 EC first written submission, paras. 566 et seq.; EC second written submission, footnote 213.
1175 For instance, the Commission did not forward draft measures to the Council when the Regulatory
Committee did not reach the required qualified majority. In contrast, the Commission initially did forward draft
measures to the Regulatory Committee for a vote.

had reached a certain procedural stage. Speci fically, the Commission initially forwarded draft
measures to the Regulatory Committee for a vote.
1176 Subsequently, however, the Commission
stopped doing so. 1177 This shift from one pattern of conduc t to another could be interpreted as a
change in implementation practice. Such a cha nge in implementation practice would in no way be
inconsistent with the view that there was an eff ective decision by the Commission not to complete the
approval process with respect to any pending or new application.1178
7.1278 The Panel now turns to address the European Co mmunities' argument that in cases where, as
here, the actions and/or omissions of different entities are alleged to be part of a single measure, it is
necessary to show that these entiti es follow a common plan or course of action. The European
Communities asserts in this respect that the term "m easure" is defined as "a plan or course of action
intended to achieve some object".
7.1279 The Panel considers that by not making full use of its powers to complete the approval
process, the Commission knowingly entered into effective ( de facto) co-operation with the Group of
Five countries. Indeed, in the Panel's view, the absence of final approvals during the relevant time
period is a direct consequence of effective co-ope ration between the Group of Five countries and the
Commission. The Group of Five countries could not have imposed the desired general moratorium on
approvals without the co-operation of the Commission. And it is most unlikely that the Commission
would have been dissuaded from making full use of the approval procedures if it had not been of the
view that the Group of Five countries constituted a credible and stable "blocking minority".
7.1280 It is important to mention that there is nothing in the record to suggest that the Commission
unqualifiedly supported the decision of the Group of Fi ve countries to prevent the final approval of
applications pending the adoption of new EC rul es on labelling and traceability. To the contrary, the
"interim approach" developed by the Commission in July 2000 was intended to allow for the
resumption of approvals.
1179 But the record shows that even after July 2000 the Commission failed to
make full use of the approval procedures. 1180 In other words, the record supports the conclusion that
even after July 2000 there continued to be eff ective co-operation between the Commission and the
Group of Five countries.
7.1281 Based on the foregoing observations, the Pane l considers that between June 1999 and
August 2003 the Group of Five countries and the Commission did follow a common "plan or course
of action".1181 The relevant "plan" consisted in preventi ng the final approval of applications pending
the adoption of new EC rules on labelling and traceab ility. The fact that the Commission might have
disliked the "plan", or sought to change it, is immaterial as long as the Commission did not actually
follow a different "plan". As noted, there is no indication that this was the case.

1176 For instance, in the case of the approval procedure concerning Falcon oilseed rape.
1177 For instance, in the case of the approval procedure concerning Bt-11 maize (EC-69).
1178 There would be no inconsistency even if it were assumed that the Commission initially sought to
test the resolve of the Group of Five countries to abide by their June 1999 declaration, by launching votes in the
Regulatory Committee. There is no indication in th e record that the Commission was the initiator of a
moratorium on approvals. The Commission's willingness to implement its effective decision not to complete the
approval process with respect to any pending or new application may well have been contingent on the Group of
Five countries acting in accordance with their June 1999 declaration.
1179 For an explanation of the "interim approach", see supra, footnote 637.
1180 See, e.g., the approval procedures concerning Bt-531 cotton, RR-1445 cotton , MON809 maize and
the Transgenic tomato.
1181 The Panel is not convinced that the Group of Five countries and the Commission followed a
common "plan" prior to June 1999.

7.1282 The European Communities submits, however, that it is not enough for the Group of Five
countries and the Commission to have followed a co mmon "plan or course of action". According to
the European Communities, the Group of Five count ries and the Commission must also have treated
their plan of preventing the final approval of applications as de facto binding. Otherwise, the
European Communities' argument implies, the applica tion of separate decisions by the Group of Five
countries and the Commission could not be considered to have produced a new and intended measure,
i.e., a general moratorium on approvals.
7.1283 The record does not indicate that either the Group of Five countries or the Commission
followed their common plan of preventing the final approval of applications as de facto binding.
However, there were clear incentiv es for the common plan to be follo wed. As we have said earlier,
the Group of Five countries could not have impos ed the desired general moratorium on approvals
without the co-operation of the Commission. And the Commission had grounds for believing that if it
did not co-operate with the Group of Five countries, it would have to complete on its own all approval
procedures concerning pending applications, due to the "blocking minority" held by the Group of Five
countries.
7.1284 At any rate, the European Communities does not ex plain the basis for its view that the Group
of Five countries and the Commission needed to treat their common plan as de facto binding. We can
see that the question of whether or not the Group of Five countries and the Commission were
following their common plan as binding might possibly have an impact on the stability and "lifespan"
of the general moratorium on approvals. But we do not consider that, in the case before us, the
question of whether the plan at issue was viewed as binding determines whether or not the general
moratorium constitutes a measure. We perceive no meaningful difference between a general
moratorium on approvals that is applied by the relevant EC entities "voluntarily" and one that is
applied pursuant to an enforceable agreement. In neither case, final approvals are granted while the
moratorium is being applied. In view of this e quivalence of effects, we see no force in the argument
that a "binding" moratorium on approvals cons titutes a measure for WTO purposes, but that a
"voluntary" moratorium on approvals does not. Indeed, were we to accept this argument, Members
could evade WTO disciplines governing the application of a moratorium on approvals by applying a
"voluntary" rather than a "binding" moratorium.
7.1285 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having rega rd to the arguments and evidence submitted
by the United States and the European Co mmunities, the Panel concludes that the
European Communities applied a general de facto moratorium on the approval of
biotech products between June 1999 and August 2003.

 (ii) DS292 (Canada)

 With reference to DS292, and having rega rd to the arguments and evidence submitted
by Canada and the European Communities, the Panel concludes that the European
Communities applied a general de facto moratorium on the approval of biotech
products between June 1999 and August 2003.

 (iii) DS293 (Argentina)

 With reference to DS293, and having rega rd to the arguments and evidence submitted
by Argentina and the European Communities, the Panel concludes that the European
Communities applied a general de facto moratorium on the approval of biotech
products between June 1999 and August 2003.

3. Whether the Panel may and should make findings on the WTO-consistency of the
general de facto moratorium on approvals
7.1286 According to the European Communities, even if the Panel finds, as it has, that a general de
facto moratorium on approvals was being applied by the European Communities between June 1999
and August 2003, this would not automatically mean that the Panel may, or should, make findings on
the WTO-consistency of the general moratorium. More particularly, the European Communities
argues that the Panel may only make findings on th e WTO-consistency of the general moratorium if
the moratorium is a challengeable measure under the WTO Agreement. And even if that is the case,
the Panel should not, in the European Communitie s' view, make findings on the WTO-consistency of
the general moratorium if the moratorium ceased to ex ist after the date of establishment of the Panel.
The European Communities considers that in such circumstances the issue of the WTO-consistency of
the general moratorium would be moot and the Panel should refrain from making a ruling on the
moratorium.
7.1287 The Panel considers that the issues raised by th e European Communities are pertinent, and it
will therefore examine below (i) whether the morato rium on approvals is a challengeable measure,
and if so, (ii) whether the Panel should decline to make findings on the WTO-consistency of the
moratorium on approvals if subsequent to the establishment of the Panel the moratorium ceased to
exist.
(a) Whether the moratorium on approvals is a challengeable measure
7.1288 The European Communities has argued that the general de facto moratorium on approvals
cannot be challenged under the WTO Agreement because, in its view, the Complaining Parties are not
challenging a measure, but a practice – a repeated pattern of suspending consideration of individual
applications. The Panel has already dealt w ith this argument, finding that the general d e facto
moratorium was the result, not of a mere practice by the Group of Five countries and the Commission,
but of separate decisions by these same EC entities, which were intended to be generally applicable.
7.1289 Nevertheless, since the issue was put before us by the European Communities, it is still useful
to consider whether the moratorium on approvals , when understood as a measure rather than as a
practice, is a challengeable measure. By "challe ngeable measure" we mean a measure which can be
the subject of WTO dispute settlement proceedings. In US – Carbon Steel
, the Appellate Body had
this to say about the measures which may be challenged before a WTO panel:
"In principle, any act or omission attributable to a WTO Member can be a measure of
that Member for purposes of dispute settlement proceedings. The acts or omissions
that are so attributable are, in the usual case, the acts or omissions of the organs of the
state, including those of the executive branch."
1182

1182 Appellate Body Report, US – Carbon Steel, para. 81 (footnotes omitted).

7.1290 What sets the moratorium on approvals apart from most other measures challenged before
WTO panels are two elements: (i) it is a de facto measure, i.e., a measure which was not adopted
through a formal EC rule- or decision-making process, and (ii) it is the result of the application of
separate decisions by the Group of Five countries and the Commission.
7.1291 We first consider the circumstance that the moratorium is a d e facto measure. We note in this
regard the Appellate B ody's reference to " any act or omission attributable to a WTO Member"
(emphasis added). In our view, the broad phrase "any act or omission" can encompass both de jure
measures and de facto measures. Reinforcing this view is the circumstance that if de facto measures
could not be challenged, Members could circumvent their WTO disciplines. For they could then
achieve through de facto measures what they would not be allowed to achieve through de jure
measures.
7.1292 As noted, the other particularity of the moratorium is the fact that the moratorium is the result
of the application of separate decisions by the Group of Five countries and the Commission. In other
words, the moratorium is a measure which is the result of other measures (decisions) applied
separately by the Group of Five countries and the Commission. The WTO Agreement nowhere says
that a measure which is the result of several separ ate measures is not a challengeable measure.
Moreover, the GATT panel in Japan – Semi-Conductors found that an inconsistency with Article XI:1
of the GATT 1994 could result from a combination of separate measures:
"All these factors led the Panel to conclude that an administrative structure had been
created by the Government of Japan which operated to exert maximum possible
pressure on the private sector to cease exporting at prices below company-specific
costs. This was exercised through such measures as repeated direct requests by MITI,
combined with the statutory requirement for ex porters to submit information on
export prices, the systematic monitoring of company and product-specific costs and
export prices and the institution of the s upply and demand forecasts mechanism and
its utilization in a manner to directly influe nce the behaviour of private companies.
[...] The Panel considered that the complex of measures exhibited the rationale as
well as the essential elements of a formal system of export control. [...] The Panel
concluded that the complex of measures constituted a coherent system restricting the
sale for export of monitored semi-conductors at prices below company-specific costs
to markets other that the United States, inconsistent with Article XI:1."
1183
7.1293 We therefore consider that the mere fact that th e moratorium is the result of the application of
separate decisions by the Group of Five countries and the Commission does not prevent it from being
a challengeable measure.
7.1294 We recall, however, the Appellate Body's statement in US – Carbon Steel that a measure of a
Member can only be challenged if the measure is attr ibutable to that Member. Thus, for the general
de facto moratorium on approvals to qualify as a challengeab le EC measure, it must be attributable to
the European Communities. We note that both th e Commission and the individual member States
which are part of the Group of Five from the perspe ctive of public international law are organs of the
European Communities. Accordingly, there can be no doubt that the general moratorium, which is
the result of the application of separate decisions by these different EC organs, is attributable to the
European Communities.

1183 GATT Panel Report, Japan – Semi-Conductors, para. 117 (emphasis added).

7.1295 In the light of the foregoing consider ations, we conclude that the general de facto moratorium
on approvals constitutes a challengeable EC measure.
(b) Whether the Panel should decline to make findings on the WTO- consistency of the
moratorium on approvals if subsequent to th e establishment of the Panel the moratorium
ceased to exist
7.1296 We now turn to examine the European Communitie s' further argument that even if the Panel
may in principle make findings on the WTO-consis tency of the moratorium on approvals because it is
a challengeable measure, the Panel nevertheless should not do so if subsequent to the establishment of
the Panel the moratorium ceased to exist.
7.1297 Specifically, the European Communities argues that if the Panel were to find that as of
August 2003 the European Communities applied a general de facto moratorium on final approvals, the
Panel would need to go on to determine whether th at measure subsequently ceased to exist. The
European Communities submits that if a measure is no longer in existence, any issues which may
have been raised in relation to that measure are moot and a panel should not rule on that measure.
1184
7.1298 The United States argues that the concept of mootness is not relevant to the claims related to
the general moratorium on approvals. The measure the United States is requesting the Panel to
examine and make findings on is th e general moratorium as it exis ted in August 2003. Any issues
relating to whether or not steps taken by the European Communities after August 2003 have brought
the European Communities into comp liance with its WTO obligations are not before the Panel. In
any event, according to the United States, this is not a case in which the measure at issue has
terminated. The United States does not agree th at two token product appr ovals – the approvals
concerning Bt-11 sweet maize (food) and NK603 maize
1185 – suffice to signal that the European
Communities has begun to process other outstanding a pplications without undue delays. The United
States points out that all other applications caught up in the moratorium remain unapproved. The
United States submits that biotech product approvals remain a controversial political issue in the
European Communities, and the recent expansi on of the European Communities from 15 to 25
member States has not simplified the situation. In addition, a number of member States believe that
yet additional legislation must be adopted before the granting of new biotech product approvals. And
the European Communities has yet to approve a single biotech product for planting in the European
Communities. Accordingly, the possibility is substantial that the European Communities – once freed
from the pressure of this WTO proceeding – would ha lt all further approvals. In the view of the
United States, it is thus of great import that the Panel issue a finding that the politically-based
moratorium is not consistent with WTO rules.
7.1299 Like the United States, Canada argues that the question of mootness is not relevant to the
claims related to the moratorium, as the morato rium has not ceased to exist. Despite recent
Commission Decisions authorizing the placing on th e market of two produc ts, Bt-11 sweet maize
(food) and NK603 maize, the evidence suggests that th e approval of biotech products continues to be
delayed and thwarted by the European Communities.
1186 In relation to the two products that have
been authorized, the Commission h as been forced to adopt decisions authorizing these products after

1184 The European Communities has also argued that the concept of mootness is not relevant to the
claims relating to the general moratorium. However, the European Communities said so under the hypothesis
that the Panel finds that a general moratorium never existed.
1185 We recall that the Commission in 2004 approved the application concerning NK603 maize under
Directive 2001/18 and the application concerning NK603 maize (food) under Regulation 258/97.
1186 Canada's third written submission, para. 196.

failures by both the Regulatory Committee and the C ouncil to take decisions. Canada submits that as
long as approvals are invariably granted only af ter products have gone through every conceivable
procedural hoop, the moratorium must be considered to remain in effect. In any event, the continued
intransigence on the part of member States, co upled with the complicated political and legal
relationship between the member States and the Commi ssion, reflect a very real possibility that, even
if it could be said that the moratorium has been lif ted, the moratorium could be reinstituted in the
future.
7.1300 Argentina argues that the approval of Bt-11 sweet maize (food) did not imply the end of the
de facto general moratorium on approvals. Argentina notes that there are in any event no assurances
that the moratorium has ended. Argentina points out in this regard that the approval of Bt-11 sweet
maize (food) may have occurred solely because of the establishment of this Panel.
7.1301 The Panel notes that the question it is mandated to answer is whether on the date of its
establishment, that is to say, on 29 August 2003, the European Communities applied a general
de facto moratorium on approvals. We have answered th is question in the affirmative. The European
Communities argues, however, that we should not review the WTO-consistency of that measure on
the grounds that the measure has since ceased to exist.
7.1302 At the outset, we examine whether the record of th is case indicates that the issue raised by the
European Communities – whethe r the measure at issue, i.e., the general de facto moratorium on
approvals, ceased to exist after 29 August 2003 – is not merely hypothetical. If the case record
indicates that this issue is not merely hypothetical, we think further examination of the EC argument
would be warranted.
7.1303 The record shows that the applications c oncerning Bt-11 sweet maize (food) and NK603
maize (food) were definitively approved by the Commission under Regulation 258/97. Thus, it is not
in doubt that after the Panel had been established at least two biotech products – Bt-11 sweet maize
(food) and NK603 maize (food) – were definitively approved and hence could be placed on the EC
market for specified uses.
7.1304 We note that the moratorium on approvals as alleged by the Complaining Parties was one
under which applications were not allowed to move to a positive final approval decision. The
Complaining Parties have also alleged that the moratorium applied across-the-board, i.e., that it was
applicable to any and all applications pending between Octobe r 1998 and August 2003. We further
note that the Complaining Parties referred to the absence of a single approval between October 1998
and December 2003 as critical evidentiary support fo r their claim that the European Communities
applied a general moratorium on a pprovals. In our earlier findings, we determined that the record
supported these assertions by the Complaining Parties.
1187
7.1305 In view of the foregoing, we consider that there is indeed an issue whether the general
de facto moratorium on approvals which we found to have existed in August 2003 ceased to exist as a
measure generally applicable to all biotech products with pending applications when the definitive
approvals for Bt-11 sweet maize (food) and NK603 ma ize (food) were granted in 2004. Indeed, the
applications concerning Bt-11 sweet maize (food) and NK603 maize (food) were applications which
were allowed to move to a positive final approval deci sion. Therefore, a more detailed examination
of the EC argument is, in our view, warranted.

1187 See supra, para. 7.1285.

7.1306 We begin our examination by noting the following statement by the panel in India – Autos:
"A WTO Panel is generally competent to consider measures in existence at the time
of its establishment. This power is not necessarily adversely affected simply because
a measure under review may have been subsequently remove d or rendered less
effective."
1188
7.1307 A similar statement was made by a previous panel in Indonesia – Autos:
"[I]n previous GATT/WTO cases, where a measure included in the terms of reference
was otherwise terminated or amended after the commencement of the panel
proceedings, panels have nevertheless made findings in respect of such a
measure."1189
7.1308 It follows from these statements that in principl e we have the authority to make findings on a
measure within our terms of reference even if that measure subsequently ceased to exist. We note that
the European Communities does not appear to contest this.1190
7.1309 The question which remains to be examined, ther efore, is whether we should make use of our
authority to review the WTO-consistency of the general moratorium on a pprovals as it existed in
August 2003, if the general moratorium later ceased to exist. We consider that in determining
whether to make findings on a measure no longer in ex istence on the date of establishment of a panel,
panels should notably take account of the object and purpose of the dispute settlement system. 1191
Pursuant to Article 3.7 of the DSU, "[t]he aim of the dispute settlement mechanism is to secure a
positive solution to a dispute".
7.1310 The Complaining Parties attach considerable importance to our offering findings on the
moratorium as it existed in August 2003, even if it late r ceased to exist. They note that most of the
applications pending as of August 2003 are still awaiting final approval decisions. The United States
and Canada also contend that there is a very real possibility that a general moratorium could
subsequently be reintroduced. We consider these to be valid arguments. As numerous applications
which were pending in August 200 3 have not yet reached the stage of final decision-making, the
approvals which were granted in 2004 do not fu lly address the concerns of the Complaining
Parties.1192 Moreover, the three approvals which were granted in 2004 were possible only because the
Commission decided to make full use of the rele vant EC approval procedures to complete the

1190 The European Communities states that the Panel "should" not rule on such a measure, not that it
does not have the authority, in principle, to rule on such a measure. EC second written submission, para. 151;
EC reply to Panel question No. 7, paras. 26, 28 and 29.
1191 This approach is consistent with that of the panel in Chile – Price Band System. The panel in that
case stated that "[a]lthough we do not consider that the termination of a measure before the commencement of
panel proceedings deprives a panel of th e authority to make findings in respect of that measure, we would only
make findings regarding the provisional safeguard measures in this case if we were to consider this necessary in
order to 'secure a positive solution' to the dispute." Panel Report, Chile – Price Band System, para. 7.115.
1192 We note, as an additional matter, that the European Communities does not argue that the relevant
applications were approved in 2004 in order to address the concerns expressed by the Complaining Parties and,
hence, to resolve the dispute in relation to the treatment of the relevant applications. The European
Communities argues that the approvals which were gran ted in 2004 are simply the consequence of these
applications having reached the final decision-maki ng stage after being assessed at member State and
Community level.

approval process. In all three cases, the releva nt Regulatory Committee and the Council failed to
achieve the required qualified majority. Also, the votes in all three cases were held after the European
Communities adopted new EC rules on labelling and traceability, and in some c ases even after these
rules had entered into force. Notwithstanding th is, some Group of Five countries continued to vote
against approvals or abstained. Moreover, the Comp laining Parties submit that certain member States
stated that there needed to be new rules concerning coexistence a nd environmental liability before
they could approve new applications.
1193
7.1311 In addition to noting the continuing existe nce of opposition to appr ovals amongst member
States, we also recall the informal, de facto nature of the general moratorium on approvals, which
means that it can be re-imposed just as soon as it can be ended. In these circumstances, we agree that
that even if the general moratorium ceased to ex ist after August 2003, if we were to find that the
European Communities acted inconsistently with its WTO obligations by applying a general
moratorium in August 2003, this could help prev ent a WTO-inconsistent general moratorium from
being reintroduced and, in this way, secure a positive solution to this dispute.1194
7.1312 In the light of the above, we do not agree w ith the European Communities that we should
refrain from making findings on the general de facto moratorium on approvals as it existed in August
2003 in the event that it later ceased to exist. For the reasons mentioned, we find it appropriate to
offer findings on the WTO-consistency of the ge neral moratorium in effect in August 2003
irrespective of whether that measure subsequently ceased to exist.
7.1313 We now turn to consider the issue raised by the European Communiti es from the perspective
of Article 19.1 of the DSU which states that "w here a panel [...] concludes that a measure is
inconsistent with a covered agreement, it sha ll recommend that the Member concerned bring the
measure into conformity with that agreement". Th e United States argues that when a panel finds that
a measure is WTO-inconsistent, it must recommend pursuant to Article 19.1 that the responding party
bring that measure into conformity with its WTO obligations, regardless of whether the measure has
ceased to exist after the panel wa s established. It should be not ed in this connection that in US –
Certain EC Products , the Appellate Body has stated that "the Panel erred in recommending that the
DSB request the United States to bring into conformity a measure which the Panel has found no
longer exists".1195 The United States emphasises that the me asure in that case had been terminated
shortly before the panel was established. This is correct. But the Appellate Body nowhere suggested
that the situation could be different in a case wher e a measure ceased to exist in the course of panel
proceedings.1196
7.1314 We further note the panel report on Canada – Wheat Exports and Grain Imports wherein the
panel refrained from making a recommendation in re lation to a WTO-inconsistent measure which had

1193 See supra, para. 7.530. See also, Exhibit EC-69/At. 125.
1194 We note that if we were not to make findings on the general moratorium, there would effectively be
a possibility of shielding it from scrutiny by a panel because this type of de facto measure could be ended
shortly before or during panel proceedings and promptly re-imposed thereafter.
1195 Appellate Body Report, US – Certain EC Products, para. 81. The Appellate Body in US – Upland
Cotton, referring to its report on US – Certain EC Products, stated that "the fact that a measure has expired may
affect what recommendation a panel may make". Appellate Body Report, US – Upland Cotton, para. 272.
1196 The Appellate Body stated that "[a]s we have uph eld the Panel's finding that [...] the measure at
issue in this dispute [...] is no longer in existence, we do not make any recommendation to the DSB pursuant to
Article 19.1 of the DSU. Appellate Body Report, US – Certain EC Products, para. 129 (emphasis added). In our
view, if the Appellate Body had intend ed to distinguish between measures which ceased to exist before a panel
was established and measures which ceased to exist in the course of panel proceedings, it would have used a
phrase like "the measure at issue in this dispute was no longer in existence when the panel was established".

been amended in the course of the panel proceedings.
1197 Similarly, in Dominican Republic – Import
and Sale of Cigarettes, the panel did not find it "appropriate" to make a recommendation in relation to
a WTO-inconsistent measure concerning the determina tion of the tax base for cigarettes because that
measure was "no longer in force" as a result of amendments which were made after the panel was
established.1198 While these cases concerned amendments, we think the same approach is logically
applicable in a situation where a measure ceased to exist in the course of panel proceedings. 1199
Indeed, the panel in EC – Commercial Vessels stated that its recommendation to the European
Communities that it bring the relevant measures into conformity with its obligations under the DSU
did not apply to certain EC member State aid sch emes which had expired soon after the panel had
been established. However, the panel's recomme ndation did cover these expired schemes to the
extent they continued to be operational.1200
7.1315 Finally, we note that the Appellate Body in Dominican Republic – Import and Sale of
Cigarettes found that a tax stamp requirement maintained by the Dominican Republic was WTO-
inconsistent. It also observed that the parties were in agreement that the tax stamp regime as a whole
had been altered by a new decree which came into fo rce after the panel had issued its final report to
the parties. The Appellate Body then went on to recommend that the tax stamp requirement be
brought into conformity with the GATT 1994 "if, and to the extent that, the [...] modifications to the
tax stamp regime have not already done so".
1201
7.1316 The foregoing WTO jurisprudence supports the in ference that panels are to avoid making
recommendations which would apply to measures th at are no longer in existence or have been
amended. Therefore, should we find that the general de facto moratorium on approvals was WTO-
inconsistent as of August 2003, in formulating any recommendations , we would take appropriate
account of the issue raised by the European Commun ities – that the general moratorium which was in
existence in August 2003 might subsequently have ceased to exist.
7.1317 We consider that, in the specific circumstances of this case, we could avoid making
recommendations which would apply to measures that are no longer in existence by qualifying any
recommendations that we would make in relation to th e general moratorium. We recall in this regard
that the Appellate Body in Dominican Republic – Import and Sale of Cigarettes qualified its
recommendation by recommending that the Dominican Republic bring the tax stamp requirement into
conformity with the GATT 1994 "if, and to the extent that, the [...] modifications to the tax stamp
regime have not already done so".
1202 In the present case, if we were to find that the European
Communities breached its WTO obligations by appl ying a general moratorium, we would similarly
recommend that the European Commu nities bring the general moratorium into conformity with the
relevant WTO obligation(s), if, and to the extent that, that measure has not already ceased to exist.1203

1197 Panel Report, Canada – Wheat Exports and Grain Imports, paras. 6.258-6.259, 7.3 and 7.6.
1198 Panel Report, Dominican Republic – Import and Sale of Cigarettes, para. 7.363.
1199 Canada appears to agree with this view. Canada's third written submission, para. 195.
1200 Panel Report, EC – Commercial Vessels, para. 8.4.
1201 Appellate Body Report, Dominican Republic – Import and Sale of Cigarettes, para. 129.
1202 Appellate Body Report, Dominican Republic – Import and Sale of Cigarettes, para. 129. We recall
that the panel in EC – Commercial Vessels also offered a qualified recommendation, stating that its
recommendation that the European Communities bring certain EC member State aid schemes into conformity
with its obligations under the DSU did not apply to aid schemes which had expired after the establishment of the
panel, except to the extent that those expired schemes continued to be operational. Panel Report, EC –
Commercial Vessels, para. 8.4.
1203 We recall that the issue raised by the European Communities is whether the general moratorium
which we found to have existed in August 2003 has sin ce ceased to exist, and not wh ether that measure, if it
were found to be WTO-inconsistent, has already been brought into conformity with the WTO Agreement.

Accordingly, we are of the view that so long as we appropriately qualify our recommendations, there
is no need to decide, in the context of the presen t proceedings, whether the general moratorium which
we found to have existed in August 2003 subsequently ceased to exist.
7.1318 In the light of this, even if we were to ag ree with the European Communities that we may
decide whether the general moratorium which we found to have existed in August 2003 subsequently
ceased to exist, we are not convinced that it woul d be necessary to do so in the context of the present
proceedings. We are also not convinced, in view of the findings and conclusions offered by us, that a
decision on whether the general moratorium ceased to exist would be necessary to enable the DSB to
make sufficiently precise recommendations to the Eur opean Communities. We consider that in the
circumstances of this case a qualified recommendation would safeguard and preserve the rights and
interests of all Parties and hence would be consis tent with the aim of securing a positive solution to
the dispute referred to the Panel.
1204 We also note in this regard th at in the interim review phase of
these proceedings, Canada and Argentina stated th at the Panel should not determine whether the
general moratorium which we found to have existed in August 2003 c ontinued to exist after the date
of establishment of the Panel. The United States c onsiders that the Panel is not charged, in these
proceedings, with determining whether the general moratorium continues to exist.
7.1319 Thus, on the basis of all of the above consider ations, we decline the European Communities'
request to decide, in the context of the presen t proceedings, whether the general moratorium on
approvals which was in effect in August 2003 subsequently ceased to exist. As a result, we undertake
no further examination of this issue.
4. Claims of inconsistency raised by the Complaining Parties
7.1320 The Complaining Parties have each presented a series of claims of inconsistency in relation to
the European Communities' general de facto moratorium on final approvals.
7.1321 The United States claims that the general de facto moratorium on final approvals is
inconsistent with, or has given rise to inconsis tencies with, the following provisions of the
SPS Agreement:1205
(a) Annex C(1)(a) and, consequently, Article 8;
(b) Annex B(1) and, consequently, Article 7;
(c) Annex C(1)(b) and, consequently, Article 8;
(d) Article 5.1 and, consequently, Article 2.2; and
(e) Article 5.5 and, consequently, Article 2.3.
7.1322 Canada claims that the general de facto moratorium on final approva ls is inconsistent with,
or has given rise to inconsistencies with, the following provisions of the SPS Agreement:1206

Furthermore, it is worth clarifying that if there were no issue in this case whether the general moratorium on
approvals applied by the European Communities in August 2003 subsequently ceased to exist, there would, in
our view, be neither a need nor a sufficient justification for a qualified recommendation.
1204 For further relevant considerations, see supra, paras. 6.80 et seq.
1205 The claims are listed in the order in which they were developed in the first written submission of
the United States.

