PRODUCT-SPECIFIC MEASURES
Document: request for the establishment of a panel
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

(d) Overall conclusion
7.1627 In the light of the above, the Panel reaches the following conclusion:
 (i) 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 10.1 of the SPS Agreement by applying a general de facto
moratorium on approvals between June 1999 and August 2003.

E.
PRODUCT-SPECIFIC MEASURES
1. Measures at issue
7.1628 In addition to the general de facto moratorium on approvals, the Complaining Parties are also
challenging a number of . Th e Panel begins its analysis by setting out the
Complaining Parties' general descriptions of the measures at issue and the European Communities'
comments in response.
(a) General
7.1629 The United States notes that it is challenging the failure by the Commission and the member
States to consider for approval certain applications specified in its request for the establishment of a
panel. The United States refers to these product- specific measures as "produc t-specific moratoria".
According to the United States, these product-spec ific moratoria are separate measures from the
general moratorium affecting all applications. The United States also notes, however, that they are
similar measures in that both refer to the European Communities' failure to consider applications for
approval. Also, since the general moratorium applie d to all applications, a necessary corollary is that
the European Communities also adopted produc t-specific moratoria on each of the relevant
applications specified in the United States' panel request. Accordingly, the evidence and arguments
the United States adduced in support of the existe nce of a general moratorium also establish the
existence of the product-specific moratoria, and that the European Communities did not undertake and
complete its approval procedures for each individual application without undue delay.
7.1630 Canada states that it is challenging the failure by the European Communities to consider or
approve, without undue delay, certain applications specified in its request for the establishment of a
panel. Canada refers to the failure by the European Communities in this regard as the product-
specific marketing bans. Canada contends that the general moratorium and the product-specific
marketing bans are closely related, though distinct , measures. The product-specific marketing bans
are a direct consequence of the moratorium as ap plied to individual applications. They are the
manifestation of the moratorium in the context of the approval procedures of the four specific
products of concern to Canada. Canada's arguments in relation to product-specific marketing bans are
intended to focus on the direct and detrimental impact of the moratorium on specific applications.
7.1631 Argentina states that it is challenging (i) the su spension by the European Communities of
consideration of specified applications for approval, or the failure to consider specified applications
for approval as well as (ii) the undue delays in completing the consideration and processing of
specified applications. Argentina argues that the product-specific suspension of processing or failure

to consider as well as the undue delay ar e effects of the application of the de facto moratorium to
specific applications for approval.
7.1632 The European Communities notes that it has considerable difficulty in understanding the
difference between the first group of claims by the Complaining Parties relating to the alleged
moratorium on approvals and the second group of clai ms relating to alleged failures to consider for
approval specific applications. According to th e European Communities, the Complaining Parties'
assertions about a "suspension of procedures" or any "failure to consider applications" are assertions
about delay.
7.1633 The Panel notes that, according to the Complaining Parties, the
they are challenging are distinct from the general de facto moratorium on approvals. At the same time
all three Complaining Parties point out that the pr oduct-specific measures are related to the general
moratorium on approvals. Based on these statements and the Complaining Parties' arguments, it is
our understanding that the are, or arise from:
− specified acts and/or omissions through wh ich the relevant EC entities were giving
effect, in the context of particular approva l procedures, to their decisions to impose a
general moratorium on approvals, or
− specified acts and/or omissions through whic h relevant EC entities chose to respond,
again in the context of particular approval procedures, to the circumstance that other
EC entities were imposing a general moratorium on approvals.

7.1634 It should be noted, however, that in their requests for the establishment of a panel, the
Complaining Parties have described the product-speci fic measures in more general terms. Moreover,
each Complaining Party has used a so mewhat different description. It is therefore useful to address
these different descriptions one by one.
7.1635 The United States in its panel request says that the measure at issue is the failure by the
European Communities to consider particular applica tions for approval. It is clear to us that the
United States does not contend that the European Communities has not considered the relevant
applications at all. In our view, the United Stat es contends that the European Communities has failed
to consider the relevant applications for final approval. We understand this to be essentially a
contention that the consideration of these applicati ons was affected by the general moratorium on
final approvals, in the sense that their consideration was either effectively suspended at some point in
the approval process or continued at a delayed p ace. This understanding would appear to be
supported by the fact that when referring to the pr oduct-specific measures, the United States speaks of
the "product-specific moratoria".
7.1636 Canada in its panel request says that the measu re at issue is the failure by the European
Communities to consider or approve, without undue delay, the applica tions mentioned in its request.
Thus, unlike the United States, Canada explicitly includes an allegation of undue delays in the
consideration and approval of th e relevant applications in the definition of the measures being
challenged. At the same time, Canada refers to the alleged failure to consider or approve the relevant
applications without undue delay as the product-sp ecific marketing bans. Canada claims in this
regard that at some point in the approval process each of the relevant applications was subjected by
the European Communities to an effective marketing ban. The validity of this claim will be discussed
further below. At this stage, it is sufficient to note that we will conduct our examination based on the
description of the set out in Canada's panel request.

7.1637 Argentina distinguishes two types of . The first type of product-
specific measure is described in Argentina's panel request as the suspension of consideration of, or the
failure to consider, particular app lications for approval. In our unde rstanding, this type of measure is
conceptually the same as the product-specific measur es referred to in the United States' panel request.
The second type of product-specific measure identif ied in Argentina's panel request concerns undue
delays in finalizing consideration of particular a pplications for approval. Accordingly, like Canada,
Argentina explicitly includes an allegation of undue delays in the consideration of the relevant
applications in the definition of the measures being challenged.
(b) Relevant applications
7.1638 As noted above, each of the product-speci fic measures challenged by a particular
Complaining Party relates to a particular application. Below it is indicated (i) how many applications
were specified by each Complaining Party and (ii) on how many of these applications the Panel has
been requested to offer product-specific findings.
(i) DS291 (United States)
7.1639 The United States in its request for the establis hment of a panel stated that the relevant
applications are mentioned in Annexes I and II to its request. These two Annexes list a total of forty-
one applications. As all forty-one applications are within the terms of reference of this Panel, there
are, in principle, forty-one which the United States could seek to challenge.
However, in its first written submission, the United St ates indicated that it is making claims in respect
of only twenty-seven applications.
1336 We conclude from this that the United States has abandoned its
product-specific claims in respect of the remaining fourteen applications.1337
7.1640 According to the United States' first written su bmission, the twenty-seven applications in
respect of which it is pursuing product-specific cl aims include eighteen which were submitted under
Directive 90/220 and were pending under Directive 2001/18 on the date of establishment of this Panel
as well as nine applications pending under Regulation 258/97. 1338 Among the nine applications the
United States claims were pending under Regulati on 258/97, there are two applications which were
withdrawn before the Panel was established. They are Transgenic red-hearted chicory (food) and
Transgenic green-hearted chicory (food). Evid ence provided by the European Communities shows
that both were withdrawn by the applicant in May 2003. 1339 We note in this respect that, in a
submission made subsequent to its first written submission, the United States stated that it is not
requesting findings on applications that were withdrawn prior to the establishment of the Panel. 1340 In
the light of this categorical statement, we consid er we need not, and hence do not, make findings in
respect of the two aforementioned a pplications concerning transgenic chicory. This means that there
are in total twenty-five applications on which the Pa nel is expected to offer product-specific findings

1336 US first written submission, paras. 67, 131, 137-138.
1337 It should be noted that the United States discussed the applications concerning MS1/RF2 oilseed
rape and MS1/RF1 oilseed rape (EC-89) under the head ing "product-specific moratoria". US second written
submission, para. 53. However, the United States also presented arguments relating to its general moratorium
claim under that heading. US second written submission, paras. 52-53. Accordingly, we do not understand the
United States to have increased the number of measures in respect of which it is making product-specific claims.
1338 The eighteen applications pending under Directive 2001/18 are identified at paras. 49-51 of the US
first written submission; the nine applications pending und er Regulation 258/97 are identified at paras. 54-55 of
the US first written submission.
1339 Exhibits EC-97/At. 32 and EC-98/At. 42. The Un ited States also acknowle dges this fact. US
second written submission, footnote 76.
1340 US reply to Panel question No. 197, footnote 26.

– eighteen which were pending under Direc tive 2001/18 and seven which were pending under
Regulation 258/97.
7.1641 The eighteen applications which were pendi ng under Directive 2001/18 as of August 2003
comprise those concerning:
− Bt-531 cotton
− RR-1445 cotton
− Falcon oilseed rape
− MS8/RF3 oilseed rape
− RR fodder beet
− Transgenic potato
− Liberator oilseed rape
− Bt-11 maize (EC-69)
− GA21 maize (EC-78) (withdrawn in September 2003)
− MON810 x GA21 maize (withdrawn in September 2003)
− LL soybeans (EC-71) (withdrawn in June 2004)
− LL oilseed rape
− BXN cotton
1341
− Bt-1507 maize (EC-74)
− Bt-1507 maize (EC-75)
− NK603 maize (approved by Commission in July 2004)
− RR oilseed rape (EC-70) (approved by Commission in August 20051342)
− RR sugar beet (withdrawn in April 2004)

7.1642 The seven applications which were pending under Regulation 258/97 as of August 2003 are
those concerning:
− GA21 maize (food)
− Bt-11 sweet maize (food) (approved by Commission in May 2004)
− NK603 maize (food) (approved by Commission in October 2004)
− LL soybeans (food) (withdrawn in July 2004)
− Bt-1507 maize (food)
− RR sugar beet (food) (withdrawn in April 2004)
− MON810 x GA21 maize (food)

(ii) DS292 (Canada)
7.1643 Canada's request for the establishment of a panel identifies four applications. They were all
submitted under Directive 90/220. As of A ugust 2003, they were either pending under
Directive 2001/18 or awaiting the lead CA's written consent to the placing on the market. Canada
requests product-specific findings on all four applications. The applications at issue are those
concerning:

1341 According to the European Communities, the application concerning BXN cotton was withdrawn
by the applicant after the establishment of the Panel. However, the European Communities has provided no
support for this assertion.
1342 We recall that after the second substantive me eting, on 1 September 2005, the Panel received a
letter from the European Communities stating that the Commission had approved the application concerning RR
oilseed rape (EC-70) under Directive 2001/18.

− MS1/RF1 oilseed rape (EC-89) (awaiting the lead CA's written consent)
− MS1/RF2 oilseed rape (awaiting the lead CA's written consent)
− MS8/RF3 oilseed rape
− RR oilseed rape (EC-70) (approved by Commission in September 2005
1343)

(iii) DS293 (Argentina)
7.1644 Argentina's request for the establishment of a pa nel contains an attachment, Annex I, which
identifies seventeen applications. It appears that An nex I is intended to illustrate the impact of the
general de facto moratorium on specific applications as well as to specify the applications in respect
of which Argentina is making product-specific clai ms. Among the seventeen a pplications referred to
in Annex I, there are two which are mentioned twice. 1344 There are four additional applications in
respect of which Argentina makes no claims in its submissions.1345 The eleven remaining applications
are the applications on which we think we are requ ested to make product-specific findings. Of these
eleven applications, six were submitted unde r Directive 90/220. With one exception 1346, they were
pending under Directive 2001/18 on the date of establis hment of this Panel. Argentina claims that the
other five applications were all submitted under Regulation 258/97.
7.1645 The six applications submitted under Directive 90/220 comprise those concerning:
− Bt-531 cotton
− RR-1445 cotton
− GA21 maize (EC-78) (withdrawn in September 2003)
− GA21 maize (EC-85) (withdrawn in June 2001)
− NK603 maize (approved by Commission in July 2004)
− LL soybeans (EC-71) (withdrawn in June 2004)

7.1646 The five applications which Argentina say s were submitted under Regulation 258/97 are
those concerning:
− Bt-531 cotton
− RR-1445 cotton
− GA21 maize (food)

1343 We recall that after the second substantive meeting, on 1 September 2005 the Panel received a
letter from the European Communities stating that the application concerning RR oilseed rape (EC-70) was
approved by the Commission in September 2005. We further note that in the context of presenting its product-
specific claims in respect of the application concerning RR oilseed rape (EC-70), Canada also presented
arguments on RR oilseed rape (EC-79). E.g., Canada's first written submission, paras. 86-87 and 295. See also
Canada's reply to Panel question No. 60. The application concerning RR oilseed rape (EC-79) was submitted to
France. However, Annex I to Canada's panel request refers only to the application submitted to the Netherlands,
which is that concerning RR oilseed rape (EC-70). Accordingly, we will not entertain Canada's product-specific
claims in respect of the application concerning RR oilseed rape (EC-79) submitted to France. We consequently
offer no product-specific findings on that application.
1344 This is the case of the applications concerni ng GA21 maize (food) and LL soybeans (EC-71).
Argentina in its submissions to the Panel does not argue that the applications which we consider are mentioned
twice are in fact different applications.
1345 This is the case of the applications concerning GA21 maize (EC-78) (alleged procedure under
Regulation 258/97), T14 maize (procedure under Directive 90/220 and alleged procedure under
Regulation 258/97) and LL soybeans (EC-81). T14 maize is mentioned in footnote 188 of Argentina's first
written submission, but no claim is raised there.
1346 The application concerning GA21 maize (EC-85) was withdrawn in June 2001.

− NK603 maize (food) (approved by Commission in October 2004)
− LL soybeans (food) (withdrawn in July 2004)

(c) Withdrawn and approved applications
7.1647 The above analysis shows that among the app lications in respect of which the Panel is
requested to make product-specific findings are appli cations which were withdrawn either before or
after the Panel was established. There also are applications which were approved by the Commission
in the course of the Panel proceedings. The Eur opean Communities argues that the Panel should not
make findings with regard to withdrawn or approv ed applications. Accordingly, we must decide
whether it is appropriate to assess the WTO-consistency of the relevant .
(i) Applications withdrawn before the establishment of the Panel
7.1648 We note at the outset that if an application is withdrawn, this means that the product-specific
measure complained of no longer exists. In th e case of the application concerning GA21 maize
(EC-85), the product-specific measure complained of by Argentina is the alleged "undue delay in
finalizing consideration of that application". Once that application was withdrawn, this meant that
there no longer was an undue delay in finalizing consideration of that application.
7.1649 As we pointed out earlier, the product-specifi c measure which relates to the application
concerning GA21 maize (EC-85) is within the terms of reference of DS293 (Argentina).
Notwithstanding this, the European Communities s ubmits that claims concerning applications
withdrawn before the Panel was established are without object and, hence, inadmissible ab initio. In
our view, the mere fact that the product-specific measure concerning GA21 maize (EC-85) no longer
existed as of the date of esta blishment of the Panel does not, ipso facto, deprive us of our authority to
make findings on a measure that is within our terms of reference.
1347
7.1650 This is also clear from the Appellate Body report in US – Certain EC Products . That dispute
concerned a measure which was withdrawn almost two months before a panel was established. 1348
The panel considered the measure, offered findi ngs on it and recommended that it be brought into
conformity with WTO rules. 1349 The Appellate Body found that the panel should not have made a
recommendation regarding a meas ure that no longer existed. 1350 But the Appellate Body nowhere
suggested that the panel erred in making findings regarding that measure.1351 We recognize that in our
case the application concerning GA21 maize (EC-85) was withdrawn more than two years before the
Panel was established. However, there is nothing in the DSU to suggest that our jurisdiction, which is
established by our terms of reference
1352, is affected by such considerations of time.
7.1651 Having said this, past jurisprudence shows that a panel is not necessarily required to make use
of its authority to make findings in respect of m easures which were no longer in existence on the date
of establishment of a panel. In Argentina – Textiles and Apparel , the panel decided not to make

1347 A different issue (which we do not reach) is whether we have the authority to make
recommendations in relation to the product-specific measure in question.
1348 The panel in that case was established on 16 June 1999, while the measure at issue (the "3 March
Measure") ceased to exist on 19 April 1999 when a new measure (the "19 April Action") was adopted.
1349 Panel Report, US – Certain EC Products, para. 7.3.
1350 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.
1351 Ibid., para. 271.
1352 Appellate Body Report, Brazil – Desiccated Coconut, p. 22.

findings on the WTO-consistency of a measure whic h had been revoked eleven days before the panel
was established.
1353 Moreover, as noted by the panel in US – Gasoline , "it had not been the usual
practice of a panel established under the General Ag reement [on Tariffs and Trade 1947] to rule on
measures that, at the time the panel's terms of refe rence were fixed, were not and would not become
effective".1354
7.1652 We consider that in determining whether to make findings on a measure no longer in
existence on the date of establishment of a panel, pa nels should notably take account of the object and
purpose of the dispute settlement system. 1355 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".
7.1653 In the case of the application concerning GA21 maize (EC-85), we are not persuaded that
making product-specific findings with regard to th at application is necessary to "secure a positive
solution to [the] dispute" between Argentina and th e European Communities. We note in this regard
that there is no agreement between the Parties that it would be useful for us to make findings on the
product-specific measure concerning the application in question. Moreover, the application was
withdrawn more than two years prior to the est ablishment of the Panel. Thus, unlike in the US –
Certain EC Products case where the measure at issue was in for ce for just over a month, this is a case
where Argentina could have presented its clai ms while the application was still pending. 1356 Finally,
we note that the applicant resubmitted the applic ation to another member State and that the
resubmitted application – the application concer ning GA21 maize (EC-78) – was still pending on the
date of establishment of this Panel. We will make findings on the resubmitted application. As a
result, we are resolving the dispute between Arge ntina and the European Communities insofar as it
relates to GA21 maize.
7.1654 In the light of these considerations, we w ill neither examine nor make product-specific
findings on the application concerning GA21 maize (EC-85).
(ii) Applications withdrawn after the establishment of the Panel
7.1655 In relation to applications which were withdrawn after the Panel was established, we note that
only the United States and Argentina are seeki ng product-specific findings on applications falling
within this category.
7.1656 The European Communities argues that the Panel should not address concerning applications wh ich were withdrawn after the Pane l was established. According
to the European Communities, the is sue has become moot and the relevant claims must be considered
inadmissible. The European Communities bases its argument on three provisions of the DSU. First,
Article 3.3 of the DSU states that the basic aim of the dispute settlement system is "the prompt
settlement of situations in which a Member consid ers that any benefits accruing to it directly or
indirectly under the covered agreements are being impaired by measures taken by another Member"
(emphasis added). This shows that the purpose of dispute settlement is to address and redress
situations that are in actual existence. Secondly, Article 3.4 of the DSU provides that

1353 Panel Report, Argentina – Textiles and Apparel, para. 6.15.
1355 This approach is consistent with that of the panel in Chile – Price Band System , which stated that
"[a]lthough we do not consider that the terminati on of a measure before the commencement of panel
proceedings deprives a panel of the 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.
1356 We note that the application was first submitted in December 1997.

"recommendations or rulings by the DSB shall be ai med at achieving a satisfactory settlement of the
matter". This cannot be the case if there is no matter to settle (i.e., if no measure is being applied).
Thirdly, Article 3.7 of the DSU provides that "befor e bringing a case a Member shall exercise its
judgment as to whether action under these procedures would be fruitful. The aim of the dispute
settlement mechanism is to secure a positive solution to a dispute". A case on a measure that is not in
existence any longer would be de void of any purpose and not fruitf ul. The European Communities
also points out that it is a legal principle recognized in jurisdictions around the world and commonly
applied by international tribunals, including the Inte rnational Court of Justice (the "ICJ"), that a
tribunal should not rule on a measure no longer in existence.
1357
7.1657 The United States argues that the concept of mootness is of no relevance, since the product-
specific measures existed in August 2003, when the te rms of reference were set. The United States
refers to the panel report on India – Autos, which states that "[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 re view may have been subsequently removed or
rendered less effective".1358 Regarding the European Communities' argument with regard to a "legal
principle" concerning mootness, the United Stat es notes that the European Communities failed to
mention that GATT and WTO panels in the past considered terminated measures, and that the
European Communities failed to explain how such a principle would be consistent with the text of the
DSU.
7.1658 Argentina argues that the European Communities' statement on mootness is not supported by
WTO jurisprudence. Argentina refers to the panel report on Chile – Price Band System , wherein the
panel stated that "Article 19.1 of DSU does not prevent us from making findings regarding the
consistency of an expired pr ovisional safeguard measure". 1359 Argentina also refers to the above-
quoted passage from the panel report on India – Autos.
7.1659 Subsequently, the European Communities clarified its position. It notes that it is not its
position that the Panel may not consider product- specific measures concerning applications which
were withdrawn after the Panel was established. 1360 But the European Communities remains of the
view that such measures are " sans objet", and that there is no longer any utility in considering such
measures because there does not exist, in respect of such measures, a dispute between the Parties.
7.1660 The Panel notes that there is no disagreement among the Parties that the which relate to applications withdrawn af ter the establishment of the Panel are within the
Panel's terms of reference. There also is no disagreement among the Parties that the Panel in principle
has the authority to consider measures which ceased to exist after the establishment of the Panel. We
agree with both points. In relation to the second point – the authority of panels to consider measures
which ceased to exist after the establishment of a panel – we note that the panel in India – Autos
observed that:

1357 The European Communities refers to the following ICJ judgments: Questions of Interpretation and
Application of the 1971 Montreal Convention ra ising from the Aerial Incident at Lockerbie (Libyan Arab
Jamahiriya v. United States of America), Judgment, ICJ Reports 1998, at 131, para 45; Nuclear Tests (Australia
v. France), Judgment, ICJ Reports 1974, p.272, para 62; and Border and Transborder Armed Actions
(Nicaragua v. Honduras), Jurisdiction and Admissibility, Judgment, ICJ Reports 1988, p.95, para. 66.
1359 Panel Report, Chile – Price Band System, para. 7.124.
1360 The European Communities nonetheless notes that the Panel should not issue recommendations in
respect of such measures.

"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."
1361
7.1661 The Parties disagree on whether the Panel should make use of its authority to make findings
on the concerning the withdrawn applications. The European Communities
argues that it is no longer useful for the Panel to consider the relevant , and
that the Panel should therefore refrain from ruli ng on these measures. According to the European
Communities, this would be consiste nt with international practice, including that of the International
Court of Justice.
7.1662 In considering this issue, we note that prev ious panels have addressed measures which ceased
to exist after the establishment of the panel. The panel in Indonesia – Autos stated in this regard that:
"[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."1362
7.1663 We would agree with the European Communities that it may be appropriate for panels to look
to the practice of international tribunals for inspir ation, particularly in situations where the WTO
agreements, GATT/WTO jurisprudence or practice provi de no useful guidance. But we do not find
ourselves in a situation of this kind. As is clear from the above remarks, there is specific GATT/WTO
jurisprudence and practice to guide us. In these circumstances, we see no need to draw on the
jurisprudence of the International Court of Justice.
7.1664 We do not consider that Articles 3.3 or 3.4 of the DSU support the view that we should
refrain from making findings on the relevant product-speci fic measures. In relation to Article 3.3, the
European Communities appears to argue that if bene fits are no longer "being" impaired by a measure,
because the measure has ceased to exist, the Panel should not make findings on it. However, the main
objective of Article 3.3 is to emphasise the importance of the prompt settlement of situations in which
benefits are being impaired by a measure. In our view, it cannot be deduced from this that in
situations where benefits are no longer being im paired by a measure, a panel should refrain from
making findings on it. We note that pursuant to Artic le 3.2 of the DSU the dispute settlement system
also serves "to preserve the rights and obligations of Members under the covered agreements". We
think that it is consistent with this function of the dispute settlement system for a panel to make
findings on the WTO-consistency of a measure whic h has ceased to exist, especially if so requested
by one of the parties.
7.1665 Turning to Article 3.4, we note that that pr ovision states that recommendations or rulings by
the DSB must be aimed at achieving a satisfactor y settlement of the "matter". The European
Communities suggests that if a measure has ceased to ex ist, there is no longer a "matter" to be settled.
However, the "matter" to be settled is the matter re ferred to the DSB for settlement. As is clear from
Article 7.1 of the DSU and the Appellate Body report in Guatemala – Cement I1363, the matter referred
to the DSB is the matter described by a Complaining Party in its request for the establishment of a
panel. Pursuant to Article 6.2 of the DSU, the request for establishment of a panel must identify the

1363 Appellate Body Report, Guatemala – Cement I, para. 72.

specific measures at issue. Applying these consider ations to the present case, it is clear that the
"matter" to be settled by the DSB in a satisfact ory manner includes the
identified by the United States and Argentina in thei r respective panel requests. Therefore, we do not
agree that once the relevant ceased to exist, there was, to that extent, no
longer a "matter" which could be settled by the DSB.
7.1666 Regarding whether it is useful for the Pa nel to address the
concerning the withdrawn applications, we recall our view that in making that determination, account
should notably be taken of the object and purpose of the dispute settlement system, which is to secure
a positive solution to a dispute. We note in this rega rd that there is no agreement between the Parties
that it would be useful for us to make findi ngs on the concerning the
applications in question. However, the United St ates and Argentina as Complaining Parties did not
say that in view of the withdrawal of the app lications in question, they were no longer seeking
findings on the concerning th ese applications. On the contrary, Argentina,
for instance, explicitly requested th e Panel to offer such findings. Moreover, unlike in the case of the
application concerning GA21 maize (EC-85), our findings on other do not
resolve the dispute relating to the relevant biotech products. Finally, we note that the applications
were withdrawn by the applicants. It is clear, th erefore, that this is not a case where the relevant
measures were terminated by the responding party in the course of panel proceedings in a good faith
effort to resolve the underlying dispute. Thus, we do not consider that if we make findings on the
 at issue, we would be frustrating efforts undertaken to reach a positive
solution to the dispute. In these circumstanc es, we are unable to agree with the European
Communities that it is no longer useful for us to offer findings on the at
issue.
7.1667 In the light of the above, the Panel will make findings on the
concerning those applications which were withdrawn after the Panel was established.
(iii) Applications approved after the establishment of the Panel
7.1668 The last category of applicati ons to be addressed concerns a pplications which were approved
by the Commission in the course of the Panel pro ceedings. All three Complaining Parties are seeking
product-specific findings on such applications. In our view, applications which were definitively
approved
1364 in the course of the Panel proceedings may be assimilated, for the purposes of the present
inquiry, to applications which were withdrawn in the course of the Panel proceedings. Both
categories of applications have in common the fact that the underlying approval procedures were
pending on the date of establishment of the Panel, but were subsequently discontinued. The only
difference is that in the case of a definitively approved a pplication, the relevant approval procedure
was discontinued as a result of action directly attr ibutable to the European Communities. We do not
consider that this difference, by itself, warrants a different approach by the Panel. We note in this
regard that the European Communities does not argue that the Commission approved applications in
order to resolve its dispute with the Complaining Parties in relation to the relevant applications.1365

1364 We use the phrase "definitively approved" to refer to a situation where according to information on
our record the applicant may proceed w ith the placing on the market of the biotech product which is the subject
of the approved application.
1365 The European Communities argues that the approvals of the relevant applications are simply the
consequence of these applications having reached the final decision-m aking stage after being assessed at
member State and Community level. EC comments on the Complaining Parties' replies to Panel questions,
paras. 62-63.

7.1669 In the light of this, the Panel will make findings also with regard to those that concern applications which were definitively approved in the course of the Panel
proceedings. The evidence on record supports the conclusion that two app lications – namely, the
application concerning Bt-11 sweet maize (food) an d the application concerning NK603 maize (food)
– were definitively approved in the course of th e Panel proceedings. Fo r the other relevant
applications approved by the Commission in the co urse of the Panel proceedings, the record does not
allow us to determine whether these applications have been definitively approved, such that they may
be placed on the market.
1366 In any event, it is clear from the foregoing that we would offer findings
on concerning such appli cations even if they had been definitively
approved after the date of the establishment of the Panel.
(iv) Conclusion
7.1670 In the light of the foregoing considerations, we will offer no findings on the product-specific
measure concerning GA21 maize (EC-85) (DS293), but we will make findings on concerning applications which were withdrawn after the Panel was established as well as on
the product-specific measure concerning Bt-11 sweet maize (food) (DS291), an application which was
definitively approved in the course of the Panel proceedings. However, we will not make any
recommendations in the event that we find that th e concerning applications
which were withdrawn after the Panel was established, or the product-specific measure concerning
Bt-11 sweet maize (food) (DS291), are WTO-inconsistent.
2. Claims of inconsistency raised by the Complaining Parties
7.1671 The Complaining Parties have each presented a series of claims of inconsistency in relation to
the European Communities' product-specific EC measures they are challenging
7.1672 The United States claims that the product-specific EC measures it is challenging are
inconsistent with, or have given rise to inconsistencies with, the following WTO provisions:1367
(a) Annex C(1)(a) and, consequently, Article 8 of the SPS Agreement;
(b) Annex B(1) and, consequently, Article 7 of the SPS Agreement;
(c) Annex C(1)(b) and, consequently, Article 8 of the SPS Agreement;
(d) Article 5.1 and, consequently, Article 2.2 of the SPS Agreement;
(e) Article 5.5 of the SPS Agreement.
7.1673 Canada claims that the product-specific EC measur es it is challenging are inconsistent with,
or have given rise to inconsistencies with, the following WTO provisions:1368

1366 We note in this regard that in relation to the applications concerning NK603 maize (for animal feed
use) and RR oilseed rape (EC-70) the record contains no evidence that the relevant lead CA has given its written
consent for the placing on the market of these products after they were approved by the Commission under
Directive 2001/18.
1367 The claims are listed in the order in which they were developed in the first written submission of
the United States.
1368 The claims are listed in the order in which they were developed in the first written submission of
Canada.

(a) Article 5.1 and, consequently, Article 2.2 of the SPS Agreement;
(b) Article 5.6 and, consequently, Article 2.2 of the SPS Agreement;
(c) Article 5.5 and, consequently, Article 2.3 of the SPS Agreement;
1369
(d) Annex C(1)(a) and, consequently, Article 8 of the SPS Agreement;
(e) Article III:4 of the GATT 1994;
(f) Articles 2.1, 2.2, 5.1.2 and 5.2.1, first part, of the TBT Agreement.
7.1674 With regard to Canada's claims under the TBT Agreement, Canada explained that, if the Panel
determines that parts of the relevant pr oduct-specific measures are covered by the TBT Agreement in
addition to the SPS Agreement, its claims under the TBT Agreement are to be considered cumulative
rather than alternative.
7.1675 Argentina claims that the product-speci fic EC measures are inconsistent with, or have given
rise to inconsistencies with, the following WTO provisions:1370
(a) Article 5.1 and, consequently, Article 2.2 of the SPS Agreement;
(b) Articles 5.5 and 5.6 of the SPS Agreement;
(c) Annex C(1)(a), (b), (c) and (e) and, consequently, Article 8 of the SPS Agreement;
(d) Article III:4 of the GATT 1994;
(e) Articles 2.1, 2.2, 5.1.1, 5.1.2, 5.2.1, 5.2.2 and 12 of the TBT Agreement.
7.1676 As previously indicated, the Panel will make fi ndings in relation to ten product-specific EC
measures challenged by Argentina. However, Arge ntina's claims under Article 8 and Annex C(1) of
the SPS Agreement and those under Article 5.2 of the TBT Agreement concern only eight of the ten
"relevant ". The two measures which are not the subject of a claim under
these provisions are the measures affecting the a pproval of Bt-531 cotton and RR-1445 cotton under
Regulation 258/97.
7.1677 We further note that Argentina's claims under the TBT Agreement are put forth as alternatives
to its claims under the SPS Agreement.
7.1678 The European Communities argues that none of the product-specific claims presented by
the three Complaining Parties is founded, and that it has not acted inconsistently with any of the WTO
provisions which are being invoked by the Complain ing Parties in respect of any of the product-
specific measures.
7.1679 In view of the European Communities' view that all of the Complaining Parties' product-
specific 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' substantive claims under

1369 Canada's claim under Article 5.5 is put forth as an alternative to its claim under Article 5.6.
1370 The claims are listed in the order in which they were developed in the first written submission of
Argentina.

Articles 5 and 2 of the SPS Agreement, and, if appropriate, will go on to examine the transparency
claim under Annex B of the SPS Agreement and the procedural claims under Annex C of the
SPS Agreement. Finally, to the extent it is necessary to do so, we will also examine Canada's and
Argentina's claims under the GATT 1994 and under the TBT Agreement.
3. Consistency of the with Article 5.1 of the SPS Agreement
7.1680 All three Complaining Parties claim that the European Communities has acted inconsistently
with its obligations under Article 5.1 of the SPS Agreement in respect of the they are challenging.
7.1681 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."
7.1682 The United States argues that like the general moratorium, to the extent the – the product-specific moratoria – are preventing the sale or marketing of biotech products,
each failure by the European Communities to consider for approval a pending application of a biotech
product is an "SPS measure" that is not "based on a risk assessment" as required by Article 5.1. The
United States considers that the product-specific morato ria, which, in effect, ban the relevant biotech
products from the EC market, are "SPS measures" as defined in Annex A(1) of the SPS Agreement.
The EC approval regime, including that part of the regime modified by the product-specific moratoria,
are plainly "sanitary or phytosanitary" measures. Similarly, the product-specific moratoria, although
unwritten, are "measures" under the SPS Agreement, just as the general mo ratorium affecting all
products is a "measure" under the SPS Agreement. Regarding the requirement that SPS measures be
based on a risk assessment, the United States submits that with respect to fourteen of the pending
applications, the European Communities has not put forth any risk asse ssment whatsoever. As for the
remaining thirteen applications, the European Communities has undertaken risk assessments but the
product-specific moratoria are not based on these assessments.
7.1683 Canada argues that the failure of the European Communities to consider or approve, without
undue delay, the four applications of specific inte rest to Canada is an SPS measure as defined in
Annex A(1). According to Canada, the failure to consider and approve these applications, which
Canada refers to as the "product-specific marketing bans", is not "based on" risk assessments contrary
to Article 5.1. While the European Communities ha s completed risk assessments for each of the four
applications, it has failed to base its failure to consider, and approve, these applications on these
assessments.
7.1684 Argentina argues that the suspension of considera tion of, or the failure to consider, the
particular applications of interest to Argentin a constitutes an SPS measure and is contrary to the
requirements of Article 5.1 because it is not based on any risk assessments. Argentina points out that
there are applications that have not been approved in spite of the fact that member States or the EC
scientific committees have conducted risk assessments and the assessments were favourable. In these
cases, the requirements of Article 5.1 have not b een met because the favourable risk assessment has
not been taken into consideration. Other appli cations have had their processing suspended without
any risk assessment having been conducted either by me mber States or EC scientific committees. In
these cases, the requirements of Article 5.1 ha ve not been met because no risk assessment was

performed on account of the suspension of considera tion of, or failure to consider, the relevant
applications.
7.1685 The European Communities argues that the delays (or failure to act within a specific
timeframe) in the approval process alleged by th e Complaining Parties can be reviewed under the
SPS Agreement as an issue of application of an SPS measure and more specifically, of the approval
system set up under the EC GMO legislation, an d that the delays of the kind alleged by the
Complaining Parties here thus cannot constitute an SPS measure in the sense of Annex A(1). As a
matter of logic, it is clear that alleged behaviour by a Member cannot be an SPS measure itself as well
as the application of another SPS measure. As th e delays of the kind alleged by the Complaining
Parties do not fall within the definition of an SPS measure defined by Annex A(1), the European
Communities considers that Article 5.1 is not applicable to these delays.
7.1686 The Panel notes that, by its clear terms, Article 5.1 applies to SPS measures. Accordingly,
for a particular product-specific measure to be subject to Article 5.1, it must be an SPS measure. The
European Communities contests that the product- specific measures constitute SPS measures within
the meaning of Article 5.1. It is therefore necessary to consider this issue.
7.1687 We recall that the Complaining Parties have stated that the they are
challenging are related to the general moratorium on approvals. We have observed that based on
these statements we understand that the are, or arise from:
− specified acts and/or omissions through wh ich the relevant EC entities were giving
effect, in the context of particular approva l procedures, to their decisions to impose a
general moratorium on approvals, or
− specified acts and/or omissions through whic h relevant EC entities chose to respond,
again in the context of particular approval procedures, to the circumstance that other
EC entities were imposing a general moratorium on approvals.

7.1688 In relation to the general moratorium on appr ovals, we have found earlier that the European
Communities' decision to apply a general moratori um on approvals was not a decision effectively
imposing an across-the-board definitive marketing ba n, but a decision concerning the application, or
operation, of approval procedures. We also found that the decision in question was not, itself, a
measure applied to achieve the European Commun ities' appropriate level of protection. These
findings led us to conclude that the European Co mmunities' decision to apply a general moratorium
on approvals was not an "SPS measure" within the meaning of Annex A(1) and Article 5.1.
7.1689 If, as we believe, the European Communities' decision to apply a general moratorium on
approvals was not an "SPS measure", logic suggest s that the same should be true for the product-
specific measures, considering that, in our unders tanding, they essentially are acts and/or omissions
through which relevant EC entities were giving eff ect to the decision to apply a general moratorium
on approvals, or through which they were reacting to the circumstance that other EC entities were
imposing a general moratorium.
1371 Notwithstanding the fact that there is a logical link between the
general moratorium and the , it is appropriate to examine in more detail
whether the latter measures constitute SPS measur es within the meaning of Annex A(1) and
Article 5.1. As the Complaining Parties have provi ded slightly different de scriptions of the product-

1371 We recall that in relation to the second categor y of acts and/or omissions, the Complaining Parties
essentially allege that applications were processed at a delayed pace in view of the existence of a general
moratorium on final approvals until certain conditions were met.

specific measures of which they are complaini ng, we examine this issue separately for each
Complaining Party.
1372
(a) DS291 (United States)
7.1690 As we have previously noted, the United Stat es is challenging the alleged failure by the
European Communities to consider particular appli cations for final approval. We recall that for a
particular measure to be subject to Article 5.1 it must be an "SPS measure". To determine whether the
European Communities' alleged fa ilure to consider a particular application for final approval
constitutes an "SPS measure", we first look to the defi nition of that term set out in Annex A(1) of the
SPS Agreement. According to Annex A(1), SPS measures include "requirements and procedures".
7.1691 Regarding "requirements", we note that failure to consider a particular application for final
approval, even if intentional, is not the same thing as a negative final approval decision on that
application. Nor does failure to consider for fi nal approval necessarily lead to, or predetermine, a
negative final approval decision. Consequently, we are of the view that the European Communities'
alleged failure to consider a pa rticular application for final a pproval would not have imposed a
substantive SPS "requirement" within the meaning of the Annex A(1) definition of the term "SPS
measure".
7.1692 The United States argues, however, that, in eff ect, the European Communities' alleged failure
to consider particular applications for final approval banned the relevant biotech products from the EC
market. We would agree that failure to consider a particular application for final approval would
ordinarily result in delays in the completion of the relevant approval procedure. In turn, these delays
would have the effect of extending the time-peri od during which the biotech product in question was
subject to the provisional marketing ban flowing from the EC pre-marketing approval requirement.
But a failure to consider a particular application for final approval would not have imposed a new ban;
a ban was already in place, as a consequence of the pre-marketing approval requirement. In other
words, the origin of the provisional marketing ban, including of the effectively extended ban, would
not have been the failure to consider the releva nt application for final approval, but the EC pre-
marketing approval requirement, i.e., the European Communities' substantive decision to ban biotech
products until they have been approved.
7.1693 Consistent with the foregoing, we agree that fa ilure to consider a particular application for
final approval would have had an impact on how lo ng the provisional marketing ban was in place for
the relevant biotech product. Yet we are unable to ag ree that a failure to consider an application for
final approval effectively woul d have imposed a new marketing ban, and, hence, a negative
"requirement", on the biotech product concerned. If the United States had been of the view that the
aforementioned impact on the provisional market ing ban resulted in that ban being applied
inconsistently with Article 5.1, it was open to it to challenge that ban ( i.e., the pre-marketing approval
requirement) as the source of the provisional marketing ban. The United States chose not to do so in
this case.
7.1694 Regarding "procedures", we note the United States' argument that the European Communities'
alleged failure to consider par ticular applications for final a pproval "modified" part of the EC
approval regime. Since the alleged product-specifi c measures in question would not, in our view,
have imposed any new substantive requirement, we do not think that they would have modified any
substantive requirement which is part of the EC approval regime. What remains to be examined, then,

1372 See also our discussion of the Complaining Parties' Article 5.1 claim in Section VII.D.5 above.

is whether the would have modified the relevant EC approval
procedures.
1373
7.1695 Clearly, the European Communities' alleged failure to consider a particular application for
final approval would not itself have constituted, or established, a procedure for approving the relevant
biotech product or, more to the point, for preventing the final approval of this biotech product. The
failure to consider a particular application for fi nal approval also would not have effectively amended
the relevant EC approval procedure for the speci fic biotech product in question. As we have
explained in earlier findings on the general morato rium on approvals, the European Communities did
not apply a different type of approval procedure. The applications in question continued to be
assessed in accordance with the procedure set out in Directives 90/220 and 2001/18, as well as
Regulation 258/97. Therefore, we are not persuaded that the alleged failure to consider a particular
application for final approval woul d have "modified" the relevant EC approval procedure. In our
assessment, the foregoing also leads to the conclusion that the alleged failure to consider a particular
application for final approval cannot be considered a "procedure" within the meaning of Annex A(1).
7.1696 Thus far, we have found that the European Communities' alleged failure to consider a
particular application for final approval qualifi es neither as a "requirement" nor as a "procedure"
within the meaning of Annex A(1). But we have not yet determined in positive terms what is the
legal nature of the failure in question. We thi nk the United States' reference to the failure by the
European Communities to consider a particular a pplication for final approval should be understood,
and makes sense, as a reference to the applicati on by the European Communities of a particular way
of operating the relevant EC approval procedure – a way which reflected the intention, or the
anticipation, that there would be no final approval decision on the application in question until certain
conditions were met. In other words, we think th at, in essence, the United States is complaining of a
particular manner of operating the EC approval procedures in specific cases.
7.1697 In terms of Annex A(1), this means that we ar e concerned with the application, or operation,
of "procedures". As we have said in our earlier findings, while "procedures" as such may according
to the Annex A(1) definition constitute SPS measur es, the application, or operation, of such
procedures does not, itself, constitute an SPS measure within the meaning of Annex A(1).
Accordingly, we come to the conclusion that the European Communities' alleged failure to consider a
particular application for final approval does not meet all of the constituent elements of the definition
of the term "SPS measure" as provided in Annex A(1).
7.1698 Turning now to Article 5.1, we recall our ear lier finding that the term "SPS measure" in
Article 5.1 should be interpreted to refer to a me asure applied for achieving the relevant Member's
appropriate level of sanitary or phytosanitary prot ection. In our view, the European Communities'
alleged failure to consider a par ticular application for final approva l would not, itself, have been a
measure applied for achieving the European Comm unities' appropriate le vel of sanitary or
phytosanitary protection. Rather, as we have said, it would have been the application of a particular
way of operating the relevant EC approval procedure. As we explained above, the practical effect of
the alleged failure to consider a particular appli cation for final approval would have been to extend
the time-period during which the relevant biotech product was subject to the provisional marketing
ban flowing from the pre-marketing approval require ment. 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 requi rement is a separate measure from the European
Communities' alleged failure to cons ider a particular application for final approval. By itself, the

1373 The relevant approval procedures are set out in Directive 90/220 and its successor,
Directive 2001/18, as well as Regulation 258/97.

alleged failure to consider a particular applica tion for final approval woul d not have achieved or
implied a particular level of protection.
7.1699 As the European Communities' alleged failure to consider a particular application for final
approval would not, itself, have been a measur e 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.
7.1700 Based on the above considerations, we thus determine that the European Communities'
alleged failure to consider a par ticular application for final approva l cannot be considered an "SPS
measure" within the meaning of Article 5.1 and A nnex A(1). As only "SPS measures" are subject to
the provisions of Article 5.1, it follows that the pr ovisions of Article 5.1 are not applicable to the
European Communities' alleged failure to consider particular applicati ons for final approval. In view
of this conclusion, we need not continue our analysis of the United States' claim under Article 5.1.
(b) DS292 (Canada)
7.1701 In relation to DS292, we have noted above that Canada is challenging the alleged failure by
the European Communities to consider or approve, w ithout undue delay, particular applications of
specific interest to Canada. Canada also refers to this failure to consider or approve applications as an
effective "product-specific marketing ban".
7.1702 Regarding Canada's reference to an effective product-specific marketing ban, we note that we
have already addressed a similar argument of the Un ited States. Thus, we need only recall that we
agree that the alleged failure by the European Communities to consider or approve a particular
application would have had an impact on how long the provisional marketing ban resulting from the
EC pre-marketing approval requirement was in place for the relevant biotech product. But we are
unable to agree that the alleged failure to consider or approve an application effectively would have
imposed a new marketing ban, and, hence, a negative "requirement", on the biotech product
concerned.
7.1703 Instead, similar to what we have said of th e measures challenged by the United States, we
consider that Canada's reference to the failure by the European Communities to consider or approve a
particular application should be unde rstood, and makes sense, as a reference to the application by the
European Communities of a particular way of opera ting the relevant EC approval procedure – a way
which reflected the intention, or the anticipation, that there would be no final approval decision on the
application in question until certain conditions were met. Thus, we think that, in essence, Canada is
complaining of a particular manner of operating the EC approval procedures in specific cases.
7.1704 For the same reasons as those we have given in the context of our analysis of the measures
challenged by the United States, the type of measure Canada is challenging in our view (i) does not
itself constitute an SPS measure within the meaning of Annex A(1) and (ii) is not a measure applied
for achieving the European Communities' appropriate level of sanitary or phytosanitary protection and
hence cannot be considered an "SPS measure" within the meaning of Article 5.1.
7.1705 As only "SPS measures" are subject to the provisions of Article 5.1, it follows that the
provisions of Article 5.1 are not applicable to the European Communities' alleged failure to consider
or approve particular applications. In view of this conclusion, we need not continue our analysis of
Canada's claim under Article 5.1.

(c) DS293 (Argentina)
7.1706 In relation to DS293, we note that Argen tina makes claims under Article 5 of the
SPS Agreement regarding all ten applications in respect of which the Panel has decided to offer
product-specific findings. We first address the appl ications concerning Bt-5 31 cotton and RR-1445
cotton which Argentina says have yet to be approved under Regulation 258/97.
(i) affecting the approval of Bt-531 cotton and RR-1445 cotton under
Regulation 258/97
7.1707 Argentina challenges under Article 5.1 the susp ension of consideration of, or failure to
consider, applications concerning Bt-531 cott on and RR-1445 cotton which were allegedly submitted
for "approval"
1374 under Regulation 258/97.
7.1708 Argentina has provided no evidence of the existence of applications concerning Bt-531 cotton
and RR-1445 cotton which were submitted for "a pproval" under Regulation 258/97. The only
evidence provided by Argentina in support of its claim relates to cottonseed oil derived from Bt-531
cottonseed or RR-1445 cottonseed. These products were subject to the simplified procedure set out in
Article 5 of Regulation 258/97. As indicated by us earlier, under the simplified procedure, there are
no "applications" for the placing on the market of subject products which are then "approved" by
member State assessment bodies. Moreover, in its requ est for the establishment of a panel, Argentina
identifies Bt-531 cotton and RR-1445 cotton as a rele vant biotech product, but not cottonseed oil
derived from Bt-531 cottonseed or RR-1445 cottonseed . Thus, cottonseed oil derived from Bt-531
cottonseed or RR-1445 cottonseed is outside the terms of reference of DS293 (Argentina).
7.1709 In view of the fact that we have seen no ev idence that applications concerning Bt-531 cotton
and RR-1445 cotton were submitted for approval under Regulation 258/97, we find that Argentina has
failed to meet its burden of demonstrating the existe nce of a suspension of consideration of, or failure
to consider, Bt-531 cotton and RR-1445 cotton fo r approval under Regulation 258/97. As the
existence of these product-specifi c measures has not been demonstrated, we cannot but reject
Argentina's claim that the Europ ean Communities has acted inconsistently with its obligations under
Article 5.1 in relation to these alleged measures.
(ii) Other challenged by Argentina
7.1710 We now turn to address the remaining eight in respect of which the
Panel has decided to make findings. As noted, Ar gentina describes the it is
challenging under Article 5.1 as the suspension by th e European Communities of consideration of, or
the failure to consider, particular applications of interest to Argentina.
7.1711 As with the measures challenged by the United St ates, we are of the view that the measures
challenged by Argentina qualify neither as "require ments" nor as "procedures" within the meaning of
Annex A(1). Instead, we think Arge ntina's reference to the suspension of consideration of, or failure
to consider, a particular application should be u nderstood, and makes sense, as a reference to the
application by the European Communities of a part icular way of operating th e relevant EC approval
procedure – a way which reflected the intention, or the anticipation, that there would be no final
approval decision on the application in question until cer tain conditions were met. In other words, we
think that, in essence, Argentina is complaining of a particular manner of operating the EC approval
procedures in specific cases.

1374 Argentina's first written submission, paras. 201-202.

7.1712 For the same reasons as those we have given in the context of our analysis of the measures
challenged by the United States, the type of measure Argentina is challenging in our view (i) does not
itself constitute an SPS measure within the meaning of Annex A(1) and (ii) is not a measure applied
for achieving the European Communities' appropriate level of sanitary or phytosanitary protection and
hence cannot be considered an "SPS measure" within the meaning of Article 5.1.
7.1713 As only "SPS measures" are subject to the provisions of Article 5.1, it follows that the
provisions of Article 5.1 are not applicable to the European Communities' alleged suspension of
consideration of, or failure to cons ider, particular applications. In view of this conclusion, we need
not continue our analysis of Argentina's claim under Article 5.1.
(d) Conclusions
7.1714 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 in respect of any of the
on which the Panel is offering findings.

 (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 in respect of any of the relevant .

 (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 in respect of any of the on which the Panel
is offering findings.

4. Consistency of the with Article 5.6 of the SPS Agreement
7.1715 Canada and Argentina claim that the European Communities has acted inconsistently with its
obligations under Article 5.6 of the SPS Agreement in respect of the they
are challenging.
7.1716 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 into account technical and economic feasibility."
(footnote omitted)
7.1717 Canada argues that the failure of the European Communities to consider or approve, without
undue delay, the four applications of specific inte rest to Canada is an SPS measure as defined in
Annex A(1). The failure to consider and approve these applications, which Canada refers to as the
"product-specific marketing bans", is "more trade rest rictive than required", contrary to Article 5.6.
This is because there is another SPS measure that is reasonably available, taking into account
technical or economic feasibility; achieves the Eur opean Communities' appropriate level of sanitary
and phytosanitary protection; and is significantly less restrictive to trade than the contested SPS
measure.
7.1718 Argentina argues that the suspension of considera tion of, or the failure to consider, the
particular applications of interest to Argentin a constitutes an SPS measure and is contrary to the
requirements of Article 5.6. This violation of Article 5.6 results from the fact that there exists another
SPS measure that: (1) is reasonably available taki ng into account technical and economic feasibility;
(2) achieves the European Communities' appropriate level of sanitary and phytosanitary protection;
and (3) is significantly less restrictive to trade than the contested SPS measure.
7.1719 The European Communities argues that the delays (or failure to act within a specific
timeframe) in the approval process alleged by th e Complaining Parties can be reviewed under the
SPS Agreement as an issue of application of an SPS measure and more specifically, of the approval
system set up under the EC GMO legislation, an d that the delays of the kind alleged by the
Complaining Parties thus cannot constitute an SPS measure in the sense of Annex A(1). As a matter
of logic, it is clear that alleged behaviour by a Member cannot be an SPS measure itself as well as the
application of another SPS measure. As the delays of the kind alleged by the Complaining Parties do
not fall within the definition of an SPS measure defined by Anne x A(1), the European Communities
considers that Article 5.6 is not applicable to these delays.
7.1720 The Panel will analyse Canada's and Argentina's claim separately.
1375
(a) DS292 (Canada)
7.1721 In relation to DS292, we note that for a particul ar measure to be subject to Article 5.6 it must
be an SPS measure. We also note that Article 5.6 explicitly refers to "[SPS] measures to achieve the
appropriate level of sanitary or phytosanitary protec tion". Furthermore, we recall that in the context
of our earlier analysis of Canada's claim under Artic le 5.1 we found that the type of measure Canada
is challenging in our view (i) does not itself c onstitute an SPS measure within the meaning of
Annex A(1) and (ii) is not a measure applied fo r achieving the European Communities' appropriate
level of sanitary or phytosanitary protection. It follows from these elements that the alleged failure by
the European Communities to consider or approve a particular application cannot be considered an
"SPS measure" within the meaning of Article 5.6.
7.1722 As only "SPS measures" are subject to the pr ovisions of Article 5.6, the provisions of
Article 5.6 are not applicable to the European Co mmunities' alleged failure to consider or approve
particular applications. In view of this conclusi on, we need not continue our analysis of Canada's
claim under Article 5.6.

1375 See also our discussion of Canada's and Argentina's Article 5.6 claim in Section VII.D.6 above.

(b) DS293 (Argentina)
7.1723 In relation to DS293, we begin our analysis with the applications concerning Bt-531 cotton
and RR-1445 cotton which Argentina says have yet to be approved under Regulation 258/97.
(i) affecting the approval of Bt-531 cotton and RR-1445 cotton under
Regulation 258/97
7.1724 Argentina challenges under Article 5.6 the susp ension of consideration of, or failure to
consider, applications concerning Bt-531 cott on and RR-1445 cotton which were allegedly submitted
for "approval"
1376 under Regulation 258/97.
7.1725 We recall that in respect of the same allege d Argentina presented a
claim under Article 5.1 of the SPS Agreement. In the context of our analysis of that claim, we have
pointed out that we have seen no evidence that applications concerning Bt-531 cotton and RR-1445
cotton were submitted for approval under Regulati on 258/97, and we therefore found that Argentina
has failed to meet its burden of demonstrating the existence of a suspension of consideration of, or
failure to consider, Bt-531 cotton and RR-1445 cotton for approval under Regulation 258/97. As the
existence of these product-specifi c measures has not been demonstrated, we cannot but reject
Argentina's claim that the Europ ean Communities has acted inconsistently with its obligations under
Article 5.6 in relation to these alleged measures.
(ii) Other challenged by Argentina
7.1726 We now turn to address the remaining eight in respect of which the
Panel has decided to make findings.
7.1727 We recall that for a particular measure to be s ubject to Article 5.6 it must be an SPS measure.
We also recall that Article 5.6 explicitly refers to "[SPS] measures to achieve the appropriate level of
sanitary or phytosanitary protection". Furthermore, we recall that in the context of our earlier analysis
of Argentina's claim under Article 5.1 we found that the type of measure Argentina is challenging in
our view (i) does not itself constitute an SPS measure within the meaning of Annex A(1) and (ii) is
not a measure applied for achieving the European Communities' appropriate level of sanitary or
phytosanitary protection. It follows from these elements that the European Communities' alleged
suspension of consideration of, or failure to consider , a particular application cannot be considered an
"SPS measure" within the meaning of Article 5.6.
7.1728 As only "SPS measures" are subject to the pr ovisions of Article 5.6, the provisions of
Article 5.6 are not applicable to the European Communities' alleged suspension of consideration of, or
failure to consider, particular applications. In vi ew of this conclusion, we need not continue our
analysis of Argentina's claim under Article 5.6.

1376 Argentina's first written submission, paras. 201-202

(c) Conclusions
7.1729 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 in respect of any of the relevant .

 (ii) 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 5.6 of the
SPS Agreement in respect of any of the on which the Panel
is offering findings.

5. Consistency of the with Article 5.5 of the SPS Agreement
7.1730 All three Complaining Parties claim that the European Communities has acted inconsistently
with its obligations under Article 5.5 of the SPS Agreement in respect of the they are challenging.
7.1731 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.[....]"
7.1732 The United States argues that the product-specific moratoria, which, in effect, ban the
relevant biotech products from the EC market, ar e "SPS measures" as defined in Annex A(1) of the
SPS Agreement. The United States argues that like th e general moratorium, the product-specific
moratoria meet all three elements that are required to establish a violation of Article 5.5. First, the
European Communities has set forth distinct levels of sanitary protection in "different situations":
products produced with biotech processi ng aids and other biotech products. Second, those levels of
protection exhibit differences that are "arbitrary or unjustifiable." Third, the product-specific
moratoria result in "discrimination or a disguised restriction on international trade."
7.1733 Canada puts forth its claim under Article 5.5 as an alternative to its claim under Article 5.6.
In putting forth the Article 5.6 claim, Canada as sumed that the European Communities' appropriate
level of protection is a "high level of protection" , but not a zero-risk level. However, if this
assumption is not correct and the European Communitie s' appropriate level of protection for the four
applications of specific interest to Canada at issu e is that reflected by the product-specific marketing
bans, namely a zero-risk level, then Canada is of the view that the European Communities has
violated Article 5.5 of the SPS Agreement.