(a) Article 5.1 and, consequently, Article 2.2;
(b) Article 5.6 and, consequently, Article 2.2;
(c) Article 5.5 and, consequently, Article 2.3;
1207
(d) Annex C(1)(a) and, consequently, Article 8; and
(e) Annex B(1) and, consequently, Article 7.
7.1323 Argentina claims the general de facto moratorium on final approval s is inconsistent with, or
has given rise to inconsistencies with, the following provisions of the SPS Agreement:1208
(a) Article 5.1 and, consequently, Article 2.2;
(b) Article 5.5 and, consequently, Article 2.3;
(c) Article 7 and Annex B(1); and
(d) Article 10.1.
7.1324 The European Communities argues that none of the claims presented by the three
Complaining Parties are founded, and that it has not ac ted inconsistently with any of the provisions of
the SPS Agreement which are being invoked by the Complaining Parties.
7.1325 Since it is the European Communities' view that all of the Complaining Parties' claims should
be dismissed in their entirety, it is clear that the Panel needs to assess the merits of those claims. We
will first examine the Complaining Parties' s ubstantive claims under Articles 5 and 2 of the
SPS Agreement, and, if appropriate, will go on to examin e the transparency claim under Annex B of
the SPS Agreement, the procedural claims under Annex C of the SPS Agreement and Argentina's
claim that it was denied special and differential trea tment contrary to the provisions of Article 10 of
the SPS Agreement.
5. Consistency of the general de facto moratorium on approvals with Article 5.1 of the
SPS Agreement
7.1326 All three Complaining Parties claim that by applying a general de facto moratorium on
approvals, the European Communities has acted incons istently with its oblig ations under Article 5.1
of the SPS Agreement.
7.1327 Article 5.1 of the SPS Agreement provides:
"Members shall ensure that their sanitary or phytosanitary measures are based on an
assessment, as appropriate to the circumstances, of the risks to human, animal or
plant life or health, taking into account risk assessment techniques developed by the
relevant international organizations."

1206 The claims are listed in the order in which they were developed in the first written submission of
Canada.
1207 Canada's claim under Article 5.5 is put forth as an alternative to its claim under Article 5.6.
1208 The claims are listed in the order in which they were developed in the first written submission of
Argentina.

7.1328 The Complaining Parties submit that the general moratorium on approvals constitutes a
"sanitary or phytosanitary measure" (hereafter "SPS me asure") because it is applied, in their view, to
protect against certain of the risks identified in Annex A of the SPS Agreement. They further allege
that the European Communities has not put fort h a risk assessment in support of the general
moratorium and that the general moratorium is, th erefore, an SPS measure which is not "based on" a
risk assessment as required under Article 5.1.
7.1329 The European Communities argues that certain provisions of the SPS Agreement relate to
the development of SPS measures while others relate to the application of SPS measures.
1209
According to the European Communities, Article 5.1 contains obligations relating to the development
of SPS measures, not their application. SPS measures as defined in Annex A(1) of the
SPS Agreement presuppose the existence of an act. Th e European Communities submits that the
Complaining Parties' assertions about a moratorium are in reality complaints about delay in the
completion of approval procedure. Delay of this kind cannot constitute an SPS measure within the
meaning of Annex A(1). Delay is a failure to act in a timely manner. A failure to act in a timely
manner can be reviewed under the procedural obligati ons set out in Article 8 and Annex C(1) of the
SPS Agreement as an issue of the application of an SPS measure (in this case, the EC approval
system).1210
7.1330 The European Communities submits that the Complaining Parties describe as an SPS measure
the very same failure to take final decisions wh ich they challenge as the application of an SPS
measure under Article 8 and Annex C(1). Yet as a matte r of logic, it is clear that alleged behaviour
cannot at the same time constitute an SPS measure and the application of another SPS measure. The
European Communities deduces from these considerations that since, in its view, the Complaining
Parties are not complaining about an SPS measure, but its application, and since Article 5.1 does not
contain obligations relating to th e application of an SPS measure, th e alleged general moratorium on
approvals is not subject to Article 5.1.
7.1331 The Panel notes that, by its clear terms, Article 5.1 applies to SPS measures. Accordingly,
for a particular measure to be subject to Artic le 5.1 it must be an SPS measure. The European
Communities contests that the general moratorium on approvals constitutes an SPS measure within
the meaning of Article 5.1. It is therefore necessary to examine this issue in detail.
(a) "Sanitary or phytosanitary measure"
7.1332 Article 1 of the SPS Agreement states that for the purposes of the SPS Agreement, "the
definitions provided in Annex A shall apply". Annex A(1) of the SPS Agreement contains a definition
of the term "sanitary or phytosanitary measure". The definition provided reads as follows:
Sanitary or phytosanitary measure - Any measure applied:
(a) to protect animal or plant life or h ealth within the territory of the Member
from risks arising from the entry, establishm ent or spread of pests, diseases, disease-
carrying organisms or disease-causing organisms;

1209 The European Communities bases th is view on Article 1.1 of the SPS Agreement, the second
sentence of which provides that SPS measures "shall be developed and applied in accordance with the
provisions of this Agreement" (emphasis added).
1210 For the text of Article 8 and Annex C(1), see infra, sections VII.C.11 and VII.C.12.

(b) to protect human or animal life or he alth within the territory of the Member
from risks arising from additives, contaminants, toxins or disease-causing organisms
in foods, beverages or feedstuffs;
(c) to protect human life or health within the territory of the Member from risks
arising from diseases carried by animals, plants or products thereof, or from the entry,
establishment or spread of pests; or
(d) to prevent or limit other damage within the territory of the Member from the
entry, establishment or spread of pests.
Sanitary or phytosanitary measures include all relevant laws, decrees, regulations,
requirements and procedures including, inter alia, end product criteria; processes and
production methods; testing, inspection, certification and approval procedures;
quarantine treatments including relevant requirements associated with the transport of
animals or plants, or with the materials necessary for their survival during transport;
provisions on relevant statistical methods , sampling procedures and methods of risk
assessment; and packaging and labelling requirements directly related to food safety."
7.1333 It is clear from the above definition that all me asures are not SPS measures. In other words,
not every measure that qualifi es as a measure with in the meaning of the DSU constitutes, ipso facto,
an SPS measure.
7.1334 Whether a particular DSU measure constitutes, at the same time, an SPS measure is to be
determined, according to the above definition, by re ference to such criteria as the objective of the
measure, its form and its nature. Regarding the objective of SPS measures, subparagraphs (a) through
(d) indicate that SPS measures must "be applied" to protect against certain enumerated risks.
Regarding the form of SPS measu res, the second paragraph of the definition provides that SPS
measures include "all relevant laws, decrees [and] re gulations". This enumeration suggests that the
SPS Agreement does not prescribe a particular legal form and that SPS measures may in principle take
many different legal forms. Finally, in relation to the nature of SPS measures, the second paragraph
stipulates that SPS measures include "requirements and procedures". The second paragraph then goes
on to mention, by way of example, a number of relevant substantive requi rements (prescribed end
product criteria, prescribed quarantine treatments, cer tain packaging and labelling requirements, etc.)
and procedures (testing procedures, inspection procedures, certification procedures, approval
procedures, etc.). We note that the term "require ments" is broad in scope. For instance, both an
authorization to market a particular product and a ban on the marketing of a particular product may be
considered "requirements", in that one is effec tively a requirement to permit the marketing of a
product and the other a requirement to ban the marketing of a product.
7.1335 Still in relation to the reference in the second paragraph of Annex A(1) to "requirements and
procedures", we note that no reference is made to the "application" of "requirements and
procedures".
1211 This omission suggests that whereas requirements and procedures as such may
constitute SPS measures, the application of such re quirements and procedures would not, itself, meet
the definition of an SPS measure. The provisions of the SPS Agreement support the view that the
omission of a reference to "application" is deliber ate, for there are several provisions which establish

1211 We agree with the European Communities that Article 1.1 of the SPS Agreement, which states that
SPS measures shall be "developed and applied" in accordance with th e provisions of the SPS Agreement,
confirms that the distinction between SPS measures as such and the applica tion of SPS measures is a relevant
one for the purposes of the SPS Agreement.

obligations specifically with regard to the "applica tion" of SPS measures. For instance, Article 2.3,
second sentence, states that SPS measures "shall no t be applied in a manner which constitute a
disguised restriction on international trade". Similarl y, Article 10.1 states in relevant part that "[i]n
the preparation and application of [SPS] measures, Members shall take account of the special needs of
developing country Members". Finally, we note that Article 8 draws a distinction between, on the one
hand, the "operation" of procedures and, on the ot her hand, the "procedures", which, themselves, are
defined in Annex A(1) as SPS measures.
1212
7.1336 It should be added in this context that the term "requirements" as it appears in the second
paragraph of Annex A(1) is un qualified and thus is applicable both to requirements which are
generally applicable and to requirements wh ich have been imposed on specific products. 1213 In our
view, the application of a generally applicable SPS "requirement" (e.g., a pre-marketing approval
requirement for biotech products) to a specific product may result in a different, product-specific SPS
"requirement" (e.g., a ban on the marketing of a speci fic biotech product). In other words, there may
be cases where the application of an SPS "requirement " and, hence, of an SPS measure, may give rise
to a new SPS requirement and, hence, a new SP S measure. Applying these considerations to
Article 5.1, it could be argued that a generally applicable SPS requirement as set out, e.g., in a law and
a product-specific decision based on that requirement might both constitute SPS measures which must
be based on a risk assessment.
7.1337 Before proceeding further, a fina l point should be made. It is important to keep in mind that
Annex A(1) is intended to provide a general definition of the term "SPS measure". This general
definition must not be applied in mechanistic fashion. In particular, we note that the mere fact that a
measure within the meaning of the DSU meets th e definition of an "SPS measure" set out in
Annex A(1) does not mean that it is, ipso facto , subject to every provision of the SPS Agreement
which applies to "SPS measures". A good illustration of this point is afforded by the chapeau of
Annex C(1)(a) of the SPS Agreement, which states that "Members shall ensure, with respect to any
procedure to check and ensure the fulfilment of [SPS] measures, that such procedures are [...]
completed without undue delay" (emphasis added). The definition of "SPS measures" given in
Annex A says that "SPS measures" include "procedur es". Clearly, however, Annex C cannot be read
as meaning that "Members shall ensure, with resp ect to any procedure to check and ensure the
fulfilment of [SPS] procedures, that such procedures are [...] completed without undue delay".
Rather, the term "SPS measures" in Annex C(1)(a) must be interpreted as meaning substantive "SPS
requirements".
1214 It is clear from this example that in interpreting the term "SPS measure(s)", in
addition to the Annex A(1) defin ition, account should also be taken of the specific context within
which that term appears.

1212 Article 8 provides:

Members shall observe the provisions of Annex C in the operation of control, inspection and
approval procedures, including national systems for approving the use of additives or for
establishing tolerances for contaminants in foods, beverages or feedstuffs, and otherwise
ensure that their procedures are not inconsistent with the provisions of this Agreement
(emphasis added).
1213 We note in this respect that the footnote to Annex B(1) defi nes "[SPS] regulations" as "[SPS]
measures [...] which are applicable generally". It follows, a contrario, that there can be SPS measures which are
not applicable generally.
1214 This view draws support from a parallel provision in the TBT Agreement. Annex 1(3) of the
TBT Agreement defines conformity assessment procedures as "[a]ny procedure used, directly or indirectly, to
determinate that requirements in technical regulations [… ] are fulfilled" (emphasis added).

(b) Nature of the general de facto moratorium on approvals
7.1338 For the purposes of establishing whether the general de facto moratorium on approvals
constitutes an "SPS measure" within the meaning of Annex A(1) and Article 5.1, it is key, in our
view, to determine its nature. More particularly, consistent with the language used in Annex A(1), it
must be determined whether the general morato rium is a substantive SPS "requirement", a
"procedure" or a measure of a different nature.
(i) Was the decision to apply a general morato rium on approvals a decision to reject all
applications or did it predetermine such rejections?
7.1339 To determine the nature of the general moratori um on approvals, it is well to recall our earlier
findings. We found, inter alia:
(a) that the Group of Five countries decided to use their powers in the approval process
so as to prevent any and all new applicati ons from being finally approved, until new
EC rules on labelling and traceability were adopted, and
(b) that the Commission responded by not making full use of the relevant procedures to
complete the approval process, and that in so doing, it knowingly entered into
effective co-operation with the Group of Five countries, and
(c) that, consequently, the Group of Five countries and the Commission followed an
inexplicit common "plan or course of action" which consisted in preventing the final
approval of applications pending the a doption of new EC rules on labelling and
traceability.
7.1340 Based on these findings, and the relevant supporting arguments and evidence, we are of the
view that the decisions by the Group of Five c ountries and the Commission to prevent applications
from reaching final approval and t hus to apply a general moratori um on approvals were, in essence,
decisions to delay final positive approval decisions on individual applications until certain conditions
were met.
1215 Consistent with what we have done earlier in our findings, we will hereafter refer, not
to decisions by the Group of Five countries and the Commission, but to a decision by the European
Communities.
7.1341 In principle, it would also be correct to descr ibe the decision to delay final approval decisions
as a decision not to approve individual applications until certain conditions were met. We prefer not
to use that description, though. This is because th e term "decision not to approve applications" could
be understood as referring to a decision to reject all applications. However, as we explain below, the
decision to apply a general moratorium was not a substantive decision to reject all applications.
7.1342 By deciding to apply a general moratorium , the European Communities did not give a
negative substantive reply to the question "May th e biotech products with pending or future
applications be marketed in the European Co mmunities?". Rather, the reply the European
Communities effectively gave to that question was th at certain conditions needed to be met before it
could provide positive substantive replies.
1216 In that sense, it can be said that the decision to apply a

1215 To recall, as of August 2003, relevant conditi ons (new EC rules on labelling and traceability) had
not been met.
1216 We note that, in the meantime, pending and subsequent applications were subject to a provisional
marketing ban. However, as we will explain in detail below, that provisional ban was a consequence, not of the

general moratorium was a procedural decision not to make final and favourable substantive decisions
on applications until certain conditions were satisfied.
7.1343 Thus, the decision to apply a general morato rium on approvals did not itself constitute a
substantive decision to reject all applications. For completeness, we should examine, in addition,
whether the decision to apply a general moratorium on approvals predetermi ned negative substantive
decisions on pending and future applications. Th e June 1999 declaration by the Group of Five
countries said that the relevant member States woul d take steps to "suspe nd" new approvals, pending
the adoption of EC rules on labelling and traceability. The June 1999 declaration did not imply that
once the new EC rules were adopted, the Group of Fi ve countries would seek to complete all pending
and new approval procedures with a negative approval decision. We note that there are Group of Five
countries which subsequently indicated that add itional conditions needed to be met before new
approvals could be granted.
1217 However, these additional conditions identified by some Group of
Five countries did not predetermine the outcome of approval procedures any more than the conditions
set out in the June 1999 declaration. At any rate, there is no evidence to suggest that the
Commission's effective decision not to complete approval procedures until the adoption of new EC
rules on labelling and traceability predetermined the outcome of individual approval procedures.
More particularly, there is no evidence to suggest that the Commission would complete all pending
and new approval procedures with a negative de cision once the new EC rules were adopted.
Accordingly, the decision to apply a general morato rium on approvals cannot be considered to have
predetermined negative final decisions on all pending and future applications.
7.1344 Whereas it is clear from the foregoing considera tions that we are of the view that the
European Communities' decision to apply a gene ral moratorium on approvals can be properly
characterized as a decision to delay final positive approval decisions
1218, the Complaining Parties are
of the view that this is not the most appropriate lega l characterization. In the light of this, we suspend
a final conclusion on this issue until after we have examined whether the Complaining Parties have
offered a more appropriate legal characterization of the European Communities' decision to apply a
general moratorium on approvals. The Complaining Parties have put forward two alternative legal
characterizations: (i) that the European Commun ities' decision to apply a general moratorium on
approvals was a decision to impose an effective ma rketing ban on all biotech products subject to
approval, and (ii) that the decision in question established a new procedure or amended the existing
EC approval procedure. We first these two characterizations in turn.
(ii) Did the decision to apply a general moratori um on approvals impose an effective marketing
ban?
7.1345 The United States argues that the general moratorium is, effectively, a marketing ban that
affects any and all biotech products. More partic ularly, the United States submits that a decision to
delay completion of approval procedures for biotech pr oducts for an indefinite period of time – in this
case from late 1998 up through at least August 2003 – is effectively equivalent to a decision to adopt a
ban on the marketing of all biotech products subject to the EC approval procedures.
7.1346 Canada recalls that the European Communities' own pre-marketing approval requirement
effectively imposes a ban on biotech products until th ey are approved. According to Canada, the

European Communities' decision to apply a general moratorium on approvals, but of the EC pre-marketing
approval requirement.
1217 See supra, para. 7.530. See also, Exhibit EC-69/At. 125.
1218 In order to avoid verbiage, we will hereafter be using the phrase "a decision to delay final approval
decisions" rather than the longer, more complete phrase "a decision to delay final positive approval decisions".

general moratorium is a conscious decision on the part of the European Communities not to approve
biotech products for an unspecified period of time. In Canada's view, the general moratorium thus
effectively renders inoperative the EC approval proce dures, resulting in an indefinite suspension of
the placing on the market of biotech products. This indefinite suspension converts the pre-marketing
approval requirement established by EC legislation into a complete, rather than conditional, marketing
ban.
7.1347 Argentina argues that the general moratorium functio ns as a ban on the marketing of biotech
products.
7.1348 The European Communities argues that the Complaining Parties are improperly
characterizing the alleged general moratorium as a marketing ban. The only ban in place in the
European Communities is the prohib ition to market biotech products that have not undergone prior
assessment in accordance with the requirements of EC law. The fact that biotech products cannot be
marketed until approved is an intrinsic feature of EC legislation and, indeed, of any approval system.
The WTO-consistency of the applicable EC legisl ation, the EC approval system and the ban on the
marketing of non-approved biotech products is not an issue before the Panel as none of these
measures have been identified in the Complaining Parties' requests for the establishment of a panel.
7.1349 The European Communities submits that the acts of which the Complaining Parties are
complaining should be characterized as delay – they cannot, therefore, amount to a ban. The
Complaining Parties' submissions blur this fundamental point, and they seem to insinuate that the EC
approval procedures for biotech products are little mo re than a façade to prevent the marketing of
biotech products. The European Communities rejects any such allegation as EC legislation and policy
are not intended to prevent the marketing of biotech products.
7.1350 The Panel notes that, according to the Complaini ng Parties, the European Communities'
decision to apply a general moratorium on approvals should be characterized, for the purposes of the
Panel's legal analysis, as a decision to adopt an across-the-board marketing ban on biotech products
requiring approval. In considering this argument, it is important to bear in mind that the decision to
apply a general moratorium on approvals was made in the context of a pre-marketing approval
system. Therefore, before addressing the merits of the Complaining Parties' argument, it is useful to
recall the main features of the European Communities' pre-marketing approval system. EC legislation
does not provide for a blanket ban on the marketing of biotech products. EC legislation provides that
the marketing of biotech products is s ubject to approval, or authorization.
1219 In other words, EC
legislation imposes a pre-marketing approval require ment. Like any pre-marketing approval system,
the EC pre-marketing approval system for biotech products envisages a case-by-case assessment of
the products for which marketing a pproval is sought. Consistent wi th this case-by-case approach, the
European Communities conducts a risk assessment for each individual biotech product which is
submitted for marketing approval.
1220
7.1351 As a result of the EC pre-marketing approval requirement, a biotech product for which
marketing approval is sought cannot be legally marketed in the European Communities until the time
a final substantive decision has been made on whether or not to approve the marketing of the product.
In other words, the pre-marketing approval require ment imposes a provisional ban on the marketing

1219 Articles 6, 10, 11 and 13 and preambular paragraphs 17, 18 and 20 of Directive 90/220; Articles 4,
6, 13, 15 and 19, and preambular paragraphs 28 and 47 of Directive 2001/18; Articles 3, 4, 6 and 7 and
preambular paragraph 2 of Regulation 258/97.
1220 Articles 12 and 13 of Directive 90/220; Articles 4, 14 and 18 of Directive 2001/18; and Articles 6
and 7 of Regulation 258/97.

of a biotech product for which marketing approval is sought.
1221 The provisional ban remains in effect
until a final approval decision has been made.1222
7.1352 While applicable EC legislation imposes some deadlines on EC entities charged with carrying
out approval procedures, in our understanding, EC legislation does not provide that if approval
procedures are not completed within a specified maxi mum time-period, the relevant application must,
as a matter of law, be accepted or rejected. This me ans, for example, that a failure by a relevant EC
entity to observe deadlines imposed on it, while possi bly constituting a breach of EC legislation, will
normally translate into a delay in the completion of the relevant approval procedure.1223 Simply put, it
can thus be said that in the European Communities the marketing of biotech products is subject to a
provisional ban until such time as a final approval d ecision has been made, regardless of how long it
takes to reach a final approval decision.
7.1353 It is important to note that the Complaining Pa rties in this case chose not to challenge the EC
pre-marketing approval system as such. In other wo rds, they chose not to ch allenge the fact that the
European Communities maintains a pre-marketing a pproval requirement for biotech products. Thus,
for the purposes of these proceedings, we must pres ume that the pre-marketing approval requirement
is WTO-consistent. One of the consequences which flows from the EC pre-marketing approval
requirement is the fact that the marketing of biotech products for whic h approval is sought is
provisionally banned until such time as a final approval decision has been made. Since this is a direct
and necessary consequence of the EC pre-marketing approval requirement, logic dictates that if the
pre-marketing approval requirement must be presume d to be WTO-consistent, the same holds true for
the provisional ban.
7.1354 With the foregoing observations in mind, we now turn to address the merits of the
Complaining Parties' argument that the Eur opean Communities' decision to apply a general
moratorium on approvals was effectively a decision to adopt an across-the-board marketing ban.
Canada has gone furthest in developing this ar gument. According to Canada, the European
Communities' decision to apply a general moratori um on approvals "converted" the EC pre-marketing
approval requirement into a definitive marketing ban. 1224 As we understand it, the core of this
argument is that as a result of its decision to ap ply a general moratorium on approvals, the European
Communities no longer operated a pre-marketing approval system, but imposed an outright marketing
ban. Canada argues that the decision to apply a general moratorium on approvals essentially rendered
the EC approval procedure irrelevant, in the sen se that it prevented the biotech products with
outstanding applications from being approved regardless of the scientific evidence.
7.1355 As an initial matter, we recall our view that , properly understood, the decision to apply a
general moratorium on final approvals was a decisi on to delay final approval decisions. We found
that the Group of Five countries and the Commissi on followed a common "plan", which consisted in

1221 Instead of saying that the European Communities maintains a pre-marketing approval requirement,
one could say with equal justification that the European Communities maintains a conditional marketing ban on
biotech products, with the applicable condition being the absence of formal EC marketing approval.
1222 We use the term "provisional ban" to reflect the fact that this is a provisional measure which is
replaced by a final, or definitive, measure upon completi on of the approval procedure for the biotech product in
question.
1223 We recall in this context that both at Community and at member State level applicants have the
possibility of seeking judicial review of the legality of the actions/inaction by relevant EC entities.
1224 We note that Canada does not use the term "definitive ban", but instead refers to a "complete, rather
than conditional, ban". Canada's reply to Panel question No. 67. We find the term "complete ban" problematic
in that it might suggest that the provisional ban effec tively imposed by the pre-mark eting approval requirement
is something other than a complete ban.

preventing the final approval of applications pendi ng the adoption of new EC rules on labelling and
traceability. Thus, the "plan" was precisely to prevent final, or definitive, approval decisions. It is
consistent with this view that between June 199 9 and August 2003 no applica tions were rejected, and
that it was not until after the adoption of the afor ementioned EC rules that the Commission approved
three applications. In fact, Canada itself acknow ledges that the European Communities' decision to
apply a general moratorium on fina l approvals was a "decision not to decide", or a "decision not to
approve" applications, and that th is type of decision is not the same as a substantive decision
definitively to reject any and all applications.
1225 In the light of this, we do not consider that the
European Communities' decision to apply a genera l moratorium on final approvals was designed to
convert the pre-marketing approval requirement into a definitive marketing ban.
7.1356 The question thus becomes whether the decision to apply a general moratorium on approvals,
while not designed to convert the pre-marketing approval requirement into a definitive marketing ban,
nonetheless had the effect of doing so. It is therefor e necessary to consider the effect of the decision
to apply a general moratorium on a pprovals. In this regard, we reca ll once more that the decision we
are concerned with in essence was a decision to dela y final approval decisions. The decision to delay
final approval decisions had the effect of ex tending the time-period during which non-approved
biotech products were subject to the provisional marketing ban flowing from the pre-marketing
approval requirement.
1226 For clarity, two observations should be made in relation to this effect.
First, the effect in question is not an inherent effect of a decision to delay final approvals. If the
decision to delay final approval decisions effec tively extended the time-period during which the
provisional ban was in effect for individual applica tions, this was because that decision was made in
the context of the EC pre-marketing approval sy stem. Had the European Communities opted for a
system under which biotech products could be prov isionally marketed until a final approval decision
was made, a decision to delay final approvals would not have had the effect of extending a provisional
marketing ban, but of extending a provisional marketing authorization. Secondly, the effect in
question is an indirect one. The direct effect of the decision to delay final approval decisions was to
delay the completion of individual approval proc edures. Under the EC pre-marketing approval
system, the marketing of biotech products is banned until it has been approved. Hence, if a decision is
made to delay final approvals, this indirectly h as an effect, via the principle of "banned until
approved", on how long the marketing of the relevant biotech products is provisionally banned.
7.1357 It is clear from the preceding paragraph that th e decision to delay final approval decisions and
the decision provisionally to ban biotech products are sep arate and distinct measures. It is also clear
that the decision to delay final approval decisions did not impose a new ban. The decision to delay
final approval decisions merely had the effect of extending the duration of the provisional ban on the
marketing of all non-approved biotech products. That ban was already there, as a consequence of the
pre-marketing approval requirement. The provisiona l marketing ban did not expire prior to the
European Communities' decision to delay final a pproval decisions, and that decision consequently
cannot be said to have re-imposed it.
7.1358 It follows from the foregoing considerations that the decision to delay final approval decisions
did not have the effect of converting the pre- marketing approval requirement into a definitive

1225 See, e.g., Canada's reply to Panel question No. 172.
1226 We recall that under the European Communities' general moratorium on final approvals,
applications were allowed to make some progress in th e approval process. Thus, for all those applications
which were not affected by the decision to delay fina l approvals, there was no effective extension of the
provisional marketing ban. In contrast, for all applications which as of August 2003 had been affected by the
decision to delay final approvals, there had been an effective extension of the provisional marketing ban, but its
duration varied from application to application.