7.1734 Canada argues that the failure of the European Communities to consider or approve, without
undue delay, the four applications of specific inte rest to Canada is an SPS measure as defined in
Annex A(1). Canada claims that the failure to consider and approve these applications, which Canada
refers to as the "product-specific marketing bans" meet all three elements that are required to establish
a violation of Article 5.5. First, the European Communities has adopt ed different appropriate levels
of sanitary and phytosanitary protection in "d ifferent situations" that are comparable. Second, those
different appropriate levels of protect ion are "arbitrary or unjustifiable." Third, the measures
embodying those differences, the product-specific marketing bans, result in "discrimination or a
disguised restriction on international trade".
7.1735 According to Canada, the "comparable" situa tions above are of the following two kinds: (i)
the biotech products whose applications have been stalled as a result of the product-specific marketing
bans on the one hand and the biotech products that we re approved for commercialization prior to the
imposition of the moratorium on the other; (ii) the biotech produc ts whose applications have been
stalled as a result of the product-specific marketing bans on the one hand and novel non-biotech
products such as those produced by conventional plant breeding techniques on the other.
7.1736 Argentina argues that the suspension of considera tion of, or the failure to consider, the
particular applications of interest to Argentin a constitutes an SPS measure and is contrary to the
requirements of Article 5.5. This is because the suspension of consideration of, or the failure to
consider, the particular applications of interest to Argentina meets the three distinct and cumulative
elements which are required to be demonstrated in support of a claim under Article 5.5: (i) The
Member that imposes the measure that is the subj ect of the complaint must have adopted its own
levels of sanitary protection against risks to human, animal or plant life or health in various different
situations, which are comparable; (ii) these levels of protection exhibit arbitrary or unjustifiable
differences in the treatment of different situations; and (iii) these arbitrary or unjustifiable differences
must result in discrimination or a restriction of international trade.
7.1737 According to Argentina, the "comparable" s ituations are of the following two kinds: (1)
biotech products introduced before and after the moratorium; (2) new "non-biotech" products and new
biotech products.
7.1738 The European Communities argues that the delays (or failure to act within a specific
timeframe) in the approval process alleged by th e Complaining Parties can be reviewed under the
SPS Agreement as an issue of application of an SPS measure and more specifically, of the approval
system set up under the EC GMO legislation, an d that the delays of the kind alleged by the
Complaining Parties thus cannot constitute an SPS measure in the sense of Annex A(1). As a matter
of logic, it is clear that alleged behaviour by a Member cannot be an SPS measure itself as well as the
application of another SPS measure. As the delays of the kind alleged by the Complaining Parties do
not fall within the definition of an SPS measure defined by Anne x A(1), the European Communities
considers that Article 5.6 is not applicable to these delays.
7.1739 The Panel will analyse separately the claim presented by each Complaining Party.1377
(a) DS291 (United States)
7.1740 In relation to DS291, we recall that we have dete rmined in the context of our analysis of the
challenge to the general EC moratorium that Arti cle 5.5 implies a reference to "SPS measures" and
that the SPS measures at issue in Article 5.5 are those which are applied for achieving a particular

1377 See also our discussion of the Complaining Parties' Article 5.5 claim in Section VII.D.7 above.

level of sanitary or phytosanitary protection ( i.e., measures implementing a particular level of
protection). Accordingly, Article 5.5 implies that the measure complained of is an implementing
"SPS measure". We recall that in the context of our earlier analysis of the United States' product-
specific claim under Article 5.1 we found that the type of measure the United States is challenging in
our view (i) does not itself constitute an SPS measure within the meaning of Annex A(1) and (ii) is
not a measure applied for achieving the European Communities' appropriate level of sanitary or
phytosanitary protection. It follows from these el ements that the alleged failure by the European
Communities to consider a particular application for final approval cannot be considered an "SPS
measure" within the meaning of Annex A(1) and Article 5.5 as interpreted by the Appellate Body.
7.1741 As Article 5.5 in our view implies that the measures complained of are implementing "SPS
measures", we consider that the provisions of Ar ticle 5.5 are not applicable to the European
Communities' alleged failure to consider particular a pplications for final approval. In view of this
conclusion, we need not continue our analysis of the United States' claim under Article 5.5.
(b) DS292 (Canada)
7.1742 In relation to DS292, we recall that we have dete rmined in the context of our analysis of the
challenge to the general EC moratorium that Arti cle 5.5 implies a reference to "SPS measures" and
that the SPS measures at issue in Article 5.5 are those which are applied for achieving a particular
level of sanitary or phytosanitary protection ( i.e., measures implementing a particular level of
protection). Accordingly, Article 5.5 implies that the measure complained of is an implementing
"SPS measure". We recall that in the context of our earlier analysis of Canada's product-specific
claim under Article 5.1 we found that the type of m easure Canada is challengi ng in our view (i) does
not itself constitute an SPS measure within the me aning of Annex A(1) and (ii) is not a measure
applied for achieving the European Communities' a ppropriate level of sanitary or phytosanitary
protection. It follows from these elements that the alleged failure by the European Communities to
consider or approve a particular application ca nnot be considered an "SPS measure" within the
meaning of Annex A(1) and Article 5.5 as interpreted by the Appellate Body.
7.1743 As Article 5.5 in our view implies that the me asure complained of is an implementing "SPS
measure", we consider that the provisions of Ar ticle 5.5 are not applicable to the European
Communities' alleged failure to consider or approv e particular applications. In view of this
conclusion, we need not continue our analysis of Canada's claim under Article 5.5.
(c) DS293 (Argentina)
7.1744 In relation to DS293, we begin our analysis with the applications concerning Bt-531 cotton
and RR-1445 cotton which Argentina says have yet to be approved under Regulation 258/97.
(i) affecting the approval of Bt-531 cotton and RR-1445 cotton under
Regulation 258/97
7.1745 Argentina challenges under Article 5.5 the susp ension of consideration of, or failure to
consider, applications concerning Bt-531 cott on and RR-1445 cotton which were allegedly submitted
for "approval"
1378 under Regulation 258/97.
7.1746 We recall that in respect of the same allege d Argentina presented a
claim under Article 5.1 of the SPS Agreement. In the context of our analysis of that claim, we have

1378 Argentina's first written submission, paras. 201-202.

pointed out that we have seen no evidence that applications concerning Bt-531 cotton and RR-1445
cotton were submitted for approval under Regulati on 258/97, and we therefore found that Argentina
has failed to meet its burden of demonstrating the existence of a suspension of consideration of, or
failure to consider, Bt-531 cotton and RR-1445 cotton for approval under Regulation 258/97. As the
existence of these product-specifi c measures has not been demonstrated, we cannot but reject
Argentina's claim that the Europ ean Communities has acted inconsistently with its obligations under
Article 5.5 in relation to these alleged measures.
(ii) Other challenged by Argentina
7.1747 We now turn to address the remaining eight in respect of which the
Panel has decided to make findings.
7.1748 We recall that we have determined in the cont ext of our analysis of the challenge to the
general EC moratorium that Article 5.5 implies a reference to "SPS measures" and that the SPS
measures at issue in Article 5.5 are those which are applied for achieving a particular level of sanitary
or phytosanitary protection ( i.e., measures implementing a particular level of protection).
Accordingly, Article 5.5 implies that the measure complained of is an implementing "SPS measure".
We recall that in the context of our earlier an alysis of Argentina's product-specific claim under
Article 5.1 we found that the type of measure Arge ntina is challenging in our view (i) does not itself
constitute an SPS measure within the meaning of A nnex A(1) and (ii) is not a measure applied for
achieving the European Communities' appropriate leve l of sanitary or phytosanitary protection. It
follows from these elements that the allege d suspension by the European Communities of
consideration of, or the failure to consider, a par ticular application cannot be considered an "SPS
measure" within the meaning of Annex A(1) and Article 5.5 as interpreted by the Appellate Body.
7.1749 As Article 5.5 in our view implies that the measures complained of are implementing "SPS
measures", we consider that the provisions of Ar ticle 5.5 are not applicable to the European
Communities' alleged suspension of consideration of, or the failure to consider, particular
applications. In view of this conclusion, we need not continue our analysis of Argentina's claim under
Article 5.5.
(d) Conclusions
7.1750 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 in respect of any of the
on which the Panel is offering findings.

 (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 in respect of any of the relevant .

 (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 in respect of any of the on which the Panel
is offering findings.

6. Consistency of the with Article 2.2 of the SPS Agreement
7.1751 All three Complaining Parties claim that the European Communities has acted inconsistently
with its obligations under Article 2.2 of the SPS Agreement in respect of the they are challenging.
7.1752 Article 2.2 of the SPS Agreement provides:
"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."
7.1753 The United States claims that, as the basic obligations provided in Article 2.2 have been
viewed as being specifically applied in Article 5.1, the – the product-
specific moratoria – are also inconsistent with Article 2.2, because they are not based on risk
assessments as required by Article 5.1 and Annex A, paragraph 4.
7.1754 Canada argues that Articles 5.1 and 5.6 can be viewed as a specific application of the basic
obligation contained in Article 2.2, and a violatio n of Articles 5.1 and 5.6 can be thus presumed to
imply a violation of the more general provision of Artic le 2.2. Canada is of the view that, as it has
already demonstrated that the product-specific ma rketing bans are not "based on" risk assessments
and are therefore inconsistent with Articles 5.1 a nd 5.6, it can therefore be presumed that the product-
specific marketing bans also violate the requirements of Article 2.2.
7.1755 Argentina argues that since it has demonstrated that the suspension of consideration of, or the
failure to consider, the particular applications of interest to Argentin a is not "based on a risk
assessment", it has duly proven that the said suspension does not meet the requirements of Article 2.2.
7.1756 The European Communities argues that the delays (or failure to act within a specific
timeframe) in the approval process alleged by th e Complaining Parties can be reviewed under the
SPS Agreement as an issue of application of an SPS measure and more specifically, of the approval
system set up under the EC GMO legislation, an d that the delays of the kind alleged by the
Complaining Parties here thus cannot constitute an SPS measure in the sense of Annex A(1). As a
matter of logic, it is clear that alleged behaviour by a Member cannot be an SPS measure itself as well
as the application of another SPS measure. As th e delays of the kind alleged by the Complaining
Parties do not fall within the definition of an SPS measure defined by Annex A(1), the European
Communities considers that Article 2.2 is not applicable to these delays.

(a) Evaluation
7.1757 The Panel notes that the Complaining Parties' claim under Article 2.2
1379 is in the nature of a
consequential claim. The Complaining Parties submit that an inconsistency with Article 2.2 follows
by implication from a demonstrated inconsistency with Article 5.1. However, we have determined
above that Article 5.1 is not applicable to the as defined by the
Complaining Parties and that, consequently, the Eu ropean Communities has no t acted inconsistently
with its obligations under Article 5.1 in respect of the relevant . Since the
European Communities has not acted inconsistently with Article 5.1, and since the Complaining
Parties' claim under Article 2.2 is premised on th e existence of a breach of Article 5.1 by the
European Communities, the Complaining Parties' claim under Article 2.2 in our view cannot succeed.
7.1758 In relation to DS292, we note that Canada ar gues in addition that an inconsistency with
Article 2.2 also follows by implication from a demonstrated inconsistency with Article 5.6. However,
we have reached the same conclu sion on Canada's claim under Artic le 5.6 as we have on Canada's
claim under Article 5.1. Accordingly, our reasoning in the preceding paragraph mutatis mutandis also
applies to Canada's argument based on the alleged inconsistency of the relevant with Article 5.6.
7.1759 In relation to DS293, we recall, in addition, our earlier finding that Argentina has failed to
meet its burden of demonstrating the existence of a suspension of consideration of, or failure to
consider, Bt-531 cotton and RR-1445 cotton for approva l under Regulation 258/97. As the existence
of these has not been dem onstrated, we cannot but reject Argentina's claim
that the European Communities has acted inconsiste ntly with its obligations under Article 2.2 in
relation to these alleged measures.
(b) Conclusions
7.1760 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 failed to establish that the European Communities has acted
inconsistently with its obliga tions under Article 2.2 of the SPS Agreement in respect
of any of the on which the Panel is offering findings.

 (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
failed to establish that the European Comm unities has acted inconsistently with its
obligations under Article 2.2 of the SPS Agreement in respect of any of the relevant

1379 See also our discussion of the Complaining Parties' Article 2.2 claim in Section VII.D.8 above.

 (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
failed to establish that the European Comm unities has acted inconsistently with its
obligations under Article 2.2 of the SPS Agreement in respect of any of the product-
specific measures on which the Panel is offering findings.

7. Consistency of the with Article 2.3 of the SPS Agreement
7.1761 Canada claims that the European Communities ha s acted inconsistently with its obligations
under Article 2.3 of the SPS Agreement in respect of the it is challenging.
7.1762 Article 2.3 of the SPS Agreement provides:
"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."
7.1763 Canada argues that, as the product-specific mark eting bans are inconsistent with the
European Communities' obligations unde r Article 5.5, they are, by implication, also inconsistent with
the European Communities' obligations under Artic le 2.3, in accordance with the jurisprudence
established by the Appellate Body.
7.1764 The European Communities argues that the delays (or failure to act within a specific
timeframe) in the approval process alleged by th e Complaining Parties can be reviewed under the
SPS Agreement as an issue of application of an SPS measure and more specifically, of the approval
system set up under the EC GMO legislation, an d that the delays of the kind alleged by the
Complaining Parties thus cannot constitute an SPS measure in the sense of Annex A(1). As a matter
of logic, it is clear that alleged behaviour by a Member cannot be an SPS measure itself as well as the
application of another SPS measure. As the delays of the kind alleged by the Complaining Parties do
not fall within the definition of an SPS measure defined by Anne x A(1), the European Communities
considers that Article 2.3 is not applicable to these delays.
(a) DS292 (Canada)
7.1765 The Panel notes that Canada's claim under Article 2.3
1380 is in the nature of a consequential
claim. Canada submits that an inconsistency with Article 2.3 follows by implication from a
demonstrated inconsistency with Article 5.5. Howeve r, we have determined above that Article 5.5 is
not applicable to the as defined by Canada and that, consequently, the
European Communities has not acted inconsistently with its obligations under Article 5.5 in respect of
the relevant . Since the European Communities has not acted inconsistently
with Article 5.1, and since Canada's claim under Ar ticle 2.3 is premised on the existence of a breach
of Article 5.5 by the European Communities, Cana da's claim under Article 2.3 in our view cannot
succeed.

1380 See also our discussion of Canada's Article 2.3 claim in Section VII.D.9 above.

(b) Conclusion
7.1766 In the light of the above, the Panel reaches the following conclusion:
 (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 Canada has
failed to establish that the European Comm unities has acted inconsistently with its
obligations under Article 2.3 of the SPS Agreement in respect of any of the relevant

8. Consistency of the with Article 7 and Annex B(1) of the
SPS Agreement
7.1767 The United States claims that the European Co mmunities has failed to publish promptly the
existence of the the Un ited States is challenging and that the European
Communities has thereby acted inconsistently with its obligations under Article 7 and Annex B(1) of
the SPS Agreement.
7.1768 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."
7.1769 Annex B(1) of the SPS Agreement provides:
"Members shall ensure that all san itary and phytosanitary regulations
1381 which have
been adopted are published promptly in such a manner as to enable interested
Members to become acquainted with them."
7.1770 The United States submits that the product-specific me asures it is challenging – the product-
specific moratoria – are subject to the publication requirement in Annex B(1). The United States
argues that this is for the sa me reasons which it has provided to establish the applicability of
Annex B(1) to the general moratorium. The Un ited States considers that because the European
Communities has failed to publish, and, therefore, to publish promptly, the existence of the product-
specific moratoria, the European Communities has acted inconsisten tly with its obligations under
Annex B(1) and Article 7.
7.1771 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 measures challenged
by the United States are alleged failures to act within a particular timeframe. Thus, the United States
is in reality complaining about delay in the comp letion of specified individual approval procedures.
In the European Communities' view, delay of this kind cannot constitute an SPS measure within the

1381 Sanitary and phytosanitary measures such as laws, decrees or ordinances which are applicable
generally.

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 measures are not subject to Article 7.
7.1772 The Panel notes that the United States alleges an inconsistency of the identified by it with Annex B(1). The United States uses the alleged inconsistency with
Annex B(1) as a basis for a consequential claim of inconsistency under Article 7. Accordingly, we
will begin our analysis with the United States' claim under Annex B(1).
(a) "Sanitary and phytosanitary regulations"
7.1773 As we have stated earlier, Annex B(1) appli es to "sanitary and phytosanitary regulations"
(hereafter "SPS regulations") which have been "ado pted". An explanatory footnote 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 generally".
7.1774 It follows from the foregoing that a threshold i ssue before us is whether the challenged by the United States constitute generally applicable SPS measures which have
been adopted. We first examine whether the re levant are "generally
applicable".
7.1775 We recall that what the United States is challenging in the case of each of the is an alleged failure by the European Co mmunities to consider a specified application for
final approval. As is already clear from our own description of these measures, these measures are
product-specific. In other words, each of these m easures affects an application concerning a specific
biotech product. None of these measures is applicab le to all biotech products generally, or at least to
all biotech products which fall within the scope of the relevant EC approval procedures and require
approval. To that extent, there is thus a cl ear difference between the
identified by the United States and the genera l moratorium on approvals, which we found was
generally applicable inasmuch as it was applicable to all applications wh ich were pending between
June 1999 and August 2003.
7.1776 In the light of this, we are unable to agree w ith the United States that each of the product-
specific measures it is challenging is a measure wh ich is "applicable generally". As general
applicability is a necessary definitional element of the term "SPS regulations", it is not necessary for
us to examine whether the relevant product-speci fic measures are "SPS measures" and whether they
have been "adopted". We therefore find that none of the challenged by the
United States is an "SPS regulation" within the mean ing of Annex B(1). It follows that the provisions
of Annex B(1) are not applicable to these measures.
7.1777 We recall that the United States seeks to establish an inconsistency with Article 7 on the basis
of an alleged inconsistency with Annex B(1). As we have found th at the provisions of Annex B(1)
are not applicable to the product-specific measur es challenged by the United States, these measures
cannot be inconsistent with these provisions. Under the approach followed by the United States, there
can then logically be no inconsistency with Article 7 either, even assuming that Article 7 is applicable
to these measures.

(b) Conclusion
7.1778 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
European Communities has not acted inc onsistently with its obligations under
Annex B(1) and Article 7 of the SPS Agreement in respect of any of the product-
specific measures on which the Panel is offering findings.

9. Consistency of the with Article 8 and Annex C(1)(a), first
clause, of the SPS Agreement
(a) General

7.1779 All three Complaining Parties claim that the European Communities has acted inconsistently
with its obligations under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement in respect
of the they are challenging.
7.1780 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."
7.1781 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 completed without undue delay [...]."
7.1782 The Complaining Parties seek to establish an in consistency with Article 8 on the basis of an
inconsistency with Annex C(1)(a), first clause. 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. Accordingly, should we
conclude that the European Communities has failed to observe the provisions of Annex C(1)(a), first
clause, in respect of any of the product-specifi c measures on which we make findings, we will also
conclude that the European Communities has, by im plication, also acted inconsistently with the
provisions of Article 8.
7.1783 In relation to Annex C(1)(a), first clause, we note that we have addressed the interpretation of
this provision in Section VII.D.11 above.
1382 We further note that in accordance with the lead-in to

1382 We note that like the other Parties, Argentina has addressed the meaning of Annex C(1)(a), first
clause. However, Argentina's relevant arguments do not lead us to an interpretation of Annex C(1)(a), first
clause, which is different from the one we set out earlier.

Annex C(1) the provisions of Annex C(1)(a) 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) a nd, as such, are subject to the provisions of
Annex C(1), which include those of Annex C(1)(a). Therefore, the European Communities was and is
required under the provisions of Annex C(1)(a) to "undertake and complete" the approval procedures
set out in Directives 90/220 and 2001/18 as well as Regulation 258/97 (to the extent it is an SPS
measure) "without undue delay".
7.1784 We recall that the United States is challe nging the alleged failure by the European
Communities to consider particular applications fo r final approval, while Ca nada is challenging the
alleged failure by the European Communities to consid er or approve, without undue delay, particular
applications. We have observed in this regard that these are essen tially challenges to the application
by the European Communities of a particular way of operating the relevant EC approval procedures.
We also recall that Argentina is challenging allege d undue delays in completing the consideration and
processing of specified applications.
7.1785 It is clear to us, therefore, that the type of measure challenged by each of the Complaining
Parties could in principle constitute, or lead to, a breach of the European Communities' obligations
under Annex C(1)(a), first clause, and that this type of measure can therefore be examined in the light
of the provisions of Annex C(1)(a), first clause. Since the Complaining Parties seek to establish an
inconsistency with Article 8 on the basis of an alle ged inconsistency with Anne x C(1)(a), first clause,
this conclusion applies also to Article 8.
(b) Deliberate Release – Applications submitted under Directive 90/220 and/or Directive 2001/18

7.1786 We now begin our examination of the a pproval procedures whic h were conducted under
Directives 90/220 and 2001/18 for the applications identified by the Complaining Parties. Before
going further, however, we should briefly address certain issues presented by the application of
Annex C(1)(a), first clause, to approval procedures conducted under the aforementioned Directives.
(i) Application of Annex C(1)(a), first clause, to approval procedures begun under
Directives 90/220 and continued under 2001/18
7.1787 Each of the relevant approval procedures on which the Panel is making findings was begun
under Directive 90/220 but not completed by the da te of repeal of Directive 90/220 (17 October
2002). Pursuant to the provisions of Directive 2001/18, applications which were pending on the date
of repeal of Directive 90/220 (17 October 2002) b ecame subject to Directive 2001/18 and 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 were to be
undertaken in accordance with the provisions of Directive 2001/18.
1383 For each of the approval
procedures here at issue, approval procedures were undertaken under Directive 2001/18 after the
applicant had complemented its application.
7.1788 This presents the question whether approval procedures undertaken under Directive 2001/18
in respect of applications which had previous ly been assessed under Directive 90/220 should be
viewed as new approval procedures or as a continua tion of the approval procedures which were not

1383 Article 35 of Directive 2001/18. None of the Complaining Parties questioned the WTO-
consistency of Article 35.

completed under Directive 90/220. We have alrea dy examined this question in the context of our
analysis of the general EC moratorium on approvals.
1384 It is therefore sufficient at this juncture to
recall our conclusion that (i) approval procedures undertaken under Directive 2001/18 in respect of
applications which had previously been assessed under Directive 90/220 were a continuation of the
approval procedures previously conducted under Directive 90/220, and that (ii) an approval procedure
begun under Directive 90/220 and c ontinued under Directive 2001/18 constitutes one single approval
procedure for the purposes of Annex C(1)(a), first clause.
7.1789 It follows from this conclusion that there is no need, in the context of our inquiry under
Annex C(1)(a), first clause, to distinguish betw een 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 for the same application was continued under Directive 2001/18. Notably, our
conclusion means that a failure to observe the pr ovisions of Annex C(1)(a), first clause, can be
established on the basis of undue delays which occurred while Directive 90/220 was in force.
Likewise, a failure to observe the provisions of Annex C(1)(a), first clause, can also be established on
the basis of undue delays which occurred after the en try into force of Directive 2001/18. In either
case, the relevant approval procedure would have be en unduly delayed, contra ry to the requirements
of Annex C(1)(a), first clause.
7.1790 Finally, we recall that in Section VII.D we have addressed whether the reason for the general
EC moratorium on final approvals could have provided a justificati on for delays which might have
occurred as a result of that moratorium. We have also addressed whether the adoption of
Directive 2001/18 could have justified delaying the completion of approval procedures conducted
under Directive 90/220 so that as of October 2002 th ey would become subject to the new provisions
of Directive 2001/18. These earlier observations are re levant and applicable also to our examination
of the Directive 90/220 (and 2001/18) approval procedures identified by the Complaining Parties.
7.1791 With these general observations in mind, we now proceed with the examination of the
individual complained against.
(ii) Falcon oilseed rape (EC-62)
7.1792 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning Falcon oilseed rape has been unduly delayed.
7.1793 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 under the applicable EC legislation, in the absence of action by the Regulatory Committee, the
Commission was required to submit a draft measure, wh ether favourable or negative, to the Council.
The United States recalls in this respect that the SPS Agreement requires that the European
Communities make a decision without undue delay. In this case, the Commission failed to forward a
decision to the Council.
7.1794 The United States submits, in add ition, that the application con cerning Falcon oilseed rape is
one of nine applications identified by the United St ates which were stalled at the Commission level at
the time Directive 90/220 expired and which, as of th e date of establishment of the Panel, have been
pending for an average of six and one half years. The United States contends in this respect that

1384 See supra, paras. 7.1535-7.1536.

although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
Falcon oilseed rape is undue. The United States further argues that before the European Communities
adopted its moratorium, all approval procedur es under Directive 90/220 were undertaken and
completed in less than three years.
7.1795 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 newly expressed protein on the
biogeochemical cycle and the food chain as well as the likelihood of spreading. The European
Communities also states that in May 2001, the applicant modified the scope of its application, and that
after that, the application proceeded with furt her submissions by the applicant of additional
information.
7.1796 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 and on the food chain and on the
spreading of the gene due to the possibility of crossing between the PGM and wild species. The
United States points out in this respect that the a pplicant responded to Italy's request on 30 November
2000 even though, in the Untied States' view, Italy's request was not scientifically justified.
7.1797 The Panel begins its analysis by addressing the US argument concerning the Commission's
failure to re-convene the Regulatory Committee for a vote on the Commission's draft measure.
Failure by the Commission to re-convene th e Regulatory Committee for a vote on a draft
measure
7.1798 The Panel recalls that the Regulatory Comm ittee met twice, on 29 October 1999 and on 9
March 2000, to consider a draft measure submitted by the Commission. At neither meeting was there
a vote on the draft measure, and the Regulatory Comm ittee did not meet again for another attempt at
taking a vote on the application.
7.1799 The Panel also recalls that in November 2000 the applicant provided the additional
information which had been requested by Italy. In late May 2001, following a request by the lead CA
of April 2000, the applicant clarified certain aspects of its application. According to the lead CA,
uncertainty as to these aspects had preven ted the Regulatory Committee from voting on the
application in March 2000.
7.1800 When the applicant clarified certain aspects of its application in late May 2001, it also
submitted additional and updated information to the lead CA. The applicant apparently did so of its
own motion. It stated that this information confir med that the application was already "in line with
the main provisions" of Directive 2001/18, which ha d been adopted in March 2001. The applicant
requested the lead CA to inform the other member States about the new set of documents at the next
Regulatory Committee meeting.1385 However, the lead CA did not forward the documents to the other
member States and the Commission because it consid ered that further clarification was necessary. 1386

1385 Exhibit EC-62/At. 98.
1386 Exhibit EC-62/At. 101.

The applicant provided the requested clarification on 30 October 2001.
1387 Towards the end of
November 2001, the applicant wrote to the Commi ssion, drawing atten tion to the additional
information and indicating its desire to present th e information to the other member States at a
meeting of the "working group on herbicide-tolera nt crops" scheduled for early December 2001. 1388
The record does not indicate whether this meeting took place.
7.1801 The Panel has previously stated its view that after the March 2000 meeting of the Regulatory
Committee, it was incumbent on the Commission 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.
7.1802 In approaching this question, the Panel takes note of the following elements. To begin with,
by the end of May 2001 the applicant had met all requests for information and clarification conveyed
to it in the wake of the March 2000 Regulatory Comm ittee meeting. As noted, however, at the end of
May 2001 the applicant also provided additional a nd updated information to the lead CA. That
information was apparently never forwarded by th e lead CA to the other member States and the
Commission. Nevertheless, the record indicates that the Commission was made aware of its existence
in June 20011389, inquired about it in September 2001 1390, and also in September 2001 was told by the
lead CA that it would be informed about when the applicant would provide the clarification sought by
the lead CA 1391. In November 2001, the Commission was told directly by the applicant that the
applicant had provided the clarification requested by the lead CA at the end of October 2001.
7.1803 Furthermore, it is important to remember that the applicant provided the additional
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 the additional information before transmitting it to
the other member States and the Commission. Indeed , the lead CA did not purport to undertake an
assessment, for it merely asked the applicant for clarification and made suggestions for modifications,
to avoid questions from other member States or to "further acceptance" by other member States.1392
7.1804 In view of these elements, the Panel considers th at at the latest at the end of November 2001,
after the applicant had clarified and revised the additional information first submitted in May 2001
and directly approached the Commission in this regard, the Commission could have stepped in and
requested the lead CA to forward the additiona l information to other member States and itself. 1393 At
least, the Commission could have done so if, as is likely, it wanted member States to have access to
the additional information before re-convening the Regulatory Committee.
7.1805 The Panel notes that in its November 2001 letter to the Commission, the applicant made
known its desire to present the additional information to the other member States at a meeting of the

1387 Exhibit EC-62/At. 105.
1388 Ibid.
1389 Exhibit EC-62/At. 101.
1390 Exhibit EC-62/At. 102 (e-mail from lead CA to applicant).
1391 Exhibit EC-62/At. 101.
1392 Exhibit EC-62/At. 98.
1393 It should be noted that more than five months after the applicant had provided the clarification
requested by the lead CA, the latter sought further modifications and additional information. Exhibit
EC-62/At. 106. However, as the lead CA was not require d to make an assessment of the clarification provided
by the applicant before transmitting the new documents to other member States and the Commission, there is no
reason to consider that the Commission could not have sought the transmission of these documents to itself and
other member States in November 2001.

"working group on herbicide-tolera nt crops" scheduled for early December 2001. The European
Communities has not explained the mandate of the "working group on herbicide-tolerant crops".
There is no indication that this working group played a part in the lead-up to the October 1999 and
March 2000 meetings of the Regulatory Committee. At any rate, the fact that the applicant wished to
"present" the additional information to the worki ng group does not imply that the applicant did not
want the information to be distributed to the other member States until after its presentation.
7.1806 Had the Commission requested the lead CA to forward the additional information towards the
end of November 2001, it could have scheduled a meeting of the Regulatory Committee for early
2002, thus giving other member States and itself time to review the additional information. As well,
since Directive 90/220 was not repealed until mi d-October 2002, there was 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.
1394
7.1807 In earlier findings, we observed that the Co mmission 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 ac hieve the required qualified majority, with the
consequence that the Commission would have to co mplete the procedure by adopting its own draft
measure. In our view, neither consideration would provide a justification for the Commission's failure
to re-convene a Regulatory Committee meeting in early 2002.
7.1808 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
measure would achieve a qualified majority in the Regulatory Committee. 1395 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.
7.1809 Regarding the possibility that certain member States might have been reluctant to proceed to a
vote on the Commission's draft measure, it may also be noted that the applicant strengthened the
Commission's position by supplying new information which it said confirmed that its application was

1394 In earlier findings on the application concerning Falcon oilseed rape, we noted that 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 measure w ould 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 c onsider that this would have justified the Commission's
failure to re-convene the Regulatory Committee for a vote. The Commission would 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 th e 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 in early 2002.
1395 To recall, the record does not indicate, and th e European Communities di d not argue, that the
Commission after the March 2000 meeting of the Regulatory Committee launched inter-service consultations to
reconsider the relevant draft measure.

already in accordance with the main provisions of the new Directive 2001/18.
1396 Certainly as of the
end of November 2001, after the applicant had clar ified and revised the additional information first
submitted in May 2001, the Commission therefore ha d additional arguments for seeking a vote on its
draft measure in the Regulatory Committee.
7.1810 Based on the above considerations, the Panel is of the view that at the latest in early 2002 the
Commission should have re-convened the Regul atory Committee meeting for a vote on the
application concerning Falcon oilseed rape. Accordi ngly, the Panel concludes that the time actually
taken by the Commission to convene a further Regulatory Committee meeting – no meeting was
convened between March 2000 and October 2002 – was unjustifiably long.
7.1811 In addition, we recall that the United States claims that the approva l procedure concerning
Falcon oilseed rape was unduly delayed because, due to the moratorium, the European Communities
failed to consider the application in question for fi nal approval. In this respect, we note our earlier
findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and August 2003 a nd that (ii) the Commission's failure to re-
convene the Regulatory Committee for a vote on the a pplication concerning Falcon oilseed rape after
May 2001 is consistent with the application of such a moratorium. In the light of this, and in the
absence of effective rebuttal by th e European Communities, we agree with the United States that it is
reasonable to infer that the Commission's inaction was a consequence of the general moratorium on
approvals.
7.1812 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 examine other arguments put
forward by the United States in support of its claim under Annex C(1)(a), first clause, and Article 8 of
the SPS Agreement.
Conclusion

7.1813 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel reca lls its findings that the time taken by the
Commission to convene a further Regulat ory Committee 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 the United States' contention that, consistent with the
general moratorium, the European Commun ities failed to consider the application
concerning Falcon oilseed rape for final a pproval, and that this resulted in "undue
delay" in the completion of the relevant a pproval procedure. Accordingly, the Panel
concludes that in respect of the approva l procedure concerning Falcon oilseed rape,
the European Communities has breached its obligations under Annex C(1)(a), first
clause, and Article 8 of the SPS Agreement.