marketing ban in the sense of imposing a new ban. But the decision in question had an effect on an
already existing ban, the provisional marketi ng ban flowing from the pre-marketing approval
requirement. Accordingly, we need to examine whether, through its effect on the provisional
marketing ban, the European Communities' decision to delay final approval decisions converted the
EC pre-marketing approval requirement into a defin itive marketing ban. More specifically, we need
to examine whether the decision to delay final approval decisions effectively converted the pre-
marketing approval requirement into an instrument with the same effect as a definitive marketing ban.
7.1359 We note in this regard that if the provisiona l marketing ban effectively imposed by the EC
pre-marketing approval requirement is applied for three years, the practical effect of this is much the
same as that of a definitive ma rketing ban imposed for three years. In either case, the producer
seeking to market the relevant biotech product cannot lawfully do so for a three-year period.
1227
Similarly, if a provisional ban is in effect indefin itely, practically speaking, this is little different from
a definitive ban imposed for an indefinite period of time. 1228 Thus, the EC pre-marketing approval
requirement inherently produces very similar effe cts as a definitive marketing ban. The European
Communities' decision to delay final approval decisions had an effect on the time-period during which
the provisional marketing ban was applicable. But it did not lead to the EC pre-marketing approval
requirement producing a different kind of effects. Consequently, it cannot be said that the European
Communities' decision to delay final approval deci sions "converted" the EC pre-marketing approval
requirement into an instrument with the same effect as a definitive marketing ban.
7.1360 We accept that the European Communities' deci sion to delay final approval decisions for an
unspecified period of time had the indirect effect of extending the provisional marketing ban for an
unspecified period of time. Howeve r, as we have stated, the source of the provisional marketing ban,
including of the effectively extended ban, is not the decision to delay, but the EC pre-marketing
approval requirement. Or to put it differently, what prevents applicants from marketing their biotech
product at a given point in time is the European Communities' substantive decision to ban biotech
products until they have been approved. If the Co mplaining Parties had been of the view that the
effective extension of the provisional marketing ban in some instances rendered the imposition of that
ban inconsistent with Article 5.1, it was open to them to challenge the imposition of that ban ( i.e., the
pre-marketing approval requirement as the sour ce of the provisional marketing ban). The
Complaining Parties chose not to do so in this case.
7.1361 Instead, the Complaining Parties decided to ch allenge the European Communities' decision to
delay final approval decisions. The fact that this procedural decision had an impact on how long the
provisional marketing ban resulting from the EC pre-marketing approval requirement was in effect for
each application does not turn that decision into a substantive decision provisionally to ban biotech
products. A procedural decision to delay final ap proval decisions does not cease to be procedural
merely because it has a substantive impact. Indeed, procedural decisions virtually always have some
substantive impact.
7.1362 Within this context, we need to address anothe r argument put forward by Canada. According
to Canada, a decision to delay final approval deci sions, if it gives rise, as in the present case, to

1227 We note that while in the case of the provisional marketing ban, the ultimate approval decision
could be positive or negative, in the case of the three-y ear definitive marketing ban, the relevant product could
be lawfully marketed upon expiry of the three-year period, unless the ban was re-imposed.
1228 We note that an indefinite definitive marketing ban, on the one hand, and an indefinite provisional
marketing ban, on the other, may have a different economic impact on producers of biotech products. For
example, the adverse effect on long-term investments might be smaller in the case of the provisional ban,
provided applicants expect that approval decisions will be resumed at some point in the future.

prolonged delays, may be equated with a substantive decision to ban biotech products on the basis
that, at some point, a delay effectively becomes a ban. In support of this argument, Canada points to
the fact that numerous applications were withdr awn between June 1999 and August 2003. While this
is correct, it should also be noted that almost none of the applicants withdrawing their applications
cited undue delays in the processing of their application as a reason for the withdrawal.
1229
Nonetheless, we agree with Canada that the absence of a reference to the moratorium or to undue
delays does not necessarily indicate that undue delays did not cause, or contribute to, the withdrawals.
7.1363 Canada notes that some applicants in thei r letters of withdraw al invoked "commercial
reasons" and submits that this is a reference to the limited commercial life of biotech products.
Canada contends that the biotech products at issue in this dispute have a short life-cycle, such that if
they are not approved within reasonable periods of time, the marketing of these products may no
longer be of any commercial interest. While this may well be true for some biotech products, the
record does not support the view that this is the cas e generally. In fact, many applicants maintained
their applications despite lengthy delays in their processing. 1230 Furthermore, while numerous
applications were withdrawn between June 1999 and August 2003, qu ite a few others were submitted
for approval during the same time-period. 1231 If these applicants did not believe that they would
eventually be able to have their applications a pproved, it is difficult to see why the applicants would
spend time and money on these applications. Thus, in our view, the facts do not support the general
conclusion that, practically speaking, there is no distinction between the European Communities'
procedural decision to delay final approval decisions and a substantive decision definitively to ban all
biotech products for which approval had been sought.
7.1364 As we have said, we recognize the possibility th at, due to short product life-cycles, prolonged
delays in the completion of approval procedures coul d, in some instances, leave applicants with no
choice but to withdraw their applications. However, this potential effect of a procedural decision to
delay final approval decisions does not provide su fficient grounds for equating that decision with a
substantive decision to ban biotech products. The distinction between substa nce and procedure is a
fundamental legal distinction and we see no ju stification for disregarding it in this case.
Annex C(1)(a) of the SPS Agreement specifically requires Members to complete their approval
procedures without undue delay. A Member is theref ore not allowed to cause prolonged delays in the
completion of an approval procedure, unless there is a justification for doing so. And if there is a
justification, we do not think it would be appropria te to equate delay with a negative substantive
decision based on product life-cycle considerations . Where a Member has legitimate reasons for
delaying an approval decision, e.g., in order to obtain scientific information required in order to
complete a risk assessment, it should not be deemed to have completed its approval procedure with a
negative decision (and thus be exposed to the risk of a successful challenge to that presumed decision
based on Article 5.1 of the SPS Agreement) merely because the applicant's product is nearing the end
of its life-cycle. Provided a Member completes an approval procedure without undue delay, the fact
that the time taken significantly diminishes the a pplicant's market opportunities is of no particular
relevance.
7.1365 In conclusion, we note that, for the reasons set out above, we are unable to accept the
Complaining Parties' argument that the Eur opean Communities' decision to apply a general
moratorium on approvals was effectively equivale nt to a decision to impose an across-the-board
marketing ban.

1229 The application concerning RR oilseed rape (EC-79) is a notable exception. Exhibit EC-79/At. 30.
1230 For instance, the application c oncerning Bt-531 cotton was subm itted in December 1996 and was
still pending in August 2003 and beyond.
1231 See, e.g., Exhibits EC-94, EC-95, EC-96, EC-104, EC-106 and EC-107.

(iii) Did the decision to apply a general moratori um on approvals itself establish a procedure or
amend the existing EC approval procedures?
7.1366 In addition to asserting that the decision to apply a general moratorium on approvals
effectively banned the marketing of all biotech pr oducts with pending or fu ture applications, the
Complaining Parties present arguments which present the issue of whether that decision could be
considered either to have established a new procedure or to have amended the existing EC procedures.
As this issue is directly relevant to the legal characterization of the decision to apply a general
moratorium on approvals, it is necessary to address it.
7.1367 The United States argues that the decision to apply a general moratorium on approvals
modified the European Communities' approval regi me. More specifically, the United Stats argues
that the suspension by the European Communities of the consideration of applications for, or granting
of, approval of biotech products is a procedur e within the meaning of Annex A(1) of the
SPS Agreement, although an unwritten one . The United States points out in this regard that the New
Shorter Oxford English Dictionary defines the term "procedure" as a "particular mode or course of
action" or a "set of instructions for performing a specific task which may be invoked in the course of a
[computer] program".
7.1368 Canada does not argue that the decision to a pply a general moratorium on approvals
established an unwritten procedure. Canada contends, however, that that decision led to a significant
departure from the existing EC approval procedure in that it resulted in the European Communities
moving from approvals based on risk assessment to no approvals regardless of the scientific evidence.
According to Canada, the decision to apply a genera l moratorium on approvals amounted to a mis- or
non-application of the applicable legislati on and essentially rendered the approval procedure
irrelevant. Canada submits that the moratorium superseded the EC approval procedure as the measure
that exerted effective control over applications.
7.1369 Like Canada, Argentina does not argue that the decision to apply a general moratorium on
approvals established an unwritten pr ocedure. Argentina neverthel ess argues that that decision
modified the existing EC approval procedures by introducing additional procedural stages not
envisaged in the relevant legislation. Specifi cally, Argentina contends that the inter-service
consultations launched and held by the Commission in the context of some individual approval
procedures have no legal basis in the legislation.
7.1370 The Panel begins by recalling its view that the decision to apply a general moratorium on
approvals was a decision to delay final approval decisi ons. The first issue to be examined in view of
the United States' argument is whether the decisi on to delay final approval decisions laid down a
"procedure". Relevant dictionary definitions of th e term "procedure" are: "[a] particular mode or
course of action"
1232 or "an established or official way of doing something"1233.
7.1371 In our view, the decision to delay final approva l decisions did not itself establish a procedure
for approving biotech products or, more to the point, for preventing the final approval of biotech
products. To begin with, it did not establish "[a] pa rticular mode or course of action" to be followed
by the Group of Five countries and/or the Commissi on. Nor did it establish an "[un]official way" of
approving, or not approving, applications. It is instructive in this regard to recall the June 1999
declaration by the Group of Five countries, which states in relevant part that "in exercising the powers

1232 The New Shorter Oxford English Dictionary , L. Brown (ed.) (Clarendon Press, 1993), Vol. 2,
p. 2363.
1233 The Concise Oxford Dictionary, 10th edn., J. Pearsall (ed.) (Clarendon Press, 1999), p. 1139.

vested in them regarding the growing and placing on the market of genetically modified organisms
[…] they [the Group of Five countries] will take steps to have any new authorizations for growing and
placing on the market suspended".
1234 The declaration itself does not establish a procedure, as it does
not specify the steps to be taken to bring about a suspension of approvals. We also recall that the
general moratorium on approvals was given effect through various types of action and/or omission by
the Group of Five countries and/or the Commission. But the record does not support the conclusion
that the relevant acts and/or omissions were a reflection of an established procedure.
1235
7.1372 It remains to be examined, then, whether th e decision to delay final approval decisions
effectively amended the relevant EC approval procedures. The relevant approval procedures are set
out in Directive 90/220 and its successor, Directiv e 2001/18, as well as Regulation 258/97. The main
elements and similarities of these approval procedures have been described earlier in Section VII.C.
7.1373 We do not consider that the decision to de lay final approvals resulted in the European
Communities applying a different type of approva l procedure between June 1999 and August 2003.
Indeed, it can be seen from our earlier findings that applications continued to be assessed in
accordance with the procedures set out in Directives 90/220 and 2001/18, as well as
Regulation 258/97. Accordingly, applications were still being assessed first at member State level
and subsequently at Community level. Lead CAs continued to prepare initial assessment reports. The
Commission continued to seek the assistance of EC scientific committees and, at least initially,
submitted draft measures to the Regulatory Committ ee for a vote. While it is correct that the
Commission conducted inter-service consultations in the context of some of the approval procedures
in question, we have previously found that such c onsultations were not an additional procedural stage
devised by the Commission to prevent the approval of biotech products.
1236
7.1374 Moreover, it has not been explained to us pr ecisely how the decision to delay final approval
decisions would have modified the approval procedures se t out in the applicable EC legislation. It is
not clear to us what was the particular "mode or course of action" to be followed under the supposedly
modified EC approval procedures, or what was the newly established "[un]official way" of approving,
or not approving, applications. As we have noted , the June 1999 declaration by the Group of Five
countries does not predetermine any particular "mode or course of action" to be followed. The mere
fact that some applications did not reach Community level or were not put to a vote in the Regulatory
Committee, and that no approval procedure was comp leted with a final approval decision does not
demonstrate that the European Communities applied a different type of approval procedure. In our
view, a more appropriate conclusion to be drawn from the absence of final approvals and the delays in
the processing of applications is that the Eu ropean Communities applied its existing approval
procedures, but that it intentionally did not make full use of these procedures to complete the approval

1234 Declaration by the Danish, Greek, French, Italian and Luxembourg delegations concerning the
suspension of new GMO authorizations, 2194 th Council Meeting - Environment-, Luxembourg, 24/25 June
1999. Exhibits US-76 and 77; Exhibit CDA-3; Exhibit ARG-12.
1235 We have noted earlier that the Commission's conduct might possibly be considered to reflect an
(evolving) implementation practice. See supra, para. 7.1277.
1236 See supra, para. 7.1260. We note that these earlier findings concerned inter-service consultations
held in the context of an approval procedure conducted pursuant to Directive 90/220. However, the same
considerations apply equally to inter-service consultations held in the context of an approval procedures
conducted pursuant to Directive 2001/18 and Regulation 258/97.

process.
1237 To our minds, this is a natural and logical way of implementing a decision to delay final
approval decisions.
7.1375 Canada argues that the decision to delay fina l approval decisions led to "a significant
departure from the existing EC approval procedure" or "superseded the EC approval procedure as the
measure that exerted effective control over applicati ons". As we see it, the decision to delay final
approval decisions neither led to a departure fro m the existing approval procedures nor superseded
them. Based on the information on the record, we ar e of the view that the decision to delay final
approval decisions was implemented through, and within the framework of, the existing approval
procedures. As pointed out by Canada, this resulte d in at least a partial "non-application" of the
existing approval procedures. However, non-applic ation of one particular approval procedure does
not logically imply application of a different approval procedure.
7.1376 We note, as an additional matter, Canada's conten tion that "the measure that exerted effective
control over applications" was the decision to de lay final approval decisions, and not the existing
approval procedures. The first observation to be made in relation to this contention is that, legally
speaking, applications remained fully subject to the approval procedures in force. However, it is clear
that the approval procedures set out in the applicable EC legislation left member States and the
Commission a degree of discretion with regard to the application, or operation, of these approval
procedures. A decision by a relevant EC entity re lating to the application, or operation, of the
applicable approval procedures may have – and, inde ed, may be intended to have – an impact on the
manner and/or speed of assessment of applications. If it does, that decision plainly would exert a
degree of "effective control" over applications.
7.1377 In our analysis, the European Communities' d ecision to delay final approval decisions was
such a decision relating to the application, or operation, of the EC approval procedures.
1238 I t
essentially was a decision to operate the EC approval pr ocedures in such a way that there would be no
final approval decisions until certain conditions were met. Moreover, since the objective of that
decision was to delay final approval decisions, it is inevitable that it exerted a degree of effective
control over individual applications. However, as we have noted above, we do not think that
applications were effectively no longer controlled, at all, by the EC approval procedures set out in the
legislation. If in practice the decision to de lay final approval decisions nonetheless exerted a
significant degree of effective control, this was in pa rt a consequence of the objective of that decision,
which was to prevent final approval decisions. Quite possibly, the fact that applicants chose not to
seek judicial review, either before member State c ourts or the European Court of Justice, of action
taken, or not taken, by lead CAs or the Commissi on in the context of individual approval procedures
was another reason why in practice the decision to delay final approval decisions exerted a significant
degree of effective control over individual applications.1239
7.1378 In the light of the foregoing, we conclude that the European Communities' decision to apply a
general moratorium on approvals did not itself estab lish a procedure for approving, or not approving,
applications, and that it did not effectively ame nd the existing EC approval procedures either. We

1237 We recall in this regard the European Communities' argument that the EC legislation which sets out
the relevant approval procedures was considered inadeq uate by some member States and segments of public
opinion.
1238 We recall that the EC approval procedures as such have not been challenged by the Complaining
Parties.
1239 We recall that according to an uncontested stat ement by the European Communities no complaints
were brought before the European Court of Justice in respect of the products subject to these proceedings. Only
one case was instituted before a member State court, but that case concerned a member State safeguard measure.

nonetheless consider that the decision to apply a ge neral moratorium on approval was procedural in
nature, in that it was a decision relating to the app lication, or operation, of the existing EC approval
procedures.
(iv) Conclusion
7.1379 It is clear from the preceding analysis that we are unable to accept either of the alternative
legal characterizations of the general moratorium on approvals which the Complaining Parties have
put forward. Accordingly, we confirm the view a nd conclusion we offered at the beginning of our
analysis, namely that the European Communities' decision to apply a general moratorium on
approvals should be characterized as a procedural decision to delay final substantive approval
decisions. The decision was procedural in na ture insofar as it was a decision relating to the
application, or operation, of the existing EC approval procedures.
7.1380 We recall that the second paragr aph of Annex A(1) of the SPS Agreement provides that SPS
measures include "requirements and procedures". We have stated above that in order to establish
whether the general moratorium on approvals const itutes an "SPS measure" within the meaning of
Article 5.1 and Annex A(1), it must be determined whether the gene ral moratorium is a substantive
SPS "requirement", a "procedure" or a measure of a different nature. Our findings above on the
nature of the general moratorium on approvals enable us to make that determination.
7.1381 We have found above that the decision to appl y a general moratorium on approvals did not
impose an effective marketing ban. If it had, it co uld have been considered to impose a substantive
"requirement", on the basis that a ban is eff ectively equivalent to a negative requirement, i.e., a
requirement not to permit the marketing of a produc t. We further found that the decision to apply a
general moratorium on approvals ne ither established nor amended a pr ocedure. If it had established
or amended a procedure, it might have been considered to lay down a "procedure".
7.1382 We have characterized the decision to a pply a general moratorium on approvals as a
procedural decision to delay final substantive approv al decisions. In our assessment, this procedural
decision did not impose a substantive "requirement" in relation to biotech products with pending or
future applications. It neither a pproved nor rejected applications. Si milarly, we are of the view that
the decision to delay final substantive approval deci sions cannot appropriately be viewed as providing
for a "procedure", considering that it did not itself establish a new procedure or amend the existing EC
approval procedures. We have said that the decisi on to delay final approval d ecisions was procedural
in nature insofar as it was a decision relating to th e application, or operation, of the existing EC
approval procedures. However, the mere fact that the decision in question related to the application,
or operation, of procedures does not turn that decision into a procedure for the purposes of
Annex A(1).
1240
7.1383 Based on these considerations, we conclude that the European Communities' decision to apply
a general moratorium on approvals was a decision concerning the application, or operation, of
procedures. As such, it did not provide for "requi rements [or] procedures" within the meaning of
Annex A(1).

1240 We recall in this regard that the second paragraph of Annex A(1) makes no reference to the
"application" of "[substantive] requirements and procedures".

(c) Applicability of Article 5.1 to the European Communities' decision to apply a general de facto
moratorium on approvals
7.1384 Having ascertained the nature of the Europ ean Communities' decision to apply a general
moratorium on approvals, we can now proceed to determine whether that decision was an "SPS
measure" within the meaning of Article 5.1 and An nex A(1). We recall in this regard that for a
particular measure to be subject to Article 5.1 it must be an "SPS measure".
7.1385 In relation to the Annex A(1) definition of the term "SPS measure", we note once again that
the second paragraph of Annex A(1) of the SPS Agreement provides that SPS measures include
"requirements and procedures". We have found ab ove that the European Communities' decision to
apply a general moratorium on approvals did not pr ovide for "requirements [o r] procedures" within
the meaning of Annex A(1). We found that the decision in question was a decision concerning the
application, or operation, of "procedures".
7.1386 We have observed earlier that the second paragr aph of Annex A(1) does not refer to the
"application" of "requirements and procedures" and th at this omission must be given meaning in view
of the distinction made in various provisions of the SPS Agreement between SPS measures and their
"application", or "operation". We consequently f ound that although requirements and procedures as
such may in accordance with the Annex A(1) defi nition constitute SPS measures, the application of
such requirements and procedures would not, it self, meet the definition of an SPS measure.
1241 Since
we determined that the European Communities' d ecision to apply a general moratorium on approvals
was a decision concerning the application, or opera tion, of the EC approval procedures, it follows
from the preceding considerations that that decisi on does not meet all of the constitutive elements of
the definition of the term "SPS measure" as provided in Annex A(1).
7.1387 The Annex A(1) definition is directly applicable to Article 5.1. However, we have stated
earlier that in interpreting the term "SPS measure", in addition to the Annex A(1) definition, account
should be taken of the specific context within which that term appears. For this reason, we now go on
to analyse whether the provisions of Article 5.1 re nder the provisional conclusion we have reached on
the basis of the Annex A(1) definition inappropriate.
7.1388 Article 5.1 requires that an SPS measure applied by a Member be based on a risk assessment.
In our view, the term "SPS measure" in Article 5.1 should be taken to refer to a measure applied for
achieving the relevant Member's appropriate level of sanitary or phyto sanitary protection. We note in
this regard that Article 5.3 of the SPS Agreement provides in relevant part that "[i]n determining the
risk to animal or plant life or health and determining the measure to be applied for achieving the
appropriate level of sanitary or phytosanitary prot ection, Members shall take into account [certain]
economic factors". Thus, Article 5.3 establishes a link between the assessment of risk and the
determination of "the measure to be applied for achieving the appr opriate level of sanitary or
phytosanitary protection from such risk" (emphasis added). Indeed, as we see it, one of the purposes
of a risk assessment is to allow the importing Memb er to determine "the measure to be applied for
achieving the appropriate level of san itary or phytosanitary protection".
1242 And one of the purposes
of the requirement that SPS measures be based on a risk assessment is to ensure that the measure

1241 We have pointed out, however, that in some circumstances the application of a requirement may
result in another requirement.
1242 We note that Annex A(4) of the SPS Agreement defines the term "risk assessment" as meaning an
assessment of risk "according to the [SPS] measures which might be applied".

actually applied for achieving the appropriate level of sanitary or phytosanitary protection bears a
rational relationship to the risk.
1243
7.1389 The view that the term "SPS measure" in Artic le 5.1 should be interpreted to refer to a
measure applied for achieving the re levant Member's appropriate le vel of sanitary or phytosanitary
protection draws further support from Article 5.6. Pursuant to Article 5.6, "when establishing or
maintaining [SPS] measures to achieve the appropriate level of sanitary or phytosanitary protection ,
Members shall ensure that such measures are not more trade-restrictive than re quired to achieve their
appropriate level of sanitary or phytosanitary protec tion" (emphasis added). We think that Article 5.6
states explicitly what is implied in Article 5.1 and that the two provisions therefore use the term "SPS
measures" in the same sense. We note in this rega rd that Article 5.6 follows Article 5.1 and builds on
it, inasmuch as Article 5.6 lays down an obliga tion that goes beyond the obligation laid down in
Article 5.1. Indeed, an SPS measure applied for achieving a Member's appropriate level of protection
may be based on a risk assessment, but at the same time may be more trade-restrictive than required to
achieve the appropriate level of protection.
7.1390 It follows from the preceding observations that we need to examine whether the European
Communities' decision to apply a general moratorium on approvals was a measure applied to achieve
the European Communities' appropriate level of sanit ary or phytosanitary protection. In addressing
this issue, we recall that the European Communities' decision was made in the context of the EC pre-
marketing approval system. In our view, the pre- marketing approval requirement which results in a
provisional marketing ban may be properly consider ed a measure that is applied for achieving the
European Communities' appropriate le vel of protection. Moreover, it is not open to doubt that final
substantive approval decisions on individual appli cations are also measures applied for achieving the
European Communities' appropriate level of protection.1244
7.1391 In contrast, we do not consider that the Eur opean Communities' decision to apply a general
moratorium on approvals was, as such, a measure applied to achieve the European Communities'
appropriate level of protection. We recall in this regard that that decision was a procedural decision to
delay final approval decisions. As we explained above , the practical effect of that decision was to
extend the time-period during which non-approved bi otech products were subject to the provisional
marketing ban flowing from the pre-marketing a pproval requirement. The pre-marketing approval
requirement which imposes the provisional marketing ban is a measure applied to achieve the
European Communities' level of protection, but that requirement is a separate measure from the
decision to delay final approval decisions. By itsel f, the procedural decision to delay final approval
decisions did not achieve or imply a particular level of protection.1245

1243 According to the Appellate Body, the requirement of a risk assessment "was intended as a
countervailing factor in respect of the right of Members to set their appropriate level of protection". Appellate
1244 We recall our view that the application of a "requirement" may result in another "requirement"
within the meaning of Annex A(1) of the SPS Agreement. Specifically, the application of the EC pre-marketing
approval requirement to a specific biot ech product for which marketing approval has been sought results in a
final approval decision on that product which may be considered a "requirement" – either a requirement to
permit the marketing of the relevant product or a requirement to prohibit the marketing of the relevant product.
1245 Had the European Communities opted for a system under which biotech products could be
provisionally marketed until a final approval decision was made, a decision to delay final approval decisions
would not have had the effect of extending a provisional marketing ban, but of extending a provisional
marketing authorization. But in this scenario as well, it would be the decision to grant provisional marketing
authorization which achieves a particular level of sanitary or phytosanitary protection, not the decision to delay
final approval decisions.

7.1392 As the European Communities' decision to appl y a general moratorium on approvals was not,
itself, a measure applied for achieving the European Communities' appropriate level of sanitary or
phytosanitary protection, it cannot, in our view, be considered an "SPS measure" within the meaning
of Article 5.1. As a result, the provisions of Article 5.1 do not cast doubt on the provisional
conclusion we have reached on the basis of the Anne x A(1) definition. Rather, they reinforce our
provisional conclusion.
7.1393 Based on the above considerations, we thus determine that the European Communities'
decision to apply a general moratorium on approvals was not an "SPS measure" within the meaning of
Article 5.1 and Annex A(1). It follows that since only "SPS measures" are subject to the provisions of
Article 5.1, the provisions of Article 5.1 are not ap plicable to the European Communities' decision to
apply a general moratorium on approvals.
7.1394 In view of this conclusion, we need not con tinue our analysis of the Complaining Parties'
claim under Article 5.1.
(d) Conclusions
7.1395 In the light of the above, the Panel reaches the following conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having rega rd to the arguments and evidence submitted
by the United States and the European Co mmunities, the Panel concludes that the
European Communities has not acted inc onsistently with its obligations under
Article 5.1 of the SPS Agreement by applying a general de facto moratorium on
approvals between June 1999 and August 2003.

 (ii) DS292 (Canada)

 With reference to DS292, and having rega rd to the arguments and evidence submitted
by Canada and the European Communities, the Panel concludes that the European
Communities has not acted inconsistently with its obligations under Article 5.1 of the
SPS Agreement by applying a general de facto moratorium on approvals between
June 1999 and August 2003.

 (iii) DS293 (Argentina)

 With reference to DS293, and having rega rd to the arguments and evidence submitted
by Argentina and the European Communities, the Panel concludes that the European
Communities has not acted inconsistently with its obligations under Article 5.1 of the
SPS Agreement by applying a general de facto moratorium on approvals between
June 1999 and August 2003.

6. Consistency of the general de facto moratorium on approvals with Article 5.6 of the
SPS Agreement
7.1396 Canada claims that by applying a general de facto moratorium on approvals between June
1999 and August 2003, the European Communities has ac ted inconsistently with its obligations under
Article 5.6 of the SPS Agreement.

7.1397 Article 5.6 of the SPS Agreement provides:
"Without prejudice to paragraph 2 of Artic le 3, when establishing or maintaining
sanitary or phytosanitary measures to achieve the appropriate level of sanitary or
phytosanitary protection, Members shall en sure that such measures are not more
trade-restrictive than required to achieve their appropriate level of sanitary or
phytosanitary protection, taking in to account technical and economic
feasibility."(footnote omitted)
7.1398 Canada submits that the general moratorium on a pprovals is more trade-restrictive than
required to achieve the European Communities' appropriate level of protection. According to Canada,
an obvious alternative measure to the moratorium is for the European Communities to comply with its
existing approval legislation and permit biotech produc ts to be considered for, and granted or denied,
approval. For the purposes of its claim with respect to Article 5.6, Canada assumes that the European
Communities' appropriate level of protection is that which the European Communities has expressed
in its approval legislation for biot ech products. The EC approval procedures continue to serve as an
adequate framework for determining whether biot ech products pose risks to human health and the
environment. In Canada's view, it is therefore reasonable to conclude that the European Communities'
own approval procedure, properly functioning, would achieve its appropriate level of protection.
Finally, Canada submits that compliance by th e European Communities with its own approval
procedures would be significantly less trade-restrictive than the existing moratorium.
7.1399 The European Communities argues that certain provisions of the SPS Agreement relate to
the development of SPS measures while others relate to the application of SPS measures.
1246
According to the European Communities, Article 5.6 contains obligations relating to the development
of SPS measures, not their application. SPS measures as defined in Annex A(1) of the
SPS Agreement presuppose the existence of an act. Th e European Communities submits that the
Complaining Parties' assertions about a moratorium are in reality complaints about delay in the
completion of approval procedure. Delay of this kind cannot constitute an SPS measure within the
meaning of Annex A(1). Delay is a failure to act in a timely manner. A failure to act in a timely
manner can be reviewed under the procedural obligati ons set out in Article 8 and Annex C(1) of the
SPS Agreement as an issue of the application of an SPS measure (in this case, the EC approval
system).
1247
7.1400 The European Communities submits that the Complaining Parties describe as an SPS measure
the very same failure to take final decisions wh ich they challenge as the application of an SPS
measure under Article 8 and Annex C(1). Yet as a matte r of logic, it is clear that alleged behaviour
cannot at the same time constitute an SPS measure and the application of another SPS measure. The
European Communities deduces from these considerations that since, in its view, the Complaining
Parties are not complaining about an SPS measure, but its application, and since Article 5.6 does not
contain obligations relating to th e application of an SPS measure, th e alleged general moratorium on
approvals is not subject to Article 5.6.
7.1401 The Panel notes the European Communities' argum ent that the European Communities'
decision to apply a general moratorium on approvals does not fall to be assessed under Article 5.6. In
view of this argument, we must first examine whether the provisions of Article 5.6 are applicable.