1396 It should also be recalled that in November 2000 the applicant provided the additional information
which had been requested by Italy. In addition, in late May 2001, following a request by the lead CA of April
2000, the applicant clarified certain aspects of its application.

(iii) MS8/RF3 oilseed rape (EC-63)
7.1814 Two Complaining Parties, the United States and Canada, claim that the completion of the
approval procedure concerning MS8/RF3 oilseed rape has been unduly delayed.
7.1815 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.
7.1816 The United States submits, in addition, that th e application concerning MS8/RF3 oilseed rape
is one of nine applications identified by the Un ited States which were stalled at the Commission level
at the time Directive 90/220 expired and which, as of the date of establishment of the Panel, have
been pending for an average of six and one half year s. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
MS8/RF3 oilseed rape is undue. The United St ates further argues that before the European
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were
undertaken and completed in less than three years.
7.1817 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 attempts by the applicant, th e processing of the application has been delayed,
which Canada believes demonstrates that the Euro pean 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.
7.1818 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.
7.1819 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.

7.1820 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".
7.1821 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.
7.1822 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.
7.1823 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.
Failure by the Commission to re-convene th e Regulatory Committee for a vote on a draft
measure
7.1824 The Panel recalls that the Regulatory Comm ittee met twice, on 29 October 1999 and on 9
March 2000, to consider a draft measure submitted 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.
7.1825 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. 1397 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. 1398 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

1397 The record contains a summary of the conclusi ons for the October 1999 Regulatory Committee
meeting, but not for the March 2000 meeting.
1398 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".

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.
1399
7.1826 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. 1400 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. 1401 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.
1402 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.
1403 No reason was given for why an opinion had been requested.
7.1827 The Panel has previously stated its view that after the March 2000 meeting of the Regulatory
Committee, it was incumbent on the Commission 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.
7.1828 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.
7.1829 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.
7.1830 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 form the provisions of Directive 90/220, but in an effort to convince member States to vote in

1399 Exhibit EC-63/At. 89 and 90.
1400 Exhibit EC-63/At. 92.
1401 Exhibit EC-63/At. 91.
1402 Ibid.
1403 Exhibit EC-63/At. 93.

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."
1404 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." 1405 It was noted that in this way the relevant experts would have an
opportunity to gain experience in the evaluation of such documents.1406
7.1831 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 2001/18.1407
7.1832 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. 1408 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.1409
7.1833 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.1410

1404 Exhibit EC-63/At. 102.
1405 Ibid.
1406 Ibid.
1407 See our earlier analysis of the approval procedure concerning Falcon oilseed rape.
1408 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.
1409 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.
1410 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

7.1834 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.
7.1835 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
measure would achieve a qualified majority in the Regulatory Committee.
1411 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.
7.1836 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.
7.1837 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.
7.1838 In relation to DS291, we recall that the United States claims that the approval procedure
concerning MS8/RF3 oilseed rape was unduly delayed because, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and August 2003 a nd that (ii) the Commission's failure to re-
convene the Regulatory Committee for a vote on the application concerning MS8/RF3 oilseed rape
after November 2001 is consistent with the application of such a measure. In the light of this, and in

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
would 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.
1411 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.

the absence of effective rebuttal by the European Communities, we agree with the United States that it
is reasonable to infer that the Commission's inacti on was a consequence of the general moratorium on
approvals.
7.1839 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 examine other arguments put
forward by the United States and Canada in support of their claim under Annex C(1)(a), first clause,
and Article 8 of the SPS Agreement.
Conclusion

7.1840 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.
Based on these findings, the Panel accepts the United States' contention that,
consistent with the general moratorium, th e European Communities failed to consider
the application concerning MS8/RF3 oilseed rape for final approval, and that this
resulted in "undue delay" in the completi on of the relevant approval procedure.
Accordingly, the Panel concludes that in respect of the approval procedure
concerning MS8/RF3 oilseed rape, the Eu ropean Communities has breached its
obligations under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.

 (ii) DS292 (Canada)

 With reference to DS292, the Panel reca lls its finding 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. Based on this finding, the Panel accep ts Canada's contention that the European
Communities failed to "consider or approve , without undue delay", the application
concerning MS8/RF3 oilseed rape, and that it consequently did not complete the
relevant approval procedure without " undue delay". Accordingly, the Panel
concludes that in respect of the approva l procedure concerning MS8/RF3 oilseed
rape, the European Communities has breached its obligations under Annex C(1)(a),
first clause, and Article 8 of the SPS Agreement.

(iv) RR fodder beet (EC-64)
7.1841 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning the RR fodder beet has been unduly delayed.
7.1842 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 under the applicable EC legislation, in the absence of action by the Regulatory Committee, the

Commission was required to submit a draft measure, wh ether favourable or negative, to the Council.
The United States recalls in this respect that the SPS Agreement requires that the European
Communities make a decision without undue delay. In this case, the Commission failed to forward a
decision to the Council.
7.1843 The United States submits, in addition, that th e application concerning RR fodder beet is one
of nine applications identified by the United Stat es which were stalled at the Commission level at the
time Directive 90/220 expired and which, as of the date of establishment of the Panel, have been
pending for an average of six and one half years. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
RR fodder beet is undue. The United States furthe r argues that before the European Communities
adopted its moratorium, all approval procedur es under Directive 90/220 were undertaken and
completed in less than three years.
7.1844 The European Communities argues that contrary to the US argument, the Commission
launched a voting procedure in June 1999, and th e Regulatory Committee met twice on the matter –
first on 29 October 1999 and then on 9 March 2000. The Regulatory Committee did not vote on 29
October 1999 due to outstanding requests for information.
7.1845 The United States responds that contrary to the European Communities' assertion that there
were outstanding requests for information, the applicants had voluntari ly provided additional
information in an attempt to remove any possibl e remaining obstacle to a Regulatory Committee vote
during the one and a half years between when th e SCP issued its opinion and when the Regulatory
Committee finally met. The United States also notes that when the applicants attempted to get a
resolution of this matter on 12 July 2000, stating that they had fully addressed all objections raised by
member States and requesting the lead CA "to info rm all member States that the application was
complete and subject to a Community decision"
1412, the European Communities ignored, for six
months, the applicant's request.
7.1846 The Panel begins its analysis by addressing the US argument concerning the Commission's
failure to re-convene the Regulatory Committee for a vote on the Commission's draft measure.
Failure by the Commission to re-convene th e Regulatory Committee for a vote on a draft
measure
7.1847 The Panel recalls that, after the SCP issued its favourable opinion with regard to this
application on 23 June 1998, the Regulatory Committee met twice, on 29 October 1999 and on 9
March 2000, to consider a draft measure submitted 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.
7.1848 We also recall that in July 2000 the applican t provided the additional information requested
by the Italian CA, as well as data on molecular char acterization which were apparently generated at
the request of the United Kingdom's CA. The conclu sion of the July 2000 letter states that, in the
applicant's view, all objections raised by th e CAs within the 60-day period provided for in
Directive 90/220 had now been fully addressed. We fu rther recall that the lead CA did not forward
the new documents to the other CAs. As also not ed earlier, the Commission received a copy of the
applicant's July 2000 letter.

1412 Exhibit EC-64/At. 119.

7.1849 The Panel has previously stated its view that after the March 2000 meeting of the Regulatory
Committee, it was incumbent on the Commission 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.
7.1850 In approaching this question, the Panel takes note of the following elements. To begin with,
by mid-July 2000 the applicant had apparently addr essed all objections raised by the CAs within the
60-day period provided for in Directive 90/220 and c onveyed to the applicant. That information was
never forwarded by the lead CA to the other CAs. However, it should be recalled in this respect that
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 a doption 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).
1413 The lead CA did not follow the applicant's suggestion.
7.1851 Furthermore, as noted, the Commission received a co py of the applicant's July 2000 letter. It
is likely that the Commission wanted the other CAs to have access to the additional information
provided in July 2000 before re-convening the Regulat ory Committee. Yet even as the date of repeal
of Directive 90/220 was approaching, the Commi ssion apparently did not request the lead CA
promptly to circulate the additional information provided by the applicant in July 2000 so that a
further attempt at completing the approval procedure under Directive 90/220 could be made.
7.1852 In view of these elements, we consider that af ter July 2000, once the applicant had provided
the additional information sought by the Italian CA, or at the latest in 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.
7.1853 In earlier findings, we observed that the Co mmission 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 ac hieve the required qualified majority, with the
consequence that the Commission would have to co mplete the procedure by adopting its own draft
measure. In our view, neither consideration would provide a justification for the Commission's failure
to re-convene the Regulatory Committee for a vote prior to the repeal of Directive 90/220.
7.1854 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's suspension of the appr oval process until it was confident that its draft
measure would achieve a qualified majority in the Regulatory Committee.
1414 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 anticipated significant member
State opposition and regardless of whether there were valid reasons for such opposition.

1413 Ibid.
1414 To recall, the record does not indicate, and th e European Communities di d not argue, that the
Commission after the March 2000 meeting of the Regulatory Committee launched inter-service consultations to
reconsider the relevant draft measure.

7.1855 Regarding the possibility that certain member States might have been reluctant to proceed to a
vote on the Commission's draft measure, it may also be noted that the applicant strengthened the
Commission's position by supplying supplementary in formation addressing objections raised by other
CAs.
7.1856 Based on the above considerations, the Panel is of the view that at the latest in the summer of
2001 the Commission should have re-convened the Regulatory Committee for a vote on the
application concerning RR fodder beet. Accordingly, the Panel concludes that the time actually taken
by the Commission to convene the Regulatory Co mmittee for a further meeting – no meeting was
convened between March 2000 and October 2002 – was unjustifiably long.
7.1857 In addition, we recall that the United States claims that the approval procedure concerning RR
fodder beet was unduly delayed because, due to the moratorium, the European Communities failed to
consider the application in question for final appr oval. In this respect, we note our earlier findings
that (i) a general de facto moratorium on approvals was in e ffect in the European Communities
between June 1999 and August 2003 and that (ii) the Commission's failure to re-convene the
Regulatory Committee for a vote on the applicati on concerning RR fodder beet after July 2000 is
consistent with the application of such a moratori um. In the light of this, and in the absence of
effective rebuttal by the European Communities, we agree with the United States that it is reasonable
to infer that the Commission's inaction was a consequence of the general moratorium on approvals.
7.1858 In view of our conclusion with regard to the Commission's failure to re-convene the
Regulatory Committee for a vote on its draft measur e, we do not go on to examine other arguments
put forward by the United States in support of its claim under Annex C(1)(a), first clause, and
Article 8 of the SPS Agreement.
Conclusion

7.1859 In the light of the above, the Panel reaches the following overall conclusion:
 (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.
Based on these findings, the Panel accepts the United States' contention that,
consistent with the general moratorium, th e European Communities failed to consider
the application concerning RR fodder beet for final approval, and that this resulted in
"undue delay" in the completion of the relevant approval procedure. Accordingly, the
Panel concludes that in respect of the approval procedure concerning RR fodder beet,
the European Communities has breached its obligations under Annex C(1)(a), first
clause, and Article 8 of the SPS Agreement.

(v) Bt-531 cotton (EC-65)
7.1860 Two Complaining Parties, the United States and Argentina, claim that the completion of the
approval procedure concerning Bt-531 cotton has been unduly delayed.

7.1861 The United States submits that the application concerning Bt-531 cotton under
Directive 90/220 suffered a three-and-a-half-year peri od of inactivity by EC regulators. From 7 May
1999, after the launch of inter-service consultations on a draft measure to be submitted to the Council,
until 12 February 2003, when the lead CA fina lly circulated the updated application to the
Commission, the application was totally ignored by the Commission and lead CA. The United States
considers this lengthy delay to be unwarranted and thus undue.
7.1862 The United States points out in this respect th at the application in question had received a
favourable scientific assessment by the European Co mmunity's own scientific committee, the SCP.
That certain member States objected in the Regul atory Committee does not justify the Commission's
refusal to act on the application. The United States submits that those objections which were
explained in statements, notably those by Aust ria and the United Kingdom, were the subject of
detailed scientific consideration in the SCP's positiv e opinion in July 1998. The United States also
notes that there is at any rate nothing to indicate that the Commission undertook any process
whatsoever to resolve the member State concerns. Moreover, nothing in the record indicates that the
applicant was ever requested to submit additional information to address the member State objections,
nor that the basis of these objections was ever even notified to the applican t. The United States is
therefore of the view that the delay in questi on was not caused, as the European Communities claims,
by a pending request to the applicant for additional information.
7.1863 The United States notes in addition that the EC legislative framework provides a specific
avenue for further action where the Regulatory Co mmittee is unable to come to a decision: the
Commission is to forward the application to the Co uncil "without delay" for a decision. The United
States considers that where the European Comm unities' own legislation provides timelines, a
suspension of the approval procedure without any sci entific justification must be considered undue
delay.
7.1864 The United States submits, finally, that the application concerning Bt-531 cotton is one of
nine applications identified by the United States which were stalled at the Commission level at the
time Directive 90/220 expired and which, as of the date of establishment of the Panel, have been
pending for an average of six and one half years. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
Bt-531 cotton is undue. The United States also argues that before the European Communities adopted
its moratorium, all approval procedures under Dir ective 90/220 were undertaken and completed in
less than three years.
7.1865 Argentina argues that after the Regulatory Committee in February 1999 failed to achieve a
qualified majority in favour of approving the a pplication concerning Bt-531 cotton, the Commission
refused to submit a draft measure to the Council until the application had to be resubmitted under
Directive 2001/18. Argentina submits that this was not due to any action or omission on the part of
the applicant. According to Ar gentina, there notably are no EC documents which specifically
requested the applicant to provide additional informa tion. Argentina considers that the delay which it
says was caused by the Commission is undue. Argentin a argues in this respect that the requirements
of legislation not yet in force do not provide grounds for a prolonged failure to process an application.
In particular, the application concerning Bt-531 co tton should not have been forced to start the
procedure again under the new Directive 2001/18 when the procedure under the old Directive 90/220
had already been in progress for three years. Furthe rmore, Argentina asserts that there is no scientific
evidence to justify the delay after the Regulatory Committee vote. Those member States which in the
Regulatory Committee voted against approving Bt-531 cotton ignored the positive scientific opinion
of the SCP of July 1998. Moreover, Argentina c ontests the scientific validity of the statements

offered by some member States in support of thei r votes inasmuch as these statements do not refute
the positive opinion of the SCP.
1415
7.1866 Argentina singles out another instance of delay which it considers undue. Argentina asserts
that although the applicant in January 2003 submitte d an updated application in accordance with the
requirements of Directive 2001/18, the application did not progress. Argentina submits that, as a
result, as of the date of its first written submi ssion – April 2004 – the application concerning Bt-531
cotton had been inactive for an additional period of 1 year and 3 months.
7.1867 Finally, Argentina submits that the total tim e consumed by the procedures under Directives
90/220 and 2001/18, from the time the application w as first submitted until April 2004, the date of
Argentina's first written submission, has been 7 year s and 4 months. In Argentina's view, this delay
can in no way be justified in the light of the dead lines stipulated in the relevant EC legislation.
Argentina contends that the procedure under Dir ective 90/220 should normally have been completed
within 240 days, which does not include the tim e during which a CA or the Commission may be
awaiting additional information it may have request ed or the time needed by an EC scientific
committee to issue an opinion ("clock-stop"). Similarly, Argentina contends that under
Directive 2001/18, a procedure should be completed with in 285 days if no objections to the lead CA's
initial assessment are made, and 450 days if objections are made. Again, this does not include the
time spent waiting for additional information or fo r a scientific committee opinion. Argentina asserts
that the delay affecting the approval procedure conc erning Bt-531 cotton cannot be justified by such
"clock-stops".
7.1868 The European Communities argues that the Regulatory Committee in February 1999 failed
to reach a qualified majority because a number of member States raised 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 requested additional information, and that the tr anslation 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
requested additional information.
7.1869 Regarding the requirement contained in Article 21 of Directive 90/220 that the Commission
"shall, without delay, submit to the Council a pro posal relating to the measures to be taken", the
European Communities points out that in the Pharos case
1416, the European Court of Justice examined
an identical requirement to submit a proposal to the Council "without delay" in the context of
legislation on the setting of maximum residue limits of veterinary medicinal products in foodstuffs of
animal origin (Regulation 2377/90). The Court stat ed that nothing in the wording of the relevant
provision "suggests any conclusion regarding the le ngth of time indicated by the expression 'without
delay', other than that, while a certain degree of rapidity is required, the Commission is not required to
act within a precise period of time nor at once, contrary to the appellant's submission".
1417 The Court
then went on to point out that the Commission was fr ee to modify its proposal before submitting it to
the Council and found that "if the Commission has the right to amend the proposal relating to the
measures to be taken which it subm its to the Council, it must have sufficient time to consider the
various courses of action open to it".
1418 On that basis, the Court found that the Commission, which
had taken over eleven months before forwarding a proposal to the Council, had not breached its

1415 Exhibit ARG-54, p. 3.
1416 European Court of Justice, Case C-151/98, Pharos against Commission [1999] ECR I-8157.
1417 Ibid., para. 20.
1418 Ibid., para. 24.

obligation to act "without delay".
1419 The Court pointed to the fact that the matter with which the
Commission was confronted was "highly complex and sensitive". 1420 The Court also made it clear
that the Commission could not be criticised for havi ng sought additional advice from an EC scientific
committee in an effort to prevent its proposal from being rejected by the Council.1421
7.1870 Concerning the case at hand, the European Communities argues th at the concerns raised by
certain member States were all legitimate and scien tifically sound. They could not be ignored or
brushed off by the Commission without detailed cons ideration. Moreover, according to the European
Communities, in the light of the impending legisl ative changes, further reflection was necessary
before proceeding further. The European Comm unities submits that this is in line with the
jurisprudence of the European Court of Justice.
7.1871 In relation to the delay which occurred after the application was resubmitted under
Directive 2001/18, 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.
7.1872 The Panel begins its analysis by addressing the delay allegedly caused by the Commission.
Failure by the Commission to submit a draft measure to the Council
7.1873 The Panel begins its analysis by addressing the delay allegedly caused by the Commission.
The Panel recalls that on 7 May 1999, the Commissi on launched inter-service consultations on a draft
measure to be submitted to the Council. But at no point prior to 17 October 2002, the date of repeal
of Directive 90/220, did the Commission submit a dr aft measure to the Council. The United States
and Argentina argue that the Commission should ha ve completed its inter-service consultations and
submitted a draft measure to the Council before October 2002.
7.1874 It is clear that the preparation by the Commiss ion of a draft measure and its submission to the
Council is not a process which necessarily takes more than three years. To begin with, in other
approval procedures, the Commission was able to prepare and submit draft measures to the Council
within a few months, despite the fact that in tho se procedures some member States also voted against
the Commission's draft measure in the Regulatory Committee, and that some made written
statements.
1422 Moreover, as the Panel understands it, th e preparation by the Commission of a draft
measure to be submitted to the Council is not a pr ocess that is fundamentally different from the
preparation by the Commission of a draft measure to be submitted to the Regulatory Committee. In
the approval procedure here at issue, the Commission prepared a draft measure and launched a vote in

1419 The Panel notes that the judgement indicates th at during the eleven-month period, the Commission
initially reconsidered the file for six months and then sought a second scientific opinion. Ibid., para. 32.
1420 Ibid., para. 26.
1421 Ibid., para. 27.
1422 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 sweet maize
(food) 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.

the Regulatory Committee in less than three months.
1423 It may be inferred from these examples that
the Commission could in principle have completed its task well before October 2002.
7.1875 The issue thus becomes whether in the specifi c circumstances of this case the Commission
could in fact have completed its task before October 2002. The European Communities argues that
the Commission did not need to forward a draft measure to the Council because the applicant took too
long to provide information which had been request ed of it. The European Communities notes that
the applicant did not provide that information until 25 July 2001, and that the translation of this
material was made available only in February 2002. However, in its earlier analysis of the approval
procedure in question, the Panel found that there is no evidence to suggest that the Commission was
waiting for the additional information provided by the applicant in July 2001. The Panel pointed out
that even after the applicant had provided the information, the Commission did not forward a draft
measure to the Council, although Directive 90/220 re mained in force for another seventeen months,
until October 2002. Accordingly, the information provided by the applicant in July 2001 does not
justify the Commission's failure to forward a draft measure to the Council.
7.1876 Another argument put forward by the Europ ean Communities to justify the Commission's
failure to forward a draft measure to the Council relates to the fact that the Regulatory Committee
failed to achieve the necessary qualified majority to approve the application concerning Bt-531 cotton
and that Austria, Sweden and the United Kingdom, in written statements supporting their votes,
expressed certain concerns. The European Co mmunities submits that these concerns were
scientifically sound and had not been previously a ddressed by the applicant, and that they could not,
therefore, be ignored or brushed off by the Commission without detailed consideration.
7.1877 As no qualified majority was reached in the Re gulatory Committee, the Panel considers that,
as a general matter, it was justifiable for the Commissi on to take some time, as part of its inter-service
consultations, to analyse the reasons for the outco me 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.
7.1878 The Panel recognizes that, as a matter of EC la w, the Commission's draft measure did not
need to obtain a qualified majority in the Council to complete the approval procedure. If the Council
had failed to reach a favourable qualified majority, the Commission would have had to adopt its draft
measure and hence approve the app lication concerning Bt-531 cotton.
1424 However, it must be borne
in mind that an EC decision to approve the ap plication concerning Bt-531 cotton would have
authorized the applicant to market its product in al l EC member States. In the light of this, the
Commission had good reasons, in the Panel's view, to seek a qualified majority in the Council as this
would have enhanced the legitimacy and acceptability of an EC decision to approve the application
concerning Bt-531 cotton.1425 This means that the Commission could take a reasonable period of time
to explore ways of modifying its draft measure with a view to increasing the measure's chances of

1423 Exhibit EC-65/Ats. 48 and 51. The Panel does not express a view as to whether this three-month
period was necessary in the circumstances to complete the relevant procedural stage.
1424 Article 21 of Directive 90/220. If the Council had reached a qualified majority against approving
the application, then the application would, however, have had to be rejected.
1425 It should also be recalled that the Complaining Parties did not question the design of the approval
procedure set out in Directive 90/220 (or its successor, Directive 2001/18), and in particular the fact that
member States vote on applications. If the Commission were obliged to press on immediately, preventing it
from taking into account the votes a nd views expressed by member States , it would undermine the European
Communities' ability to operate its approval procedure as designed.

being accepted by the Council by a qualified majority.
1426 It does not mean that the Commission
could simply wait for the majorities in the Council to change enough to allow the Commission's
original draft measure to be accepted by a qua lified majority. The obligation imposed on the
European Communities is to complete its approval procedures without undue delay. This obligation
may at times require the Commission to complete an approval procedure even if it does not have the
(qualified) majority support of the Council.
7.1879 How much time is to be accorded to the Comm ission for the purpose of reconsidering a draft
measure which did not obtain a qualified majori ty in the Regulatory Committee can only be
determined in the light of the circumstances of each case.
7.1880 Turning, then, to the circumstances of this case, the European Comm unities asserts that the
concerns identified in the written statements by Austria, Sweden and the United Kingdom had not
been addressed by the applicant before. The Panel is unable to agree with this assertion. As pointed
out by the United States, the concerns referred to in the statements by the three member States were
addressed in the SCP opinion of July 1998.
1427 At any rate, the record does not indicate that after the
Regulatory Committee vote, the Commission or the lead CA sought additional information from the
applicant in an effort to allay these concerns.
7.1881 Even if it were assumed that during its in ter-service consultations the Commission was
undertaking its own assessment of the scientific valid ity of the specific concerns expressed with a
view to supporting its draft measure with scientific arguments 1428, it is well to recall that the SCP was
able to undertake a comprehensiv e scientific assessment of the a pplication concerning Bt-531 cotton
in little over three months' time. 1429 The Panel also notes that th e European Communities does not
assert that the concerns raised by the member States in question presented either new or particularly
complex scientific problems.
7.1882 Another circumstance invoked by the European Communities is the fact that Directive 90/220
was being revised at the time. According to the European Communities, a period of time for
reflection was therefore needed before proceeding fu rther. To recall, the Commission in this case
launched its inter-service consultations on a draf t measure to be submitted to the Council in May
1999. At the end of June 1999, the Council reach ed a political agreement – the Common Position –
on the proposal to amend Directive 90/220, but Directive 2001/18, the Directive amending
Directive 90/220, was not adopted until March 2001 a nd did not enter into force until October 2002.
Thus, the Commission started its inter-service consulta tions almost three-and-a-half years before the
entry into force of Directive 2001/18. In the light of this, even accepting that the Commission could
take some time to reconsider its draft measure, the Commission's failure to forward a draft measure to
the Council cannot be excused on the grounds that there was not enough time to complete the
approval procedure while Directive 90/220 was still in force.
1430

1426 The Panel recalls once more that in other approval procedures the Commission was able to prepare
and submit draft measures to the Council within a few months, despite the fact that in those procedures some
member States also voted against the Commission's draft measure in the Regulatory Committee.
1427 Exhibit EC-65/At. 47, paras. 6.2.1 and 6.3.3-6.3.4. The Panel notes that Sweden voted in favour of
the Commission's draft measure and that Sweden's statement suggests that its concerns were met.
1428 The European Communities did not specifically assert that it was undertaking a scientific
assessment of the concerns in question; it merely implied that the Commission embarked on a "detailed
consideration" of these concerns.
1429 Exhibit EC-65/Ats. 43 and 47.
1430 In its earlier findings on the application concerning Bt-531 cotton, the Panel noted that the
Commission had reason to believe that due to the "blocking minority" of the Group of Five countries in the

7.1883 Furthermore, the fact that some member St ates and segments of public opinion may have
considered that Directive 90/220 was no longer ad equate and may have voi ced opposition to further
approvals under that Directive 90/220 did not, in the Panel's view, provide a justification for the
Commission to delay the approval procedure in ques tion until new legislation had been put in place.
The EC legislator allowed Directive 90/220 to rema in in force and hence applicable until October
2002. Moreover, if the Commission saw a need to respond to concerns about perceived inadequacies
inherent in Directive 90/220, there were other courses of action open to it. Thus, the Commission
could in the first instance have sought voluntary commi tments from the applicant. Alternatively, it
could have proposed that the application be approved subject to conditions. In this respect, it is worth
noting that Directive 90/220 provided additional safe guards if new information on risks of Bt-531
cotton had become available after its EC-wide approval.
1431 In such an event, a member State could,
pursuant to Article 16, provisionally restrict or prohi bit the marketing of Bt-531 cotton. Finally, if in
fact the Commission had been of the view that th e risks arising from the marketing of Bt-531 cotton
could not be adequately assessed or managed under Directive 90/220, it could arguably have sought
the rejection of the application, subject to the ri ght of the applicant to submit the application for
reconsideration under the revised Directive, once it entered into force.1432
7.1884 Based on the above considerations, the Panel is of the view that in the specific circumstances
of this procedure, the time actually taken by th e Commission to prepare and forward a draft measure
to the Council – no draft measure was forwar ded between June 1999 a nd October 2002 – was
unjustifiably long.
7.1885 Regarding DS291, we recall that the United St ates claims that the approval procedure
concerning Bt-531 cotton was unduly delayed because, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and August 2003 and that (ii) the Commission's failure to submit a
draft measure concerning Bt-531 cotton to the Counc il 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 that it is reasonable to infer that the Commission's
inaction was a consequence of the general moratorium on approvals.
7.1886 In view of our conclusion with regard to th e Commission's failure to submit a draft measure
to the Council, we do not go on to examine othe r arguments put forward by the United States and
Argentina in support of their claim under Annex C(1)(a), first clause, and Article 8 of the
SPS Agreement.

Council, it would have to adopt the draft measure it submitte d to the Council. In the Panel's view, even in this
scenario, there was enough time for the Commission to complete the procedure in question while
Directive 90/220 was still in force.
1431 The Commission usually made this point in its decisions approving applications. See, e.g., Exhibit
ARG-35 ("[w]hereas Article 11(6) and Article 16(1) of Directive 90/220/EEC provide additional safeguards if
new information on risks of the product becomes available").
1432 The fact that such a final decision might possibly have been challenged by the applicant before an
EC court would obviously not have been a legitimate reason for not completing the approval procedure.

Conclusions

7.1887 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 forward a draft measure to the Council – no draft measure was
forwarded between June 1999 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 the United States' contention that, consistent with the
general moratorium, the European Commun ities failed to consider the application
concerning Bt-531 cotton for final approval, and that this resulted in "undue delay" in
the completion of the relevant approval pro cedure. Accordingly, the Panel concludes
that in respect of the approval procedure concerning Bt-531 cotton, the European
Communities has breached its obligations under Annex C(1)(a), first clause, and
Article 8 of the SPS Agreement.

 (ii) DS293 (Argentina)

 With reference to DS293, the Panel reca lls its finding that the time taken by the
Commission to forward a draft measure to the Council – no draft measure was
forwarded between June 1999 and October 2002 – was unjustifiably long. In the light
of this finding, the Panel concludes th at the European Communities failed to
complete the approval procedure concerni ng Bt-531 cotton without "undue delay",
thus breaching its obligations under Annex C(1 )(a), first clause, and Article 8 of the
SPS Agreement.

(vi) RR-1445 Cotton (EC-66)
7.1888 Two Complaining Parties, the United States and Argentina, claim that the completion of the
approval procedure concerning RR-1445 cotton has been unduly delayed.
7.1889 The United States submits that the application concerning RR-1445 cotton was delayed for
nearly four years under Directive 90/220 by EC re gulators. The United States submits that from 22
February 1999, after the failure of the Regulator y Committee to reach a decision, and despite the
launch of inter-service consultations on a draft meas ure to be submitted to the Council starting 7 May
1999, the application was totally ignored by the Commission and lead CA until is was re-submitted
under Directive 2001/18 on 16 January 2003. The Unite d States considers this lengthy delay to be
unwarranted and thus undue.
7.1890 The United States points out in this respect th at the application in question had received a
favourable scientific assessment by the SCP. In th e United States' view, the fact that certain member
States objected in the Regulatory Committee does not justify the Commission's refusal to act on the
application. The United States submits that tho se objections which were explained in statements,
notably those by Austria, Sweden and the Unite d Kingdom, were the subject of detailed scientific
consideration in the SCP's positive opinion in July 1998. None of the member States objecting at the
Regulatory Committee stage offered any competing ri sk assessment or scientif ic evidence for their
objections, nor did they identify any specific inadeq uacies in the SCP review. The United States also
notes that there is at any rate nothing to indicate that the Commission undertook any process

whatsoever to resolve the member State concerns. Moreover, nothing in the record indicates that the
applicant was ever requested to submit additional information to address the member State objections,
nor that the basis of these objections was ever even notified to the applican t. The United States is
therefore of the view that the delay in questi on was not caused, as the European Communities claims,
by a pending request to the applicant for additional information.
7.1891 The United States notes in addition that the EC legislative framework provides a specific
avenue for further action where the Regulatory Co mmittee is unable to come to a decision: the
Commission is to forward the application to the Co uncil "without delay" for a decision. The United
States considers that where the European Comm unities' own legislation provides timelines, a
suspension of the approval procedure without any sci entific justification must be considered undue
delay.
7.1892 The United States submits, finally, that the a pplication concerning RR-1445 cotton is one of
nine applications identified by the United States which were stalled at the Commission level at the
time Directive 90/220 expired and which, as of the date of establishment of the Panel, have been
pending for an average of six and one half years. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
RR-1445 cotton is undue. The United States further argues that before the European Communities
adopted its moratorium, all approval procedur es under Directive 90/220 were undertaken and
completed in less than three years
7.1893 Argentina argues that after the Regulatory Committee in February 1999 failed to achieve a
qualified majority in favour of approving the application concerning RR-1445 cotton, the Commission
refused to submit a draft measure to the Council until the application had to be resubmitted under
Directive 2001/18. Argentina submits that this was not due to any action or omission on the part of
the applicant. According to Ar gentina, there notably are no EC documents which specifically
requested the applicant to provide additional informa tion. Argentina considers that the delay which it
says was caused by the Commission is undue. Argentin a argues in this respect that the requirements
of legislation not yet in force do not provide grounds for a prolonged failure to process an application.
In particular, the application concerning RR-1445 cotton should not have been forced to start the
procedure again under the new Directive 2001/18 when the procedure under the old Directive 90/220
had already been in progress for three years. Furthe rmore, Argentina asserts that there is no scientific
evidence to justify the delay after the Regulatory Committee vote. Those member States which in the
Regulatory Committee voted against approving RR-1445 cotton ignored the positive scientific
opinion of the SCP of July 1998. Moreover, Argentina contests the scientific validity of the
statements offered by some member States in support of their votes inasmuch as these statements do
not refute the positive opinion of the SCP.
7.1894 Argentina identified another instance of dela y which it considers undue. Argentina asserts
that although the applicant in January 2003 submitte d an updated application in accordance with the
requirements 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.
7.1895 Finally, Argentina submits that the total tim e consumed by the procedures under Directives
90/220 and 2001/18, from the time the application w as first submitted until April 2004, the date of
Argentina's first written submission, has been 6 year s and 9 months. In Argentina's view, this delay
can in no way be justified in the light of the dead lines stipulated in the relevant EC legislation.
Argentina contends that the procedure under Dir ective 90/220 should normally have been completed

within 240 days, which does not include the time during which a lead CA or the Commission may be
awaiting additional information it may have request ed or the time needed by an EC scientific
committee to issue an opinion. Similarly, Argentina contends that under Directive 2001/18, a
procedure should be completed within 285 days if no objections to the lead CA's initial assessment are
made, and 450 days if objections are made. Again, this does not include the time spent waiting for
additional information or for a scientific committee opinion. Argentina asserts that the delay affecting
the approval procedure concerning RR-1445 cotton cannot be justified by such "clock-stops".
7.1896 The European Communities argues that the Regulatory Committee in February 1999 failed
to reach a qualified majority because a number of member States raised scientific concerns which had
not been addressed in any of the applicant's previous submissions. These related in particular to the
long-term effects of herbicide tolerant crops on th e environment, to the presence of an antibiotic
resistance marker gene, residue-limit levels and to the effects on biodiversity of changes in crop
management.
7.1897 Regarding the requirement contained in Article 21 of Directive 90/220 that the Commission
"shall, without delay, submit to the Council a pro posal relating to the measures to be taken", the
European Communities points out that in the Pharos case
1433, the European Court of Justice examined
an identical requirement to submit a proposal to the Council "without delay" in the context of
legislation on the setting of maximum residue limits of veterinary medicinal products in foodstuffs of
animal origin (Regulation 2377/90). The Court stat ed that nothing in the wording of the relevant
provision "suggests any conclusion regarding the le ngth of time indicated by the expression 'without
delay', other than that, while a certain degree of rapidity is required, the Commission is not required to
act within a precise period of time nor at once, contrary to the appellant's submission".
1434 The Court
then went on to point out that the Commission was fr ee to modify its proposal before submitting it to
the Council and found that "if the Commission has the right to amend the proposal relating to the
measures to be taken which it subm its to the Council, it must have sufficient time to consider the
various courses of action open to it". 1435 On that basis, the Court found that the Commission, which
had taken over eleven months before forwarding a proposal to the Council, had not breached its
obligation to act "without delay". 1436 The Court pointed to the fact that the matter with which the
Commission was confronted was "highly complex and sensitive". 1437 The Court also made it clear
that the Commission could not be criticised for havi ng sought additional advice from an EC scientific
committee in an effort to prevent its proposal from being rejected by the Council.1438
7.1898 Concerning the case at hand, the European Communities argues th at the concerns raised by
certain member States were legitimate and scientifically sound. They could not be ignored or brushed
off by the Commission without detailed consider ation. Moreover, according to the European
Communities, in the light of the impending legisl ative changes, further reflection was necessary
before proceeding further. The European Comm unities submits that this is in line with the
jurisprudence of the European Court of Justice.
7.1899 In relation to the delay which occurred after the application was resubmitted under
Directive 2001/18, the European Communities submits that the application contained an incomplete

1433 European Court of Justice, Case C-151/98, Pharos against Commission [1999] ECR I-8157.
1434 Ibid., para. 20.
1435 Ibid., para. 24.
1436 The Panel notes that the judgement indicates th at during the eleven-month period, the Commission
initially reconsidered the file for six months and then sought a second scientific opinion. Ibid., para. 32.
1437 Ibid., para. 26.
1438 Ibid., para. 27.

monitoring plan. According to the European Co mmunities, the lead CA was awaiting additional
information on the post-marketing monitoring plan that it had 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.
7.1900 The Panel begins its analysis by addressing the delay allegedly caused by the Commission.
Failure by the Commission to submit a draft measure to the Council

7.1901 The Panel recalls that, following the failure of the Regulatory Committee to reach a decision,
on 7 May 1999 the Commission launched inter-servi ce consultations on a draft measure to be
submitted to the Council. But at no point prio r to 17 October 2002, the date of repeal of
Directive 90/220, did the Commission submit a draft measure to the Council. The United States and
Argentina argue that the Commission should have completed its inter-service consultations and
submitted a draft measure to the Council before October 2002.
7.1902 It is clear that the preparation by the Commiss ion of a draft measure and its submission to the
Council is not a process which inherently takes more than three years. To begin with, in other
approval procedures, the Commission was able to prepare and submit draft measures to the Council
within a few months, despite the fact that in tho se procedures some member States also voted against
the Commission's draft measure in the Regulatory Committee, and that some made written
statements.
1439 Moreover, as the Panel understands it, th e preparation by the Commission of a draft
measure to be submitted to the Council is not a pr ocess that is fundamentally different from the
preparation by the Commission of a draft measure to be submitted to the Regulatory Committee. In
the approval procedure here at issue, the Commission prepared a draft measure and launched a vote in
the Regulatory Committee in four months after receipt of the SCP opinion. 1440 It may be inferred
from these examples that the Commission could in principle have completed its task well before
October 2002.
7.1903 The issue thus becomes whether in the specifi c circumstances of this case the Commission
could in fact have completed its task before October 2002. The European Communities argues that
the Commission was not able to forward a draft measure to the Council because the applicant took too
long to provide information which had been request ed of it. The European Communities notes that
the applicant did not provide that information until 25 July 2001, and that the translation of this
material was made available only in February 2002. However, in our earlier analysis of the approval
procedure concerning RR-1445 cotton, we found that there is no evidence to suggest that the
Commission was waiting for the additional information provided by the applicant in July 2001. We
pointed out that 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. Accordingly, the information prov ided by the applicant in July 2001 in our view
does not justify the Commission's failure to forward a draft measure to the Council.

1439 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 sweet maize
(food) 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.
1440 Exhibit EC-66/Ats. 44 and 46. The Panel does not express a view as to whether this four-month
period was necessary in the circumstances to complete the relevant procedural stage.

7.1904 Another argument put forward by the Europ ean Communities to justify the Commission's
failure to forward a draft measure to the Council relates to the fact that the Regulatory Committee
failed to achieve the necessary qualified majority to approve the appli cation concerning RR-1445
cotton and that Austria, Italy, Sweden and the United Kingdom, in written statements supporting their
votes, expressed certain concerns. The European Communities submits that these concerns were
scientifically sound and had not been previously a ddressed by the applicant, and that they could not,
therefore, be ignored or brushed off by the Commission without detailed consideration.
7.1905 As no qualified majority was reached in the Re gulatory Committee, the Panel considers that,
as a general matter, it was justifiable for the Commissi on to take some time, as part of its inter-service
consultations, to analyse the reasons for the outco me 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.
7.1906 The Panel recognizes that, as a matter of EC la w, the Commission's draft measure did not
need to obtain a qualified majority in the Council to complete the approval procedure. If the Council
had failed to reach a favourable qualified majority, the Commission would have had to adopt its draft
measure and hence approve the a pplication concerning RR-1445 cotton.
1441 H o w e v e r , i t m u s t b e
borne in mind that an EC decision to approve the application concerning RR-1445 cotton would have
authorized the applicant to market its product in al l EC member States. In the light of this, the
Commission was entitled, in the Panel's view, to try to obtain a qualified majority in the Council as
this would have enhanced the legitimacy and acceptability of an EC decision to approve the
application concerning RR-1445 cotton. 1442 This means that the Commission could take a reasonable
period of time to explore ways of modifying its draft measure with a view to increasing the measure's
chances of being accepted by the Council by a qualified majority. 1443 But the Commission could not
simply wait for the majorities in the Council to change enough to allow the Commission's original
draft measure to be accepted by a qualified majo rity. The obligation imposed on the European
Communities is to complete its approval procedures without undue delay. This obligation may at
times require the Commission to complete an appr oval procedure even if it does not have the
(qualified) majority support of the Council.
7.1907 How much time is to be accorded to the Comm ission for the purpose of reconsidering a draft
measure which did not obtain a qualified majori ty in the Regulatory Committee can only be
determined in the light of the circumstances of each case.
7.1908 Turning, then, to the circumstances of this case, the European Comm unities asserts that the
concerns identified in the written statements by Austria, Italy, Sweden and the United Kingdom had
not been addressed by the applicant before. 1444 The Panel is unable to agree with this assertion.
Austria and the United Kingdom expressed concerns arising from the antibiotic resistance marker

1441 Article 21 of Directive 90/220. If the Council had reached a qualified majority against approving
the application, then the application would, however, have had to be rejected.
1442 It should also be recalled that the Complaining Parties did not question the design of the approval
procedure set out in Directive 90/220 (or its successor, Directive 2001/18), and in particular the fact that
member States vote on applications. It is arguable that if the Panel effectively were to require the Commission
to press on immediately, preventing it from taking into account the votes and views expressed by member
States, it would undermine the European Communities' ability to operate its approval procedure as designed.
1443 The Panel recalls once more that in other approval procedures the Commission was able to prepare
and submit draft measures to the Council within a few months, despite the fact that in those procedures some
member States also voted against the Commission's draft measure in the Regulatory Committee
1444 The statements are provided in Exhibit EC-66/At. 57. Italy voted in favour of the Commission's
draft measure in the Regulatory Committee.

gene, which according to Dr. Squire had b een explicitly addressed in the SCP assessment.
1445 Th e
concern identified by Italy was to ensure that the herbicide residues were within the limits established
by other EC legislation, which according to the Pa nel's understanding is not a concern related to the
safety of RR-1445 cotton per se . Only the general concerns raised by Sweden and the United
Kingdom regarding long-term effects of herbicid e tolerant crops on the environment were not,
according to Dr. Andow fully addressed by the SCP with regard to RR-1445 cotton. 1446 However, Dr.
Andow indicated that the long-term experiments suggested by Sweden were not feasible and that the
concerns identified could best be addressed in a monitoring plan, but that the necessity of a
monitoring plan could not be determined from the objections as submitted. At any rate, the record
does not indicate that after the Regulatory Committ ee vote, the Commission or the lead CA sought
additional information from the applicant in an effort to allay these concerns.
7.1909 Even if it were assumed that during its in ter-service consultations the Commission was
undertaking its own assessment of the scientific valid ity of the specific concerns expressed with a
view to supporting its draft measure with scientific arguments
1447, it is well to recall that the SCP was
able to undertake a comprehensive scientific a ssessment of the application concerning RR-1445
cotton in little over three months' time. 1448 The Panel also notes that the European Communities does
not assert that the concerns raised by the member States in question presented either new or
particularly complex scientific problems.
7.1910 Another circumstance invoked by the European Communities is the fact that Directive 90/220
was being revised at the time. According to the European Communities, a period of time for
reflection was therefore needed before proceeding fu rther. To recall, the Commission in this case
launched its inter-service consultations on a draf t measure to be submitted to the Council in May
1999. At the end of June 1999, the Council reach ed a political agreement – the Common Position –
on the proposal to amend Directive 90/220, but Directive 2001/18, the Directive amending
Directive 90/220, was not adopted until March 2001 a nd did not enter into force until October 2002.
Thus, the Commission started its inter-service consulta tions almost three-and-a-half years before the
entry into force of Directive 2001/18. In the light of this, even accepting that the Commission could
take some time to reconsider its draft measure, the Commission's failure to forward a draft measure to
the Council cannot be excused on the grounds that there was not enough time to complete the
approval procedure while Directive 90/220 was still in force.
1449
7.1911 Furthermore, the fact that some member St ates and segments of public opinion may have
considered that Directive 90/220 was no longer ad equate and may have voi ced opposition to further
approvals under that Directive 90/220 did not, in the Panel's view, provide a justification for the
Commission to delay the approval procedure in ques tion until new legislation had been put in place.
The EC legislator allowed Directive 90/220 to rema in in force and hence applicable until October
2002. Moreover, if the Commission saw a need to respond to concerns about perceived inadequacies
inherent in Directive 90/220, there were other courses of action open to it. Thus, the Commission

1445 Annex H, para. 468.
1446 Annex H, paras. 443-448.
1447 The European Communities did not specifically assert that it was undertaking a scientific
assessment of the concerns in question; it merely implied that the Commission embarked on a "detailed
consideration" of these concerns.
1448 Exhibit EC-66/Ats. 40 and 43.
1449 In its earlier findings on the application concerning RR-1445 cotton, the Panel noted that the
Commission had reason to believe that due to the "blocking minority" of the Group of Five countries in the
Council, it would have to adopt the draft measure it submitte d to the Council. In the Panel's view, even in this
scenario, there was enough time for the Commission to complete the procedure in question while
Directive 90/220 was still in force.

could in the first instance have sought voluntary commi tments from the applicant. Alternatively, it
could have proposed that the application be approved subject to conditions. In this respect, it is worth
noting that Directive 90/220 provided additional saf eguards if new information on risks of RR-1445
cotton had become available after its EC-wide approval.
1450 In such an event, a member State could,
pursuant to Article 16 of Directive 90/220, provisionally restrict or prohibit the marketing of RR-1445
cotton. Finally, if in fact the Commission had b een of the view that the risks arising from the
marketing of RR-1445 cotton could not be adequate ly assessed or managed under Directive 90/220, it
could arguably have sought the rejection of the a pplication, subject, perhaps, to the right of the
applicant to submit the application for reconsideration under the revised Directive, once it entered into
force.1451
7.1912 Based on the above considerations, the Panel is of the view that in the specific circumstances
of this procedure, the time actually taken by th e Commission to prepare and forward a draft measure
to the Council – no draft measure was forwar ded between June 1999 a nd October 2002 – was
unjustifiably long.
7.1913 Regarding DS291, we recall that the United St ates claims that the approval procedure
concerning RR-1445 cotton was unduly delayed because, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and August 2003 and that (ii) the Commission's failure to submit a
draft measure concerning RR-1445 cotton to the Council 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 that it is reasonable to infer that the Commission's
inaction was a consequence of the general moratorium on approvals.
7.1914 In view of our conclusion with regard to th e Commission's failure to submit a draft measure
to the Council, we do not go on to examine othe r arguments put forward by the United States and
Argentina in support of their claim under Annex C(1)(a), first clause, and Article 8 of the
SPS Agreement.
Conclusions

7.1915 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 forward a draft measure to the Council – no draft measure was
forwarded between June 1999 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 the United States' contention that, consistent with the
general moratorium, the European Commun ities failed to consider the application
concerning RR-1445 cotton for final approval, a nd that this resulted in "undue delay"

1450 The Commission usually made this point in its decisions approving applications. See, e.g., Exhibit
ARG-35 ("[w]hereas Article 11(6) and Article 16(1) of Directive 90/220/EEC provide additional safeguards if
new information on risks of the product becomes available").
1451 The fact that such a final decision might possibly have been challenged by the applicant before an
EC court would obviously not have been a legitimate reason for not completing the approval procedure.

in the completion of the relevant approva l procedure. Accordingly, the Panel
concludes that in respect of the appr oval procedure concerning RR-1445 cotton, the
European Communities has breached its ob ligations under Annex C(1)(a), first
clause, and Article 8 of the SPS Agreement.

 (ii) DS293 (Argentina)

 With reference to DS293, the Panel reca lls its finding that the time taken by the
Commission to forward a draft measure to the Council – no draft measure was
forwarded between June 1999 and October 2002 – was unjustifiably long. In the light
of this finding, the Panel concludes th at the European Communities failed to
complete the approval procedure concerni ng RR-1445 cotton without "undue delay",
thus breaching its obligations under Annex C(1 )(a), first clause, and Article 8 of the
SPS Agreement.

(vii) Transgenic potato (EC-67)
7.1916 Only one Complaining Party, the United States, claims that the completion of the approval
procedure concerning the Transgenic potato has been unduly delayed.
7.1917 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.
7.1918 The United States submits, in addition, that th e application concerning the Transgenic potato
is one of nine applications identified by the Un ited States which were stalled at the Commission level
at the time Directive 90/220 expired and which, as of the date of establishment of the Panel, have
been pending for an average of six and one half year s. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
the Transgenic potato is excessive and unjustifie d and, hence, undue. The United States further
argues that before the European Communities adopted its moratorium, all approval procedures under
Directive 90/220 were undertaken and completed in less than three years.
7.1919 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.
7.1920 The Panel begins its analysis by addressing the delay allegedly caused by the Commission.
Failure by the Commission to submit a draft measure to the Regulatory Committee

7.1921 The Panel recalls that the SCP issued a favourable opinion on 18 July 2002. Following the
issuance of the SCP opinion, the Commission did not submit a draft measure to the Regulatory
Committee. In fact, it seems that unlike in other approval procedures
1452, the Commission in this
procedure did not even launch inter-service cons ultations on a draft measure. In October 2002,

1452 See, e.g., Exhibits EC-62/At. 76; EC-65/At. 48.

Directive 90/220 was repealed. The United States argues that the Commission should have submitted
a draft measure to the Regulatory Committee before October 2002.
7.1922 The preparation by the Commission of a draft measure and its submission to the Regulatory
Committee is not a process which inherently takes very long. In some approval procedures, the
Commission was able to prepare and submit draft measures to the Regulatory Committee within a
matter of a few months. For example, in the procedure concerning Bt-531 cotton, the Commission
prepared a draft measure and launched a vote in th e Regulatory Committee in slightly less than three
months.
1453 Likewise, in the procedure concerning NK603 maize, the Regulatory Committee voted on
the application a little less than three months after EFSA issued its opinion.1454
7.1923 In the case of the approval procedure concerni ng the Transgenic potato, the SCP issued its
opinion almost exactly three months before Dir ective 90/220 was repealed. The Panel understands
the European Communities to argue that in these circumstances, the Commission did not need to
submit a draft measure to the Regulatory Committee. This argument presents the issue whether the
Commission could justifiably have reached the conclu sion that three months would be insufficient to
approve the application concerning the Transgenic potato.
7.1924 In its earlier findings, the Panel found that before the Transgenic potato could be approved, a
number of procedural steps remained to be unde rtaken 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 Committee,
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. Directive 90/220 does not stipulate
specific deadlines for any of these procedural steps.
7.1925 As pointed out above, the record shows that in one particular approval procedure, the
Commission was able to obtain a Regulatory Committee vote less than three months after EFSA
issued its opinion. If in the approval procedure concerning the Transgenic potato the Commission had
proceeded with a sense of urgency, it might thus have succeeded in obtaining a Regulatory Committee
vote in slightly less than three months.
1455 If the Commission's draft measure had achieved a qualified
majority, the approval procedure would then have had to be completed within a matter of a few days.
7.1926 The record does not provide confirmation that th is would have been possible. Regarding the
adoption by the Commission of its own draft measure, the approval procedure concerning Bt-11 sweet
maize is of interest, although that procedure was conducted under Regulati on 258/97. In that
procedure, the Commission took close to a month to adopt its own draft measure after the Council
failed to achieve a qualified majority. 1456 Regarding the written consent to be given by the lead CA,
the Panel finds informative the provisions of Ar ticle 18(2) of Directive 2001/18 according to which
the lead CA must give its written consent, transm it it to the applicant and inform the other member
States and the Commission thereof "within 30 days following the publication or notification of the
[Commission's] decision [to adopt its draft measure]". While, as noted, Directive 90/220 stipulates no
such deadline, the aforementioned steps were also to be completed under that Directive.
1457 I t i s

1453 The Commission launched inter-service consultations on 4 September 1998 and launched a vote in
the Regulatory Committee on 26 November 1998. Exhibit EC-65/Ats. 48 and 51.
1454 EFSA issued its opinion on 25 November 2003 and the Regulatory Committee voted on the
Commission's draft measure on 18 February 2004. Exhibit EC-76/Ats. 70 and 72.
1455 The United States has submitted no evidence or argument to show that the Commission could have
completed this task in substantially less time.
1456 Exhibit EC-92/At. 81.
1457 Article 13(4) of Directive 90/220.

reasonable to infer from the thirty-day deadline set out in Article 18(2) that the relevant steps could
not invariably be completed in just a few days . Notwithstanding the foregoing, it may be assumed
that if both the Commission and the lead CA had proceeded on an urgency basis in view of the
exceptional circumstance of the imminent repeal of Directive 90/220, they might well have been able
to complete their respective procedural steps in less than a month each. However, the evidence before
the Panel is insufficient to support the conclusion th at the procedural steps to be completed by the
Commission and the lead CA should altogether have taken no more than a few days.
7.1927 In conclusion, based on the evidence on the r ecord, the Panel is not convinced that the
approval procedure concerning the Transgenic potato could have been completed in the three-month
period preceding the date of repeal of Directive 90/220, and that the Commission should therefore
have launched inter-service cons ultations on a draft measure to be submitted to the Regulatory
Committee. Accordingly, the Panel finds that it h as not been established that the time actually taken
by the Commission to prepare and forward a draft measure – no draft measure was prepared and
forwarded between July 2002 and October 2002 – was unjustifiably long.
Total amount of time taken since submission of application

7.1928 The United States also puts forward the argument that the total amount of time during which
the application concerning the Transgenic potato w as pending is excessive and unjustified and, hence,
undue. The application concerning the Transgenic potato was first submitted for approval under
Directive 90/220 in August 1996. This means that as of the end of August 2003, the approval
procedure had been pending for more than seven years.
7.1929 The Panel agrees with the United St ates that, in absolute terms, this is a long period of time.
However, the mere identification of the total am ount of time during which an application has been
pending does not demonstrate, in and of itself, that the time taken was unjustifiably long. Indeed,
certain delays might be attributable, not to the Eu ropean Communities, but to the applicant. Other
delays might be attributable to the European Commun ities, but they might be justifiable. In the case
of applications which were submitted under Direct ive 90/220 – and the application concerning the
Transgenic potato is one of these – it must also be remembered that in accordance with Article 35 of
Directive 2001/18, applications submitted under Dir ective 90/220, but not approved by October 2002
became subject to Directive 2002/18 and had to be re-assessed by the lead CA. As a necessary
consequence, applications which had progressed to an advanced stage in the approval process under
Directive 90/220 and then were resubmitted to th e lead CA under Directive 2001/18 were pending for
long periods of time. Yet despite the fact that Article 35 of Directive 2001/18 resulted in certain
approval procedures – including that concerning th e Transgenic potato – being delayed, the United
States did not question the provisions of Article 35. In these circumstances, it would be incongruous
not to take account of the fact that some of the to tal time taken to assess a relevant application was a
direct consequence of the operation of Article 35.
7.1930 Moreover, even if the United States were corr ect in asserting that before there was an EC
moratorium, approval procedures used to be completed in less than three years, it must be
remembered that the European Communities assesses applications on a case-by-case basis. Thus, the
fact that the approval procedure concerning the Tr ansgenic potato was not completed in less than

three years in our view does not demonstrate that it was not justifiable for the European Communities
to take more time to process the application concerning the Transgenic potato.
1458
7.1931 The United States further argues that in the light of the acknowledgement by EC officials of
the existence of a moratorium on approvals, the fact that the application in question had been pending
for more than seven years demonstrates the existenc e of undue delay. We recall in this respect our
finding that the record supports the conclusi on that the European Communities applied a de facto
moratorium on approvals as of June 1999. At that time, the application concerning the Transgenic
potato had already been pending for more than two years and ten months. Thus, some of the total
time taken cannot be explained by the moratorium . Moreover, the mere fact that a general
moratorium was in effect does not necessarily imply that a particular application was affected by it.
The United States itself has repeatedly stated that "the moratorium was a decision by the EC not to
move products to a final decision in the approval process" and that "certain progress in the process,
short of a final decision, is not the least bit in consistent with a morato rium on final approvals".
1459
Therefore, by itself, the fact that a moratorium on approvals was in eff ect between June 1999 and
August 2003 is not sufficient to demonstrate that the period of time during which the application
concerning the Transgenic potato was pending as of August 2003 reflects a failure on the part of the
lead CA to complete the relevant approval procedure without undue delay.
7.1932 Accordingly, the Panel is unable to accept the United States' assertion that the total period of
time during which the application concerning the Transgenic potato had been pending as of August
2003 demonstrates that the time taken was unjustifiably long.
Conclusion

7.1933 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that it has not been established
that the time taken by the Commission to pr epare and forward a draft measure to the
Regulatory Committee once the SCP had issued its opinion – no draft measure was
forwarded between late July 2002 and Oct ober 2002 – was unjustifiably long, or that
the total amount of time taken by the Eu ropean Communities up to August 2003 was
unjustifiably long. Based on these findings , the Panel is unable to accept the United
States' contention that, consistent with the general moratorium, the European
Communities failed to consider the applica tion concerning the Transgenic potato for
final approval, and that this resulted in "undue delay" in the completion of the
relevant approval procedure. Accordingly, the Panel concludes that in respect of the
approval procedure concerning the Transgenic potato, the United States has failed to
establish that the European Communiti es has breached its obligations under
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.

1458 It is worth recalling, more generally, that the approval procedures which were completed before
there was a moratorium on approvals were not affected by the special circumstance that Directive 90/220 was
repealed in 2002.
1459 See, e.g., US second written submission, para. 51 (emphasis in original).