1246 The European Communities bases th is view on Article 1.1 of the SPS Agreement, the second
sentence of which provides that SPS measures "shall be developed and applied in accordance with the
provisions of this Agreement" (emphasis added).
1247 For the text of Article 8 and Annex C(1), see infra, section VII.C.11 and VII.C.12.

(a) Applicability of Article 5.6 to the European Communities' decision to apply a general de facto
moratorium on approvals
7.1402 We note that, by its clear terms, Article 5.6 a pplies to "[SPS] measures". Accordingly, for a
particular measure to be subject to Article 5.6 it mu st be an SPS measure. Pursuant to Article 1 of the
SPS Agreement, the Annex A(1) definition of the term "SPS measure" is directly applicable to
Article 5.6. We have found above that the Eu ropean Communities' decision to apply a general
moratorium on approvals does not meet the defini tion of the term "SPS measure" as it appears in
Annex A(1). However, we also stated that in in terpreting the term "SPS measure", in addition to the
Annex A(1) definition, account s hould be taken of the specific context within which that term
appears. For this reason, we proceed to analyse whether the provisions of Article 5.6 render the
provisional conclusion we have reached on the basis of the Annex A(1) definition inappropriate.
7.1403 When analysing the Complaining Parties' clai m under Article 5.1, we have highlighted the
fact that Article 5.6 explicitly refers to "[SPS] measu res to achieve the appropriate level of sanitary or
phytosanitary protection". It is therefore clear that the SPS measures at issue in Article 5.6 are those
applied for achieving the appropriate level of protection.
7.1404 We found above that the European Communities' decision to apply a general moratorium on
approvals was not, as such, a measure applied to achieve the European Communities' appropriate
level of protection.
1248 It follows that that decision cannot be considered an "SPS measure" within the
meaning of Article 5.6. Reinforcing this view is the fact that the procedural decision to delay final
approval decisions did not itself restrict trade. Trade was restricted as a result of a distinct measure,
namely, the pre-marketing approval requirement which imposes a provisional marketing ban on
biotech products. Consequently, the provisions of Article 5.6 support rather than undermine the
provisional conclusion we have reached on the basis of the Annex A(1) definition.
7.1405 Based on the above considerations, we thus determine that the European Communities'
decision to apply a general moratorium on approvals was not an "SPS measure" within the meaning of
Article 5.6 and Annex A(1). As onl y "SPS measures" are subject to the provisions of Article 5.6, we
consider that the provisions of Article 5.6 are not applicable to the European Communities' decision to
apply a general moratorium on approvals.
7.1406 In view of this conclusion, we need not c ontinue our analysis of Canada's claim under
Article 5.6.
(b) Conclusions
7.1407 In the light of the above, the Panel reaches the following conclusions:
 (i) DS292 (Canada)

 With reference to DS292, and having rega rd to the arguments and evidence submitted
by Canada and the European Communities, the Panel concludes that the European
Communities has not acted inconsistently with its obligations under Article 5.6 of the
SPS Agreement by applying a general de facto moratorium on approvals between
June 1999 and August 2003.

1248 See supra, para. 7.1371.

7. Consistency of the general de facto moratorium on approvals with Article 5.5 of the
SPS Agreement
7.1408 All three Complaining Parties claim that by applying a general de facto moratorium on
approvals, the European Communities has acted incons istently with its oblig ations under Article 5.5
of the SPS Agreement.
7.1409 Article 5.5 of the SPS Agreement provides:
"With the objective of achieving consistency in the application of the concept of
appropriate level of sanitary or phytosanitary protection against risks to human life or
health, or to animal and plant life or h ealth, each Member shall avoid arbitrary or
unjustifiable distinctions in the levels it considers to be appr opriate in different
situations, if such distinctions result in discrimination or a disguised restriction on
international trade. Members shall coopera te in the Committee, in accordance with
paragraphs 1, 2 and 3 of Article 12, to develop guidelines to further the practical
implementation of this provision."
7.1410 The Complaining Parties submit that the European Co mmunities has adopted different
appropriate levels of protection in three different situations that can be compared. The United States
argues that the European Communities has identifie d a different level of protection for biotech
products and products produced with biotech processi ng aids. Canada and Argentina argue that the
European Communities has identified a different leve l of protection for biotech products that have
been stalled as a result of the general moratorium , biotech products that were approved for marketing
prior to the imposition of the general moratorium , and novel non-biotech products such as those
produced by conventional plant breeding techniques. The Complaining Parties further argue that the
identified differences in appropriate levels of prot ection in comparable situations are "arbitrary or
unjustifiable". Finally, the Complaining Parties ar gue that the general moratorium as the measure
embodying the differences in the levels of protecti on has resulted in discrimination or a disguised
restriction on international trade.
7.1411 Canada notes that it is making a claim under Article 5.5 in the alternative, in the event that
contrary to Canada's assumption, the European Communities' appropriate level of protection is
reflected, not in the applicable EC approval legislation, but in the general moratorium itself.
7.1412 The European Communities argues that certain provisions of the SPS Agreement relate to
the development of SPS measures while others relate to the application of SPS measures.
1249
According to the European Communities, Article 5.5 is premised on, and requires, the existence of an
SPS measure. It does not refer to the applicati on of an SPS measure. SPS measures as defined in
Annex A(1) of the SPS Agreement presuppose the existence of an act. The European Communities
submits that the Complaining Parties' assertions a bout a moratorium are in reality complaints about
delay in the completion of approval procedure. Delay of this kind cannot constitute an SPS measure
within the meaning of Annex A(1). Delay is a failure to act in a timely manner. A failure to act in a
timely manner can be reviewed under the procedural obligations set out in Article 8 and Annex C(1)

1249 The European Communities bases th is view on Article 1.1 of the SPS Agreement, the second
sentence of which provides that SPS measures "shall be developed and applied in accordance with the
provisions of this Agreement" (emphasis added).

of the SPS Agreement as an issue of the application of an SPS measure (in this case, the EC approval
system).
1250
7.1413 The European Communities submits that the Complaining Parties describe as an SPS measure
the very same failure to take final decisions wh ich they challenge as the application of an SPS
measure under Article 8 and Annex C(1). Yet as a matte r of logic, it is clear that alleged behaviour
cannot at the same time constitute an SPS measure and the application of another SPS measure. The
European Communities deduces from these considerations that since, in its view, the Complaining
Parties are not complaining about an SPS measure, but its application, and since Article 5.5 does not
refer to the application of an SPS measure, the alle ged general moratorium on approvals is not subject
to Article 5.5.
7.1414 The Panel notes the European Communities' argum ent that the European Communities'
decision to apply a general moratorium on approvals is not subject to the provisions of Article 5.5. In
view of this argument, we must first examine whether the provisions of Article 5.5 are applicable.
(a) Applicability of Article 5.5 to the European Communities' decision to apply a general de facto
moratorium on approvals
7.1415 Article 5.5 contains obligations relating to the application of the concept of the appropriate
level of sanitary or phytosanitary protection. Ho wever, we note that the "Guidelines to Further the
Practical Implementation of Article 5.5", adopt ed by the SPS Committee in accordance with the
second sentence of Article 5.5, state in this regard th at "the concept of appropriate level of protection
is applied in practice through sanitary or phytosanitary measures". 1251 This statement is consistent
with relevant Appellate Body jurisprudence. In EC – Hormones, the Appellate Body found that three
elements must be demonstrated to establish an inconsistency with Article 5.5:
"The first element is that the Member imposing the measure complained of has
adopted its own appropriate levels of sanitary protection against risks to human life or
health in several different situations. Th e second element to be shown is that those
levels of protection exhibit arbitrary or unjustifiable differences ('distinctions' in the
language of Article 5.5) in their treatment of different situations. The last element
requires that the arbitrary or unjustifiabl e differences result in discrimination or a
disguised restriction of international trad e. We understand the last element to be
referring to the measure embodying or implementing a pa rticular level of protection
as resulting, in its application, in discr imination or a disguised restriction on
international trade."1252
7.1416 In the light of this, we consider that althoug h Article 5.5 does not explicitly refer to "SPS
measures", implicitly it envisages that the "measure complained of" is an "implementing measure"1253.
In other words, the measure complained of must be an SPS measure applied for achieving a particular
level of sanitary or phytosanitary protection. In this respect, there is therefore no difference between
Article 5.5, on the one hand, and Articles 5.1 and 5.6, on the other hand.
7.1417 If, as Appellate Body jurisprudence leads us to believe, Article 5.5 implies a reference to
"SPS measures", the general definition of th at term set out in Annex A(1) of the SPS Agreement must

1250 For the text of Article 8 and Annex C(1), see infra, section VII.C.11 and VII.C.12.
1251 G/SPS/15, B.1.
1252 Appellate Body Report, EC – Hormones, para. 214 (italics in original; underlining added).
1253 Ibid., para. 215.

be applicable in the context of Article 5.5 as well. We have found above that the European
Communities' decision to apply a general moratorium on approvals does not meet the definition of the
term "SPS measure" as it appears in Annex A(1). Howe ver, we also stated that in interpreting the
term "SPS measure", in addition to the Annex A(1) definition, account should be taken of the specific
context within which that term appears. For this reason, we proceed to analyse whether the provisions
of Article 5.5 render the provisional conclusion we have reached on the basis of the Annex A(1)
definition inappropriate.
7.1418 As we have pointed out, the SPS measures at issue in Article 5.5 are those applied for
achieving a particular level of protection. We found above that the pre-marketing approval
requirement which results in a provisional market ing ban may be properly considered a measure
which is applied for achieving the European Communitie s' appropriate level of protection. Similarly,
we found that final substantive approval decisions on individual applications are measures applied for
achieving the European Communities' appropriate leve l of protection. But, most importantly, we
found that the European Communities' decision to apply a general moratorium on approvals was not,
as such, a measure applied to achieve a particular le vel of protection, and did not imply a particular
level of protection either. That decision cannot, ther efore, be considered an "implementing measure".
This being so, it is clear that the provisions of Article 5.5 as interpreted by the Appellate Body and the
SPS Committee do not undermine, but reinforce the provisional conclusion we have reached on the
basis of the Annex A(1) definition.
7.1419 Based on the above considerations, we thus determine that the European Communities'
decision to apply a general moratorium on approvals was not an implementing "SPS measure" within
the meaning of Annex A(1) and Article 5.5 as inte rpreted by the Appellate Body. As Article 5.5
implies that the measure complained of is an implementing "SPS measure", we consider that
Article 5.5 is not applicable to the European Comm unities' decision to apply a general moratorium on
approvals.
7.1420 In view of this conclusion, we need not con tinue our analysis of the Complaining Parties'
claim under Article 5.5.
(b) Conclusions
7.1421 In the light of the above, the Panel reaches the following conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having rega rd to the arguments and evidence submitted
by the United States and the European Co mmunities, the Panel concludes that the
European Communities has not acted inc onsistently with its obligations under
Article 5.5 of the SPS Agreement by applying a general de facto moratorium on
approvals between June 1999 and August 2003.

 (ii) DS292 (Canada)

 With reference to DS292, and having rega rd to the arguments and evidence submitted
by Canada and the European Communities, the Panel concludes that the European
Communities has not acted inconsistently with its obligations under Article 5.5 of the
SPS Agreement by applying a general de facto moratorium on approvals between
June 1999 and August 2003.

 (iii) DS293 (Argentina)

 With reference to DS293, and having rega rd to the arguments and evidence submitted
by Argentina and the European Communities, the Panel concludes that the European
Communities has not acted inconsistently with its obligations under Article 5.5 of the
SPS Agreement by applying a general de facto moratorium on approvals between
June 1999 and August 2003.

8. Consistency of the general de facto moratorium on approvals with Article 2.2 of the
SPS Agreement
7.1422 All three Complaining Parties claim that by applying a general de facto moratorium on
approvals between June 1999 and Au gust 2003, the European Communities has acted inconsistently
with its obligations under Article 2.2 of the SPS Agreement.
7.1423 Article 2.2 of the SPS Agreement provides in relevant part:
"Members shall ensure that any sanitary or phytosanitary measure is applied only to
the extent necessary to protect human, animal or plant life or health, is based on
scientific principles and is not maintained without sufficient scientific evidence,
except as provided for in paragraph 7 of Article 5."
7.1424 It is apparent from the text of Article 2. 2 that this provision contains three separate
requirements: (i) the requirement that SPS measures be applied only to the extent necessary to protect
human, animal or plant life or health; (ii) the requirement that SPS measures be based on scientific
principles; and (iii) the requirement that SPS measures not be maintained without sufficient scientific
evidence.
7.1425 The Complaining Parties consider that Article 2.2 is applicable to the general moratorium on
approvals. The United States submits that the genera l moratorium is inconsistent with the second and
third requirements in Article 2.2, while Canada and Argentina submit that it is inconsistent with all
three requirements contained in Article 2.2.
7.1426 The European Communities argues that certain provisions of the SPS Agreement relate to
the development of SPS measures while others relate to the application of SPS measures.
1254
According to the European Communities, Artic le 2.2 contains obligations concerning the
development of SPS measures, not their applicati on. The European Communities submits that by
challenging the way in which applications are dealt with under the EC approval system, the
Complaining Parties are challenging the applicati on of an SPS measure. The European Communities
therefore considers that Article 2.2 is not app licable to the alleged general moratorium on
approvals.1255
7.1427 The Panel will first analyse the claims under the first requirement in Article 2.2. The claims
under the second and third requirements will be analysed subsequently, in a joint subsection.

1254 The European Communities bases th is view on Article 1.1 of the SPS Agreement, the second
sentence of which provides that SPS measures "shall be developed and applied in accordance with the
provisions of this Agreement" (emphasis added).
1255 It should be noted that the European Communities initially remarked that one could argue on
whether Article 2.2 contains obligations relating to th e application of an SPS measure rather than to its
development. The European Communities submitted that the question could be left open in this case.

(a) First requirement in Article 2.2
7.1428 Canada argues that there is a relationship between the first requirement in Article 2.2 and
Article 5.6. Canada notes that the panel in Australia – Salmon stated that "Article 5.6 should, in
particular, be read in light of Article 2.2".
1256 Canada also submits that Article 5.6 is a more specific
expression of the general obligation found in Article 2.2 that SPS measures may be applied only to the
extent necessary to protect human, animal or plant life or health. Canada considers, therefore, that an
SPS measure found to be in violation of Article 5.6 must be presumed to violate the first requirement
in Article 2.2. As previously noted, in Canada 's view the general moratorium on approvals is
inconsistent with Article 5.6. Ca nada concludes from this that the general moratorium must also be
presumed to be contrary to the first requirement in Article 2.2.
7.1429 Argentina considers that the requirement that SPS measures be applied only "to the extent
necessary" applies to the imposition of an SPS measur e and is valid for any SPS measure. Regarding
the general de facto moratorium on approvals, Argentina notes that it has been implemented
generally, that is to the extent of all biotech products. Argentina argues that the general moratorium is
therefore an SPS measure which has been applied to an unjustifiably broad extent. Argentina points
out in this regard that the applicable EC legisla tion itself states that the safety of biotech products
must be assessed on a case-by-case basis. In Argent ina's view, the unjustifiabl y broad application of
the general moratorium is contrary to the first requirement set out in Article 2.2.
7.1430 The Panel begins its analysis with Canada's cl aim. Canada's claim based on the first
requirement in Article 2.2 is in the nature of a consequential claim. Canada submits that an
inconsistency with the first requirement in Artic le 2.2 follows by implication from a demonstrated
inconsistency with Article 5.6. We begin our consideration of Cana da's claim by recalling our earlier
finding that Article 5.6 is not applicable to the European Communities' deci sion to apply a general
moratorium on approvals and that, consequently, the European Communities has not acted
inconsistently with its obligations un der Article 5.6 by applying a general de facto moratorium on
approvals between June 1999 and August 2003. Since the Euro pean Communities has not acted
inconsistently with Article 5.6, and since Canada's claim under the first requirement in Article 2.2 is
premised on the existence of a breach of Article 5.6 by the European Communities, Canada's claim
under the first requirement in Article 2.2 cannot succeed.
7.1431 We now turn to consider Argentina's clai m. Argentina claims that the European
Communities' general de facto moratorium on approvals is a measure that has been applied to an
unjustifiably broad extent, and that this is contrary to the first re quirement in Article 2.2. More
specifically, Argentina argues that the moratorium should not have been applied to all biotech
products in respect of which applications were pendi ng during the relevant time period, given that the
EC approval legislation states that the safety of biotech products should be assessed on a case-by-case
basis.
7.1432 Argentina argues that for the purposes of its clai m under the first requirement in Article 2.2
the general de facto moratorium on approvals should be cons idered as an "SPS measure". However,
based on the Annex A(1) definition of the term "SPS measures", we have found earlier that the
European Communities' decision to apply a general de facto moratorium on approvals was a decision
relating to the application, or operation, of the ex isting EC approval procedures and that, as such, it

did not constitute an "SPS measure" within the meaning of Annex A(1).
1257 This view seems to us to
be appropriate also in the specific context of the first requirement in Article 2.2.
7.1433 We note in this regard that the panel in EC - Hormones stated that Article 5.1 may be viewed
as a specific application of the basic obligations contained in Article 2.2.1258 Furthermore, the panel in
Japan – Agricultural Products II stated that the more specific language of Article 5.6 should be read in
the light of the more general language in the first requirement of Article 2.2. 1259 If, as the
aforementioned panels suggested, Article 2.2 and Article 5.6 are to be read together, and if Article 5.6
is a specific application of the first obligation provided for in Article 2.2, then our previous
considerations as to why we believe the provisions of Article 5.6 are not applicable to the European
Communities' decision to apply a moratorium are releva nt also in the context of the first requirement
of Article 2.2. Therefore, as is the case with Article 5.6, we are of the view that the first requirement
in Article 2.2 is applicable to measures applied fo r achieving a Member's appropriate level of sanitary
or phytosanitary protection.1260
7.1434 We have already found that the European Co mmunities' procedural decision to delay final
approval decisions did not itself constitute a measu re which is applied for achieving the European
Communities' appropriate level of sanitary or phytosanitary protection. Accordingly, we consider that
that decision does not constitute an SPS measure within the meaning of Article 2.2. It follows that the
particular claim presented by Argentina under the first requirement of Article 2.2 cannot succeed.
(b) Second and third requirements in Article 2.2
7.1435 The United States and Canada note that the Appellate Body in Australia – Salmon agreed
with the panel in that case that "i n the event a sanitary measure is not based on a risk assessment as
required in Articles 5.1 and 5.2, this measure can be presumed, more generally, not to be based on
scientific principles or to be maintained without sufficient scientific evidence". 1261 A s p r e v i o u s l y
noted, in the United States' and Canada's view the general moratorium on appr ovals is inconsistent
with Article 5.1. The United States and Canada c onclude from this that the general moratorium must
also be presumed not to be based on scientific pr inciples and to be maintained without sufficient
scientific evidence, contrary to Article 2.2.
7.1436 Argentina argues that the European Communities h as no scientific basis for maintaining a
general moratorium on approvals. Argentina submits that there is no known scientific evidence that
might support the moratorium. In Argentina's view, the lack of any scientific basis means that the
general moratorium is inconsistent with Article 2.2. Argentina further argues that according to the
Appellate Body there must be a reasonable rela tionship between the SPS measure at issue and the
scientific evidence. 1262 Argentina argues that the general mo ratorium has been maintained for a
period of more than five years (1998 – 2004) wi thout sufficient scientific evidence. Argentina
considers that this demonstrates the lack of the required reasonable relationship.

1257 We recall that in accordance with Article 1.1 of the SPS Agreement the definitions provided in
Annex A are applicable to Article 2.2.
1258 Panel Report, EC – Hormones (Canada), para. 8.96.
1259 Panel Report, Japan – Agricultural Products II, para. 8.71.
1260 We note that Argentina is not arguing that for the purposes of its claim under the first requirement
in Article 2.2 the EC approval procedures are the releva nt SPS measures. Therefore, we need not, and do not,
determine whether approval procedures as such can be subject to the first requirement in Article 2.2.
1261 Appellate Body Report, Australia – Salmon, paras. 137-138.
1262 Argentina refers to Appellate Body Report, Japan – Agricultural Products II, para. 73.

7.1437 The Panel first considers the United States' and Ca nada's claim based on the second and third
requirements in Article 2.2. This claim is in the nature of a consequential claim. The United States
and Canada submit that an inconsistency with the second and third requirements in Article 2.2 follows
by implication from a demonstrated inconsistency with Article 5.1. It is correct that the Appellate
Body in Australia – Salmon found that by maintaining an SPS m easure in violation of Article 5.1,
Australia as the responding party in that case, by im plication, also acted inconsistently with the
second and third requirements in Article 2.2.
1263 However, we have determined above that Article 5.1
is not applicable to the Europ ean Communities' decision to apply a general moratorium on approvals
and that, consequently, the European Communities h as not acted inconsistently with its obligations
under Article 5.1 by applying a general de facto moratorium on approvals between June 1999 and
August 2003. Since the European Communities has not acted inconsistently with Article 5.1, and
since the United States' and Cana da's claim under the second and thir d requirements in Article 2.2 is
premised on the existence of a breach of Article 5. 1 by the European Commun ities, the United States'
and Canada's claim under the second and third requirements in Article 2.2 cannot succeed.
7.1438 Argentina claims that the European Communities maintained its general de facto moratorium
on approvals without sufficient scientific evidence, c ontrary to the third requirement in Article 2.2.
Under this claim, the general de facto moratorium on approvals is considered as an "SPS measure".
Based on the Annex A(1) definition of the term "SPS measures", we have found earlier that the
European Communities' decision to apply a general de facto moratorium on approvals was a decision
relating to the application, or operation, of the ex isting EC approval procedures and that, as such, it
did not constitute an "SPS measure" within the meaning of Annex A(1). 1264 This view seems to us to
be appropriate also in the specific context of the second and third requirement in Article 2.2.
7.1439 We note in this regard that in EC - Hormones the Appellate Body agreed with a statement by
the panel in that case that Article 5.1 may be view ed as a specific application of the basic obligations
contained in Article 2.2 and that Articles 2.2 and 5.1 should "constantly be read together". 1265 I f
Article 2.2 and Article 5.1 must be read together, a nd if Article 5.1 is a specific application of the
second and third obligations provided for in Article 2. 2, then our earlier considerations as to why we
believe the provisions of Article 5.1 are not app licable to the European Communities' decision to
apply a moratorium on approvals are relevant also in the context of the second and third requirements
of Article 2.2. Therefore, we are of the view th at the second and third requirements in Article 2.2 are
applicable to measures applied for achieving a Member's appropriate level of sanitary or phytosanitary
protection.1266
7.1440 We have already found that the European Co mmunities' procedural decision to delay final
approval decisions did not itself constitute a measu re which is applied for achieving the European
Communities' appropriate level of sanitary or phytosanitary protection. Accordingly, we consider that
that decision does not constitute an SPS measure within the meaning of Article 2.2. It follows that the
particular claim presented by Argentina under the second and third requirements of Article 2.2 cannot
succeed.

1263 Ibid., para. 138.
1264 We recall that in accordance with Article 1.1 of the SPS Agreement the definitions provided in
Annex A are applicable to Article 10.1.
1265 Appellate Body Report, EC – Hormones , para. 180. See also Appellate Body Report, Japan –
Agricultural Products II, para. 82.
1266 We note that Argentina is not arguing that for the purposes of its claim under the second and third
requirements in Article 2.2 the relevant SPS measures ar e the EC approval procedures. Therefore, we need not,
and do not, determine whether approval procedures as such can be subject to the second and third requirements
in Article 2.2.

(c) Conclusions
7.1441 In the light of the above, the Panel reaches the following conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having rega rd to the arguments and evidence submitted
by the United States and the European Co mmunities, the Panel concludes that the
United States has not established that the European Communities has acted
inconsistently with its obliga tions under Article 2.2 of the SPS Agreement by
applying a general de facto moratorium on approvals between June 1999 and
August 2003.

 (ii) DS292 (Canada)

 With reference to DS292, and having rega rd to the arguments and evidence submitted
by Canada and the European Communities, the Panel concludes that Canada has not
established that the European Communiti es has acted inconsistently with its
obligations under Article 2.2 of the SPS Agreement by applying a general de facto
moratorium on approvals between June 1999 and August 2003.

 (iii) DS293 (Argentina)

 With reference to DS293, and having rega rd to the arguments and evidence submitted
by Argentina and the European Communities, the Panel concludes that Argentina has
not established that the European Commun ities has acted inconsistently with its
obligations under Article 2.2 of the SPS Agreement by applying a general de facto
moratorium on approvals between June 1999 and August 2003.

9. Consistency of the general de facto moratorium on approvals with Article 2.3 of the
SPS Agreement
7.1442 All three Complaining Parties claim that by applying a general de facto moratorium on
approvals, the European Communities has acted incons istently with its oblig ations under Article 2.3
of the SPS Agreement.
7.1443 Article 2.3 of the SPS Agreement provides in relevant part:
"Members shall ensure that their san itary and phytosanitary measures do not
arbitrarily or unjustifiably discriminate between Members where identical or similar
conditions prevail, including between their ow n territory and that of other Members.
Sanitary and phytosanitary measures shall not be applied in a manner which would
constitute a disguised restriction on international trade."
7.1444 The Complaining Parties note that, according to the Appellate Body, in cases where all three
elements under Article 5.5 of the SPS Agreement have been fulfilled, and, therefore, Article 5.5 has
been violated, the relevant SPS measure, by im plication, necessarily violates the more general
obligations set out in Article 2.3.
1267 The Complaining Parties recall their view that the European
Communities has, by maintaining the general de facto moratorium on approvals, acted inconsistently

1267 The Complaining Parties refer to Appellate Body Report, Australia – Salmon, paras. 248-252.

with its obligations under Article 5.5. The Complain ing Parties submit that, in the light of this, the
European Communities has, by implication, also acted inconsistently with its obligations under
Article 2.3.
7.1445 The European Communities argues that certain provisions of the SPS Agreement relate to
the development of SPS measures while others relate to the application of SPS measures.
1268
According to the European Communities, Artic le 2.3 contains obligations concerning the
development of SPS measures, not their applicati on. The European Communities submits that by
challenging the way in which applications are dealt with under the EC approval system, the
Complaining Parties are challenging the applicati on of an SPS measure. The European Communities
therefore considers that Article 2.3 is not app licable to the alleged general moratorium on
approvals.1269
(a) Evaluation
7.1446 The Panel notes that the Complaining Parties' claim under Article 2.3 is in the nature of a
consequential claim. The Complaining Parties submit that an inconsistency with Article 2.3 follows
by implication from a demonstrated inconsistency with Article 5.5. We note that this argument draws
support from Appellate Body jurisprudence, for in Australia – Salmon , the Appellate Body observed
that "a finding of viol ation of Article 5.5 will necessarily impl y a violation of Article 2.3, first
sentence, or Article 2.3, second sentence".1270
7.1447 We have determined above that Article 5.5 is not applicable to the European Communities'
decision to apply a general moratorium on appr ovals and that, consequently, the European
Communities has not acted inconsistently with its ob ligations under Article 5.5 by applying a general
de facto moratorium on approvals between June 1999 and August 2003. Since the European
Communities has not acted inconsistently with Article 5.5, and since the Complaining Parties' claim
under Article 2.3 is premised on the existence of a breach of Article 5.5 by the European
Communities, the Complaining Parties' claim under Article 2.3 cannot succeed.
(b) Conclusions
7.1448 In the light of the above, the Panel reaches the following conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having rega rd to the arguments and evidence submitted
by the United States and the European Co mmunities, the Panel concludes that the
United States has not established that the European Communities has acted
inconsistently with its obliga tions under Article 2.3 of the SPS Agreement by
applying a general de facto moratorium on approvals between June 1999 and August
2003.

1268 The European Communities bases th is view on Article 1.1 of the SPS Agreement, the second
sentence of which provides that SPS measures "shall be developed and applied in accordance with the
provisions of this Agreement" (emphasis added).
1269 It should be noted that the European Communities initially remarked that one could argue on
whether Article 2.3 contains obligations relating to th e application of an SPS measure rather than to its
development. The European Communities submitted that the question could be left open in this case.
1270 Appellate Body Report, Australia – Salmon, para. 252.

 (ii) DS292 (Canada)

 With reference to DS292, and having rega rd to the arguments and evidence submitted
by Canada and the European Communities, the Panel concludes that Canada has not
established that the European Communiti es has acted inconsistently with its
obligations under Article 2.3 of the SPS Agreement by applying a general de facto
moratorium on approvals between June 1999 and August 2003.

 (iii) DS293 (Argentina)

 With reference to DS293, and having rega rd to the arguments and evidence submitted
by Argentina and the European Communities, the Panel concludes that Argentina has
not established that the European Commun ities has acted inconsistently with its
obligations under Article 2.3 of the SPS Agreement by applying a general de facto
moratorium on approvals between June 1999 and August 2003.

10. Consistency of the general de facto moratorium on approvals with Article 7 and
Annex B(1) of the SPS Agreement
7.1449 All three Complaining Parties claim that the European Communities has failed to publish the
existence of the general de facto moratorium on approvals and that it has thereby acted inconsistently
with its obligations under Article 7 and Annex B(1) of the SPS Agreement.
7.1450 Article 7 of the SPS Agreement provides:
"Members shall notify changes in their san itary or phytosanitary measures and shall
provide information on their sanitary or ph ytosanitary measures in accordance with
the provisions of Annex B."
7.1451 Annex B(1) of the SPS Agreement provides:
"Members shall ensure that all san itary and phytosanitary regulations
1271which have
been adopted are published promptly in such a manner as to enable interested
Members to become acquainted with them."
7.1452 The Complaining Parties submit that the general moratorium on approvals is subject to the
publication requirement in Annex B(1). First, the general moratorium is an "adopted" measure as it
has existed since October 1998 and remains in effect. Secondly, the general moratorium is
"applicable generally", in that it has applied to all new biotech products subject to the EC approval
procedures. Thirdly, the general moratorium constitutes a "sanitary or phytosanitary regulation". The
Complaining Parties recall in this regard that, in their view, the de facto general moratorium is an
"SPS measure" and has a similar effect as a law, decree or ordinance. The Complaining Parties
further contend that the existence of the genera l moratorium has not been published, let alone
"promptly". The Complaining Parties argue that by failing to publish promptly the existence of the
general moratorium, the European Communities has acted inconsistently with its obligations under
Annex B(1) and Article 7.

1271 (original footnote) Sanitary and phytosanitary measures such as laws, decrees or ordinances which
are applicable generally.

7.1453 The European Communities argues that Article 7 contains procedural obligations
(publication) regarding an SPS measure. Thus, th e applicability of Article 7 is premised on the
existence of an SPS measure. SPS measur es as defined in Annex A(1) of the SPS Agreement
presuppose the existence of an act. The European Communities submits that the Complaining Parties'
assertions about a moratorium are in reality compla ints about delay in the completion of approval
procedures. Delay of this kind cannot constitute an SPS measure within the meaning of Annex A(1).
Delay is a failure to act in a timely manner. The European Communities deduces from these
considerations that the alleged general moratorium on approvals is not subject to Article 7.
7.1454 The Panel notes that the Complaining Parties alle ge an inconsistency of the general de facto
moratorium on approvals with Anne x B(1) and use the alleged inc onsistency with Annex B(1) to
make a consequential claim of inconsistency under Article 7. Accordingly, we will begin our analysis
with the Complaining Parties' claim under Annex B(1).
(a) "Sanitary and phytosanitary regulations"
7.1455 Annex B(1) applies to "sanitary and phytosan itary regulations" (hereafter "SPS regulations")
which have been "adopted". An explanatory footno te to Annex B(1) indicates that the term "SPS
regulations" should be understood as meaning " [s]anitary and phytosanitary measures such as laws,
decrees or ordinances which are applicable genera lly". That SPS regulations are "SPS measures" is
confirmed by Article 7 which states that Members must notify changes in their "SPS measures" and
provide information on their "SPS measures" "in acco rdance with the provisions of Annex B". It can
be inferred from this that the "SPS regulations" at issue in Annex B(1) are a sub-category of "SPS
measures". Regarding the meaning of the term "SPS measures", we recall Article 1 of the
SPS Agreement. It states that for the purposes of the SPS Agreement, "the definitions provided in
Annex A shall apply". We further note that Article 1.3 of the SPS Agreement states that the annexes
to the SPS Agreement – which include Annex B – are an integral part of the SPS Agreement. This
means that the reference in the footnote to Annex B(1) to "SPS measures" must be interpreted in
accordance with the Annex A(1) definition of the term "SPS measures".
7.1456 It follows from the foregoing that a threshol d issue before us is whether the general de facto
moratorium on approvals was a generally applicable "SPS measure" which had been adopted. It is
clear from our earlier findings that the moratorium on final approvals was applicable generally
inasmuch as it was applicable to all applicati ons which were pending be tween June 1999 and August
2003.
7.1457
 Our earlier findings have also addressed in detail the question of whether the general de facto
moratorium on approvals met the definition of an "SPS measure" set out in Annex A(1). We found
that it was a measure relating to the application, or operation, of the existing EC approval procedures
and that such a measure did not constitute an "SPS measure" within the meaning of Annex A(1).
However, we also stated that in interpreting the term "SPS measure", in addition to the Annex A(1)
definition, account should be taken of the specific cont ext within which that term appears. For this
reason, we now go on to analyse whether the provisions of Annex B(1) render the conclusion we have
reached on the basis of the Annex A(1) definition inappropriate.
7.1458 Annex B(1) read in conjunction with the accompanying footnote provides that a generally
applicable "SPS measure" which has been adopted must be published promptly. We recall that
according to Annex A(1) the term "SPS measures" includes "requirements and procedures". It can be
deduced from this that a generally applicable measure imposing a substantive SPS requirement or
establishing an SPS procedure is to be published, since such a measure would itself be an "SPS
measure". In contrast, neither Annex B(1) nor its accompanying footnote suggests that a generally

applicable measure concerning the administration, or operation, of an SPS measure – such as a
measure providing for a particular operation of an SPS approval procedure – is, also, to be published.
7.1459 Article 7 supports this view. It requires Me mbers to notify changes in their "SPS measures"
and provide information on their "SPS measures". It does not require Members to notify changes in
the administration of SPS measures and provide information on the administration of their SPS
measures.
7.1460 We attach meaning to the absence in the text of Annex B(1) and Article 7 of any reference to
the administration, or operation, of SPS measures. We find instructive in this regard the provisions of
Article 18.5 of the Agreement on Implementation of Article VI of the General Agreement on Tariffs
and Trade 1994 , which parallel those of Article 7. Article 18.5 provides that " [e]ach Member shall
inform the [Anti-dumping] Committee of any changes in its laws and regulations relevant to this
Agreement and in the administration of such laws and regulations" (e mphasis added). In view of the
provisions of Article 18.5, it has to be assumed th at where the publication requirement was intended
to extend to the administration of generally applicab le measures, this was made explicit in the text of
the relevant WTO provision.
1272
7.1461 The Appellate Body in Japan – Agricultural Products II stated that the scope of application of
the publication requirement of Annex B(1) "should be interpreted in the light of [its] object and
purpose".1273 According to the Appellate Body, " [t]he object and purpose of paragraph 1 of Annex B
is 'to enable interested Members to become acquainted with' the sanitary and phytosanitary
regulations adopted or maintained by other Memb ers and thus to enhance transparency regarding
these measures". 1274 We would agree that extending the publication requirement contained in
Annex B(1) to measures concerning the administrati on, or operation, of SPS regulations would serve
the purpose of enhancing transparency. But the object and purpose of Annex B(1) does not entitle us
to expand the scope of the publication requirement negotiated by Members, even if we were to
consider that it might in principle be desirable to do so.
1275 At any rate, the Appellate Body has made
it clear that the principles of treaty interpretation set out in Article 31 of the Vienna Convention
"neither require nor condone the imputation in to a treaty of words that are not there". 1276 As we have
said, neither the text of Annex B(1) nor that of Artic le 7 refers to the administration, or operation, of
SPS regulations or SPS measures.
7.1462 In view of the above considerations, we fi nd our earlier conclusion – that the general de facto
moratorium on approvals was not an "SPS measure" within the meaning of Annex A(1) – to be
appropriate also in the specific context of Annex B( 1) and Article 7. We thus determine that the
general de facto moratorium on approvals was not an "SPS measure" within the meaning of the
footnote to Annex B(1). Consequent ly, we also find that the general de facto moratorium on
approvals was not an "SPS regulation" within the meaning of Annex B(1). This finding in turn makes
it unnecessary for us to consider whether the general de facto moratorium on approvals had been
"adopted" within the meaning of Annex B(1). Since the provisions of Annex B(1) apply only to "SPS
regulations", and since the European Communities' general de facto moratorium on approvals was not

1272 We note that the text of Article 32.6 of the Agreement on Subsidies and Countervailing Measures is
identical to that of Article 18.5 of the Agreement on Implementation of Article VI of the General Agreement on
Tariffs and Trade 1994.
1273 Appellate Body Report, Japan – Agricultural Products II, para. 106.
1274 Ibid., para. 106.
1275 Pursuant to Article 19.2 of the DSU, panels cannot add to the obligations provided in the covered
agreements.
1276 Appellate Body Report, India – Patents (US), para. 45.

an "SPS regulation", it follows that the provisions of Annex B(1) are not applicable to the general
moratorium.
7.1463 We recall that the Complaining Parties seek to establish an inconsistency with Article 7 on the
basis of an alleged inconsistency with Annex B( 1). As we have found that the provisions of
Annex B(1) are not applicable to the general de facto moratorium on approvals, there can be no
inconsistency with these provisions. Under the appr oach followed by the Complaining Parties, there
can then logically be no inconsistency with Article 7 either, even assuming that Article 7 is applicable
to the general moratorium.
7.1464 In connection with the preceding findings, it is well to point out that Annex C(1) of the
SPS Agreement contains additional transparency requirements which apply specifically to the
operation of approval procedures. In particular, Annex C(1)(b) provides that "upon request, the
applicant [must be] informed of the stage of the procedure, with any delay being explained". Thus, to
the extent the application by the European Communities of a general de facto moratorium on
approvals led to delays, the European Communities was under an obligation to explain, upon request
from an applicant, that these delays were the consequence of a general moratorium. Accordingly, the
European Communities was required to provide in formation on the general moratorium to those
directly affected by it. We note that only the United States has alleged that the European
Communities has acted inconsistently with the aforementioned transparency requirement of
Annex C(1)(b) by applying a general de facto moratorium on approvals.
1277
(b) Conclusions
7.1465 In the light of the above, the Panel reaches the following conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having rega rd to the arguments and evidence submitted
by the United States and the European Co mmunities, the Panel concludes that the
European Communities has not acted inc onsistently with its obligations under
Annex B(1) and Article 7 of the SPS Agreement in respect of the general de facto
moratorium on approvals which it applied between June 1999 and August 2003.

 (ii) DS292 (Canada)

 With reference to DS292, and having rega rd to the arguments and evidence submitted
by Canada and the European Communities, the Panel concludes that the European
Communities has not acted inconsistently w ith its obligations under Annex B(1) and
Article 7 of the SPS Agreement in respect of the general de facto moratorium on
approvals which it applied between June 1999 and August 2003.

 (iii) DS293 (Argentina)

 With reference to DS293, and having rega rd to the arguments and evidence submitted
by Argentina and the European Communities, the Panel concludes that the European
Communities has not acted inconsistently w ith its obligations under Annex B(1) and
Article 7 of the SPS Agreement in respect of the general de facto moratorium on
approvals which it applied between June 1999 and August 2003.

1277 See infra, para. 7.1571.

11. Consistency of the general de facto moratorium on approvals with Article 8 and
Annex C(1)(a), first clause, of the SPS Agreement
7.1466 The United States and Canada, but not Argentina, claim that the general de facto moratorium
on approvals has led to a failure by the European Communities to comply with the requirements of
Article 8 and Annex C(1)(a), first clause, of the SPS Agreement.
7.1467 Article 8 of the SPS Agreement provides:
"Members shall observe the provisions of Annex C in the operation of control,
inspection and approval procedures, includi ng national systems for approving the use
of additives or for establishing tolerances fo r contaminants in foods, beverages or
feedstuffs, and otherwise ensure that thei r procedures are not inconsistent with the
provisions of this Agreement."
7.1468 Annex C(1)(a), first clause, of the SPS Agreement provides:
"1. Members shall ensure, with respect to any procedure to check and ensure the
fulfilment of sanitary or phytosanitary measures, that:
(a) such procedures are undertaken and co mpleted without undue delay [...]."
7.1469 The United States argues that the European Communiti es' approval procedures for biotech
products must comply with Article 8 and Annex C(1 )(a), which refers to "undue delay". The United
States notes that the ordinary meaning of "undue" is "inappropriate, unsuitable, improper; unrightful;
unjustifiable[;] [g]oing beyond what is warra nted or natural; excessive; disproportionate".
1278 T h e
United States further notes that the ordinary meaning of "delay" is "hindrance to progress; (a period
of) time lost by inaction or inability to proceed".
1279 Thus, in the United States' view, the ordinary
meaning of "undue delay" under Annex C(1)(a) is th e "unjustifiable" and "excessive" "hindrance" in
undertaking or completing an approval procedure. According to the United States, the ordinary
meaning of "undue delay" suggests that both the re ason for the delay and its duration are relevant
considerations in determining whether the delay is "undue".
7.1470 The United States argues that although it may be difficult in particular cases to decide
whether approval procedures are undertaken without undue delay, an across-the-board suspension of
final approvals must be considered an "undue delay" under Annex C(1)(a). The United States submits
that it has been recognized by EC officials that th ere was no scientific basis for the failure to move
forward under the procedures and timelines pr ovided in the European Communities' own
legislation.1280 The United States also notes that many of the biotech products caught up in the
general moratorium on approvals have been subject to positive assess ments by the lead CA and the
European Communities' own scientific committees.
7.1471 The United States considers that where the Eu ropean Communities' own legislation provides
procedures and timelines for the approval of biot ech products, an indefinite suspension of that

1278 The New Shorter Oxford English Dictionary , L. Brown (ed.) (Clarendon Press, 1993), Vol. II,
p. 3480.
1279 Ibid., Vol. I, p. 623.
1280 The United States refers to the above-mentioned October 2001 news report about a statement
attributed to Environment Commissioner Wallström.

approval procedures, without any scientific justifica tion, must be considered "undue delay" under
Annex C(1)(a). In the light of this, the Unite d States submits that the imposition of a general
moratorium on approvals has resulted in the Eur opean Communities breaching Annex C(1)(a) and, as
a consequence, Article 8.
7.1472 Canada argues that the EC approval procedures su spended by the general moratorium on
approvals are "approval procedures" to "check and ensure the fulfilment of sanitary or phytosanitary
measures" and that the European Communities must therefore comply with Annex C(1)(a). Canada
notes that Annex C(1)(a) requires that the Europ ean Communities both "undertake" and "complete"
the approval procedures without "undue delay". Regarding the term "undertake", Canada submits that
that term should be interpreted in the light of th e steps that WTO Members are obligated to take in
processing an approval application outlined in Annex C(1)(b). Annex C(1)(b) provides that Members
shall ensure that:
"[T]he standard processing period of each procedure is published or that the
anticipated processing period is communicat ed to the applicant upon request; when
receiving an application, the competent body promptly examines the completeness of
the documentation and informs the applicant in a precise and complete manner of all
deficiencies; the competent body transmits as soon as possible the results of the
procedure in a precise and complete manner to the applicant so that corrective action
may be taken if necessary; even when the application has deficiencies, the competent
body proceeds as far as practicable with the procedure if the applicant so requests;
and that upon request, the applicant is inform ed of the stage of the procedure, with
any delay being explained."
7.1473 Thus, in Canada's view, in undertaking an a pproval procedure, the European Communities is
obligated to take the steps outlined in Annex C(1 )(b) in the processing of applications under that
procedure. In respect of the approval of biotech products, the European Communities is obligated to
ensure that an application is exam ined and that the applicant is informed promptly of deficiencies
identified in the application that may hinder progr ess through the procedure. Canada notes that the
European Communities is also obligated to "compl ete" the approval procedures for biotech products.
According to Canada, "complete" in the sense used in Annex C(1)(a) means to take a decision as to
whether or not the biotech product in question will be permitted to be placed on the market.
7.1474 Regarding the term "undue delay", like the Unite d States, Canada considers that the ordinary
meaning of "undue delay" under Annex C(1)(a) is th e "unjustifiable" and "excessive" "hindrance" in
undertaking or completing an approval procedure. Ca nada considers that this interpretation suggests
that both the reason for the delay and its duration ar e relevant considerations in determining whether
the delay is "undue".
7.1475 Canada is of the view that the requirements of Annex C(1)(b) are re levant to determining
whether a delay is excessive. Canada notes that Annex C(1)(b) obligates Members to ensure: that
standard processing times are published; that the competent body promptly examines the applications
for completeness and informs the applicant of defi ciencies; that the competent body transmits the
results of the procedures as soon as possible ; that where there are deficiencies the competent body
proceeds as far as practicable with the procedure; and that any delay is explained to the applicant.
According to Canada, the purpose of Annex C(1)(b) is to ensure that the processing of an application
proceeds as promptly as possible in the circumst ances. Thus, the competent body reviewing the
application is obligated to undertake the specifi c steps outlined in Annex C(1)(b) to process the
application, in particular, the obligation to explain any delay. Canada notes that, to its knowledge, the

European Communities has failed to provide appli cants for biotech products with a justifiable
explanation for the delay in processing biotech approvals.
1281
7.1476 Canada further submits that in the context of A nnex C(1), the justification for a delay must be
consistent with the provisions of the SPS Agreement, namely, that SPS measures must be based on
scientific evidence. Article 2.2 of the SPS Agreement specifically requires that all SPS measures be
"based on scientific principles" and not "maintained without sufficient scientific evidence". Thus, a
delay in undertaking and completing an approval proce dure is "unjustified" if the delay is caused by a
measure that is not based on scientific evidence.
7.1477 According to Canada, there is no sound justifica tion for the European Communities' failure to
undertake and complete the approval procedures for biot ech products. Canada considers that there is
no scientific evidence upon which the general moratorium on approvals is based. Rather, the
moratorium undermines the scientific inquiry require d as a part of the approval procedures. Canada
submits that not only is there no scientific evidence to justify the across-the-board moratorium, for
many of the pending applications there is scien tific evidence from the Eu ropean Communities' own
experts which support the approval of the product in question. Thus, in Canada's view, the delay,
resulting from the moratorium, in undertaking a nd completing the approval procedures for biotech
products is "unjustified" and "excessi ve". Canada considers that the fact that the general moratorium
has been in place for more than five years compounds the excessiveness of the delay.
7.1478 Canada submits that, in the case of the gene ral moratorium, the delay in undertaking and
completing the approval procedures for biotech produc ts was caused by a general suspension of those
procedures. According to Canada, the SPS Agreement does not permit a Member to suspend existing
SPS approval procedures, thereby effectively banni ng products with pending a pplications, every time
that Member seeks to update its legislation. Canada considers that a suspension of an approval regime
may be warranted in some circumstances, for exampl e, if there was credible scientific evidence that
the continued processing of applications under the ex isting regime would give rise to actual risks to
human health or the environment. However, in Ca nada's view, this is not the case here. Canada
submits that the legislative amendments, for the most part, were to implement measures to identify the
occurrence of hypothetical adverse effects or to facilitate the removal of a product from the
marketplace in the unlikely event of a hypothetical risk materializing, e.g., monitoring for
unanticipated adverse effects.
7.1479 For these reasons, Canada is of the view that , as a result of the general moratorium, the
European Communities has failed to undertake and complete its approval procedures for biotech
products without undue delay in viol ation of Annex C(1)(a). Canada further submits that as Article 8
of the SPS Agreement requires Members to observe the provisions of Annex C, the failure by the
European Communities to adhere to the requirements of Annex C(1)(a) to undertake and complete the
approval procedures for biotech product without undue delay violates Article 8.
7.1480 The European Communities accepts that, to the extent it addresses risks coming under
Annex A(1) of the SPS Agreement, the approval system set up under th e relevant EC legislation is a
"procedure to check and ensure the fulfilment of sanitary or phytosanitary measures" within the
meaning of Annex C(1). Regarding the meani ng of the term "undue delay", the European
Communities argues that out of the rather lengthy lis t of meanings of the words "undue" and "delay"
as offered by the New Shorter Oxford English Dictionary , the United States and Canada arbitrarily

1281 Canada notes that the unjustifiable delay to which it refers does not include the time necessary for
the applicant to respond to bona fide questions from the competent authority or bodies responsible for the
approval procedure.

settle on the choice of "an unjustifiable and excessive hindrance". While not objecting to the choice
of "unjustifiable", the European Communities does not see the necessity of adding "excessive", nor
does it agree with the choice of "hindrance" as oppo sed to, for example, "period of time lost by
inaction or inability to pr oceed". It does, however, agree that both the reason for the delay and its
duration are relevant considerations in determining whether any delay is "undue".
7.1481 Regarding Canada's argument based on Annex C(1)(b), the European Communities argues
that the purpose of Annex C(1)(b) is one of transp arency and is not linked in any way to the concept
of "undue" in Annex C(1)(a). Annex C(1)(b) only requires Members to publish the "standard", i.e.,
average or indicative, processing period, or to communicate to the applicant the anticipated processing
period. The European Communities notes that nowhe re does it say that Members must always abide
by the standard processing periods foreseen in their legislation.
7.1482 The European Communities also rejects the United States' argu ment that an "undue delay"
exists when and because the procedural deadlines set forth in the EC legislation have been exceeded.
The European Communities considers it clear from a plain reading of Annex C(1)(a) that the meaning
of the words "undue delay" is not to be inferred from the domestic legislation of the Members. Had
the drafters of the SPS Agreement intended to give the words "undue delay" meaning by reference to
domestic law, they would have used different word ing. The European Communities submits that it is
not the purpose of the SPS Agreement to elevate national legislation to the level of international law.
Equally, it is not the role of the dispute settlement organs (but that of national courts) to enforce that
legislation.
7.1483 The European Communities believes that the qu estion of when a period of time becomes a
delay is a matter of fact to be established on a case-by-case basis. In particular, in the case of
approval procedures for novel products, each specific product presents characteristics and specificities
that are peculiar to it. These al so vary according to the specific habitat/environment in which the
product is to be produced and/or marketed. In th e European Communities' view, the question of time
cannot, therefore, be separated from the scientific is sues associated with an individual product. For
the European Communities, this also confirms that any time-limits provided for in legislation setting
up an approval procedure cannot be but "standard".
7.1484 The European Communities rejects the United Stat es' and Canada's assertion that a delay is
"unjustified" if it is caused by a measure that is not based on scientific ev idence. The European
Communities submits that delays may occur for reasons completely outside the realm of science. The
European Communities offers the example of a case of force majeure: an earthquake destroying the
building of a competent authority including all archives containing the pending applications. In the
European Communities' view, any delays in re -constituting the application files would not be
considered "undue" or "unjustifiable". The Eur opean Communities argues that, for the same reason,
other causes for delay of a non-scientific nature, such as legislative changes or lack of resources, need
to be assessed on their own merits.
7.1485 The European Communities further submits that delays caused by legitimate requests for
additional information are justified and therefore not "undue". In the European Communities' view, it
is legitimate to request additional information necessary for the completio n of a risk assessment
and/or the compliance with certain standards of ri sk management and risk communication which have
been established by a regulator and which apply to the product in question. According to the
European Communities, this applies a fortiori when the product at issue is based on a new technology
which is generally untried and untested and which is recognised by the international community to
have characteristics which inherently require prudence and caution. The European Communities

submits in this regard that the precautionary pr inciple is to be taken into account when assessing
"undueness" under Annex C(1)(a).
7.1486 In relation to the United States' and Canada's as sertions that an unjustified general suspension
of an approval procedure is on its face an "undue delay" within the meaning of Annex C(1)(a), the
European Communities submits that, in the present case, no "undue delays" have occurred in any of
the pending applications. More specifically, none of the relevant applications for the approval of
biotech products has been subject to a "general suspension", and none were stalled in the approval
process. In all cases, there have been scientifically valid reasons to delay the approval procedure.
7.1487 The European Communities argues that what has happened in many of these applications is
that, at different stages of the procedure, request s for additional information have been put to the
applicants. The European Communities submits that all of these requests were related to issues of risk
assessment, risk management and sometimes risk communication concerning the individual product
in question. Those requests were justified on th e basis of standards of risk assessment, risk
management and risk communication which not only the European Communities, but the international
community has endorsed.
1282 Some of the requests focussed on risk issues falling outside the scope,
others on risk issues coming within the scope of Annex A(1) of the SPS Agreement. Some requests
were based on existing legislati on, others on (stricter) requireme nts as set out in the European
Communities' new legislation. Where requests were based on new legislation at a time where that
legislation had not yet entered into force, they were conditioned on the applicant's voluntary
agreement or were slightly delayed to awa it the entry into force of that legislation.
1283 According to
the European Communities, there is nothing unusua l about such an approach, which is common to
many legal systems facing transitional arrangements where one set of rules is to be replaced by
another.
7.1488 Moreover, the European Communities contends that to the extent there were delays,
sometimes this was for reasons lying in the sphere of the applicant. In the European Communities'
view, delays caused by the applicant would be jus tified. Where delays were caused by requests for
additional information, the European Communities considers that only those delays which were
caused by requests focussing on risk issues falli ng within the scope of Annex A(1) of the
SPS Agreement can be reviewed by the Panel in the light of Annex C(1)(a).

1282 The European Communities refers to the example of Codex Alimentarius, Principles for the risk
analysis of foods derived from modern biotechnology (Exhibit EC-44). The European Communities notes that
these Principles provide (i) that "a pre-market safety assessment should be undertaken following a structured
and integrated approach and be performed on a case-by-case basis. The data and information, based on sound
science, obtained using appropriate methods and analysed using appropriate statistical techniques, should be of a
quality and, as appropriate, of a quantity that would withstand scientific peer review" (paragraph 12); (ii) that
"risk management measures may include, as appropriate, food labelling, conditions for marketing approvals and
post-market monitoring" (paragraph 19); and (iii) that "specific tools may be needed to facilitate the
implementation and enforcement of risk management measures. These may includ e appropriate analytical
methods; reference materials" (paragraph 21). The Eu ropean Communities submits that it is clear from the
detailed chronologies submitted by the European Communitie s that the delays – if any – in the processing of
applications for the authorization of GM food under Regu lation 258/97 in most, if not all, cases result either
from the failure or time taken by the applicant in supplying either the qualitatively or quantitatively appropriate
data for the purpose of the safety assessment, and/or the reference materials, and/or the analytical methods
required for the purpose of risk management measures.
1283 In the European Communities' view, the question of whether or not such requests could be made
under the existing legislation is a question of EC law and, as such, a matter for courts in the European
Communities. The European Communities submits that for the Panel, the question is whether such requests are
legitimate under the standards of the SPS Agreement.