(viii) Liberator oilseed rape (EC-68)
7.1934 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning Liberator oilseed rape has been unduly delayed.
7.1935 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 two-year delay was therefore undue.
7.1936 The United States submits, in addition, that th e application concerning Liberator oilseed rape
is one of nine applications identified by the Un ited States which were stalled at the Commission level
at the time Directive 90/220 expired and which, as of the date of establishment of the Panel, have
been pending for an average of six and one half year s. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
Liberator oilseed rape is undue . The United States further argu es that before the European
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were
undertaken and completed in less than three years.
7.1937 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".
1460 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. The
European Communities submits that it cannot be held responsible for delays that are caused by the
lack of diligence or the failings of an applicant.
7.1938 The Panel begins its analysis by addressing the delay allegedly caused by the Commission.
Failure by the Commission to submit a draft measure to the Regulatory Committee

7.1939 The Panel recalls that the SCP issued a fa vourable opinion on 30 November 2000. Following
the issuance of the SCP opinion, the Commission did not submit a draft measure to the Regulatory
Committee until Directive 90/220 was repealed in October 2002. After the repeal of
Directive 90/220, on 5 November 2002, the lead CA c ontacted the applicant to remind it of the need
to update the application so that it could be fu rther considered under Directive 2001/18. The United
States argues that the Commission should have submitted a draft measure to the Regulatory
Committee before October 2002.
7.1940 The preparation by the Commission of a draft measure and its submission to the Regulatory
Committee is not a process which i nherently takes more than twenty-two months. In other approval
procedures, the Commission was able to prepare and submit draft measures to the Regulatory
Committee within a matter of a few months. For example, in the procedure concerning Bt-531 cotton,

1460 Exhibit EC-68/At. 88.

the Commission prepared a draft measure and launc hed a vote in the Regulatory Committee in less
than three months.
1461 Likewise, in the procedure concerning NK603 maize, the Regulatory
Committee voted on the application less than th ree months after EFSA issued its opinion. 1462 It may
be inferred from these examples that the Commi ssion could in principle have submitted a draft
measure to the Regulatory Committee well before October 2002.
7.1941 The fact that the Commission could in prin ciple have submitted a draft measure to the
Regulatory Committee before October 2002 does not necessarily mean that the Commission could
have done so in the specific circumstances of this case. The European Communities essentially
asserts that its failure to do so is justified in view of the applicant's failure to present a code of practice
for the field management of Liberator oilseed rape once the SCP had issued its opinion. However, in
its earlier analysis of the approval procedure in question, the Panel found that it was not persuaded
that the applicant was supposed to present a proposal for a code of practice, nor that the Commission
failed to submit a draft measure to the Regulator y Committee because it was waiting for the applicant
to propose a code of practice. The Panel further f ound that, in any event, the Commission in this case
did not launch inter-service consultations on a dr aft measure to be submitted to the Regulatory
Committee, and that the fact that the applicant di d not present a proposal was not an obstacle to the
Commission launching such consultations.
1463 Accordingly, the Panel is unable to agree with the
European Communities that the a pplicant's failure to present a code of practice justified the
Commission's failure to forward a draft measure to the Regulatory Committee before October 2002.
7.1942 Separately, it should be noted that the SCP opinion in this procedure dates from
November 2000. Directive 90/220 was not repealed until almost two years later. There was thus
enough time for the Commission to launch and co mplete inter-service consultations on a draft
measure to be submitted to the Regulatory Commi ttee and for the Commission to adopt its draft
measure in the event of a favourable vote in the Regulatory Committee. In the Panel's assessment, the
Commission's inaction cannot, therefore, be excu sed on the grounds that the approval procedure
concerning Liberator oilseed rape could not be completed while Directive 90/220 was still in force.
7.1943 In its earlier findings on the application concer ning Liberator oilseed rape, the Panel noted
that 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 measure would not achieve
the required qualified majority and that the Commiss ion would then have to complete the procedure
by adopting its draft measure. In the Panel's view , even in this scenario, there was enough time for
the Commission to complete the procedure in questi on while Directive 90/220 was still in force. But
even if it the Commission considered it doubtfu l that there would be enough time in view of
anticipated member State opposition, the Panel does not consider that this would have justified the
Commission's failure to forward a draft measure to the Regulatory Committee. The Commission
would have anticipated a "blocking minority" on th e 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 legally 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 Regul atory Committee and Council. In the light of this,
we think the Commission could not have legiti mately invoked the June 1999 declaration as a
justification for not submitting a draft measure to the Regulatory Committee prior to October 2002.

1461 Exhibit EC-65/Ats. 48 and 51.
1462 Exhibit EC-76/Ats. 70 and 72.
1463 See supra, para. 7.687.

7.1944 Based on the above considerations, the Panel is of the view that, in the specific circumstances
of this procedure, the time actually taken by th e Commission to prepare and forward a draft measure
to the Regulatory Committee – no draft measure was forwarded between late November 2000 and
October 2002 – was unjustifiably long.
7.1945 In addition, we recall that the United States claims that the approva l procedure concerning
Liberator oilseed rape was unduly delayed becau se, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and August 2003 and that (ii) the Commission's failure to submit a
draft measure to the Regulatory Committee following the issuance of the SCP's opinion is consistent
with the application of such a moratorium. In the li ght of this, and in the absence of effective rebuttal
by the European Communities, we ag ree with the United States that it is reasonable to infer that the
Commission's inaction was a consequence of the general moratorium on approvals.
7.1946 In view of our conclusion with regard to th e Commission's failure to submit a draft measure
to the Regulatory Committee, we do not go on to ex amine other arguments put forward by the United
States in support of its claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Conclusion

7.1947 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel reca lls its findings that the time taken by the
Commission to prepare and forward a draft measure to the Regulatory Committee
once the SCP had issued its opinion – no draft measure was forwarded between late
November 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 the United States' contention that, consistent with the
general moratorium, the European Commun ities failed to consider the application
concerning Liberator oilseed rape for final approval, and that th is resulted in "undue
delay" in the completion of the relevant a pproval procedure. Accordingly, the Panel
concludes that in respect of the approval procedure concerning Liberator oilseed rape,
the European Communities has breached its obligations under Annex C(1)(a), first
clause, and Article 8 of the SPS Agreement.

(ix) Bt-11 maize (EC-69)
7.1948 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning Bt-11 maize (EC-69) has been unduly delayed.
7.1949 The United States argues that after the application concerning 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 approval system,
the next step after the SCP favourable opinion should have been to submit the application for approval
by the Regulatory Committee. According to the United States, however, there was no action on the
application for two years after the SCP opinion and instead the next entry in the chronology provided
by the European Communities is an "evaluation of updates by the lead CA" in October 2002, which is

unexplained and unsupported by any exhibit or attachment. According to the United States, the
lengthy delay after the SCP opinion was issued pr ovides compelling evidence of the existence of a
general moratorium.
7.1950 The United States submits, in addition, that the application concerning Bt-11 maize (EC-69)
maize is one of nine applications identified by the United States which were stalled at the
Commission level at the time Directive 90/220 expired and which, as of the date of establishment of
the Panel, have been pending for an average of six and one half years. The United States contends in
this respect that although time alone is not dispos itive, in the light of the acknowledgement by EC
officials of the existence of a moratorium on approvals, this delay in completing the approval
procedure concerning Bt-11 maize (EC-69) is undue. The United States further argues that before the
European Communities adopted its moratorium, a ll approval procedures under Directive 90/220 were
undertaken and completed in less than three years.
7.1951 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 molecu lar characterization of the Bt-11 line, taking into account the
provisions of the new Directive, inter alia on monitoring, traceability and labelling.
7.1952 The United States responds that the monitoring plan referred to in the SCP opinion is an
"Insect Resistance Management" (IRM) plan, and th at the SCP never recommended any changes to
the applicant's proposed IRM plan. The United St ates 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 insect s, or 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.
7.1953 The Panel begins its analysis by addressing the delay allegedly caused by the Commission.
Failure by the Commission to submit a draft measure to the Regulatory Committee

7.1954 The Panel recalls that in the approval pro cedure concerning Bt-11 maize (EC-69), 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. In October 2002,
Directive 90/220 was repealed. The United States argues that the Commission should have submitted
a draft measure to the Regulatory Committee before October 2002.
7.1955 The preparation by the Commission of a draft measure and its submission to the Regulatory
Committee is not a process which i nherently takes more than twenty-two months. In other approval
procedures, the Commission was able to prepare and submit draft measures to the Regulatory
Committee within a matter of a few months. For example, in the procedure concerning Bt-531 cotton,
the Commission prepared a draft measure and launc hed a vote in the Regulatory Committee in less
than three months. 1464 Likewise, in the procedure concerning NK603 maize, the Regulatory
Committee voted on the application less than th ree months after EFSA issued its opinion. 1465 It may

1464 Exhibit EC-65/Ats. 48 and 51.
1465 Exhibits EC-76/At. 70-72.

be inferred from these examples that the Commi ssion could in principle have submitted a draft
measure to the Regulatory Committee well before October 2002.
7.1956 The fact that the Commission could in prin ciple have submitted a draft measure to the
Regulatory Committee before October 2002 does not necessarily mean that the Commission could
have done so in the specific circumstances of this case. The Panel understands the European
Communities to assert that the Commission did not send a draft measure to the Regulatory Committee
because, after the SCP opinion, the lead CA, the a pplicant and the Commission continued discussions
on a monitoring plan well into 2002. The Panel al so understands the European Communities to assert
that the applicant submitted additional information in May 2002, just before the new Directive entered
into force.
7.1957 Regarding the monitoring plan, we stated in ear lier findings on this approval procedure that
we are not persuaded by the European Communitie s' assertion that the Commission did not submit a
draft measure to the Regulatory Committee because the SCP recommended a monitoring plan and the
issue remained unsettled. We further found that, in any event, the Commission in this case did not
launch inter-service consultations on a draft measure to be submitted to the Regulatory Committee,
and that the fact that the SCP stated that monito ring should be carried out was not an obstacle to the
Commission launching inter-service consultations on a draft measure. Accordingly, we are unable to
agree with the European Communities that the f act that the SCP recommended a monitoring plan
justified the Commission's failure to forward a draft measure to the Regulatory Committee before
October 2002.
7.1958 Regarding the additional inform ation submitted by the applic ant in May 2002, we have
already observed earlier that this information was apparently 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 justify
the Commission's failure to submit a draft measure to the Regulatory Committee between November
2000 and May 2002.
7.1959 Separately, it should be noted that the SCP opi nion 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 consultations on a draft
measure to be submitted to the Regulatory Commi ttee and for the Commission to adopt its draft
measure in the event of a favourable vote in the Regulatory Committee.
1466 In our assessment, the
Commission's inaction cannot, therefore, be excu sed on the grounds that the approval procedure
concerning Bt-11 maize (EC-69) could not be completed while Directive 90/220 was still in force.
7.1960 In our earlier findings on the application concerning Bt-11 maize (EC-69), we noted that 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 measure would not achieve the
required qualified majority and that the Commission would then have to complete the procedure by
adopting its draft measure. In our view, even in this scenario, there was enough time for the
Commission to complete the procedure in question while Directive 90/220 was still in force. But
even if it the Commission considered it doubtfu l that there would be enough time in view of

1466 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.

anticipated member State opposition, the Panel does not consider that this would have justified the
Commission's failure to forward a draft measure to the Regulatory Committee. On the other hand, the
Commission could have anticipated a "blocking minority" on the basis of the June 1999 declaration
by the Group of Five countries. Yet, 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, we think the Commission could not have i nvoked the June 1999 declaration as a justification
for not submitting a draft measure to the Regulatory Committee prior to October 2002.
7.1961 Based on the above considerations, the Panel is of the view that, in the specific circumstances
of this procedure, the time actually taken by th e Commission to prepare and forward a draft measure
to the Regulatory Committee – no draft measure was forwarded between late November 2000 and
October 2002 – was unjustifiably long.
7.1962 In addition, we recall that the United States claims that the approva l procedure concerning
Bt-11 maize (EC-69) was unduly delayed because, due to the moratorium, the European Communities
failed to consider the application in question for fi nal approval. In this respect, we note our earlier
findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and August 2003 and that (ii) the Commission's failure to submit a
draft measure to the Regulatory Committee following the issuance of the SCP's opinion is consistent
with the application of such a moratorium. In the li ght of this, and in the absence of effective rebuttal
by the European Communities, we ag ree with the United States that it is reasonable to infer that the
Commission's inaction was a consequence of the general moratorium on approvals.
7.1963 In view of our conclusion with regard to th e Commission's failure to submit a draft measure
to the Regulatory Committee, we do not go on to ex amine other arguments put forward by the United
States in support of its claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Conclusion

7.1964 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel reca lls its findings that the time taken by the
Commission to prepare and forward a draft measure to the Regulatory Committee
once the SCP had issued its opinion – no draft measure was forwarded between late
November 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 the United States' contention that, consistent with the
general moratorium, the European Commun ities failed to consider the application
concerning Bt-11 maize (EC-69) for final a pproval, and that this resulted in "undue
delay" in the completion of the relevant a pproval procedure. Accordingly, the Panel
concludes that in respect of the approva l procedure concerning Bt-11 maize (EC-69),
the European Communities has breached its obligations under Annex C(1)(a), first
clause, and Article 8 of the SPS Agreement.

(x) RR oilseed rape (EC-70)
7.1965 Two Complaining Parties, the United States and Canada, claim that the completion of the
approval procedure concerning RR oilseed rape (EC-70) has been unduly delayed.
7.1966 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
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. The United
States considers this delay in completing the approval procedure concerning RR oilseed rape (EC-70)
to be undue.
7.1967 The United States notes, in addition, that Denm ark, Italy, Belgium, Austria, France and
Germany all objected to the lead CA's favourable in itial assessment on the grounds that new EC rules
concerning the traceability and labelling of biotech pr oducts needed to be in place before they could
support the approval of any application. The Unite d States submits that this shows an unwillingness
to acknowledge the strength of the scientific conc lusions reached by the lead CA and opposition to
approval regardless of the merits of the application in question. The United States notes, in addition,
that Austria and Denmark also objected because in their view issues concerning liability and
coexistence remained to be reso lved. The United States submits th at a desire for rules addressing
these issues cannot justify delay. Otherwise, a Member could always say it would like a better
regulatory regime in aspects unrelated to the en vironment, human or animal health and delay
approvals indefinitely, rendering the "no undue delay" discipline meaningless.
7.1968 The United States also points out that the appli cation concerning RR oilseed rape (EC-70) is
one of nine applications identified by the United States which have been pending at the member State
level for an average of three years and ten months. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
RR oilseed rape (EC-70) is undue. The United St ates further argues that before the European
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were
undertaken and completed in less than three years.
7.1969 Canada notes that in February 2000, the Dutch State Institute for Quality Control of
Agricultural Products (RIKILT-DLO), which is 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), wh ich is responsible for providing scientific
advice relating to human health and the environm ent, concluded its assessment with a favourable
conclusion. In January 2003, the Netherlands CA published a favourable overall 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 and excessive.
7.1970
 Canada also argues that the total time taken by the Netherlands to review 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.
7.1971 Regarding the delay caused by the issue of c onfidentiality, Canada notes that Annex C(1)(d)
of the SPS Agreement states that WTO Members shall ensure "the confidentiality of information about
imported products arising from or supplied in connection with cont rol, inspection and approval is
respected […] in such a manner that legitimate comm ercial interests are protected". Under Article 25
of Directive 2001/18, an applicant is entitled to re quest that commercially sensitive information be
protected, which the applicant in this case did in Ma rch 2001. Canada is therefore of the view that
delays arising from an applicant seeking to ensure the fulfilment of obligations, both under the
SPS Agreement and domestic law, relating to the protecti on of legitimate commercial interests should
not be attributed to the applicant.
7.1972 In addition to the foregoing, Canada submits th at the failure by the European Communities to
approve this product under Directiv e 2001/18 compounds the already unj ustified and excessive delay.
Canada submits that repeated, unj ustified "road-blocks" that have been imposed by member States
resulting in excessive delays – unjustified objections to the lead CA's favourable initial assessment in
March 2003, the failure of the Regulatory Committee to obtain a qualified majority at its meeting of
16 June 2004 – demonstrate that the European Communities has violated its obligations under
Annex C(1) of the SPS Agreement.
7.1973 Regarding member State objections, Canada notes that Denmark, Italy, France, Austria and
Belgium raised objections, not on the basis of safety concerns, but on the grounds that approval of the
application in question should be suspended pe nding the adoption of new EC legislation on
traceability and labelling. Canada further contends that Denmark (in relation to transport of RR
oilseed rape (EC-70)) and Italy (in relation to herbic ide use) raised objections outside the scope of the
assessment foreseen by Directive 2001/18. Finally, Ca nada argues that objections were raised which
were irrelevant in the light of the scope of the requested approval ( i.e. for import and processing).
Denmark requested that a monitoring plan should in clude observations on dispersal and gene transfer
to oilseed rape and wild relatives.
1467 Likewise, Italy, the United Kingdom, Spain and Austria
objected on the basis that a post-market monitori ng plan needed to be proposed to assess seed
spillage. Canada submits that the European Communities' scientific committee has confirmed
repeatedly, and in particular for oilseed rape, that the mere fact of potential dispersal of seeds and
gene transfer among domesticated or wild relatives is not per se negative for human health or the
environment. Moreover, Canada points out that the scope of the approval was for import only, as
opposed to planting – a fact that does not normally attract attention to seed spillage, because the
imported grain is processed at the port of entry where spillage is controlled in compliance with
statutory standards and to avoid economic loss.
7.1974 Canada also argues that the total time for me mber State review of the lead CA's initial
assessment was eight months (22 January 2003 to 6 October 2003) instead of 105 days, the time-
period envisaged in Article 15 of Directive 2001/18.
7.1975 Regarding the failure of the Regulatory Comm ittee to obtain a qualified majority at its
meeting of 16 June 2004, Canada notes that prio r to the vote, EFSA rendered a favourable opinion
and that in rendering its favourable opinion, EFSA co nsidered all of the member States' objections in
relation to safety issues. Canada considers, theref ore, that whatever the rationalization for member

1467 Exhibit EC-70/At. 26.

States to vote against or abstain from voting, such rationalizations were not justified by science-based
health or safety considerations. In Canada's vi ew, it follows that the failure of the Regulatory
Committee to approve the application forced additional unwarranted delays.
7.1976 Finally, Canada contends that the length of time it has taken, so far, for this application to
move through the approval system – seven years – is, by any reasonable standard, "undue" and
therefore a violation of Annex C(1)(a), keeping in mi nd that it still has not been approved. However,
the amount of time this application has languished in the approval procedure is not the sole reason for
Canada's claim that the delay has been undue. First and foremost, the European Communities has had
in place, since October 1998, an unjustified moratorium on approvals. Furthermore, the refusal to
approve the application concerning RR oilseed rape (EC-70) is not based on a risk assessment, despite
numerous favourable risk assessments conducted by the European Communities' own scientific
committees.
7.1977 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 requi rements of Directive 2001/18. According to the
European Communities, this period of time was entirely dedicated to resolving scientific and technical
issues, such as molecular characterisation and fe ed safety. The lead CA requested additional
information on molecular characterization and on certain feed safety aspects, and exchanges regarding
these issues continued until the year 2000. Afte r the adoption of Directive 2001/18 in March 2001,
the lead CA asked the applicant to provide in formation on a detection method as required under the
new legislation. The applicant requested confidenti ality 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 exchanged on the issue. The lead CA also re quested reference material which again triggered a
debate on confidentiality. The European Communiti es notes that these issues were only settled in the
autumn of 2002. By that time, Directive 2001/18 had entered into force and the lead CA and
applicant worked on up-dating the application according to Directive 2001/18. As regards the issue of
confidentiality, the European Communities submits that it was at the request of the applicant that the
discussion on these issues was undertaken and that the European Communities cannot be responsible
for any slippage in the timetable resulting from a request made by an applicant.
7.1978 The European Communities further points out that once the applicant had provided an update,
the application moved immediately to the Communi ty level. A few member States requested
additional information and six member States raised objections. The objections related to issues of
molecular characterisation (insufficient data), f eeding studies, the monitoring plan, allergenicity,
detection/identification methods as well as traceabilit y and labelling. Meetings were held with the
applicant to settle these issues and the applicant provided additional information. The European
Communities contends that the objections raised by member States were based on legitimate and
scientifically sound concerns, or regulatory requirements outside the scope of this dispute (traceability
and labelling).
7.1979 The Panel commences its analysis with the alleged delay at member State level.
Delay at member State level

7.1980 We note that in the approval procedure con cerning RR oilseed rape (EC-70), the applicant
submitted an application to the lead CA (the Ne therlands) 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.

7.1981 The United States and Canada assert that th e lead CA took too long to complete its
assessment. They note that the lead CA took mu ch more time for its own assessment of the
application than the 90 days envisaged in Article 12(2) of Directive 90/220.
1468 We consider that this
is correct.1469 However, whether or not the lead CA co mplied with the 90-day deadline stipulated in
Directive 90/220 in our view is not dispositive, per se, of whether the European Communities met its
WTO obligation to complete its approval procedur es without undue delay. Indeed, legislation of
different WTO Members may stipulate deadlines for th is type of assessment which are more or less
strict. Nevertheless, we consider that the dead line set forth in Directive 90/220 provides a useful
indicator to guide the Panel's analysis. The 90-da y deadline is binding and applies to all relevant
applications submitted under Directive 90/220. It may therefore be assumed that the EC legislator set
this binding deadline in such a wa y as to make it possible for the CAs of all member States to assess
even complex applications within the prescribed deadline.1470
7.1982 In the present case, however, the European Commun ities contends that all of the time taken
by the lead CA until December 2002, when the app licant complemented its application in accordance
with the requirements of Directive 2001/18, was necessary to resolve scientific and technical
issues.1471 Since we do not view the fact that th e 90-day deadline was exceeded as dispositive, per se,
we go on to examine whether the lead CA was just ified in forwarding an assessment report to the
Commission only in mid-January 2003.
7.1983 In its earlier findings on the approval procedure concerning RR oilseed rape (EC-70), the
Panel noted its understanding that when evaluati ng applications for placing on the market, the
Netherlands CA notably took into consideration the advice from the COGEM and the opinion of the
RIKILT-DLO. In the approval procedure in que stion, the RIKILT-DLO submitted its favourable
opinion in February 2000 1472, and the lead CA advised the applicant in March 2000 in an e-mail that
no further technical information for the risk assessment needed to be supplied. 1473 The COGEM did
not provide its favourable advice until 10 January 2001.1474
7.1984 Regarding the advice from the COGEM, it should be recalled that 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 transm itted to the applicant also in September 1998. 1475
The applicant provided the request ed information in December 1998. 1476 Yet the COGEM did not
meet again to discuss the application and the addi tional information for another two years. The
relevant meeting took place in December 2000, a month before the COGEM provided its final

1468 We recall that the 90 days envisaged in Directive 90/220 do not include any periods of time during
which the lead CA is awaiting further information which it requested from the applicant.
1469 For instance, as is clear from Exhibit EC-70, 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, which are but examples, already add up to more than seven months.
1470 Our remarks concerning the 90-day deadline set out in Article 12(2) of Directive 90/220 are also
applicable, mutatis mutandis, to the corresponding 90-day deadline set out in Article 14(2) of Directive 2001/18.
1472 Exhibit EC-70/At. 66, Summary of the evaluation carried out by the Netherlands Competent
Authority (GT73), p. 5; see also Exhibit CDA-57.
1473 Exhibit EC-70/At. 18; Exhibit CDA-132.
1474 Exhibit EC-70/At. 66, Summary of the evaluation carried out by the Netherlands Competent
Authority (GT73), p. 5; see also Exhibit CDA-57.
1475 Exhibit EC-70/At. 7.
1476 Exhibit EC-70/Ats. 9 and 10.

advice.
1477 The record does not support the inference that the COGEM provided its advice only in
January 2001 because it needed to resolve scientific or technical issues. Nor is there any indication in
the record that the COGEM had other reasons for delaying the provision of its advice. There is
therefore no apparent reason why the COGEM could not have provided its advice before or by the
time the lead CA informed the app licant by e-mail that no further tec hnical information needed to be
submitted, i.e., before or by March 2000.
7.1985 In the light of the foregoing, the Panel consider s that at the latest in March 2000 the lead CA
could have had all the elements to complete its assessment report. The European Communities notes
that the applicant submitted additional information in April and May 2000. It is correct that in the
aforementioned e-mail of March 2000 from the lead CA to the applicant, the l ead CA also noted that
the legal name and registration of the applicant woul d 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. 1478 In April 2000, the applicant confirmed its legal name and
registration.1479 And in mid-May 2000, the applicant sent a draft document to the lead CA to indicate
how it intended to modify the original application and to ask for comments and suggestions. 1480 The
lead CA replied that it would co mmunicate its "findings" as soon as possible, probably within less
than a fortnight.1481 This estimate demonstrates that the document submitted in mid-May 2000 did not
call for a lengthy analysis by the lead CA. Moreover, the Panel does not consider that the March 2000
e-mail from the lead CA constitutes a formal request for information which triggered a clock-stop.1482
7.1986 If, as the Panel believes, the lead CA could ha ve obtained all necessary elements at least by
March 2000, it may reasonably be assumed that the lead CA could have completed its assessment
report at the latest 90 days later, i.e., around the end of June 2000. It should be recalled that
Article 12(2) of Directive 90/220 requires that "at th e latest 90 days after receipt" of an application,
the lead CA must, in the case of a favourable asse ssment, forward the application to the Commission
with a favourable opinion. The Panel has already observed in respect of the corresponding 90-day
deadline stipulated in Directive 2001/18 that that d eadline provides a useful indicator for determining
how much time might be needed to complete an me mber State level assessment. Assuming that 90
days would have been sufficient seems all the mo re reasonable as by March 2000 the lead CA had
already assessed the application for more than the 90 days envisaged in Article 12(2) of
Directive 90/220.1483
7.1987 Based on the foregoing considerations, the Pane l considers that the lead CA could have
forwarded its assessment report to the Commission well before the end of 2000 and thus much before

1477 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.
1478 Exhibit EC-70/At. 18.
1479 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.
1480 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.
1481 Exhibit EC-70/At. 22.
1482 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.
1483 As noted previously and by way of example, the lead CA was assessing the application between 13
August 1998 and 25 September 1999 as well as between 2 April 1999 and 17 August 1999. These periods of
time add up to more than 90 days. Exhibit EC-70.

mid-January 2003. This means that, contrary to th e European Communities' contention, not all of the
time taken by the lead CA up to December 2002 w as necessary to resolve scientific and technical
issues. Moreover, the lead CA's failure to comp lete and forward an assessment report before the end
of 2000 could not, in the Panel's view, be excused on the basis that there wa s insufficient time to
complete the approval procedure concerning RR oilseed rape (EC-70) while Directive 90/220 was still
in force. Directive 90/220 was not repealed un til October 2002. There was thus enough time for the
other member States to review the lead CA's as sessment report within 60 days following the
circulation of the assessment report and, in the ab sence of objections, for the lead CA to give its
consent to the placing on the market of RR oilseed rape (EC-70).
1484
7.1988 In its earlier findings, the Panel also stated that even assuming that the COGEM could not
have provided its advice before January 2001, the Netherlands could still have completed and
forwarded its assessment report soone r than it did. Specifically, the Panel noted that when the
COGEM provided its advice in January 2001, the lead CA did not complete its assessment report but
on 12 March 2001 – the date of adoption of Direc tive 2001/18 – requested a detection method based
on the provisions of Directive 2001/18, even thou gh that Directive did not enter into force until
October 2002. The applicant provided a detection method four days later. 1485 However, the applicant
requested confidential treatment of the detection me thod. This resulted in an eight-month exchange
with the applicant. As we noted earlier, during that exchange, the lead CA caused delays by not
requesting clarification promptly. Our examina tion focuses on the delays caused by the lead CA
during the course of the exchange over confidentiality issues.
7.1989 We begin our examination by recalling relevant facts. In May 2001, the lead CA asked the
applicant to reconsider its request for confidential treatment of the detection method it had submitted,
or else to provide further substantiation. The lead CA also stated that in the absence of further
substantiation by June 2001, it would take a decision with respect to the request. 1486 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 request ed that the primer sequences in the protocol
remain confidential until the first patent application was published.1487 In response, the lead CA again
sought further substantiation. After receiving additi onal substantiation, the l ead CA in January 2002
granted the request that the primer sequences should be treated as confidential.
7.1990 It is clear from these facts that there was a disagreement between the lead CA and the
applicant regarding whether certain information was by nature confidential. Article 19 of

1484 In its earlier findings on the application concerning RR oilseed rape (EC-70), the Panel noted that
the Netherlands could have considered that for as long as Directive 90/220 was still in force, there was no
realistic prospect that the Group of Five countries and the Commission would allow the final approval of the
application in question. However, the Panel does not cons ider that this would have justified the Netherlands'
failure to forward an assessment report to the Commissi on. The Netherlands might have anticipated opposition
from the Group of Five countries on the basis of their June 1999 declaration. As pointed out above,
notwithstanding this declaration, the Group of Five countries retained the freedom under EC law to approve
applications. The same is true for the Commission, which had not issued a declaration comparable to that of the
Group of Five countries.
1485 As Directive 2001/18 was not yet in force on the date of the lead CA's request, the applicant was
arguably not obliged, as a matter of EC law, to comply with it. In our view, there can be no doubt in view of the
wording of the lead CA's request for a detection method that the applicant was aw are that the basis for the
request was legislation not yet in force. But there is no indication in the record that the applicant contested the
propriety of the request.
1486 Exhibit EC-70/At. 26.
1487 Exhibit EC-70/At. 30.