7.1489 Further, the European Communities submits th at even if any "undue delays" may have
occurred in the past, which the European Commun ities denies, no such "undue delays" are occurring
under the new EC legislative framework.
7.1490 The Panel notes that the claims by the United States and Canada under Article 8 are in the
nature of consequential claims. The United Stat es and Canada claim that the European Communities
has failed to observe the provisions of Annex C(1)(a ), first clause, and that, as a consequence, the
European Communities has also acted inconsistently w ith the provisions of Article 8. Therefore, the
Panel will begin its analysis with the claims under Annex C(1)(a).
(a) Annex C(1)(a), first clause
7.1491 Annex C(1) establishes obligations "with respect to any procedure to check and ensure the
fulfilment of sanitary or phytosanitary measures". We have determined earlier that Directives 90/220
and 2001/18 as well as Regulation 258/97 (to the exte nt it seeks to prevent novel foods from being a
danger for the consumer) are SPS measures within the meaning of Annex A(1). We have also
determined that Directives 90/220 and 2001/18 as we ll as Regulation 258/97 set out procedures to
check and ensure the fulfilment of one or more SPS requirements the satisfaction of which is a
prerequisite for the approval to place a product on the market. It follows from these previous findings
that the procedures set out in Directives 90/220 and 2001/18 as well as Regulation 258/97 (to the
extent it is an SPS measure) constitute procedures "to check and ensure the fulfilment of sanitary or
phytosanitary measures" within the meaning of A nnex C(1). As such, they are subject to the
provisions of Annex C(1), and notably those of Annex C(1)(a), first clause. Therefore, in accordance
with the provisions of Annex C(1)(a), the Eur opean Communities was required during the relevant
time-period (June 1999 to August 2003) to "undertak e and complete" the approval procedures set out
in Directives 90/220 and 2001/18 as well as Regulati on 258/97 (to the extent it is an SPS measure)
"without undue delay".
7.1492 We understand the United States and Canada to claim that the Eur opean Communities has
failed to undertake and complete its approval proce dures for biotech products without undue delay, as
a result of the adoption and application of the general de facto moratorium on approvals. Thus, the
measure being challe nged is the general de facto moratorium on approvals, since the United States
and Canada allege that the general moratorium has been the cause of undue delays in the processing
of applications under the relevant EC approval legislation.
7.1493 Before evaluating the merits of the claim put forward by the United States and Canada under
Annex C(1)(a), first clause, we address a number of interpretative issues.
(i) Interpretation
7.1494 Annex C(1)(a), first clause, requires Members to ensure that approval procedures are
"undertaken and completed without undue delay". We first consider the meaning of the phrase
"undertake and complete". The verb "undertake" ma kes clear that Members are required to begin, or
start, approval procedures after receiving an application for approval.
1284 The verb "complete", on the

1284 The dictionary meanings of the verb "undertake" include "[t]ake on (an obligation, duty, task, etc.);
commit oneself to perform; begin (an undertaking, enterprise, etc.)". The New Shorter Oxford English
Dictionary, L. Brown (ed.) (Clarendon Press, 1993), Vol. II , p. 3476. The French and Spanish versions of
Annex C(1)(a), first clause, also support this reading. The French version uses the verb "engager", the Spanish
version the verb "iniciar". We also note that Annex C(1)(b) requires Members to ensure, inter alia, that "when
receiving an application, the comp etent body promptly exam ines the completeness of the documentation and

other hand, indicates that approval procedures are not only to be undertaken, but are also to be
finished, or concluded.
1285 Thus, in our view, the phrase "undert ake and complete" covers all stages
of approval procedures and should be taken as meani ng that, once an application has been received,
approval procedures must be started and then carried out from beginning to end.
7.1495 It is clear from the text of Annex C(1)(a), firs t clause, that not every delay in the undertaking
or completion of approval procedures which is caused by a Member is contrary to the provisions of
Annex C(1)(a), first clause. Only "undue" delay is. 1286 Regarding the meaning of the phrase " undue
delay", we consider that of the dictionary meanings of the term "delay" which have been identified by
the United States, there is one which fits naturally with the provisions of Annex C(1)(a), first clause,
namely, "(a period of) time lost by inaction or inability to proceed" 1287. So far as concerns the term
"undue", of the dictionary meanings referred to by the United States we find two to be particularly
relevant in the specific context of Annex C(1)(a), first clause – " [g]oing beyond what is warranted
[… ]" and "unjustifiable". We note that the Unite d States, Canada and the European Communities
have all identified "unjustifiable" as a relevant m eaning of "undue". This view is supported also by
the French version of Annex C(1)(a), first clause, wh ich refers to "retard injustifié". Thus, based on
the ordinary meaning of the phrase "without undue de lay", we consider that Annex C(1)(a), first
clause, requires that approval procedures be undert aken and completed with no unjustifiable loss of
time.
7.1496 According to the United States, Canada and th e European Communities, both the reason for a
delay and its duration are relevant considerations in determining whether a delay is "undue". We
recall in this regard that, in our view, Annex C(1) (a), first clause, requires that there not be any
unjustifiable loss of time. Thus, what matters is whet her there is a legitimate reason, or justification,
for a given delay, not the length of a delay as su ch. Accordingly, if a Member causes a relatively
short, but unjustifiable delay, we do not consider that the mere fact that the delay is relatively short
would, or should, preclude a panel from finding that it is "undue". 1288 Similarly, we do not consider
that a demonstration that a particular approval pr ocedure has been delayed by, say, two years would
always and necessarily be sufficient to establish th at the relevant procedure has been "unduly"
delayed. Having said this, we note that a lengthy delay for which no adequate explanation is provided
might in some circumstances permit the inference that the delay is "undue".
7.1497 In our view, a determination of whether a par ticular approval procedure has been undertaken
and/or completed "without undue delay" must be made on a case-by-case basis, taking account of
relevant facts and circumstances. We therefore consider that it would be neither possible nor useful to
attempt to define the reasons which would render a given delay "undue", and those which would not
render it "undue". Nevertheless, it may be noted that a Member is not legally responsible for delays

informs the applicant in a precise and complete manner of all deficiencies". Thus, it is clear that approval
procedures are "undertaken" upon receipt of an application from an applicant.
1285 The dictionary meanings of the verb "complete" include "[b]ring to an end, finish, conclude". The
New Shorter Oxford English Dictionary , L. Brown (ed.) (Clarendon Press, 19 93), Vol. I, p. 460. The French
and Spanish versions of Annex C(1)(a), first clause, also support this reading. The French version uses the verb
"achever", the Spanish version the verb "ultimar".
1286 Indeed, if this had been the intended result, the text of Annex C(1)(a), first clause, would have
stated that approval procedures must be undertaken and completed "without any delay".
1287 We note that the phrase "inability to proceed" may refer to an objective inability to proceed or a
perceived inability to proceed.
1288 Indeed, we consider that where there is no justification for a delay, the provisions of
Annex C(1)(a), first cl ause, do not permit a Member deliberately to proceed at a de layed pace, even if this is
done for only a short period of time. In addition, we no te that the cumulative effect of a series of short, but
unjustifiable delays could be equally prejudicial to the interests of applicants as the effect of a single, long delay.

which are not attributable to it. Hence, delays attri butable to action, or inaction, of an applicant must
not be held against a Member when a determina tion is made regarding whether that Member has
undertaken or completed approval procedures "without undue delay".
7.1498 Furthermore, it is pertinent to call attention to the introductory paragraph of Annex C(1). It
indicates that approval procedures serve to "check a nd ensure the fulfilment of [SPS] measures". We
consider that if approval procedures serve to ch eck and ensure the fulfilment of SPS requirements,
then Members applying such procedures must in principle be allowed to take the time that is
reasonably needed to determine with adequate confidence whether their relevant SPS requirements
are fulfilled, at least if these requirements are WTO-consistent. Put another way, we view
Annex C(1)(a), first clause, essentially as a good fa ith obligation requiring Members to proceed with
their approval procedures as promptly as possible, ta king account of the need to check and ensure the
fulfilment of their relevant SPS requirements. C onsequently, delays which are justified in their
entirety by the need to check and ensure the fulfilment of a Member's WTO-consistent SPS
requirements should not, in our view, be consider ed "undue". To offer an example, if new or
additional information becomes available at a late stage in an approval procedure and that information
may appropriately be considered to have a poten tial impact on a Member's determination on whether
an application fulfils that Member's relevant SPS re quirements, it might be justifiable for the Member
concerned to delay the completion of the procedure and give itself the additional time needed to
assess the information.
7.1499 On the other hand, to offer another example, if the time taken by a Member to complete an
approval procedure, or a particular stage thereof, ex ceeds the time that is reasonably needed to check
and ensure the fulfilment of its relevant SPS requirements, for instance because the Member
concerned did not proceed as expeditiously as could be expected of it in the circumstances, the delay
caused in this way would, in our view, be "undue". This interpretation of Annex C(1)(a) is supported
by the object and purpose of the SPS Agreement. The fourth preambular paragraph of the
SPS Agreement states that one particular object and purpose of the SPS Agreement is "the
establishment of a multilateral framework of rules and disciplines to guide the [… ] enforcement of
sanitary and phytosanitary measures in order to minimize their negative effects on trade".
Annex C(1)(a), first clause, establishes disciplin es concerning the "enforcement" of SPS measures,
namely, approval procedures. If Annex C(1)(a), firs t clause, were interpreted to mean that Members
need not undertake and complete their approval procedures as soon as possible under the
circumstances, we think the object and purpose of minimizing negative trade effects of approval
procedures could not be achieved.
7.1500 Canada argues that a delay in undertaking a nd completing an approval procedure must be
considered "undue" if the delay is caused by a meas ure which is not based on scientific evidence. We
would agree that delays caused by measures which are not based on scientific evidence may in some
cases be considered "undue".
1289 However, we do not agree that such delays must in all cases be
considered "undue". A delay in undertaking and co mpleting an approval procedure may be caused by
a temporary government shutdown in the wake of a natural disaster or civil unrest. Likewise, if a
Member is confronting an unforeseeable and sharp increase in the number of products submitted for
approval, this could cause a short delay in the pro cessing of some or all pending applications, due to
the need for that Member to reallocate existing reso urces, or to obtain additional resources, to deal

1289 This could be the case, for example, if a dela y is caused by a request for additional information
which has nothing to do with the issue of whether the relevant product meets the SPS requirements concerned.

with the new situation.
1290 In both examples provided, the delay would be caused by government
action, or inaction, which is not supported by sci entific evidence. Yet, in our view, there is a
convincing argument to be made that the delay would be needed for the Member to be able to check
and ensure the fulfilment of relevant SPS requirement s. Therefore, we consider that, in both cases,
the delay in undertaking and completing approva l procedures could properly be viewed as not
"undue" and hence not inconsistent with Annex C(1)(a), first clause.
7.1501 There is one additional aspect of Annex C(1)(a), first clause, which it is appropriate to address
before examining the merits of the claims before us. The phrase "without undue delay" follows the
phrase "undertake and complete". We consider that the phrase "without undue delay" relates, not just
to the immediately preceding verb "complete", but to both elements of the phrase "undertake and
complete". In other words, we consider that Anne x C(1)(a), first clause, should be read as requiring
that Members must "undertake" approval proced ures "without undue delay" and, subsequently,
"complete" them "without undue delay". Were it otherwise, a Member could easily circumvent the
requirement to complete approval procedures wit hout undue delay by causing undue delay in the
undertaking of approval procedures.
7.1502 The view that the phrase "without undue dela y" relates to both elements of the phrase
"undertake and complete" implies that if a Member causes undue delay at any stage in an approval
procedure, this would constitute a breach of the pr ovisions of Annex C(1)(a), first clause. In our
view, there would be a breach of Annex C(1)(a) ev en if the Member concerned completed one or
more previous stages of the approval procedure sooner than could be expected. If, contrary to our
view, a Member could balance undue delay in the comp letion of a particular procedural stage against
a period of time "saved" at an earlier stage in the a pproval procedure, the implication would be that in
some cases a Member could temporarily delay the completion of an approval procedure even though
there is no need to do so. We consider that such an interpretation of Annex C(1)(a), first clause,
would not be supported by the object and purpose of the SPS Agreement. In particular, we consider
that interpreting Annex C(1)(a), first clause, as permitting a Member temporarily to delay the
completion of an approval procedure even when ther e is no need for a delay would not be consistent
with the previously mentioned object and purpose of minimizing negative trade effects of approval
procedures.
(ii) Application
7.1503 We now proceed to examine the claims of " undue delay" presented by the United States and
Canada. As we have observed earlie r, we understand the United States and Canada to claim that, as a
result of the general de facto moratorium on approvals, the European Communities has failed to
undertake and complete its approval procedures for biotech products without undue delay and
therefore has acted inconsistently with the requireme nts of Annex C(1)(a), first clause. As we have
also pointed out, the United States and Canada ar e challenging the general moratorium because they
view it as a measure which has caused undue dela y in the processing of applications under the
relevant EC approval legislation. We recall that, for the purposes of the present dispute, the relevant
EC approval legislation consists of Directives 90/220 and 2001/18 as well as Regulation 258/97.
7.1504 We consider that for the United States' and Cana da's claims to succeed, the United States and
Canada need not establish that each and every appr oval procedure which was pending at some point
between June 1999 and August 2003 (the time-period fo r which we accepted the Complaining Parties'

1290 Needless to say, it is Members' responsibility to allocate sufficient resources to their competent
authorities so that they are in a position to discharge the obligations they have assumed under the WTO
Agreement.

assertion about EC application of a general de facto moratorium on approvals) had been unduly
delayed as a result of the general de facto moratorium on approvals. In our view, for the purposes of
establishing that the European Communities has acted inconsistently with its obligations under
Annex C(1)(a), first clause, it is sufficient for th e United States and Canada to establish that the
general de facto moratorium on approvals caused undue delay in at least one instance, that is to say,
that it caused undue delay in the undertaking or completion of at least one approval procedure
conducted in respect of a biotech product at issue in this dispute.
7.1505 We will begin our analysis by examining wh ether the United States and Canada have
established that at least one approval procedure conducted under Directive 90/220 and/or 2001/18 was
unduly delayed. If this were the case, it would have been established that, as a result of applying a
general de facto moratorium on approvals, the European Communities acted inconsistently with its
obligations under Annex C(1)(a), first clause, a nd we would end our inqui ry under Annex C(1)(a),
first clause. Otherwise, we would go on to ex amine, in addition, whether the United States and
Canada have established that at least one appr oval procedure conducted under Regulation 258/97 was
unduly delayed.
1291
7.1506 Before turning to examine a particular approva l procedure, however, it is well to consider
whether the European Communities' reason for appl ying a general moratorium on final approvals
could provide a justification for any delays wh ich may have occurred in individual approval
procedures as a result of the application of the moratorium.
Reason for general EC moratorium as a justification for delay
7.1507 Initially, we recall that the European Commun ities categorically denied that it applied a
general de facto moratorium on approvals between June 1999 and August 2003.
7.1508 In determining the reason behind the applica tion of the general EC moratorium, we find
instructive the June 1999 declaration by the Group of Five countries. As noted by us previously, the
Declaration states that, pending the adoption of new EC rules ensuring labelling and traceability of
GMOs and GMO-derived products, in accordance with preventive and precautionary principles, the
Group of Five countries will take steps to have any new authorizations for growing and placing on the
market suspended. We infer from this that the Group of Five countries perceived the EC approval
legislation in force at the time as inadequate a nd considered that in these circumstances prudence and
caution warranted the suspension of new final approvals. 1292 Regarding the Commission, we recall
our view that there is nothing to suggest that it unqualifiedly supported the decision of the Group of
Five countries to prevent the final approval of a pplications pending the adopt ion of new EC rules on
labelling and traceability, but that it nonetheless effectively ( de facto) co-operated with the Group of
Five countries by not making full use of the rele vant, mandatory procedures to complete the approval
process.
7.1509 Furthermore, we note the European Communities' assertion before this Panel that during the
relevant time period (June 1999 to August 2003) rele vant science was evolving and in a state of flux,

1291 It is useful to recall that regardless of the numbe r of approval procedures we need to examine in
order to reach a conclusion on whether the application of the general EC moratorium on approvals has led to a
breach of the provisions of Annex C(1)(a), first clause , there are numerous approval procedures which we are
required to address in the light of the provisions of Annex C(1)(a), first clause, as part of our evaluation of the
Complaining Parties' product-specific claims. See infra, Section VII.E.
1292 We recall our view that the June 1999 declaration by the Group of Five countries was intended to
also apply to applications concerning biotech products submitted for approval under Regulation 258/97.

and that the European Communities therefore a pplied a prudent and precautionary approach to
identifying, assessing and managing risks to human h ealth and the environment arising from biotech
products for which marketing approval had been sought.
7.1510 In view of these elements, we will address belo w whether (i) the perceived inadequacy of
then-existing EC approval legisla tion and (ii) evolving science and the application of a prudent and
precautionary approach would provide a justification for delays which might have occurred as a result
of the application of the general EC moratorium on final approvals.
Perceived inadequacy of EC approval le gislation in force between June 1999 to
August 2003
7.1511 We turn first to address the perceived inadequ acy of the EC approval legislation in force
between June 1999 to August 2003. As is clear from the June 1999 declaration by the Group of Five
countries, the perceived inadequacy of the then-existing EC approval legislation related to the absence
of EC-level legislation ensuring labelling and traceability of GMOs and GMO-derived products.
1293
The concern appears to have been that under the existing EC approval legisl ation it was not possible
for the European Communities to impose, as a condition attached to the granting of marketing
approval for GMOs and GMO-derived products, ad equate requirements regarding the labelling and
traceability of these products.
7.1512 Thus, the issue presented is whether it was jus tifiable for the European Communities to delay
the completion of its approval procedures until the date of adoption of the new EC legislation
ensuring labelling and traceability of GMOs and GMO-derived products.1294 In addressing this issue,
we note at the outset that, during the relevant time period (June 1999 to August 2003), approval
legislation was in force in the European Communiti es. As the European Co mmunities has repeatedly
stated, the application of the approval legislation in question had never been suspended by a formal
EC decision, e.g., by the Commission or the Council and Eur opean Parliament. Nor had the granting
of final approvals ever been suspended by a formal EC decision.
7.1513 We have stated above that in principle the European Communities was entitled, in conducting
approval procedures concerning the biotech products at issue in this dispute, to take the time
reasonably needed to determine with adequate confidence whether its relevant SPS requirements were
fulfilled. However, given that the new legisla tion on labelling and traceability was not adopted until
September 2003, any requirements set out therein were not EC requirements the fulfilment of which
the European Communities could have checked dur ing the relevant time pe riod (June 1999 to August
2003).1295 Furthermore, the lack of EC-level legislation ensuring labelling and traceability did not
affect the European Communities' ability to check the fulfilment of its existing SPS requirements.
Finally, even if the European Communities consid ered that new and additional requirements relating
to labelling and traceability needed to be imposed as conditions attached to approval decisions, to
ensure the fulfilment of existing SPS requirements ( e.g., the requirement to avoid long-term adverse

1293 We recall that both Directives 90/220 (and su bsequently Directive 2001/18) and Regulation 258/97
contained labelling provisions, and that Directive 2001/18 imposed a traceab ility obligation on member States.
However, these provisions were considered inadequate.
1294 We recall that the new legislation in question was not adopted until September 2003.
1295 We note that Annex C(1)(h) of the SPS Agreement refers to "applicable" SPS regulations with
which compliance is to be ensured. We further note that the European Communities did not claim that it
effectively imposed the requirements later included in the new EC legislation. Rather, the European
Communities stated that it sought voluntary commitments from applicants which would have ensured the
labelling and traceability of GMOs and GMO-derived products.

effects on the environment), there is no reason for be lieving that the need for, and modalities of, such
conditions could only be established in September 2003.
7.1514 Thus, we are of the view that delays in th e completion of approval procedures which might
have occurred as a result of the lack of EC-lev el legislation ensuring labelling and traceability of
GMOs and GMO-derived products woul d not have been delays which we re justified by the need to
check and ensure the fulfilment of the European Communities' relevant SPS requirements.
7.1515 If the European Communities considered that it was important not to grant final approvals
without imposing additional requirements of the t ype set out in the new EC legislation ensuring
labelling and traceability of GMOs and GMO-derived pr oducts, it was open to it to try to obtain from
applicants either voluntary commitments or a request for suspension of the relevant approval
procedure pending the adoption of the new EC legislation.
1296 Alternatively, it could have imposed
such requirements as conditions attached to appr oval decisions, provided the imposition of such
requirements was WTO-consistent. We note the possi bility that the existing EC approval legislation
did not provide a clear or sufficient legal basis for imposing such new and additional requirements
relating to labelling and traceability of GMOs and GMO-derived products, and that imposing such
requirements might have exposed the European Communities to the risk of a domestic legal
challenge. However, the European Communities has repeatedly told this Panel that it should not
enforce EC law, and that the issue of compliance of certain EC action, or inaction, with EC law was a
matter for EC courts to address, not this Panel. We agree and consider that following the same logic
we should not make our determina tion of EC compliance with the requirements of Annex C(1)(a),
first clause, turn on whether or not EC law pe rmitted the European Communities to impose the new
and additional requirements regarding labelling and traceability prior to the entry into force of the new
legislation. The constraints imposed by EC law would not provide a justification for delays which
might have occurred for this reason in the completion of approval procedures.
7.1516 Two further considerations militate in favour of our view that the lack of legislation ensuring
labelling and traceability of GMOs and GMO-deri ved products would no t have provided an eo ipso
justification for delays which might have occurre d for this reason in the completion of approval
procedures. To begin with, putting in place new le gislation is by nature a time-consuming process
which not infrequently takes one or more years to complete.
1297 The European Communities itself
stated that completing and updating its legislation "inevitably took quite some time to be completed in
the light of the serious social and political debate on the issues linked to GMOs and GM food
production".1298 We also note the EC statement that legislation concerning GMOs and GMO-derived
products needs to keep pace with the "constant e volution of the scientific and regulatory debate" 1299
on these products, which suggests that a need for re gular adjustment and amendment of relevant
legislation is to be expected. The evolution of re levant EC legislation would appear to support this
statement. In these circumstances, we are concerned that if a Member could suspend and,
consequently, delay the granting of final approvals essentially every time it completes and updates its
approval legislation, there might be frequent a nd long periods of time dur ing which final approval
decisions are suspended. Incidentally, given the time required to revise legislation, a need for further
revision and updating might in some cases be identifie d even before the previous revision has made
its way through the legislative process.

1296 The record shows that the European Communities did so in a number of approval procedures.
1297 We note that proposals for new legislation need to be elaborated, the legislation needs to be passed
by the legislature and, in some countries, there may also be a need for a popular vote on the legislation before it
can be finally adopted.
1299 Ibid.

7.1517 The other consideration to be noted relates to th e use of procedural delay as an instrument to
manage or control risks. It is useful to illustrate this using an example. Fo r instance, if the European
Communities delayed the completion of a particular approval procedure because existing legislation
precluded it from imposing a traceability requirem ent for a GMO which would facilitate the
withdrawal of the product in the event of unforeseen adverse effects on human health or the
environment, the European Communities would effec tively use procedural delay as a substitute for a
substantive risk management measure (the traceabil ity requirement) that would not be imposable
under existing approval legislation. In our view, however, the pursuit of a risk management objective
would not justify a delay in the completion of an approval procedure and hence would be inconsistent
with Annex C(1)(a), first clause. If procedural de lay could be used, directly or indirectly, as an
instrument to manage or control risks, then Memb ers could evade the obligations to be observed in
respect of substantive SPS measures, such as Articl e 5.1, which requires that SPS measures be based
on a risk assessment. Clearly, we cannot interpre t Annex C(1)(a), first clause, in a manner which
would nullify or impair the usefulness and in tended effect of other provisions of the SPS Agreement.
Indeed, as we see it, a central purpose of Annex C(1)(a), first clause, is precisely to prevent a situation
where Members avoid the substantive di sciplines which Articles 2 and 5 of the SPS Agreement
impose with respect to substantive SPS decisions by not reaching final substantive decisions on
applications for marketing approval.
7.1518 In the light of the above, we conclude that th e lack of EC legislation ensuring labelling and
traceability of GMOs and GMO-derived products woul d not have provided a justification for delays
which might have occurred for this reason between June 1999 and August 2003 in the completion of
approval procedures.
Evolving science and application of a prudent and precautionary approach
7.1519 We now turn to consider whether evolving sci ence and the consequent application by the
European Communities of a prudent and precautionary approach would provide a justification for
delays which may have occurred due to the Euro pean Communities' general suspension of final
approvals between June 1999 and August 2003.
7.1520 According to the European Co mmunities, GMOs are characteriz ed by scientific complexity
and uncertainty. The European Communities c ontends that during recent years scientific
understanding of, and knowledge about, risks po tentially arising from GMOs and GMO-derived
products has evolved, but remains incomplete. The European Communities notes that many questions
remain unanswered, and that there is limited experience with GMOs in terms of time and quality. The
European Communities points out in this regard th at only very few systematic studies have so far
been conducted on indirect and long-term effects of large-scale cultivation of GMOs.
7.1521 The European Communities observ es that, in view of the fact that the underlying science is
still in a great state of flux, it has chosen to apply a prudent and precautionary approach to identifying,
assessing and managing risks to human health a nd the environment arising from GMOs and GMO-
derived products for which marketing approval has been sought.
7.1522 As an initial matter, we note that, in our view , Annex C(1)(a), first clause, does not preclude
the application of a prudent and precautionary a pproach to identifying, assessing and managing risks
to human health and the environment arising fro m GMOs and GMO-derived products. As we have
said, we consider that Annex C(1)(a), first clause, allows a Member to take the time that is reasonably
needed to determine with adequate confidence wh ether its relevant SPS requirements are fulfilled.
Consistent with this, we consider that a Member which finds it appropriate to follow a prudent and
precautionary approach in assessing and approving ap plications concerning GMOs and GMO-derived

products, might, for instance, be justified in reques ting further information or clarification of an
applicant in a situation where another Member consid ers that the information available is sufficient to
carry out its assessment and reach a decision on an application.
1300 Whether a particular request is a
reflection of genuine caution and prudence or whethe r it is a pretext to delay the completion of an
approval procedure would need to be determined in the light of all relevant facts and circumstances.
7.1523 It is apparent from the foregoing observations th at we perceive no inherent tension between
the obligation set out in Annex C(1)(a), first clau se, to complete approval procedures without undue
delay and the application of a prudent and precautionary appro ach to assessing and approving GMOs
or GMO-derived products. Nevertheless, it is clear that application of a prudent and precautionary
approach is, and must be, subject to reasonable li mits, lest the precautionary approach swallow the
discipline imposed by Annex C(1)(a), first clau se. Indeed, if a Member could endlessly defer
substantive decisions on the grounds of a percei ved need for caution and prudence in the assessment
of applications, Annex C(1)(a), first clause, would be devoid of any meaning or effect. In applying
the provisions of Annex C(1)(a), first clause, it is therefore important always to bear in mind that
Annex C(1)(a), first clause, implies as a core oblig ation the obligation to come to a decision on an
application.
7.1524 The European Communities argues that in the case of applications concerning GMOs and
GMO-derived products it is difficult to come to a decision, in view of evolving science and a body of
available scientific information and data that is s till limited. Even if we were to accept this as an
accurate description of the situation as it prevaile d between June 1999 and August 2003, we consider
that in the light of the provisions of Annex C(1)(a), first clause, this situation in and of itself would
not warrant delays in the completion of approval procedures.
7.1525 We note in this regard that if relevant scientif ic evidence were insufficient to perform a risk
assessment as defined in Annex A(1) of the SPS Agreement and as required by Article 5.1 of the
SPS Agreement, pursuant to Article 5.7 of the SPS Agreement, a Member may provisionally adopt an
SPS measure on the basis of available pertinent information.
1301 Contrariwise, in situations where
relevant scientific evidence is sufficient to perform a risk assessment, a Member must base its SPS
measure on a risk assessment. Of course, the mere fact that relevant scientific evidence is sufficient to
perform a risk assessment does not mean that the re sult and conclusion of the risk assessment are free
from uncertainties ( e.g., uncertainties linked to certain assumptions made in the course of the
performance of a risk assessment). Indeed, we c onsider that such uncertainties may be legitimately
taken into account by a Member when determin ing the SPS measure, if any, to be taken. 1302 In view
of these uncertainties, a given risk assessment may we ll support a range of possible measures. Within
this range, a Member is at liberty to choose th e one which provides the best protection of human
health and/or the environment, taking account of its appropriate level of protection, provided that the
measure chosen is reasonably s upported by the risk assessment a nd not inconsistent with other
applicable provisions of the SPS Agreement, such as Article 5.6.
7.1526 As is clear from the preceding paragraph, evolving science, scientific complexity and
uncertainty, and limited available scientific informatio n or data are not, in and of themselves, grounds
for delaying substantive approval decisions, and that the SPS Agreement does not envisage that
Members in such cases defer making substantive SPS d ecisions. Indeed, even in cases where relevant
scientific evidence does not permit the performance of a risk assessment, the SPS Agreement

1300 We recall that pursuant to Annex C(1)(c) of the SPS Agreement information requirements must be
limited to what is necessary for appropriate approval procedures.
1301 For further analysis and explanation of the provisions of Article 5.7, see infra, Section VII.F.
1302 For further analysis and explanation of the provisions of Article 5.1, see infra, Section VII.F.