Directive 90/220 provides that in such cases it is for th e lead CA to decide, after consultation with the
applicant, whether the information should be treated as confidential.
1488 It appears to the Panel that
the lead CA was following this procedure. However, it took a long time – eight months – to resolve
the issue of the confidentiality status of the relevant information. While the applicant took a total of
three and a half months to reply to the several requests for further substantiation, in June 2001 the lead
CA waited for more than a month after receiving fu rther substantiation before it followed up with a
request for yet more substantiation.1489 A similar situation arose in September 2001 when the lead CA
waited for more than two months befo re following up with another request. 1490 The substantiation
provided by the applicant in June and September 2001 was neither very extensive nor particularly
complex.1491 Moreover, in June and September 2001, there was no apparent reason for the lead CA to
consider that there was insufficient time to a pprove the application before Directive 90/220 was
repealed in October 2002. The Panel therefore does not see any justification for the lead CA's failure
to follow up more promptly. In the Panel's view, th e lead CA's delayed action in response to the June
and September submissions of the applicant de monstrates that, contrary to the European
Communities' contention, not all of the time ta ken by the lead CA up to December 2002 was
necessary to resolve scientific and technical issues.
7.1991 Based on the above considerations, the Panel concludes that the time taken by the lead CA for
its assessment of the application concerning RR oilseed rape (EC-70) – notably the time spent waiting
for COGEM to provide its advice, and the time take n to follow up on substantiation provided by the
applicant for its request for confidential treatment of certain information – was unjustifiably long.
7.1992 In relation to DS291, we recall that the United States claims that the approval procedure
concerning RR oilseed rape (EC-70) was unduly de layed because, due to the moratorium, the
European Communities failed to consider the appli cation in question for final approval. In this
respect, we note our earlier findings that (i) a general de facto moratorium on approvals was in effect
in the European Communities between June 1999 and A ugust 2003 and that (ii) the time taken by the
Netherlands to complete its assessment is consistent with the application of such a moratorium. In the
light of this, and in the absence of effective rebutta l by the European Communities, we agree with the
United States that it is reasonable to infer that the Netherlands' conduct was a consequence of the
general moratorium on approvals.
7.1993 In view of our conclusion with regard to the time taken by the Netherlands for its assessment,
we do not go on to examine other arguments put fo rward by the United States and Canada in support
of their claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Conclusions
7.1994 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that the time taken by the lead
CA for its assessment of the application concerning RR oilseed rape (EC-70) was
unjustifiably long, and that it can reasonably be inferred from surrounding

1488 Canada refers to the analogous provisions of Article 25 of Directive 2001/18. However, these
provisions were not applicable at the time.
1489 Exhibit EC-70/At. 28.
1490 Exhibit EC-70/At. 33.
1491 The June letter from the applicant is two pages long, that of September is only one page long.

circumstances that the l ead CA's conduct was a consequence of the general
moratorium on approvals. Based on these findings, the Panel accepts the United
States' contention that, consistent with the general moratorium, the European
Communities failed to consider the appli cation concerning RR oilseed rape (EC-70)
for final approval, and that this resulted in "undue delay" in the completion of the
relevant approval procedure. Accordingly, the Panel concludes that in respect of the
approval procedure concerning RR oilseed rape (EC-70), the European Communities
has breached its obligations under Annex C(1 )(a), first clause, and Article 8 of the
SPS Agreement.

 (ii) DS292 (Canada)

 With reference to DS292, the Panel recalls its finding that the time taken by the lead
CA for its assessment of the application concerning RR oilseed rape (EC-70) was
unjustifiably long. Based on this finding, th e Panel accepts Canada's contention that
the European Communities failed to "consider or approve, without undue delay", the
application concerning RR oilseed rape (EC-70), and that it consequently did not
complete the relevant approval procedure without "undue delay". Accordingly, the
Panel concludes that in respect of the a pproval procedure concerning RR oilseed rape
(EC-70), the European Communities has breached its obligations under
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.

(xi) LL soybeans (EC-71)
7.1995 Two Complaining Parties, the United States and Argentina, claim that the completion of the
approval procedure concerning LL soybeans (EC-71) has been unduly delayed.
7.1996 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.
7.1997 The United States also points out that the app lication concerning LL soybeans (EC-71) is one
of nine applications identified by the United Stat es which have been pending at the member State
level for an average of three years and ten months. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
LL soybeans (EC-71) is excessive and unjustified and, hence, undue. The United States further
argues that before the European Communities adopted its moratorium, all approval procedures under
Directive 90/220 were undertaken and completed in less than three years.
7.1998 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 delay, as the "initial reports" were not prepared.
7.1999 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 pe riod from September 1998 to
2001; (2) procedural problems arising from the fact th at 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.

7.2000 The Panel commences its analysis with the alleged delay at member State level.
Delay at member State level

7.2001 We note that in the approval procedure c oncerning LL soybeans (EC-71), the applicant
submitted an application to the lead CA (Belgium ) on 28 September 1998. In September 1999, the
applicant submitted an application for this same product to Portugal. When Directive 90/220 was
repealed on 17 October 2002, the lead CA had not yet forwarded the dossier to the Commission. The
applicant updated the application on 15 January 2003. Also in January 2003, the applicant withdrew
the parallel application to Portugal.
7.2002 We recall that in relation to Belgium's assessment of LL soybeans (EC-71) three separate time
periods can be usefully distinguished: (1) the ti me period between the submission of the application
to the Belgian CA and the concurrent submissi on 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 appli cation under Directive 2001/18 and the applicant's
withdrawal of the application.
7.2003 The Panel begins its analysis with the allege d delay at member State level during the period
before the parallel application was submitted to Port ugal. We recall that in a letter dated 31 March
1999, the Belgian Biosafety Council stated that it was "of the opinion that the file [concerning the
application submitted 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".
1492
Based on the March 1999 advice by the Biosafety Council the Belgian CA on 28 May 1999 asked for
more information, including information on mo lecular characterization, nutritional analysis
(concerning the approval procedure for LL soybeans (EC-93)) and herbicide aspects. 1493 T h e
applicant did not respond to the May 1999 request until July 2001.
7.2004 The European Communities provides no justificati on for the time taken by the lead CA to
forward the request for additional information from the Belgian Biosafety Council. While the lead
CA as the responsible agency could review the request in order to determine whether it was
appropriate to transmit it to the applicant, we ar e not convinced, in the absence of any justification
offered by the European Communities, that two mont hs were needed to review this straightforward
request for additional information. Indeed, at an ear lier stage in the approval procedure, the lead CA
forwarded a similar request from the Biosafet y Council within a matter of several days. 1494 W e
therefore consider that the lead CA could and shoul d have acted more promptly than it did when the
Biosafety Council suggested a request for additional information in March 1999.
7.2005 As noted, the applicant did not respond to the lead CA's May 1999 additional request for
information until July 2001, i.e., more than two years later. Me anwhile, however, the applicant had
submitted an application to Portugal. The time dur ing which a parallel application was maintained
concurrently in Portugal contributed to the delaye d progress of the application in Belgium. We note
in this regard that in a communication to Belg ium dated 1 December 2000, the applicant explicitly
indicated its intention of maintaining dual applications. 1495 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 Bi osafety Advisory Council of the Belgian CA

1492 Exhibit EC-71/At. 16.
1493 Exhibit EC-71/Ats. 17 and 22.
1494 Exhibit EC-71/Ats. 4 and 5.
1495 Exhibit EC-71/At. 23.

confirmed the continuation of the evaluation proces s in Belgium and requested that the applicant
forward 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.
1496 On 5 September 2001, ten
months after confirming the continuation of the evaluation process in Belgium, the Belgian CA
indicated to the applicant that further evaluati on of the application would be suspended until the
applicant specified a single country to handle the application. 1497 The applicant responded on 8
October 2001 by asserting the maintenance of double concurrent applications. 1498 No further
exchanges appear to have occurred between the a pplicant and the lead CA until January 2003, when
the applicant updated the application submitted to Belgium under Directive 2001/18. While there is
no evidence on the record to confirm this, it appears th at in view of the applicant's response the lead
CA did not further assess the application concerning LL soybeans (EC-71) between October 2001 and
January 2003. Thus, the consideration of the app lication appears to have been suspended as from
September 2001 as a result of the applicant's refusal to discontinue one of the two applications
submitted under Directive 90/220.
7.2006 We note that the applicant was of the view th at Directive 90/220 did not prevent it from filing
identical applications to different lead CAs. It nevertheless acknowledged th at this approach could
give rise to procedural problems, and it therefore indicated that it would withdraw one of the two
applications as soon as one of the applications wa s ready for transmission to the Commission. The
Belgian CA appears to have considered that the approach followed by the applicant was either not
permitted by Directive 90/220 or otherwise inappropriate.
7.2007 The United States and Argentina did not submit arguments or evidence which would indicate
that Belgium's position rested on an incorrect interpretation of Directive 90/220. While
Directive 90/220 does not explicitly require that app lications be maintained with a single competent
authority, it also does not explicitly state that app lications may be maintained with more than one
competent authority. We note that the issue of parallel applications arose also in the approval
procedure concerning Bt-11 maize (EC-80). In that pr ocedure, the lead CA in Spain did not appear to
consider this a problem. 1499 On the other hand, it should also be noted that the applicant in the
procedure concerning LL soybeans (EC-71) apparently did not contest Belgium's refusal to continue
to consider its application.
7.2008 From the information before us, it is not appare nt that Belgium's position on this issue, which
appears to have led it to suspend consideration of the application concerning LL soybeans (EC-71)
under Directive 90/220, was a mere pretext for delaying the consideration of the application. Indeed,
Belgium indicated to the applicant that it would con tinue considering the relevant application if the
applicant decided to discontinue the application su bmitted to Portugal. Furthermore, in applying the
provisions of Annex C(1)(a), first clause, we think we must be mindful of Members' limited resources
and the consequent need to avoid unnecessary duplica tion and administrative inefficiencies. Thus, a
delay in the consideration of an application wh ich was caused by a Member's refusal to conduct
concurrent approval procedures in respect of an id entical application does not appear to us to be
unjustifiable per se . Taking account of these elements, we are not convinced that in the specific
circumstances of this case, Belgium's refusal to c ontinue its assessment of the application concerning
LL soybeans (EC-71) while the applicant maintained its concurrent application to Portugal resulted in
a loss of time which was unjustifiable.

1496 Exhibit EC-71/At. 24.
1497 Exhibit EC-71/At. 28.
1498 Exhibit EC-71/At. 29.
1499 Exhibit EC-80/At. 12.

7.2009 Regarding the consideration of this application under Directive 2001/18, we note that after the
applicant updated its application under Direc tive 2001/18 (15 January 2003) and withdrew its
application in Portugal (27 January 2003), the Belgian CA acknowledged receipt of the updated
application and requested further information regarding molecular characterization, detection methods
and reference materials. The a pplicant 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 un til the applicant withdrew the application in July
2004.
7.2010 The European Communities claims that the de lay which occurred after the applicant had
provided preliminary informal answers was attributable to the applicant. Th e record shows that the
applicant provided a partial response to the lead CA's request for additional information and indicated
that further information would be forthcoming rega rding reference samples of genomic DNA for this
product. Given the applicant's stated intention of submitting further information to address questions
from the lead CA and the lack of arguments addressing this issue from the United States and
Argentina, it is reasonable to believe that the lead CA was waiting for the submission of further
information. Accordingly, we have no reason to disagree with the European Communities' contention
that the delay in question was attributable to the applicant rather than the lead CA.
7.2011 Based on the above considerations, the Panel concludes that the time taken by the lead CA for
its assessment of the application concerning LL soybeans (EC-71) – specifically the time taken by the
lead CA to forward the request for additional in formation suggested by the Biosafety Council in
March 1999 – was unjustifiably long.
7.2012 In relation to DS291, we recall that the United States claims that the approval procedure
concerning LL soybeans (EC-71) was unduly delayed because, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier finding that the record supports the conclusion that the European Communities applied a
de facto moratorium on approvals as of June 1999. Our finding that the time taken by Belgium for its
assessment of the application concerning LL soybeans (EC-71) was unjustifiably long is based on the
view that the lead CA could and should have transmitted its May 1999 request for additional
information earlier than it did. Thus, our finding above relates to a time period which pre-dates June
1999. In the light of this, we do not consider that we can infer that Belgium's conduct in March, April
and May 1999 was a consequence of the general mo ratorium on approvals which we found was in
effect between June 1999 and August 2003.
7.2013 In view of our conclusion above, in relation to DS291 we need to go on to examine other
arguments put forward by the United States in support of its claim under Annex C(1)(a), first clause,
and Article 8 of the SPS Agreement.
Total amount of time taken since submission of application

7.2014 The United States also puts forward the argument that the total amount of time during which
the application concerning LL soybeans (EC-71) was pending is excessive and unjustified. The
application concerning LL soybeans (EC-71) was fi rst submitted for approval under Directive 90/220
in September 1998. This means that as of August 2003, the approval procedure had been pending for
four years and eleven months.
7.2015 The Panel agrees with the United States that, in absolute terms, this is a long period of time
for the assessment by the lead CA. However, as we ha ve explained earlier, the mere identification of

the total amount of time during which an applicati on has been pending does not demonstrate, in and
of itself, that the time taken was unjustifiably long.
7.2016 Moreover, even if the United States were corr ect in asserting that before there was an EC
moratorium, approval procedures used to be completed in less than three years, it must be
remembered that the European Communities assesses applications on a case-by-case basis. Thus, the
fact that the approval procedur e concerning LL soybeans (EC-71) was not completed in less than
three years in our view does not demonstrate that it was not justifiable for the European Communities
to take more time to process the application concerning LL soybeans (EC-71).
1500
7.2017 The United States further argues that in the light of the acknowledgement by EC officials of
the existence of a moratorium on approvals, the fact that the application in question lingered at the
member State level for almost five years demonstrates the existence of undue delay. We recall in this
respect our finding that the record supports the c onclusion that the European Communities applied a
de facto moratorium on approvals as of June 1999. At that time, the application concerning LL
soybeans (EC-71) had already been pending for almost nine months. Thus, some of the total time
taken cannot be explained by the moratorium. Moreover, the mere fact that a general moratorium was
in effect does not necessarily imply that each particular application was affected by it at all stages of
the procedure. The United States itself has repeatedly stated that "the moratorium was a decision by
the EC not to move products to a final decision in the approval process" and that "certain progress in
the process, short of a final decision, is not the least bit inconsistent with a moratorium on final
approvals".1501 Therefore, by itself, the fact that a moratorium on approvals was in effect between
June 1999 and August 2003 is not sufficient to demo nstrate that the period of time during which the
application concerning LL soybeans (EC-71) was pending as of August 2003 reflects a failure on the
part of the lead CA to complete the relevant approval procedure without undue delay.
7.2018 Accordingly, the Panel is unable to accept the United States' assertion that the total period of
time during which the application concerning LL soybeans (EC-71) had been pending as of August
2003 demonstrates that the time taken was unjustifiably long.
Conclusions
7.2019 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that it has not been established
that the time taken by the lead CA for its assessment of the application concerning LL
soybeans (EC-71) was unjustifiably long, or that the total period of time during which
the application concerning LL soybeans (EC-71) had been pending as of August 2003
demonstrates that the time taken by the European Communities was unjustifiably
long. Based on these findings, the Panel is unable to accept the United States'
contention that, consistent with the gene ral moratorium, the European Communities
failed to consider the application concer ning LL soybeans (EC-71) for final approval,
and that this resulted in "undue delay" in the completion of the relevant approval
procedure. Accordingly, the Panel conc ludes that in respect of the approval

1500 It is worth recalling, more generally, that the approval procedures which were completed before
there was a moratorium on approvals were not affected by the special circumstance that Directive 90/220 was
repealed in 2002.
1501 See, e.g., US second written submission, para. 51 (emphasis in original).

procedure concerning LL soybeans (EC-71), the United States has failed to establish
that the European Communiti es has breached its obligations under Annex C(1)(a),
first clause, and Article 8 of the SPS Agreement.

 (ii) DS293 (Argentina)

 With reference to DS293, the Panel recalls its finding that the time taken by the lead
CA for its assessment of the application concerning LL soybeans (EC-71) was
unjustifiably long. In the light of this finding, the Panel concludes that the European
Communities failed to complete the a pproval procedure concerning LL soybeans
(EC-71) without "undue delay", thus breachi ng its obligations under Annex C(1)(a),
first clause, and Article 8 of the SPS Agreement.

(xii) LL oilseed rape (EC-72)
7.2020 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning LL oilseed rape has been unduly delayed.
7.2021 The United States argues that the total time taken at the member State level for the initial
review of this application was over four years, as this product still had not been forwarded to the
Commission at the time of establishment of the Pane l. The United States contrasts this with the 90
days referred to in Directives 90/ 220 and 2001/18. Although the Unite d States initially indicated that
the applicant had provided answers to all of the qu estions from the lead CA, in response to a question
from the Panel the United States recognized that the applicant failed to provide some of the data
requested.
1502 Nonetheless, the United States contends that the delays by the lead CA in completing
the approval procedure concerning LL oilseed rape are undue.
7.2022 The United States also points out that the appli cation concerning LL oilseed rape is one of
nine applications identified by the United States wh ich have been pending at the member State level
for an average of three years and ten months. The United States contends in this respect 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 completing the approval procedure concerning LL oilseed rape
is excessive and unjustified and, hence, undue. The United States submits, in addition, that before the
European Communities adopted its moratorium, a ll approval procedures under Directive 90/220 were
undertaken and completed in less than three years.
7.2023 The European Communities argues that the time taken by the lead CA was necessary in
order to ensure a valid safety assessment. Following receipt of the application, the lead CA requested
further information from the appli cant. The lead CA also request ed a preliminary review by its
scientific committee, the Advisory Committee on Re leases to the Environment (hereafter "ACRE").
The ACRE found that the dossier c ontained inconsistent data on mo lecular characterization and was
presented in a manner which made assessment difficu lt. In December 1999, the lead CA requested
the applicant to provide a substantial revision and clarification.
7.2024 According to the European Communities, the applicant did not get back to the lead CA on this
dossier for almost two years. In January 2003, the applicant provided some up-dated documents in
accordance with Directive 2001/18, but the European Communities argues that the full dossier was
not submitted. During the first half of 2003, ther e were various exchanges between the lead CA and
the applicant, and the applicant provided additional updates and information. Following a request in

1502 US answer to Panel question No. 168.

June 2003 for the re-submission of a complete dossi er, in March 2004 the applicant withdrew the
pending notification and submitted a new notification. The European Communities maintains that it
cannot be responsible for delays arising at the instigation of the applicant.
7.2025 The Panel commences its analysis with the alleged delay at member State level.
Delay at member State level

7.2026 We note that in the approval procedure concerning LL oilseed rape the applicant submitted an
application to the lead CA (the United Kingdom ) on 28 January 1999. When Directive 90/220 was
repealed on 17 October 2002, the lead CA had not yet forwarded the dossier to the Commission. An
updated application was submitted following the entr y into force of Directive 2001/18, although the
record is not clear as to when a complete dossier was actually submitted. At the time of establishment
of the Panel, this application was still under consideration by the lead CA.
7.2027 The United States contends that the lead CA took too long to complete its assessment. It is
correct that the lead CA took much more time for its assessment of the application than the 90 days
envisaged in Directives 90/220 and 2001/18. Howeve r, we have observed that that deadline was not
dispositive, per se , of whether the European Communities met its WTO obligation to complete its
approval procedures without undue de lay. Moreover, the European Communities contends that much
of the time taken by the lead CA until August 2003 is attributable to failures by the applicant
promptly to provide requested information. Th e European Communities submits that without this
information, it was not possible for the lead CA to complete its assessment and submit a report to the
Commission. We therefore need to examine whethe r the lead CA was justified in not completing its
assessment by August 2003.
7.2028 As we noted in our previous consideration of th is application, the record before us is not
complete. Following receipt of the applicati on, the lead CA promptly requested additional
information from the applicant in February and Marc h 1999. This information was provided in June
1999, and the lead CA acknowledge d on 30 June 1999 that the clock had been "restarted". One
month later, the lead CA requested further informa tion, but this information was not provided by the
applicant before the date of repeal of Directiv e 90/220. The letter from the lead CA dated 20 July
1999 requests that the applicant provide further info rmation and clarification on points raised in an
annex to the letter, but the annex was not provided to us.1503
7.2029 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
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. 1504 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. Indeed,
the record shows no further communication from the a pplicant until January 2003, when the applicant
updated its application under Directive 2001/18.

1503 Exhibit EC-72/At. 11.
1504 Exhibit EC-72/At. 12.

7.2030 On 16 January 2003, the applicant submitted an updated application under Directive 2001/18
to the lead CA.
1505 In acknowledging receipt of the updated a pplication, 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. 1506 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. 1507 On 13 June 2003, the lead CA requested further clarifications and suggested that a
complete version of the application be re-submitted. 1508 On 26 March 2004, the applicant withdrew
the application, saying that certain elements of th at application were incomplete or out-of-date, and
submitted a new one (C/GB/04/M5/4).1509
7.2031 In reviewing the lead CA's conduct in this a pproval procedure, we note that the exchanges
between the lead CA and the applicant generally took place in a timely fashion, with the lead CA
reacting promptly to information provided by the a pplicant. It is clear from the foregoing, however,
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 revi sion and clarification.
Based on the information submitted to us, we understand that this gap was caused by the failure of the
applicant to provide the additional information and cl arification requested by the lead CA in July and
December 1999. However, the precise reasons for th e failure of the applicant to respond to the
information solicited by the lead CA in July and December 1999 are unclear.
7.2032 We note that the United States has not specifically challenged the justifiability of any of the
requests for additional data or clarifications made by the lead CA. We nonetheless asked the experts
advising us whether the information requested by the lead CA up to and in December 1999 was
necessary to ensure that conclusions of the safety assessment were valid.1510 Dr. Nutti, the only expert
who responded to this question, concurred that the deficiencies in the application as identified by the
ACRE were such that the requested info rmation was necessary for the safety assessment. 1511 Taking
account of these elements, we have no grounds for considering that the lead CA's requests of July and
December 1999 which led to the gap between December 1999 and January 2003 were not justified.
7.2033 Regarding the assessment of the application concerning LL oilseed rape under
Directive 2001/18, we note that the United States h as offered no specific arguments relating to the
consideration of this application under Directive 2001/18. At any rate, the facts as summarized by us
above do not suggest that the time taken by the lead CA up to August 2003 for assessing the
application under Directive 2001/18 was unjustifiably long. We note in particular the repeated
requests by the lead CA for completion of the updated application, and the fact that the applicant itself
withdrew the application in March 2004 saying that certain elements of its application were
incomplete.
7.2034 Based on the above considerations , the Panel is not persuaded that the time taken by the lead
CA for its assessment of the application concerning LL oilseed rape was unjustifiably long.

1505 Exhibit EC-72/At. 15.
1506 Exhibit EC-72/At. 16.
1507 Exhibit EC-72/Ats. 18 and 19.
1508 Exhibit EC-72/At. 28.
1509 Exhibit EC-72/At. 29.
1510 Annex H, Panel Question 29.
1511 Annex H, para. 600.

Total amount of time taken since submission of application

7.2035 The United States also puts forward the argument that the total amount of time during which
the application concerning LL oilseed rape was pendi ng is excessive and unjustified. The application
concerning LL oilseed rape was first submitted for approval under Directive 90/220 in January 1999.
This means that as of August 2003, the approval proc edure had been pending for four years and seven
months.
7.2036 The Panel agrees with the United States that, in absolute terms, this is a long period of time
for the assessment by the lead CA. However, as we ha ve explained earlier, the mere identification of
the total amount of time during which an applicati on has been pending does not demonstrate, in and
of itself, that the time taken was unjustifiably long.
7.2037 Moreover, even if the United States were corr ect in asserting that before there was an EC
moratorium, approval procedures used to be completed in less than three years, it must be
remembered that the European Communities assesses applications on a case-by-case basis. Thus, the
fact that the approval procedure concerning LL oil seed rape was not completed in less than three
years in our view does not demonstrate that it w as not justifiable for the European Communities to
take more time to process the application concerning LL oilseed rape.
1512
7.2038 The United States further argues that in the light of the acknowledgement by EC officials of
the existence of a moratorium on approvals, the fact that the application in question lingered at the
member State level for over four and a half years demonstrates the existence of undue delay. We
recall in this respect our finding that the reco rd supports the conclusion that the European
Communities applied a de facto moratorium on approvals as of June 1999. At that time, the
application concerning LL oilseed rape had already been pending for almost six months. Thus, some
of the total time taken cannot be explained by the mo ratorium. Moreover, the mere fact that a general
moratorium was in effect does not necessarily imply that a particular application was affected by it.
The United States itself has repeatedly stated that "the moratorium was a decision by the EC not to
move products to a final decision in the approval process" and that "certain progress in the process,
short of a final decision, is not the least bit in consistent with a morato rium on final approvals". 1513
Therefore, by itself, the fact that a moratorium on approvals was in eff ect between June 1999 and
August 2003 is not sufficient to demonstrate that the period of time during which the application
concerning LL oilseed rape was pending as of August 2003 reflects a failure on the part of the lead
CA to complete the relevant approval procedure without undue delay.
7.2039 Accordingly, the Panel is unable to accept the United States' assertion that the total period of
time during which the application concerning LL o ilseed rape had been pending as of August 2003
demonstrates that the time taken was unjustifiably long.

1512 It is worth recalling, more generally, that the approval procedures which were completed before
there was a de facto moratorium on approvals were not aff ected by the special circumstance that
Directive 90/220 was repealed in 2002.
1513 See, e.g., US second written submission, para. 51 (emphasis in original).

Conclusions

7.2040 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that it has not been established
that the time taken by the lead CA for it s assessment of the application concerning
LL oilseed rape was unjustifiably long, or that the total period of time during which
the application concerning LL oilseed ra pe had been pending as of August 2003
demonstrates that the time taken by the European Communities was unjustifiably
long. Based on these findings, the Panel is unable to accept the United States'
contention that, consistent with the gene ral moratorium, the European Communities
failed to consider the application concerni ng LL oilseed rape for final approval, and
that this resulted in "undue delay" in the completion of the relevant approval
procedure. Accordingly, the Panel conc ludes that in respect of the approval
procedure concerning LL oilseed rape, the United States has failed to establish that
the European Communities has breached its obligations under Annex C(1)(a), first
clause, and Article 8 of the SPS Agreement.

(xiii) BXN cotton (EC-73)
7.2041 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning BXN cotton has been unduly delayed.
7.2042 The United States argues that the total time taken at the member State level for the initial
review of this application was over four years, as this product still had not been forwarded to the
Commission at the time of establishment of the Pane l. The United States contrasts this with the 90
days referred to in Directives 90/220 and 2001/18. The United States contends that although the
applicant had provided answers to all of the questi ons from the lead CA, the lead CA still failed to
complete its assessment. The United States contends that the delays by the lead CA in completing the
approval procedure concerning BXN cotton are undue.
7.2043 The United States also points out that the application concerning BXN cotton is one of nine
applications identified by the United States which ha ve been pending at the member State level for an
average of three years and ten months. The United States contends in this respect that although time
alone is not dispositive, in the light of the acknow ledgement by EC officials of the existence of a
moratorium on approvals, this delay in completi ng the approval procedure concerning BXN cotton is
undue. The United States submits, in addition, th at before the European Communities adopted its
moratorium, all approval procedures under Directiv e 90/220 were undertaken and completed in less
than three years.
7.2044 The European Communities argues that the time taken by the lead CA was necessary in
order to ensure a valid safety assessment. Following receipt of the application, the lead CA requested
further information from the applicant to address defi ciencies in the application. Spain's scientific
committee, the National Biosafety Committee, found th at a considerable amount of information was
missing on issues such as compositional analysis, e nvironmental impact, toxicity and nutritional
analysis. In addition, a number of points required clarification, such as the scope of the application
and the labelling proposal. The lead CA requested this information from the applicant in July 1999.

7.2045 The European Communities contends that the applicant did not respond to the lead CA's
request for three years, until January 2003. At that time, the lead CA was informed of a change in the
company submitting the application, and the new applicant company submitted an up-dated
notification in accordance with Directive 2001/ 18. However, according to the European
Communities, the new dossier was also incomplete w ith regard to the molecular characterization of
the product. The European Communities points out that further information was requested of the
applicant in October 2003.
7.2046 The Panel commences its analysis with the alleged delay at member State level.
Delay at member State level

7.2047 We note that in the approval procedure con cerning BXN cotton, the applicant submitted an
application to the lead CA (Spain) on 3 May 199 9. When Directive 90/220 was repealed on 17
October 2002, the lead CA had not yet forwarded the dossier to the Commission. On 16 January
2003, an updated application was submitted following th e entry into force of Directive 2001/18. At
the time of establishment of the Panel, this application was still under consideration by the lead CA.
7.2048 The United States contends that the lead CA took too long to complete its assessment. It is
correct that the lead CA took much more time for its assessment of the application than the 90 days
envisaged in Directives 90/220 and 2001/18. Howeve r, we have observed that that deadline was not
dispositive, per se , of whether the European Communities met its WTO obligation to complete its
approval procedures without undue de lay. Moreover, the European Communities contends that much
of the time taken by the lead CA until August 2003 is attributable to failures by the applicant to
promptly provide requested information. The European Communities submits that without this
information, it was not possible for the lead CA to complete its assessment and submit a report to the
Commission. We therefore need to examine whethe r the lead CA was justified in not completing its
assessment by August 2003.
7.2049 As we noted in our previous consideration of th is application, the record before us is very
incomplete. This said, it is clear that within two months of receipt of the application, the Spanish
National Biosecurity Committee identified a number of concerns with the application, and these were
communicated to the applicant in July 1999. Two months later, the applicant provided the
information requested. The applicant clarified, 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 Spanish National Biosafety Committee,
the lead CA requested further clarifications on so me of the same issues in a communication dated 2
February 2000.
1514 The applicant did not respond to this request before an updated application was
submitted in January 2003 under Directive 2001/18.1515
7.2050 On 15 January 2003, the lead CA was informed of a change in the company pursuing the
application, and on 16 January 2003 an updated application was submitted under Directive 2001/18
and completed in March 2003. It appears that the updated application concerns only the importation
of seed for processing, but not for cultivation. In August 2003, when this Panel was established, the
application appears to have been under review by the National Biosafety Committee.1516

1514 Exhibit EC-73/At. 6.
1515 This is confirmed by Exhibit EC-73/At. 12.
1516 There is no information about when the application was submitted to the National Biosafety
Committee.