envisages that Members take substantive SPS decisions . Certainly, such factors as evolving science
and limited availability of scientific evidence affe ct the confidence which Members can have in the
results of their assessments. But th ey do not inherently affect a Member's ability to reach substantive
decisions on an application, particularly since a Me mber may take account of such factors in reaching
substantive decisions.
7.1527 It is quite possible that in the situation described by the European Communities where science
evolves and there is limited available scientific ev idence, a deferral of substantive decisions might
allow for better decisions at a later point in time, provided that appropriate analyses and research are
undertaken. However, we do not consider that Annex C(1)(a), first clause, can or should be
interpreted to allow Members to go into a sort of holding pattern while they or other entities undertake
research with a view to obtaining additional scientif ic information and data. As we have stated
earlier, the core obligation implied by Annex C(1)(a ), first clause, is for Members to come to a
substantive decision. This view is entirely co nsistent, and fits well with the aforementioned
provisions of Article 5.1 and Article 5.7.
1303 It is important to note in this regard that the
SPS Agreement nowhere states that substantive decisions on applications need to give a straight yes or
no answer to applicants. Members may in principl e grant time-limited approvals or approvals subject
to other appropriate conditions. Alte rnatively, they may in principle decide to reject an application
subject to the possibility of a review of that deci sion if and when relevant circumstances change.
Relevant circumstances could incl ude the state of scientific knowledge. Thus, there is no reason to
consider that our interpretation of Annex C(1)(a), first clause, would prejudice Members' ability to
take differentiated, proportiona te action to protect human health and/or the environment from
potential risks arising from GMOs or GMO-derived products.
7.1528 The European Communities argues that it did not go as far as certain other States (or parts of
States) which actually adopted outright bans on trade in, and cultivation of, GMOs and/or GMO-
derived products. We accept that in certain circum stances an applicant might conceivably prefer it if
instead of making a prompt, but negative final appr oval decision, the European Communities held off
on making a final approval decision and undertook fu rther analysis, etc., which might lead to a
positive approval decision. However, in our view, this does not provide a justification for delays
which might have occurred as a result of the Europe an Communities' decision unilaterally to suspend
all final approval decisions. If a Member consider s that a delay in the completion of an approval
procedure might allow for a positive decision, it can communicate this assessme nt to the applicant
which can then decide whether to accept a delay and ask for a suspension of the approval procedure.
7.1529 In view of the foregoing considerations, we do not consider that the mere fact that science
may have been evolving during the relevant tim e period (June 1999 to August 2003) and the
consequent adoption by the European Communities of a prudent and precautionary approach would
provide a justification for delaying the completi on of approval procedures by imposing a general EC
moratorium on final approvals.
Conclusion
7.1530 We have concluded that (i) the perceived inade quacy of the existing EC approval legislation
and (ii) evolving science and the application of a prudent and precautionary approach would not

1303 Indeed, if a Member could delay a final approval decision on the grounds that available scientific
evidence is insufficient, that Member could avoid the disciplines imposed by Article 5.7, including the
requirement to seek to obtain additional information and to conduct a review of a provisional measure within a
reasonable period of time.

provide a justification for delays which might have occurred as a result of the application of the
general EC moratorium on final approvals.
7.1531 This conclusion does not imply, however, that the general EC moratorium on final approvals
led to undue delay in the undertaking or completion of particular approval procedures. Therefore, our
conclusion above does not dispense with the need to go on to examine whether the general EC
moratorium led to undue delay in the undertaking or completion of at least one approval procedure
conducted under Directive 90/220 and/or 2001/18.
7.1532 Before undertaking this task, we wish to note that our conclusion above should not be
construed to mean that it would under no circumstances be justifiable, in the light of the provisions of
Annex C(1)(a), first clause, to delay the comple tion of approval procedur es by imposing a general
moratorium on final approvals of biotech products. We consider that there may conceivably be
circumstances where this could be justifiable. Fo r instance, if new scientific evidence comes to light
which conflicts with available scientific evidence and which is directly relevant to all biotech products
subject to a pre-marketing approval requireme nt, we think that it might, depending on the
circumstances, be justifiable to suspend all final approvals pending an appropriate assessment of the
new evidence. The resulting delay in the completion of approval procedures might then be considered
not "undue".
Approval procedure concerning MS8/RF3 oilseed rape

7.1533 We now turn to examine whether the United St ates and Canada have established that the
general de facto moratorium on approvals le d to undue delay in the undertaking or completion of a
particular approval procedure cond ucted under Directive 90/220 and/or 2001/18. The United States
and Canada did not express a view on which of the many relevant approval procedures conducted
under Directive 90/220 and 2001/18 we should examine fi rst. For the sake of efficiency, we have
decided to begin our examination with the appr oval procedure concerning MS8/RF3 oilseed rape,
since both the United States and Canada have al so presented a product-specific claim that the
completion of this particular approval proce dure has been unduly delayed, contrary to the
requirements of Annex C(1)(a), first clause. We will analyse these product-specific claims in
Section VII.E below, when we address the various product-specific measures being challenged by the
Complaining Parties.
Relationship of the approval procedure conducted under Directive 90/220 and that
conducted under Directive 2001/18
7.1534 Prior to considering whether the approval pr ocedure concerning MS8/RF3 oilseed rape has
been unduly delayed as a result of the general de facto moratorium, we need to address the fact that
like many other approval procedures, the approval procedure concerning MS8/RF3 oilseed rape was
begun under Directive 90/220 but not completed by the date of repeal of Directive 90/220 (17 October
2002). To recall, applications which were pending on the date of repeal of Directive 90/220 (17
October 2002) became subject to Directive 2001/18 a nd therefore had to be "complemented" by the
applicant in the light of the provisions of Directive 2001/18. If the applicant did so by a specified
deadline (17 January 2003), approval procedures we re to be undertaken in accordance with the

provisions of Directive 2001/18.
1304 In the case of MS8/RF3 oilseed rape, approval procedures were
undertaken under Directive 2001/18 after the applicant had complemented its application.1305
7.1535 The question arises whether approval pro cedures undertaken under Directive 2001/18 in
respect of applications which had previously b een assessed under Directive 90/220 should be viewed
as new approval procedures or as a continuation of the approval procedures which were not completed
under Directive 90/220. In considering this issue, we find instructive that applications which were
pending on the date of repeal of Directive 90/22 0 had to be "complemented" in accordance with
Directive 2001/18. According to the European Co mmunities, this means that applicants had to
provide certain additional information as required und er Directive 2001/18. They did not need to re-
submit their applications in their entirety. This co ntention is consistent with the ordinary meaning of
the term "complement". The European Communities further told the Panel that in principle a new
assessment under Directive 2001/18 was required only for the additional information submitted in
accordance with Directive 2001/18. Based on these elements, we cons ider that approval procedures
undertaken under Directive 2001/18 in respect of ap plications which had previously been assessed
under Directive 90/220 were a continuation of th e approval procedures previously conducted under
Directive 90/220.
7.1536 The factual determination that an approval procedure not completed under Directive 90/220
was continued under Directive 2001/18 if the applican t complemented its application leads us to the
view that, for the purposes of Annex C(1)(a), first clause, an approval procedure begun under
Directive 90/220 and continued under Directive 2001/18 constitutes one single approval procedure. It
follows that for the purposes of our inquiry under A nnex C(1)(a), first clause, it is not necessary to
distinguish between undue delays which may have occurred in the processing of an application under
Directive 90/220 and undue delays which may have occurred when the procedure was continued
under Directive 2001/18. In either case, the rele vant approval procedure would have been unduly
delayed. Accordingly, we cons ider that in the case of the approval procedure concerning MS8/RF3
oilseed rape, a failure to observe the provisions of Annex C(1)(a), first clause, can be established on
the basis of the impact of the general moratori um on that approval procedure when it was conducted
pursuant to the provisions of Directive 90/220. Likewise, a failure to observe the provisions of
Annex C(1)(a), first clause, can be established on the basis of the impact of the general moratorium on
the approval procedure concerning MS8/RF3 oilseed rape when it was conducted pursuant to the
provisions of Directive 2001/18.
Adoption of Directive 2001/18 as a justification for delay
7.1537 An additional issue relating to the revision of Directive 90/220 which we briefly need to
consider is whether the adoption in March 2001 of Directive 2001/18 could have justified delaying the
completion of approval procedures conducted under Di rective 90/220 so that as of October 2002 they
would become subject to the new provisions of Directive 2001/18.
7.1538 We note that this issue is similar to the one we have already examined above concerning the
lack of EC-level legislation ensuring labelling and traceability of GMOs and GMO-derived products,
and we therefore offer only a few additional observations.

1304 Article 35 of Directive 2001/18. None of the Complaining Parties questioned the WTO-
consistency of Article 35.
1305 It should be noted, however, that in the case of MS8/RF3 the applicant had voluntarily updated its
Directive 90/220 application to comply with requiremen ts set out in Directive 2001/18 even before the entry
into force of Directive 2001/18.

7.1539 We have stated above that in principle the European Communities was entitled, in conducting
approval procedures concerning the biotech products at issue in this dispute, to take the time
reasonably needed to determine with adequate confidence whether its relevant SPS requirements were
fulfilled. However, given that Directive 2001/18 did not enter into force until October 2002, any
requirements set out therein were not, in our vi ew, EC requirements the fulfilment of which the
European Communities needed to ch eck and ensure as of March 2001 in order to complete approval
procedures pending under Directive 90/220, the Directive in force at the time.
1306 We further note that
the European Communities did not claim that it effectively imposed the requirements of
Directive 2001/18 as of the time of their adoption in March 2001. 1307 Rather, the European
Communities stated that it sought voluntary commitments from applicants.
7.1540 Thus, we consider that the adoption in Ma rch 2001 of Directive 2001/18 could not have
justified delaying the completion of approval pro cedures conducted under Directive 90/220 so that as
of October 2002 they would become subject to th e new provisions of Directive 2001/18, given that
such delay would not have been needed to chec k and ensure the fulfilment of the European
Communities' relevant SPS requirements. However, we consider that in those cases where approval
procedures could not be completed while Directive 90 /220 was still in force, delays in the completion
of these procedures might have been justifiable.
Examination of the approval procedure concerning MS8/RF3 oilseed rape
7.1541 With the preceding observations in mind, we now turn to examine whether the approval
procedure concerning MS8/RF3 oilseed rape has been unduly delayed, and if so, whether this was as a
result of the application of the general de facto moratorium, as the United States and Canada claim.
7.1542 The United States initially argued that the progress of the application concerning MS8/RF3
oilseed rape stalled when the Commission refused to submit a draft measure to the Regulatory
Committee as required by the approval process. Late r, the United States argued that the Regulatory
Committee twice failed to vote on a draft measure, and that after the second attempt the Commission
never submitted a draft measure to the Regulatory Co mmittee again. The United States submits that
the resulting delay was undue.
7.1543 The United States submits, in addition, that before the European Communities adopted its
moratorium, all approval procedures under Directiv e 90/220 were undertaken and completed in less
than three years. In contrast, the application concerning MS8/RF3 oilseed rape had been pending for
almost seven years on the date this Panel was esta blished. The United States contends that although
time alone is not dispositive, in the light of the ackno wledgement by EC officials of the existence of a
moratorium on approvals, this delay in comple ting the approval procedure concerning MS8/RF3
oilseed rape is undue.

1306 We note that Annex C(1)(h) of the SPS Agreement refers to "applicable" SPS regulations with
which compliance is to be ensured. We further note that the European Communities did not claim that it
effectively imposed the requirements later included in the new EC legislation. Rather, the European
Communities stated that it sought voluntary commitments from applicants which would have ensured the
labelling and traceability of GMOs an d GMO-derived products. Finally, we note that if the European
Communities effectively imposed such requirements, then compliance would these requirements should have
resulted in the completion of relevant approval procedures. However, the record does not indicate that this was
the case.
1307 We note that if the European Communities had effectively imposed such requirements, then
compliance would these requirements should have resulted in the completion of relevant approval procedures.
However, the record does not indicate that this was the case, even though ther e were applicants which
voluntarily complied with requirements set out in Directive 2001/18.

7.1544 Canada submits that the applicant proposed and c ontinuously revised its risk management
measures in response to concerns expressed by member States, the SCP and the Commission.
Regardless of these efforts by the applicant, the proc essing of the application has been delayed, which
Canada believes demonstrates that the European 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.
7.1545 Canada argues that since the application went to the Community level, member States took
approximately 12 months to put forth their objections to the application, and after the SCP issued its
positive opinion on the application, the European Communities took another 12 months to address
recommendations contained in the SCP opinion, including a monitoring plan. Although the
application was discussed at the Regulatory Committee in the summer of 1999, no vote was taken.
Canada notes that in August 1999 the applicant proposed to voluntarily agree to meet the
requirements of the Council's June 1999 Common Position. On the basis of these commitments, the
Commission invited the applicant to present its proposal to the Regulatory Committee in October
1999. However, while the Regulatory Committee agai n considered the proposal, it failed to hold a
vote. Subsequently, the applicant made further proposals as a further attempt to address concerns
expressed by member States. However, although the matter went yet again before the Regulatory
Committee in March 2000, it failed to hold a vote.
7.1546 Canada also claims that any delay in the co mpletion of the approval procedure following the
failure of the Regulatory Committee to adopt the draft measure approving MS8/RF3 oilseed rape in
March 2000 should be considered "undue". Canada notes in this regard the efforts made by the
applicant to respond to further requests by the lead CA. Canada observes th at while the lead CA
finally accepted the applicant's proposed post-marke ting monitoring plan and agricultural guidelines
in May 2002, the European Communities provided no information to explain the delay between May
2002 and early January 2003, when the applicant s ubmitted a further updated dossier under Article 35
of Directive 2001/18.
7.1547 Finally, Canada observes that more than ei ght years after the application was initially
submitted for approval to the lead CA in 1996 and more than six years after the SCP issued its opinion
in May 1998, MS8/RF3 oilseed rape remains un approved either for import and processing or
cultivation, despite reasonably available risk mana gement measures. Canada submits that by any
reasonable standard, the extraordinary length of tim e to process this application constitutes "undue
delay".
7.1548 The European Communities argues that the United States is mistaken in saying that the
Commission failed to submit a draft measure to the Regulatory Committee. The Commission
launched a voting procedure in the Regulatory Committee in June 1999, and the Regulatory
Committee met twice on the matter. According to the European Communities, the Regulatory
Committee did not vote on 9 March 2000 because Italy rai sed scientific issues regarding the effects of
the product in question on biogeochemical cycles and on food chains and the likelihood of spreading.
The European Communities also stat es that in May 2001, the applicant modified the scope of its
application, and that after that, the application pro ceeded with further submissions by the applicant of
additional information.
7.1549 Canada notes that Italy's questions had already b een addressed in the application dossier and
by the SCP. Further, the attempts to raise c oncerns about impacts of herbicide use on farmland
biodiversity inappropriately linked co ncerns related to herbicide use to approval of a seed variety.
Canada notes that: 1) for all other seed varieti es, seed approval legislation is distinct from the
pesticide approval legislation; 2) herbicide use is one of many factors that may have an impact on

farmland biodiversity; and 3) EC member States have actually authorized the use of glufosinate-
ammonium for general use as well as for specific use on genetically modified herbicide-tolerant crops.
Canada also counters that the European Communities fails to point out that the submission of further
information by the applicant was necessary because the information requirements were either unclear
or changing.
7.1550 The Panel begins its analysis by addressing the United States' and Canada's arguments
concerning the Commission's failure to re-convene the Regulatory Committee for a further meeting.
7.1551 We recall in this regard that the Regulatory Committee met twice, on 29 October 1999 and on
9 March 2000, to consider a draft measure submitte d by the Commission. No vote was taken on the
draft measure at either meeting and the Regulator y Committee did not meet again for another attempt
at taking a vote on the application.
7.1552 The record does not indicate why the Regulat ory Committee did not proceed to a vote on
MS8/RF3 oilseed rape at the March 2000 meeting.
1308 One reason may have been a request for
information from the Italian CA. Italy transmitte d its request to the lead CA on 14 March 2000, and
the lead CA then forwarded it to the applicant. 1309 In November 2000 the applicant provided the lead
CA with answers to the questions raised by Ital y indicating that all the issues raised had been
previously addressed by the SCP as well as the update of the application provided by the applicant in
November 1999. This communication was also circulated to the other CAs and the Commission.1310
7.1553 It should further be noted that in June 2001 the applicant sent a letter to the lead CA which
clarified certain aspects of the application, including its scope. There is no indication that this
clarification had been requested. However, the a pplicant's letter noted that following the March 2000
meeting of the Regulatory Committee th e clarification appeared necessary. 1311 In a separate letter of
the same date, "following the revision of Directive 90/220/EEC", the applicant also submitted updated
information to the lead CA, including an update d environmental risk assessment, a post-market
monitoring plan, agricultural guidelines, additional information regarding id entification and labelling
and information for the public concerning the product in question. 1312 The letter stated that this
information confirmed that the application was already "in line with the main provisions" of
Directive 2001/18, which had been adopted in March 2001. The letter requested the lead CA to
inform the other member States about the new se t of documents at the next Regulatory Committee
meeting.
1313 There is no indication that the lead CA ev er forwarded the new documents to the other
member States and the Commission. A meeting of CAs was held two weeks after the applicant
submitted the additional info rmation, but the Panel has no inform ation about what was discussed at
that meeting. It is clear from the record, however , that the lead CA confirmed receipt of the new
documents only in July 2001. The lead CA info rmed the applicant that it had forwarded the
documents to the relevant scientific committee of the Belgian Biosafety Council (hereafter the
"BBC") for an opinion.1314 No reason was given for why an opinion had been requested.

1308 The record contains a summary of the conclusi ons for the October 1999 Regulatory Committee
meeting, but not for the March 2000 meeting.
1309 Exhibit EC-63/At. 87. This fax of 14 March 2000 from the Italian CA to the lead CA specifically
"refer[s] to the conclusion of the last meeting of the Regulatory Committee meeting".
1310 Exhibit EC-63/At. 89 and 90.
1311 Exhibit EC-63/At. 92.
1312 Exhibit EC-63/At. 91.
1313 Ibid.
1314 Exhibit EC-63/At. 93.

7.1554 The Panel notes that after the March 2000 meeting of the Regulatory Committee, it was
incumbent on the Commission to take action. Specifically, Article 21 of Directive 90/220 indicates
that the action to be taken by the Commission w as to convene another meeting with a view to
obtaining a vote on its draft measure. The question thus arises whether the Commission was justified
in not convening another meeting at any point prior to the repeal of Directive 90/220 in October 2002.
7.1555 In approaching this question, the Panel takes note of the following elements. In November
2000 the applicant had met all requests for info rmation conveyed to it following the March 2000
Regulatory Committee. The additional information was circulated to all CAs and the Commission in
December 2000. As noted, however, in June 2001 th e applicant provided additional clarification and
updated information to the lead CA. The record does not indicate that the Commission was made
aware of the existence of the June 2001 information. At the same time, there is nothing in the record
to suggest that the Commission was "waiting" for the June 2001 information.
7.1556 Regarding the clarification provided by the a pplicant in June 2001, we note that if the
Commission was not waiting for that clarification, then that clarification could not provide a
justification for the Commission's failure to re-c onvene the Regulatory Committee sometime between
December 2000 and June 2001. On the other hand, if the Commission had been waiting for
clarification from the applicant, it should have inqu ired with the lead CA whether the applicant had
provided clarification. There is no evidence that the Commission did so.
7.1557 Regarding the updated information also provide d by the applicant in June 2001, it is
important to remember that the applicant provided that information, not pursuant to a requirement
flowing from the provisions of Directive 90/220, but in an effort to convince member States to vote in
favour of approving its application. Also, the lead CA had not been requested to offer an assessment
of that additional information before transmitting it to the other member States and the Commission.
Notwithstanding this, the lead CA requested an opi nion of the BBC. However, it seems that for the
BBC, it was not obvious that an opinion was n eeded. In November 2001, the BBC discussed the
information in question. According to the minutes of the internal discussion, "no opinion on the part
of the Biosafety Advisory Council was necessary prio r to the forwarding of these documents to the
European Commission; and in the past such additio nal information had already been sent straight to
the Commission on several occasions."
1315 However, as this was the first time a company had
submitted a monitoring plan, agricultural guidelines and public dossier, the BBC "thought it advisable
to ask the Biosafety Advisory Council to discu ss these documents before forwarding them to the
European Commission." 1316 It was noted that in this way the relevant experts would have an
opportunity to gain experience in the evaluation of such documents.1317
7.1558 We are not convinced that a lead CA asse ssment of the updated information was required
before that information could be transmitted to the Commission and the other CAs, and that the
Commission therefore needed to wait for the lead CA's ass essment before re-convening the
Regulatory Committee. Indeed, we note that in a para llel situation, a different lead CA did not find it
necessary to make an asse ssment of additional information submi tted by an applicant to demonstrate
that its application was already in line with the main provisions of Directive 2001/18.1318

1315 Exhibit EC-63/At. 102.
1316Ibid.
1317 Ibid.
1318 See our earlier analysis in Section VII.D of the approval procedure concerning Falcon oilseed rape.

7.1559 In any event, in the approval procedure c oncerning MS8/RF3 oilseed rape, the applicant
replied to the last pending question of the BBC in early May 2002.
1319 The record shows no further
developments in this approval procedure until Oc tober 2002, when Directive 90/220 was repealed.
Thus, there is no indication that the BBC ever pr ovided its opinion on the J une 2001 information to
the lead CA. Even assuming that the Commission kn ew about the updated info rmation of June 2001,
and even assuming that it was justifiable in princi ple for the Commission to let the lead CA undertake
some assessment of the information, it remained the Commission's responsibility to seek a vote by the
Regulatory Committee on its draft measure. Yet even as the date of repeal of Directive 90/220 was
approaching, the Commission apparently did not request the lead CA promptly to finish its assessment
of the updated information and to circulate it together with that information so that a further attempt at
completing the approval procedure under Directive 90/220 could be made.1320
7.1560 In view of these elements, we consider that if the Commission had sought the circulation of
the additional information once the applicant had repl ied to the last pending question in May 2002, it
should have been possible for the information to be circulated promptly and for a Regulatory
Committee meeting to be held in the summer of 2002 at the latest. As Directive 90/220 was not
repealed until mid-October 2002, we think this would have left enough time for the Commission to
adopt its draft measure in the event of a favourable vote in the Regulatory Committee and for the lead
CA to give its written consent.1321
7.1561 In earlier findings, the Panel observed that the Commission could have considered that some
member States simply did not wish to see the Commission call another vote on its draft measure, or
that due to the "blocking minority" of the Group of Five countries in the Regulatory Committee and
the Council, a favourable draft measure would not ha ve achieved the required qualified majority, with
the consequence that the Commission would have to complete the procedure by adopting its own draft
measure. In the Panel's view, neither consid eration would provide a justification for the
Commission's failure to re-convene the Regulatory Committee for a third meeting.
7.1562 Anticipated member State opposition might well ha ve been a concern for the Commission in
view of the consequences it could have had fo r the legitimacy and accepta bility of an eventual
decision by the Commission to approve its own draf t measure. However, this would not have
justified the Commission in suspending the appr oval process until it was confident that its draft

1319 Exhibit EC-63/At. 108. The applicant also indicated readiness to follow a suggestion by the BBC
regarding information to the public, subject to further clarification by the BBC. Ibid.
1320 If the Commission did not know about the updated information submitted by the applicant in June
2001, then the existence of that information could not provide a justification for the Commission's failure to re-
convene the Regulatory Committee after December 2000.
1321 The Commission might have considered that due to the "blocking minority" of the Group of Five
countries in the Regulatory Committee and the Council, a favourable draft measure would not achieve the
required qualified majority and that the Commission would then have to complete the procedure by adopting its
draft measure. Even assuming that in this scenario there was not enough time for the Commission to complete
the procedure in question while Directive 90/220 was still in force, the Panel does not consider that this would
have justified the Commission's failure to re-convene the Regulatory Committee for a vote. The Commission
might have anticipated a "blocking minority" on the basis of the June 1999 declaration by the Group of Five
countries. As pointed out above, there is no indication that the June 1999 declaration was intended to bind the
Governments of the Group of Five countries vis-à-vis other member States or the Commission. In other words,
the Group of Five countries retained the freedom under EC law to vote in favour of applications in the
Regulatory Committee and Council. In the light of this, the Commission could not have legitimately invoked
the June 1999 declaration as a justification for not re-convening the Regulatory Committee.

measure would achieve a qualified majority in the Regulatory Committee.
1322 Were it otherwise, the
obligation to complete approval procedures without undue delay would impose no real discipline as
the Commission could then suspend approval proce dures every time it anticipates significant member
State opposition and regardless of whether there are valid reasons for such opposition.
7.1563 Regarding the possibility that certain member States might have been reluctant to proceed to a
vote on the Commission's draft measure, it should also be noted that if th e Commission was aware of
the existence of the updated information of June 2 001, then that information would have provided it
with additional arguments for seeking a vote on its draft measure in the Regulatory Committee. To
recall, the applicant submitted the June 2001 info rmation to demonstrate that the application
concerning MS8/RF3 was already in accordance with the main provisions of the new
Directive 2001/18.
7.1564 Based on the above considerations, the Panel is of the view that at the very latest in the
summer of 2002 the Commission should have re-c onvened the Regulatory Committee for a vote on
the application concerning MS8/RF3 oilseed rape. Accordingly, the Panel concludes that the time
actually taken by the Commission to convene th e Regulatory Committee for a further meeting – no
meeting was held between March 2000 and October 2002 – was unjustifiably long.
7.1565 Turning now to the reason for the Commission's failure to act, we recall the United States' and
Canada's claim that the approval procedure concer ning MS8/RF3 oilseed rape was delayed as a result
of the application by the Eur opean Communities of the general de facto moratorium on approvals.
We recall in this respect our earlier findings that (i) a general de facto moratorium on approvals was
in effect in the European Communities betwee n June 1999 and August 20 03 and that (ii) the
Commission's failure to re-convene the Regul atory Committee for a vote on the application
concerning MS8/RF3 oilseed rape after November 2001 is consistent with the application of such a
moratorium. In the light of this, and in th e absence of effective rebuttal by the European
Communities, we agree with the United States and Canada that it is reasonable to infer that the
Commission's inaction was a consequence of the general moratorium on approvals.
7.1566 In view of our conclusion with regard to the Commission's failure to re-convene the
Regulatory Committee for a vote on a draft measure, we do not go on to address other arguments put
forward by the United States and Canada in suppo rt of their assertion that the approval procedure
concerning MS8/RF3 oilseed rape was unduly delaye d as a result of the application of a general de
facto moratorium on approvals.
Conclusions
7.1567 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, the Panel reca lls its findings that the time taken by the
Commission to convene the Regulatory Committee for a further meeting – no
meeting was convened between March 2000 and October 2002 – was unjustifiably
long, and that it can reasonably be inferred from surrounding circumstances that the
Commission's inaction was a consequence of the general moratorium on approvals.

1322 The record does not indicate, and the European Communities did not argue, that the Commission
after the March 2000 meeting of the Regulatory Committee launched inter-service consultations to reconsider
the relevant draft measure.

Based on these findings, the Panel accepts the United States' contention that the
application by the European Communities of a general de facto moratorium on
approvals led to "undue delay" in th e completion of the approval procedure
concerning MS8/RF3 oilseed rape and, con sequently, to a breach of the European
Communities' obligations under Annex C(1)(a), first clause, of the SPS Agreement.

 (ii) DS292 (Canada)

 With reference to DS292, the Panel reca lls its findings that the time taken by the
Commission to convene the Regulatory Committee for a further meeting – no
meeting was convened between March 2000 and October 2002 – was unjustifiably
long, and that it can reasonably be inferred from surrounding circumstances that the
Commission's inaction was a consequence of the general moratorium on approvals.
Based on these findings, the Panel accepts Canada's contention that the application by
the European Communities of a general de facto moratorium on approvals led to
"undue delay" in the completion of th e approval procedure concerning MS8/RF3
oilseed rape and, consequently, to a breach of the European Communities' obligations
under Annex C(1)(a), first clause, of the SPS Agreement.

7.1568 Since we have concluded that the general de facto moratorium on approvals led to undue
delay in the completion of at least one approval procedure conducted in respect of a biotech product at
issue in this dispute, we need not, and thus do not, proceed to examine whether the general de facto
moratorium on approvals led to undue delay in th e undertaking or completion of other individual
approval procedures conducted under either Directives 90/220 and 2001/18 or Regulation 258/97.
(b) Article 8
7.1569 We recall that the United States and Canada seek to establish an inconsistency with Article 8
of the SPS Agreement on the basis of an inconsistency with Annex C(1)(a). Article 8 requires, inter
alia, that Members observe the provisions of Annex C in the operation of their approval procedures.
It follows that a failure to observe the provisions of Annex C(1)(a) implies a breach of Article 8. We
have determined above that, as a result of the general de facto moratorium on approvals, the European
Communities has failed, in at least one approva l procedure conducted unde r Directives 90/220 and
2001/18, to observe the provisions of Annex C(1)(a), fi rst clause. Accordingly, we conclude that in
respect of the aforementioned approval procedure, the European Communities has, by implication,
also acted inconsistently with the provisions of Article 8.
(c) Overall conclusions
7.1570 The foregoing findings and conclusions lead the Panel to the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having rega rd to the arguments and evidence submitted
by the United States and the European Co mmunities, the Panel concludes that as a
result of the application of a general de facto moratorium on appr ovals between June
1999 and August 2003 the European Comm unities has failed to observe the
provisions of Annex C(1)(a), first clause, of the SPS Agreement and, consequently,
has also acted inconsistently with its obligations under Article 8 of the
SPS Agreement.

 (ii) DS292 (Canada)

 With reference to DS292, and having rega rd to the arguments and evidence submitted
by Canada and the European Communities, the Panel concludes that as a result of
applying a general de facto moratorium on approvals between June 1999 and August
2003 the European Communities has failed to observe the provisions of
Annex C(1)(a), first clause, of the SPS Agreement and, consequently, has also acted
inconsistently with its obligations under Article 8 of the SPS Agreement.

12. Consistency of the general de facto moratorium on approvals with Article 8 and
Annex C(1)(b) of the SPS Agreement
7.1571 Only the United States claims that by applying a general de facto moratorium on approvals,
the European Communities has acted inconsistently with its obligations under Article 8 and
Annex C(1)(b) of the SPS Agreement.
7.1572 Article 8 of the SPS Agreement provides:
"Members shall observe the provisions of Annex C in the operation of control,
inspection and approval procedures, includi ng national systems for approving the use
of additives or for establishing tolerances fo r contaminants in foods, beverages or
feedstuffs, and otherwise ensure that thei r procedures are not inconsistent with the
provisions of this Agreement."
7.1573 Annex C(1)(b) of the SPS Agreement provides:
"Members shall ensure, with respect to any procedure to check and ensure the
fulfilment of sanitary or phytosanitary measures, that:

(b) the standard processing period of each procedure is published or that the
anticipated processing period is communicated to the applicant upon request; when
receiving an application, the competent body promptly examines the completeness of
the documentation and informs the applicant in a precise and complete manner of all
deficiencies; the competent body transm its as soon as possible the results of the
procedure in a precise and complete manner to the applicant so that corrective action
may be taken if necessary; even when the application has deficiencies, the competent
body proceeds as far as practicable with the procedure if the applicant so requests;
and that upon request, the applicant is inform ed of the stage of the procedure, with
any delay being explained [...]."
7.1574 Annex C(1)(b) essentially sets out five separate, but related, obligations to be observed by
Members in the operation of approval procedures. These obligations relate to:
 (i) the publication or communication to a pplicants of the processing period of each
procedure;

 (ii) the examination of the completeness of the documentation and the communication to
applicants of deficiencies;

 (iii) the transmission of the results of the procedure;

 (iv) the processing of applications which have deficiencies; and

 (v) the provision of information about the st age of a procedure and the provision of an
explanation of any delay.

7.1575 The United States argues that the general moratorium on approvals is an unpublished, non-
transparent measure under which the European Co mmunities does not allow its approval procedures
to proceed to conclusion. As such, the general mora torium is inconsistent, in the United States' view,
with each of the related procedural obligations in Annex C(1)(b) and, consequently, with Article 8 as
well.
7.1576 Regarding the first obligation (publication or communication of processing period), the
United States submits that although the applicable EC approval legislation contain processing periods,
under the general moratorium on approvals those pr ocessing periods are not followed. Instead, the
European Communities has imposed an indefinite de lay. However, since the European Communities
does not acknowledge the moratorium, the standard processing period is not published, and the
anticipated processing period is not communicated to the applicant.
7.1577 Regarding the second obligation (completeness of documentation), the United States argues
that under the general moratorium on approvals the European Communities does not promptly
examine documentation and inform the applicant of a ll deficiencies. To the contrary, applications
under the applicable EC legislation are stalled, without explanation.
7.1578 Regarding the third obligation (transmission of results), the United States argues that under
the general moratorium on approvals results of procedures are not promptly communicated to
applicants so that corrective action may be taken. Instead, applications are stalled in the approval
process without explanation.
7.1579 Regarding the fourth obligation (processing of deficient applications), the United States
argues that under the general moratorium on appr ovals the European Comm unities does not proceed
as far as practicable in the approval process. Instead, applications are stalled in the approval process.
7.1580 Regarding the fifth obligation (explanation of delay), the United States argues that under the
general moratorium on a pprovals delays are not explained. To the contrary, the European
Communities does not even inform applicants of the existence of the general moratorium.
7.1581 The European Communities submits that the United States has offered a mere assertion that
the European Communities has not done what it is required to do under the different obligations
contained in Annex C(1)(b). The United States considers it sufficient simply to allege that
applications were stalled in the approval pro cess and gives no explanations. However, it is a
complaining party's burden to establish a prima f acie case. In any event, in the European
Communities' view, the detailed chronologies of indi vidual approval procedures and other documents
submitted by the European Communities demonstrate that the allegations of the United States are
unfounded.
7.1582 The Panel notes that in accordance with the lead-in to Annex C(1) the provisions of
Annex C(1)(b) apply "with respect to any procedure to check and ensure the fulfilment of sanitary or
phytosanitary measures". We have previously found that the procedures set out in Directives 90/220
and 2001/18 as well as Regulation 258/97 (to the extent it is an SPS measure) constitute procedures

"to check and ensure the fulfilment of sanitary or phytosanitary measures" within the meaning of
Annex C(1) and, as such, are subject to the pr ovisions of Annex C(1), which include those of
Annex C(1)(b).
7.1583 The measure being challenged by the United St ates is the European Communities' general
de facto moratorium on approvals. We understand the United States to claim that the adoption and
application of the general de facto moratorium on approvals has resulted in the European
Communities acting inconsistently with its obligations under Annex C(1)(b).
7.1584 We also note that the United States relies on the alleged breach of the provisions of
Annex C(1)(b) to make a consequential claim of inco nsistency under Article 8. Accordingly, we will
begin our analysis with the United States' claims under Annex C(1)(b).
(a) First obligation in Annex C(1)(b) (publication or communication of processing period)
7.1585 In relation to the first obligation contained in Annex C(1)(b) (publication or communication
of processing period), the United States puts forward two main arguments. The first argument is that
as a result of the general moratorium on approva ls, the European Communities did not follow the
standard processing periods which are published in the applicable EC approval legislation. The
United States appears to infer from this that the effective standard processing periods have not been
published.
7.1586 We understand the United States to argue that the failure by the European Communities to
consider a particular application for final appr oval meant that it was not following the published
standard processing period for the relevant type of procedure and that the effective standard
processing period for the relevant type of procedure was no longer published.
7.1587 Even if we were to accept that what has to be published in accordance with the first obligation
in Annex C(1)(b) is the "effective" standard pro cessing period, and that the general moratorium on
approvals effectively modified the European Communities' published standard processing periods, the
fact that they were unpublished would not be a consequence of the measure at issue, i.e., the general
moratorium. Rather, it would be a consequence of a separate and independent failure by the European
Communities to publish the new standard processing peri ods. This is confirmed by the fact that the
European Communities could apply the general mo ratorium on approvals and at the same time
publish any new standard processing periods.
7.1588 In the light of this, we conclude that the United States has failed to establish its claim under
the first obligation contained in Annex C(1)(b), in sofar as that claim is based on the requirement to
publish standard processing periods.
7.1589 The United States' second argument in support of its claim under Annex C(1)(b) is that since
the European Communities does not acknowledge the moratorium, the anticipated processing period
is not communicated to the applicant. We note that pursuant to Annex C(1)(b) the anticipated
processing period is to be communicated to the a pplicant "upon request". The United States has
provided no evidence to show (i) that an applicant requested that the anticipated processing period be
communicated to it, (ii) that the request was denied by a relevant EC entity, and (iii) that this was
because of the general moratorium on approvals. Moreover, we do not think that the general
moratorium on approvals necessarily resulted in the European Communities not communicating the
anticipated processing periods to applicants upon request. The European Communities could apply
the general moratorium on approvals and at the same communicate to applicants the anticipated
processing periods upon request.

7.1590 In the light of this, we conclude that the United States has failed to establish its claim under
the first obligation contained in Annex C(1)(b), in sofar as that claim is based on the requirement to
communicate to applicants anticipated processing periods.
(b) Second obligation in Annex C(1)(b) (completeness of documentation)
7.1591 Concerning the second obligation contained in Annex C(1)(b), the United States argues that
because of the general moratorium on approvals the European Communities did not promptly
examine the completeness of documentation and inform applicants of any deficiencies.
7.1592 We note that the United States has identifie d no concrete evidence to support this
assertion.
1323 Moreover, we do not think that the general moratorium on approvals necessarily
resulted in the European Communities not examin ing promptly the completeness of documentation
and not informing applicants of any deficiencies. The European Communities could apply the general
moratorium on approvals and at the same time examine the completeness of documentation and
inform applicants of deficiencies in the documentation submitted.1324
7.1593 In the light of this, we conclude that the United States has failed to establish its claim under
the second obligation contained in Annex C(1)(b).
(c) Third obligation in Annex C(1)(b) (transmission of results)
7.1594 With regard to the third obligation contained in Annex C(1)(b), the United States argues that
under the general moratorium results of procedures we re not promptly communicated to applicants so
that corrective action could be taken.
7.1595 We note that the United States has not identifie d any results of procedures which were not
transmitted to an applicant as soon as possible and in a precise and complete manner. Moreover, we
do not think that the general moratorium on ap provals necessarily resulted in the European
Communities not transmitting as soon as possible, and in a precise and complete manner, the results
of approval procedures. Furthermore, it should be recalled that under the general moratorium, the
European Communities prevented final results from be ing achieved. Thus, there were no final results
which could have been communicated to applicants.
7.1596 In the light of this, we conclude that the United States has failed to establish its claim under
the third obligation contained in Annex C(1)(b).
(d) Fourth obligation in Annex C(1)(b) (processing of deficient applications)
7.1597 In relation to the fourth obligation contained in Annex C(1)(b), the United States argues that
under the general moratorium the European Commun ities did not proceed as far as practicable in the
approval process.

1323 It is well to recall in this context that it is not incumbent on us to search the record for evidence
which would assist the United States in establishing a prima facie case of in consistency with one or more of the
obligations contained in Annex C(1)(b).
1324 It is well to recall that the United States itself ha s stated that "the moratorium was a decision by the
EC not to move products to a final decision in the approval process. Certain progress in the process, short of
final decision, is not the least bit inconsistent with a moratorium on final approvals". US second written

7.1598 We note that pursuant to Annex C(1)(b) the competent body is to proceed as far as practicable
with the procedure "if the applicant so requests" . The United States has provided no evidence of an
applicant making such a request and of a relevant EC entity denying that request because of the
general moratorium. Moreover, we do not think that the general moratorium on approvals necessarily
resulted in the European Communities not procee ding as far as practicable with procedures if
applicants so requested. The European Commu nities could apply the general moratorium on
approvals and at the same time proceed as far as practicable with procedures upon request.
1325
7.1599 In the light of this, we conclude that the United States has failed to establish its claim under
the fourth obligation contained in Annex C(1)(b).
(e) Fifth obligation in Annex C(1)(b) (explanation of delay)
7.1600 Regarding the fifth obligation contained in Annex C(1)(b), the United States argues that under
the general moratorium delays were not explained.
7.1601 The fifth obligation states that "upon request" the applicant is to be informed of the stage of
the procedure, with any delay being explained. The United States has provided no evidence of an
applicant making such a request and of a relevant EC entity denying an explanation of any delay
because of the general moratorium. Moreover, we do not think that the general moratorium on
approvals necessarily resulted in the European Comm unities not informing applicants of the stage of
procedures and not explaining any delays, if app licants so requested. The European Communities
could apply the general moratorium on approvals and at the same time inform applicants of the stage
of procedures and explain any delays.
7.1602 In the light of this, we conclude that the United States has failed to establish its claim under
the fifth obligation contained in Annex C(1)(b).
(f) Article 8
7.1603 Turning now to the United States' claim under Article 8, we recall that the United States seeks
to establish an inconsistency with Article 8 on the basis of an alle ged inconsistency with
Annex C(1)(b). We have determined that the United States has failed to establish its claims under
Annex C(1)(b). Under the approach followed by th e United States, this means that the consequential
claim under Article 8 has not been established either.
(g) Overall conclusion
7.1604 In the light of the above, the Panel reaches the following conclusion:
 (i) DS291 (United States)

 With reference to DS291, and having rega rd to the arguments and evidence submitted
by the United States and the European Co mmunities, the Panel concludes that the
United States has not established that the European Communities has acted
inconsistently with its obligati ons under Annex C(1)(b) of the SPS Agreement and,

1325 Here again, it is useful to recall that the United States itself has stated th at "the moratorium was a
decision by the EC not to move products to a final decision in the approval process. Certain progress in the
process, short of final decision, is not the least bit in consistent with a moratorium on final approvals". US
second written submission, para. 51 (emphasis in original).

consequently, with its obligations under Article 8 of the SPS Agreement by applying a
general de facto moratorium on approvals between June 1999 and August 2003.

13. Consistency of the general de facto moratorium on approvals with Article 10.1 of the
SPS Agreement
7.1605 Argentina claims that the general de facto moratorium on approvals applied by the European
Communities has failed to take account of Argentina' s special needs as a developing country Member
and thus is inconsistent with Article 10.1 of the SPS Agreement.
7.1606 Article 10.1 provides:
"In the preparation and application of sanitary or phytosanitary measures, Members
shall take account of the special needs of developing country Members, and in
particular of the least-developed country Members."
7.1607 Argentina argues that Article 10.1 required the European Communities to take positive
action in favour of developing countries. According to Argentina, in preparing and applying a general
de facto moratorium on approvals, the European Co mmunities should have provided preferential
market access for developing country products or im plemented its obligations in a manner beneficial,
or less detrimental, to the interests of developing country Members. Argentina argues that the general
moratorium on approvals had the effect of pr eventing Argentina's biotech products from having
access to the EC market. According to Argentina, th is had implications particularly for Argentina's
economic development as Argentina is: (i) highly de pendent on agricultural exports, (ii) the world's
second-largest producer of biotech products, (iii) th e world's leading developing country producer of
biotech products. Argentina further points out that the EC market is an integrated market consisting
of twenty-five member State markets and that the EC market is therefore of great importance for
Argentina. Argentina considers th at the fact that the general moratorium on approvals prevented its
biotech products from having access to the EC ma rket demonstrates that the European Communities
has not taken account of the special needs of Argentina.
7.1608 The European Communities states that it bears in mind the provisions concerning special
and differential treatment of developing coun try Members when developing and applying its
legislation, including, where relevant, its approva l legislation for biotech products. The European
Communities notes that Argentina's argument seems to be that since the European Communities, in
Argentina's view, has violated other WTO provisions and this affects Argentina as a developing
country, the European Communities has consequently also failed to comply with Article 10.1.
Furthermore, the European Communities does not a ccept the factual assertion of Argentina that the
measure it is complaining about restricts exports of developing country Members to the European
Communities. Trade statistics show that imports from developing countries that produce agricultural
biotech products have not decreased. On the c ontrary, imports into the European Communities from
Argentina or Brazil of commodities likely to cont ain genetically modified organisms have steadily
increased since 1995/96.
7.1609 Argentina does not agree that Article 10.1 needs to be observed only "where relevant". It
does not give Members the discretion to take account of the needs of developing country Members or
not. Argentina further argues that the European Communities has not provided any evidence proving
that it has taken into account Argentina's speci al needs as a developing country Member when
preparing and applying its legislation. The legisl ation does not contain any reference to the special
needs of developing country Members. Moreover, for the entire period of application of the general
de facto moratorium on approvals, Argentina cannot identify any evidence which would permit the

conclusion that the European Communities has take n account of Argentina's special needs in the
context of the approval procedures of interest to Argentina. In addition, the European Communities is
incorrect when it suggests that Argentina is making a consequential claim under Article 10.1. Finally,
Argentina notes that the trade statistics referred to by the European Co mmunities have not been
submitted to the Panel. In any event, those statis tics cannot relate to trad e in agricultural biotech
products after 1998 as no such products have been approved since that date. Argentina further
submits that WTO rules protect competitive expectations, not volumes of trade.
7.1610 The Panel notes that it is less than clear precisely what Argentina's claim is. We must,
therefore, address this issue before we analy se whether the European Communities has breached
Article 10.1.
(a) Argentina's claim
7.1611 Article 10.1 applies to the "preparation and a pplication of [SPS] measures". Argentina's
submissions do not indicate clearly what, in Argentina's view, is the SPS measure at issue. On the
one hand, Argentina argues that the European Co mmunities has failed to comply with Article 10.1
because of the way it has prepared and applied the general de facto moratorium on approvals.
1326 This
suggests that, as far as Argentina is concerne d, the SPS measure at issue is the general de facto
moratorium on approvals. On the other hand, Argentina appears to ar gue that the European
Communities has failed to comply with Article 10.1 because of the way it has applied the relevant EC
approval legislation. 1327 This suggests that the SPS measure at issue is the relevant EC approval
legislation.1328 We think that both ways of framing a claim under Article 10.1 are possible.
7.1612 Judging by the entirety of Argentina's submissi ons, we think that Argentina intended to claim
that the general de facto moratorium on approvals constitutes th e relevant "SPS measure". We will
examine that claim below. In view of the fact that Argentina's submissions on this issue are less than
fully clear and that Article 10.1 is a provision on differential and more favourable treatment for

1326 Argentina's first written submission, paras. 182 (re ferring to the "ordering and applying a general
moratorium") and 189 (referring to "the decision and subsequent application of the 'de facto' moratorium");
Argentina's first oral statement, para. 77 (referring to the "deciding on and applying the 'de facto' moratorium");
Argentina's second written submission, para. 123 (referring to "the application of the 'de facto' moratorium").
1327 Argentina's second written submission, paras. 116 (referring to the time of "elaborating and
applying its legislation related to agricultural biotech products") and 125 (asserting that there is no evidence that
"during the proceedings [ i.e., individual approval procedures] the EC has effectively taken into account
Argentina's special needs").
1328 It is pertinent to note that in the context of its challenge to various product-specific measures
Argentina makes similar claims under Article 12.3 of the TBT Agreement. Article 12.3 provides:

Members shall, in the preparation and app lication of technical regulations, standards
and conformity assessment procedures, take account of the special development,
financial and trade needs of developing country Members, with a view to ensuring
that such technical regulations, standards and conformity assessment procedures do
not create unnecessary obstacles to exports from developing country Members.

It is clear from Argentina's submissions that Argentin a's claims under Article 12.3 are in respect of the
application by the European Communities of its approval legislation, which Argentina says may be considered
as laying down "conformity assessment procedures" with in the meaning of Article 12.3. Argentina's first
written submission, p. 144 (heading) an d paras. 445 and 450. However, as indicated, Argentina's claims under
Article 12.3 relate to the product-specific measures, whereas we are concerned here with a claim concerning the
general de facto moratorium on approvals.

developing country Members, we will, however, of fer alternative findings. For the purposes of these
alternative findings, we will assume that Argentina in tended to make the additional claim that the EC
approval legislation also constitutes a relevant "SPS measure".
(b) General de facto moratorium on approvals as "SPS measure"
7.1613 As indicated, we first examine Argentina's cl aim that the European Communities has acted
inconsistently with Article 10.1 because of th e way it has prepared and applied the general de facto
moratorium on approvals. Unde r this claim, the general de facto moratorium on approvals is
considered as an "SPS measure".
7.1614 We have found earlier that the European Communities' decision to apply a general de facto
moratorium on approvals was a decision relating to th e application, or operation, of the existing EC
approval procedures and that, as such, it did not cons titute an "SPS measure" within the meaning of
Annex A(1).
1329 However, as we have done in other cases, we also consider the specific provisions of
Article 10.1 before reaching a defin itive conclusion on whether the general de facto moratorium on
approvals was an "SPS measure".
7.1615 Article 10.1 provides that in the "preparation and application of [SPS] measures" Members
must take account of the special needs of develo ping country Members. According to Annex A(1),
the term "SPS measures" includes "requirements and pr ocedures". It makes sense to say that in the
"preparation and application" of "requirements and procedures" Members must take account of
developing country Members' needs. In contrast , if the application, or operation, of approval
procedures were considered to be an "SPS measure" within the meaning of Article 10.1, Article 10.1
would impose an obligation on Members with regard to the "application" of the "application of an
approval procedure". Clearly, such a reading of Article 10.1 would be unreasonable and contrary to
logic.1330 It is no answer to say that in cases wher e the measure is the "application of an approval
procedure", the separate reference in Article 10.1 to the "application" of SPS measures is unnecessary.
It is well established in WTO jurisprudence that a treaty interpreter must give meaning and effect to
all the terms used in a treaty provision and must avoid interpretations which render treaty terms
redundant.1331
7.1616 In view of the above considerations, we find our earlier conclusion that the general de facto
moratorium on approvals was not an "SPS measure" within the meaning of Annex A(1) appropriate in
the specific context of Article 10.1. We thus determine that the general de facto moratorium on
approvals was not an "SPS measure" within the m eaning of Article 10.1. Since the claim we are
considering is based on the premise that the general de facto moratorium was an "SPS measure", it is
clear that this claim cannot succeed.
7.1617 Accordingly, we find that Argentina has faile d to establish its claim that the European
Communities has acted inconsistently with Artic le 10.1 because of the way it has prepared and
applied the general de facto moratorium on approvals.

1329 We recall that in accordance with Article 1.1 of the SPS Agreement the definitions provided in
Annex A are applicable to Article 10.1.
1330 It is instructive to note in this regard that the equivalent provision of the TBT Agreement,
Article 12.3, refers to the "preparation and application" of "conformity assessment procedures". This supports
our reading of Article 10.1 of the SPS Agreement.
1331 Appellate Body Report, US – Gasoline, p. 23.

(c) EC approval legislation as "SPS measure"
7.1618 As indicated above, we will offer alternative findings on the assumption that Argentina
intended to make the additional claim that the EC ap proval legislation also constitutes a relevant "SPS
measure". Thus, for the purposes of our alternativ e inquiry, we understand Argentina to claim, in
addition, that by adopting and applying a general de facto moratorium on approvals, the European
Communities has failed to apply its approval le gislation in a manner which takes account of
developing country Members' needs.
7.1619 Argentina argues that some of the products a ffected by the European Communities' general
moratorium on approvals are of particular export in terest to Argentina as a major developing country
exporter of those products. Argentina consider s that the European Communities should have
provided preferential market access for its and ot her developing countries' products, or implemented
its approval legislation in a manner beneficial, or less detrimental, to the trade interests of developing
country Members.
7.1620 Argentina's argument implies that when an importing Member applies a measure which (i)
treats exports originating in the territory of deve loping country Members in the same way as exports
originating in the territory of developed country Me mbers and (ii) has a significant adverse effect on
the developing countries' exports, the importing Memb er is acting inconsistently with its obligation
under Article 10.1. Argentina suggests that in such situations the exports of developing country
Members are entitled under Article 10.1 to special and differential treatment vis-à-vis the exports of
developed country Members. However, the obliga tion laid down in Article 10.1 is for the importing
Member to "take account" of developing country Members' needs. The dictionary defines the
expression "take account of" as "consider along with other factors before reaching a decision".
1332
Consistent with this, Article 10.1 does not prescrib e a specific result to be achieved. Notably,
Article 10.1 does not provide that the importing Member must invariably accord special and
differential treatment in a case where a measure has lead, or may lead, to a decrease, or a slower
increase, in developing country exports.
7.1621 The fact that there is no indication that between June 1999 and August 2003 the European
Communities accorded Argentina special and differential treatment – e.g., by approving the marketing
of biotech products exported from Argentina – do es not in and of itself constitute prima facie
evidence that the European Communities has failed to "take account" of Argentina's needs. While the
European Communities must take account of the interests of developing country Members in applying
its approval legislation, the European Communitie s may at the same time take account of other
legitimate interests, including those of its own consum ers, its environment, etc. There is nothing in
Article 10.1 to suggest that in weighing and balanc ing the various interests at stake, the European
Communities must necessarily give priority to the needs of Argentina as a developing country. We
therefore think it is conceivable that the Eur opean Communities "took account" of Argentina's needs
when adopting and applying its general de facto moratorium on approvals, but ultimately determined
that applications concerning pro ducts of export interest to Argentina warranted no special and
differential treatment.1333 Accordingly, we consider that the fact that the European Communities did
not accord Argentina special and differential treatment vis-à-vis other developed country exporters
does not demonstrate, by itself, an inconsistency with Article 10.1.

1332 The Concise Oxford Dictionary, 10th edn., J. Pearsall (ed.) (Clarendon Press, 1999), p. 8.
1333 We recall Argentina's statement that its claim under Article 10.1 is not a consequential claim, but
an autonomous claim. Thus, for the purposes of our analysis of Argentina's claim under Article 10.1, we must
assume that, but for a possible inconsistency with Article 10.1, the general de facto moratorium on approvals is
WTO-consistent.

7.1622 Argentina argues that the European Communities has not provided any evidence which would
prove that it has taken into account Argentina's sp ecial needs as a developing country Member. This
argument lacks merit, for it is incumbent on Argent ina as the Complaining Pa rty to adduce evidence
and argument sufficient to raise a presumption that the European Communities has failed to take into
account Argentina's special needs as a developing country Member.
1334
7.1623 Argentina also contends that there is no referenc e in the EC approval legislation to the special
needs of developing country Members. However, the absence of a reference to developing country
needs in the text of the EC approval legislation does not demonstrate that that legislation itself fails to
take account of these needs 1335, or that the European Communities is precluded from taking account,
or has not taken account, of these needs when applying th at legislation. We therefore consider that it
is not sufficient, for the purposes of establishing a claim under Article 10.1, to point to the absence in
the EC approval legislation of a reference to the needs of developing country Members.
7.1624 Argentina further argues that for the entire period of application of the general de facto
moratorium on approvals it could not identify any evidence supporting the conclusion that the
European Communities has taken account of Argentina' s special needs. We note that Argentina has
merely asserted the absence of relevant evidence, without specifying what efforts it has undertaken to
collect such evidence. Moreover, we note that Article 10.1 does not specifically require the importing
Member to document how it has complied with Article 10.1. In these circumstances, we do not
consider that Argentina's argument provides a sufficien t basis for us to find that Argentina has met its
burden of establishing an inconsistency with Article 10.1.
7.1625 Even considering all of Argentina's arguments together, we are not satisfied that Argentina
has met its burden. We recognize that Argentin a may not have ready access to information about
whether and to what extent the European Co mmunities "took account" of Argentina's needs as a
developing country Member. However, there is no evidence on record to show that Argentina ever
approached the European Communities and sought information on how the European Communities
complied with its obligation under Article 10.1 when applying its approval legislation to applications
concerning biotech products of export interest to Ar gentina. We do not mean to suggest that it is
Argentina's duty specifically to request the Eur opean Communities to take account of Argentina's
needs as a developing country Member. But under we ll-established rules on burden of proof it is for
Argentina to prove its claim that the European Communities did not take account of developing
country Members' needs.
7.1626 In the light of the above considerations, we find, in the alternative, that Argentina has failed to
establish its claim that the European Communities ha s acted inconsistently with Article 10.1 because
of the way it has applied its approval legislation between October 1998 and August 2003.

1334 It is worth noting in this context that Argentina has not explained how the European Communities
would in the present case have known that a particular application concerned a biotech product of export interest
to Argentina. As far as we are able to determine, in none of the many approval procedures affected by the
general moratorium was the applicant an Argentinean company or individual. Typically, the applicant was a
biotech company of a developed country nationality. While such applicants may have provided information on
actual or potential exporting countries as part of the information submitted with their applications, neither
Argentina nor the European Communities has confirmed that they were required to do so, or if not, that they
have consistently done so.
1335 We note, however, that Directive 2001/18 in its 13th preambular paragraph states that the content of
the Directive "duly takes into account" the European Communities' "international trade commitments".
Argentina did not acknowledge this paragraph.