7.2056 Furthermore, with regard to the time taken by the lead CA to assess the application once it
had been completed by the applicant in March 2003, 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 wh ich the lead CA is awaiting further information
which it requested from the applicant. In the pr esent case, the record shows that the lead CA
requested additional information only in October 2003.
1521 Thus, the lead CA should have completed
its assessment at the latest 90 days after 19 Marc h 2003, which is the date on which the applicant
completed its updated application. However, as of August 2003, the lead CA had still not completed
its assessment. Thus, as of 29 August 2003, the lead CA had already taken more than five months to
assess the application, and first request for additio nal information was forwarded more than a month
later.
7.2057 As we have said, the question of whether or not the lead CA complied with the 90-day
deadline stipulated in Directive 2001/18 is not dispositive, per se , of whether the European
Communities met its WTO obligation to complete its approval procedures without undue delay.
However, as we have also noted earlier, the deadline set forth in Directive 2001/18 nonetheless
provides a useful indicator to guide the Panel's analysis. The 90-day deadline is binding and applies
to all relevant applications submitted under that Dir ective. It may therefore be assumed that the EC
legislator set this binding deadlin e in such a way as to make it possible for the CAs of all member
States to assess even complex applications within the prescribed deadline.
7.2058 The European Communities provides no justificati on for the time taken by the lead CA in
excess of the 90-day period, other than the assertion that the updated application was incomplete with
regard to the molecular characterization of the product. It is correct that the lead CA in October 2003
requested additional information, including on mole cular characterization of the product. However,
we are not convinced that more than five months were needed to identify this and other substantive
shortcomings in the updated application.
7.2059 From the record of the consideration of this application by the National Biosafety Committee,
it is clear that th e Committee had also been reviewing the applications 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 was to prepare an assessment report within 90 days after receipt of an
application. It should also be noted in this connection that the National Biosafety Committee's
assessment concerning BXN cotton is quite short, i.e., there is no indication that the preparation of the
Committee's assessment required much time. Additionall y, we note that the lead CA in this case was
not examining the application concerning BXN cotton fo r the first time. While it is true that the lead
CA in 2003 had to undertake an assessment in ac cordance with the partly new requirements of
Directive 2001/18, it seems equally clear that the pr ior assessments rendered the lead CA's task less
complex than it would have been if the lead CA had had to undertake an assessment of the application
for the first time.
7.2060 Taking account of the foregoing elements, we cons ider that the lead CA could and should
have acted more promptly than it did when it rece ived an updated, but incomplete, application in
January 2003 and subsequently, when the appli cant submitted the missing summary in March 2003.
Accordingly, we conclude that the time taken by the lead CA up to August 2003 for its assessment of
the application concerning BXN cotton under Directive 2001/18 was unjustifiably long.
7.2061 In addition, we recall that the United States claims that the approva l procedure concerning
BXN cotton was unduly delayed because, due to the moratorium, the European Communities failed to

1521 Exhibit EC-73/At. 13.

consider the application in question for final appr oval. In this respect, we note our earlier findings
that (i) a general de facto moratorium on approvals was in e ffect in the European Communities
between June 1999 and August 2003 and that (ii) the time taken by Spain to assess the application
concerning BXN cotton under Directive 90/220 and subsequently under Directive 2001/18 is
consistent with the application of such a moratori um. In the light of this, and in the absence of
effective rebuttal by the European Communities, we agree with the United States that it is reasonable
to infer that Spain's conduct after the entry into force of Directive 2001/18 was a consequence of the
general moratorium on approvals.
7.2062 In view of our conclusion with regard to the time taken by Spain for its assessment, we do not
go on to examine other arguments put forward by the United States in support of its claim under
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Conclusions

7.2063 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that the time taken by the lead
CA for its assessment of the application concerning BXN cotton under
Directive 2001/18 was unjustifiably long, and that it can reasonably be inferred from
surrounding circumstances that the lead CA's conduct was a consequence of the
general moratorium on approvals. Base d on these findings, the Panel accepts the
United States' contention that, consistent w ith the general moratorium, the European
Communities failed to consider the app lication concerning BXN cotton for final
approval, and that this resulted in "undue delay" in the completion of the relevant
approval procedure. Accordingly, the Panel concludes that in respect of the approval
procedure concerning BXN cotton, the European Communities has breached its
obligations under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.

(xiv) Bt-1507 maize (EC-74)
7.2064 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning Bt-1507 maize (EC-74) has been unduly delayed.
7.2065 The United States argues that the application concerning Bt-1507 maize (EC-74) was
delayed at the member State level. The United States submits that although the applicant provided
answers to all of the questions, the lead CA nonethel ess delayed its consideration of the product. The
United States 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.
7.2066 The United States also points out that the app lication concerning Bt-1507 maize (EC-74) is
one of nine applications identified by the United States which have been pending at the member State
level for an average of three years and ten months. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
Bt-1507 maize (EC-74) is undue. The United States s ubmits, in addition, that before the European
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were
undertaken and completed in less than three years.

7.2067 The European Communities argues that the time taken by the lead CA was necessary in
order to ensure a valid safety assessment. Exch anges between the lead CA and the applicant
regarding data relating to molecular characterizati on, allergenicity, toxicity of CRY1F and labelling
went on until late 2002. In two instances, the app licant requested an extension of the time granted by
the lead CA to submit further data or information. The applicant updated the notification just after the
entry into force of Directive 2001/18. After a fu rther 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. The European Communities observes that once
the application reached the Community level, a c onsiderable number of objections were raised by
member States, including on environmental effects, the monitoring plan, molecular characterisation,
sampling and detection methods, allergenicity and toxicity.
7.2068 The Panel commences its analysis with the alleged delay at member State level.
Delay at member State level

7.2069 We recall that in the approval procedure c oncerning Bt-1507 maize (EC-74), the applicant
submitted an application to the lead CA (t he Netherlands) on 23 No vember 2000. When
Directive 90/220 was repealed on 17 October 2002, the lead CA had not yet forwarded the dossier to
the Commission. The dossier wa s forwarded to the Commission with a favourable assessment report
on 15 August 2003, after the applicant had provide d an updated application in accordance with
Directive 2001/18.
7.2070 The United States contends that the lead CA took too long to complete its assessment. On the
other hand, the European Communities contends that all of the time taken by the lead CA until August
2003 when the lead CA forwarded its assessment report to the Commi ssion was necessary to resolve
scientific and technical issues. It therefore needs to be examined whether the lead CA was justified in
forwarding an assessment report to the Commission only in August 2003.
7.2071 As we noted previously, there was frequent communication between the lead CA and the
applicant on this product from the initial applicati on on 23 November 2000 until the lead CA sent its
assessment report to the Commission on 15 August 2003 . The United States explicitly challenges the
justifiability of only one of the requests for additi onal data made by the lead CA, namely, the lead
CA's follow-up request of 13 December 2001. We recall that in response to a March 2001 request
from the lead CA the applicant on 16 October 2001 provided field trials from Chile, France and Italy,
which it considered representative for the cultiv ation areas exporting maize to the European
Communities.
1522 Yet on 13 December 2001 the lead CA indicated that it was not convinced by the
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 Communities. It
therefore requested that the applicant conduct add itional field trials and pr ovide compositional data
for two consecutive growing seasons.1523
7.2072 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.
1524 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

1522 Exhibit EC-74/At. 33.
1523 Exhibit EC-74/At. 52.
1524 Exhibit EC-74/At. 65, response to Panel Question 3.

presented in the same detail and manner as fo r France and Italy, and suggested a format.
1525 This was
apparently done by the applicant on 24 March 2003.1526
7.2073 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.
7.2074 Even assuming that the additional field trials we re not necessary, we note that the applicant's
response of 21 November 2002 was provided together with responses to a request of March 2002 for
other additional information which has not been ques tioned by the United States. It is therefore not
clear that the delay in the consideration of the a pplication until 21 November 2002 is attributable to
the request for additional field trials.
7.2075 At any rate, we note that on 21 November 2002 the applicant also updated its application in
the light of the new requirements of Directive 2001/ 18. This resulted in the lead CA requesting
further information from the applicant on 10 February 2003 with respect to a surveillance plan and the
confidentiality of the proposed detection method. Fu rthermore, 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 applic ant on 24 March 2003,
and on 28 May 2003 the applicant withdrew the re quest for confidentiality with respect to the
detection method.
7.2076 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.
7.2077 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.
7.2078 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

1525 Exhibit EC-74/At. 84.
1526 Exhibit EC-74/Ats. 87-88.

(EC-74), by the end of March 2003 the lead CA ha d all the elements to complete its safety
assessment. 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 before the end of June 2003.
7.2079 The European Communities has offered no justif ication for the time taken by the lead CA
between March and August 2003. It is pertinent to note in this respect that the lead CA in 2003 was
not examining the application concerning Bt-1507 ma ize (EC-74) for the first time. While it is true
that the lead CA in 2003 had to undertake an assessment in accordance with the partly new
requirements of Directive 2001/18, the lead CA had already spent two and a half months assessing the
application in question. Moreover, it seems clear that the lead CA's prior assessment of the same
application under Directive 90/220 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. Yet
notwithstanding this, even when the lead CA had al l the necessary information, it failed to complete
and transmit its assessment report within 90 days.
7.2080 Thus, even if we were to accept that it was le gitimate for the lead CA to insist on the
confidentiality issue being resolved before it tran smitted its assessment report to the Commission, in
the light of the generally applicable 90-day period stipulated in Directive 2001/18, and in the absence
of any justification offered by the European Comm unities, we are not convinced that the lead CA
could not have completed and transmitted its assess ment report considerably earlier than mid-August
2003. Hence, taking account of the aforementioned el ements, we consider that the lead CA should
have transmitted its assessment report to the Commission more promptly than it did.
7.2081 Based on the above considerations, the Panel concludes that the time taken by the lead CA for
its assessment of the application concerning Bt- 1507 maize (EC-74) – notably the time taken by the
lead CA after May 2003, when the applicant withdr ew the request for confidentiality with respect to
the detection method – was unjustifiably long.
7.2082 In relation to DS291, we recall that the United States claims that the approval procedure
concerning Bt-1507 maize (EC-74) was unduly delayed because, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and A ugust 2003 and that (ii) 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 application of such a mo ratorium. In the light of this, and in the absence
of effective rebuttal by the European Communitie s, we agree with the United States that it is
reasonable to infer that the Netherlands' conduct was a consequence of the general moratorium on
approvals.
7.2083 In view of our conclusion with regard to the time taken by the Netherlands for its assessment,
we do not go on to examine other arguments put forw ard by the United States in support of its claim
under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Conclusion

7.2084 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that the time taken by the lead
CA for its assessment of the applicati on concerning Bt-1507 maize (EC-74) was

unjustifiably long, and that it can reasonably be inferred from surrounding
circumstances that the l ead CA's conduct was a consequence of the general
moratorium on approvals. Based on these findings, the Panel accepts the United
States' contention that, consistent with the general moratorium, the European
Communities failed to consider the application concerning Bt-1507 maize (EC-74)
for final approval, and that this resulted in "undue delay" in the completion of the
relevant approval procedure. Accordingly, the Panel concludes that in respect of the
approval procedure concerning Bt-1507 maize (EC-74), the European Communities
has breached its obligations under Annex C(1 )(a), first clause, and Article 8 of the
SPS Agreement.

(xv) Bt-1507 maize (EC-75)
7.2085 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning Bt-1507 maize (EC-75) has been unduly delayed. To recall, this application
concerns the same product as above, however it wa s submitted to Spain and concerns the cultivation
of the product. The previous application was for processing, food and feed use, but not for
cultivation.
7.2086 The United States argues that the application concerning Bt-1507 maize (EC-75) was
delayed at the member State level.. The United St ates submits that although the applicant provided
answers to all of the questions, the lead CA none theless delayed consideration of the product. The
United States also contests the justifiability of some of the information requested by the lead CA, and
particularly of a number of the objections raised by other member States following its circulation by
the Commission.
7.2087 The United States also points out that the app lication concerning Bt-1507 maize (EC-75) is
one of nine applications identified by the United States which have been pending at the member State
level for an average of three years and ten months. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
Bt-1507 maize (EC-75) is undue. The United States s ubmits, in addition, that before the European
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were
undertaken and completed in less than three years.
7.2088 The European Communities argues that the time taken by the lead CA was necessary in
order to ensure a valid safety assess ment. The European Communities argues that following a
preliminary assessment of this application by the Spanish National Biosafety Committee, the lead CA
requested further data relating to molecular charact erization, allergenicity 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.
1527 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.
7.2089 The European Communities further observes that once the application reached the
Community level, a considerable number of objecti ons were raised by member States, including on
the monitoring plan, molecular characterization, effects on non-target organisms, toxicity,
allergenicity, and detection methods.

1527 Exhibit EC-75/Ats. 1-3.

7.2090 The Panel commences its analysis with the alleged delay at member State level.
Delay at member State level

7.2091 We recall that following the receipt of the a pplication concerning Bt-1507 maize (EC-75), the
lead CA (Spain) consulted with its National Bio safety Committee, which took more than two and a
half months to review the application. The lead CA then waited over a month, until 30 October 2001,
before requesting additional in formation from the applicant based on the advice received from the
Committee. This request was a pparently repeated in a communi cation of 28 November 2001. A
response was provided by the applicant on 14 February 2002. Once again, the lead CA consulted with
the National Biosafety Committee. The Committ ee took three months to review the additional
information submitted in February 2002. As it had done previously, the lead CA waited over a
month, until 17 June 2002, before submitting anothe r request for additional information to the
applicant. The applicant responded to these request s on 17 December 2002. This was after the date
of repeal of Directive 90/220.
7.2092 Even assuming that the October/November 2001 and June 2002 requests were necessary to
ensure that the conclusions of the safety assessment were valid, we recall that in accordance with the
requirements of Directive 90/220 the lead CA was to have completed its assessment at the latest 90
days after receipt of the application concerning Bt -1507 maize (EC-75). As we have already pointed
out, following the receipt of the application in July 2001, the lead CA exceeded the 90-day period
even before it submitted its initial request for additiona l information to the applicant. Of particular
concern in this connection is the circumstance th at the lead CA waited for more than one month
before forwarding the questions suggested by the National Biosafety Committee in September 2001.
7.2093 The European Communities has offered no justifica tion for the time taken by the lead CA to
transmit the October/November 2001 request for additi onal information. We note that the time taken
by the lead CA in this instance contrasts with other approval procedures where Spain was also the
lead CA and where the Spanish CA forwarded re quests for information from the National Biosafety
Committee more promptly.
1528 Furthermore, we note that the lead CA did not modify the questions
suggested by the National Biosafety Committee, but simply forwarded them.
7.2094 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
have the application approved or rejected while Directive 90/220 was still in force.
7.2095 Taking account of the aforementioned elements, we consider that the lead CA could, and
should, have forwarded the questions suggested by the National Biosafety Committee in September
2001 more promptly than it did.
7.2096 We recall that in May 2002 the lead CA recei ved a further suggested request for additional
information from the National Biosafety Committee. The lead CA again waited for over a month
before forwarding the request in June 2002, even though it did not modify the Committee's request.
7.2097 We recognize that May 2002 was relatively close to the date of repeal of Directive 90/220.
However, even if we were to accept, arguendo, that the application could not go through the required
steps before the repeal of Directive 90/220, in our vi ew, this would not have justified the lead CA in

1528 See, e.g., the approval procedure concerning BXN cotton. Exhibit EC-73/Ats. 2-3 and 5 and 6.

delaying the transmission of the new request for information. We note in this regard that
Directive 2001/18 entered into force in Octobe r 2002. If the application submitted under
Directive 90/220 remained incomplete or required furt her clarification, knowledge of this would have
assisted the applicant in correcting any deficien cies and submitting an updated, more complete
application soon after the entry into force of Directive 2001/18.
1529
7.2098 Therefore, as with the previously discussed de layed transmission of a request for additional
information, we consider that the lead CA could, and should, have forwarded the Committee's request
more promptly than it did.
7.2099 Based on the above considerations, the Panel concludes that the time taken by the lead CA for
its assessment of the application concerning Bt- 1507 maize (EC-75) – notably the time taken by the
lead CA to forward questions from the National Biosafety Committee – was unjustifiably long.
7.2100 In relation to DS291, we recall that the United States claims that the approval procedure
concerning Bt-1507 maize (EC-75) was unduly delayed because, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and A ugust 2003 and that (ii) the failu re of Spain to complete its
assessment of the application concerning Bt-15 07 maize (EC-75) earlier than in August 2003 is
consistent with the application of such a moratori um. In the light of this, and in the absence of
effective rebuttal by the European Communities, we agree with the United States that it is reasonable
to infer that Spain's conduct was a consequence of the general moratorium on approvals.
7.2101 In view of our conclusion with regard to the time taken by Spain for its assessment, we do not
go on to examine other arguments put forward by the United States in support of its claim under
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Conclusion
7.2102 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that the time taken by the lead
CA for its assessment of the applicati on concerning Bt-1507 maize (EC-75) was
unjustifiably long, and that it can reasonably be inferred from surrounding
circumstances that the l ead CA's conduct was a consequence of the general
moratorium on approvals. Based on these findings, the Panel accepts the United
States' contention that, consistent with the general moratorium, the European
Communities failed to consider the application concerning Bt-1507 maize (EC-75)
for final approval, and that this resulted in "undue delay" in the completion of the

1529 We note that Spain could have considered that fo r as long as Directive 90/220 was still in force,
there was no realistic prospect that the Group of Five countries and the Commission would allow the final
approval of the application in question. However, the Pane l does not consider that this would have justified the
time taken by Spain to forward the questions suggested by the National Biosafety Committee. Spain might have
anticipated opposition from the Group of Five countries on the basis of their June 1999 declaration. As pointed
out above, notwithstanding this declaration, the Group of Five countries retained the freedom under EC law to
approve applications. The same is true for the Commission, which had not issued a declaration comparable to
that of the Group of Five countries.

relevant approval procedure. Accordingly, the Panel concludes that in respect of the
approval procedure concerning Bt-1507 maize (EC-75), the European Communities
has breached its obligations under Annex C(1 )(a), first clause, and Article 8 of the
SPS Agreement.

(xvi) NK603 maize (EC-76)
7.2103 Two Complaining Parties, the United States and Argentina, claim that the completion of the
approval procedure concerning NK603 maize has been unduly delayed.
7.2104 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.
7.2105 The United States also points out that the application concerning NK603 maize is one of nine
applications identified by the United States which ha ve been pending at the member State level for an
average of three years and ten months. The United States contends in this respect that although time
alone is not dispositive, in the light of the acknow ledgement by EC officials of the existence of a
moratorium on approvals, this delay in completi ng the approval procedure concerning NK603 maize
is undue. The United States submits, in addition, th at before the European Communities adopted its
moratorium, all approval procedures under Directiv e 90/220 were undertaken and completed in less
than three years.
7.2106 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 favour 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.
7.2107 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.
1530
7.2108 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.
7.2109 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.

1530 Exhibit EC-76/At. 1.

7.2110 The Panel commences its analysis with the alleged delay at member State level.
Delay at the member State level

7.2111 We recall that the applicant sent the first app lication to the Spanish CA on 4 August 2000.
Four months later, on 20 December 2000, the appli cant resubmitted the application in Spanish and
apparently with additional st udies added to the application. 1531 We note that there is no record of
these additional studies. The Spanish CA acknowledge d receipt of the information in a letter of 2
January 2001.
7.2112 The record shows that the lead CA requested additional information in February 2001,
October 2001 and May 2002. 1532 The progress of the application was adversely affected notably by
the February and October 2001 requests, in that the a pplicant took more than six months to respond to
the February 2001 request and more than five months to respond to the October 2001 request.
7.2113 We recall that we asked the experts advising us whether the information requested by the lead
CA in February 2001 was necessary to ensure th at conclusions of the product's safety assessment
were valid. Dr. Nutti concluded that the furt her studies requested were not necessary for the
assessment of the safety of NK603 as a food. Furthermore, given that the application was for import
and use in the European Communities and not for cu ltivation, Dr. Andow concluded that requests for
additional detailed environmental studies were not justified, alt hough some information relating to
potential adverse effects of spillage could be c onsidered reasonable. The European Communities
submits that the expert replies with respect to the food safety studies were based on the mistaken
premise that certain studies had already been pr ovided, which the European Communities argues was
not the case. We note that on the basis of the information provided to us, we cannot determine
whether or not such information had been previously provided.

7.2114 Turning to the October 2001 request for additi onal information, we note that this request
concerned additional information which the Sp anish CA emphasized was "essential for product
traceability". Further details were also requested on the potential environmental impact of accidental
dissemination or germination. When the appli cant provided the additional information requested
more than five months later, in March 2002, the applicant stressed that the conclusion provided in
relation to safety was not altered by the new studi es that had been request ed. In response to a
question from the Panel regarding this second requ est for information, Dr. Andow noted that
information on the potential environmental impact of accidental release could be useful to the lead
CA, but also observed that the lead CA could ha ve been more specific regarding its particular
concerns.1533
7.2115 Even if we were to accept that all of the information requested by the lead CA in February
and October 2001 and in May 2002 was necessary to en sure the validity of the safety assessment, it is
apparent from the record that the lead CA in th is approval procedure exceeded the maximum period
of 90 days envisaged in Directive 90/220 for a lead CA assessment. Between January 2001 and
August 2002, when the applicant of its own motion updated its application in accordance with the
requirements of Directive 2001/18 1534, the lead CA spent six and a half months evaluating the
application without finishing its assessment report. This is more than twice the length of time
established in Directive 90/220.

1531 Exhibit EC-76/At. 3.
1532 Exhibit EC-76/Ats. 6, 10 and 14, respectively.
1533 Annex H, Dr. Andow's response to Panel Question 38.
1534 Exhibit EC-76/Ats. 15 and 18.

7.2116 Specifically, the lead CA initially took one and a half months to assess the application before
it forwarded the February 2001 requ est for additional information.
1535 Subsequently, the lead CA
reviewed the application for over one month befo re it transmitted its October 2001 request for
additional information. 1536 Then, the lead CA spent just under two months prior to sending its last
request for additional in formation in May 2002. 1537 The applicant responded to this last request in
June 2002. However, the lead CA did not comple te its assessment in the following two months, i.e.,
prior to the end of August of 2002, when the applicant updated its application based on the new
requirements of Directive 2001/18. This is despite th e fact that at its meeting of 11 July 2002, the
Spanish scientific body assessing the application, the National Biosafety Committee, recommended
for adoption a favourable report on the application.1538
7.2117 As we have said before, we recognize that the question of whether or not the lead CA
complied with the 90-day deadline stipulated in Directive 90/220 is not dispositive, per se, of whether
the European Communities met its WTO obligation to complete its approval procedures without
undue delay. However, we have also said that the deadline set forth in Directive 90/220 provides a
useful indicator to guide the Panel's analysis. The 90-day deadline is binding and applies to all
relevant applications s ubmitted under that Directive. It may therefore be assumed that the EC
legislator set this binding deadlin e in such a way as to make it possible for the CAs of all member
States to assess even complex applications within the prescribed deadline.
7.2118 The European Communities provides no justificati on for the time taken by the lead CA in
excess of the 90-day period, other than the assertion that the time taken by the lead CA was not
unreasonable in view of the need to digest and pr ocess the information provided by the applicant.
While we agree that the lead CA needs to be able to "digest and process" information provided at its
request, it is clear from Directive 90/220 that the EC legislator considered that 90 days was a
reasonable period of time within which to do so. Also, the European Communities does not argue that
in the case at hand the replies and documents provided by the applicant at the lead CA's request were
particularly voluminous or complex, such that more than double the amount of time was required than
the maximum amount of time Directive 90/220 allows lead CAs for the assessme nt of applications.
From a review of the relevant documents, it is not apparent to us that they are any more voluminous
or complex than others on the record which concern different applications.
7.2119 We have previously pointed out that Spain 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 Spanish CA's conduct reflects a precautionary approach. Notably, we are not
convinced that the Spanish CA could not have id entified its needs for additional information and
forwarded appropriate requests for information to the applicant sooner than it did, even while
following a precautionary approach.
7.2120 Moreover, we do not think that there was insufficient time to complete the approval procedure
while Directive 90/220 was still in force. We note th at as of July 2002, the lead CA had all necessary
information, including positive scientific advice fro m the National Biosafety Committee, to complete
its assessment. We recognize that as of July 2002 there was not much time left to complete the
approval procedure under Directive 90/220. However, if Spain had proceeded more rapidly at earlier
stages in the procedure, there would certainly have been enough time for the other member States to

1535 Exhibit EC-76/Ats. 4 and 5.
1536 Exhibit EC-76/Ats. 7 and 10.
1537 Exhibit EC-76/Ats. 11 and 14.
1538 Exhibit EC-76/At. 17.

review the lead CA's assessment report within 60 days following the circulation of the assessment
report and, in the absence of objections, for the l ead CA to give its consent to the placing on the
market of NK603 maize.
1539 As indicated above, we consider that Spain could have identified its
needs for additional information and forwarded a ppropriate requests for information sooner than it
did, particularly prior to forwarding its request for information of May 2002.
7.2121 Based on the above considerations, the Panel concludes that the time taken by the lead CA for
its assessment of the application concerning NK603 maize – notably the time taken by the lead CA up
to August 2002, when the applicant updated its a pplication in accordance with the requirements of
Directive 2001/18 – was unjustifiably long.
7.2122 In relation to DS291, we recall that the United States claims that the approval procedure
concerning NK603 maize was unduly delayed because, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and A ugust 2003 and that (ii) the failu re of Spain to complete its
assessment of NK603 maize earlier than in January 2003 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 Un ited States that it is reasonable to infer that Spain's conduct was a
consequence of the general moratorium on approvals.
7.2123 In view of our conclusion with regard to the time taken by Spain for its assessment, we do not
go on to examine other arguments put forward by th e United States and Argentina in support of their
claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Conclusions
7.2124 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that the time taken by the lead
CA for its assessment of the applicati on concerning NK603 maize was unjustifiably
long, and that it can reasonably be inferred from surrounding circumstances that the
lead CA's conduct was a consequence of the general moratorium on approvals. Based
on these findings, the Panel accepts the United St ates' contention that, consistent with
the general moratorium, the European Comm unities failed to consider the application
concerning NK603 maize for final approval, and that this resulted in "undue delay" in
the completion of the relevant approval pro cedure. Accordingly, the Panel concludes
that in respect of the approval proce dure concerning NK603 maize, the European
Communities has breached its obligations under Annex C(1)(a), first clause, and
Article 8 of the SPS Agreement.

1539 We note that Spain could have considered that fo r as long as Directive 90/220 was still in force,
there was no realistic prospect that the Group of Five countries and the Commission would allow the final
approval of the application in question. However, the Pa nel does not consider that this would have justified
Spain's failure to forward an assessment report to the Commission prior to the date of repeal of
Directive 90/220. Spain might have anticipated opposition from the Group of Five countries on the basis of
their June 1999 declaration. As pointed out above, notwithstanding this declaration, the Group of Five countries
retained the freedom under EC law to approve applications. The same is true for the Commission, which had
not issued a declaration comparable to that of the Group of Five countries.

 (ii) DS293 (Argentina)

 With reference to DS293, the Panel recalls its finding that the time taken by the lead
CA for its assessment of the applicati on concerning NK603 maize was unjustifiably
long. In the light of this finding, the Panel concludes that the European Communities
failed to complete the approval procedure concerning NK603 maize without "undue
delay", thus breaching its obligations under Annex C(1)(a), first clause, and Article 8
of the SPS Agreement.

(xvii) GA21 maize (EC-78)
7.2125 Two Complaining Parties, the United States and Argentina, claim that the completion of the
approval procedure concerning GA 21 maize (EC-78) has been unduly delayed.
7.2126 The United States argues that even though GA21 maize (EC-78) was forwarded by the lead
CA to the Commission with a favourable opinion, received a positive opinion from the SCP in
September 2000, the consultations w ith relevant member States were completed, and the scope of the
application was reduced to exclude cultivation, th e Commission failed to submit a draft measure to
the Regulatory Committee. The United States argue s that there was no action or communication by
the Commission on this application. The United Stat es 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 app lication (in the form of undertakings) to the
requirements of the impending Directive 2001/18. Furthermore, the United States argues that
although the applicant submitted all necessar y supplementary information according to
Directive 2001/18 to the lead CA on 15 January 20 03, 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.
7.2127 The United States submits, finally, that the a pplication concerning GA21 maize (EC-78) is
one of nine applications identified by the United St ates which were stalled at the Commission level at
the time Directive 90/220 expired and which, as of th e date of establishment of the Panel, have been
pending for an average of six and one half years. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
GA21 maize (EC-78) is undue. The United States further argues that before the European
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were
undertaken and completed in less than three years.
7.2128 Argentina argues that once the SCP issued its favourable opinion on 22 September 2000, the
procedure on this application was suspended. Two years and two months had elapsed between the
submission of the application and its suspensi on. 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. One year and eight months elapsed from the re-submission until
September 2003, when the application was withdrawn. In total, counting the time that elapsed under
Directives 90/220 and 2001/18, the procedure dr agged on for 5 years and 2 months without a
definitive response concerning approval.
7.2129 The European Communities argues that after assessment at both member State and
Community level, the application was withdraw n by the applicant on 15 September 2003. The
European Communities notes that the applicant, in its withdrawal letter, gave three reasons for the

withdrawal: first, the progress in the notification procedure of another Roundup Ready maize to a
more advanced stage than the GA21 maize (EC-78) notification; 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.
7.2130 Argentina responds that although the applicant's letter of withdrawal does not have a specific
reference to "undue delay", this does not imply that no "undue delay" occurred. Argentina considers
that the silence of the applicants cannot be take n as evidence of satisfaction with the process, but
rather that it was due to the applicant's concer n with maintaining good relations with the approving
authorities.
7.2131 The Panel begins its analysis by addressing the delay allegedly caused by the Commission.
Failure by the Commission to submit a draft measure to the Regulatory Committee

7.2132 We recall that 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 until Directive 90/220 was repealed in October 2002. The United States and Argentina
argue that the Commission should have submitted a draft measure to the Regulatory Committee
before October 2002. The European Communities argues that the application was being assessed
according to the procedures.
7.2133 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
1540, the Commission in this procedure never launched inter-service consultations on a draft
measure. We are therefore not persuaded by the European Communities' assertion that the application
concerning GA21 maize (EC-78) was being assessed according to the procedures.
7.2134 At any rate, we observe that the preparation by the Commission of a draft measure and its
submission to the Regulatory Committee is not a process which inherently takes more than two years.
In other approval procedures, the Commission was ab le to prepare and submit draft measures to the
Regulatory Committee within a matter of a few mont hs. For example, in the procedure concerning
Bt-531 cotton, the Commission prepared a draft measure and launched a vote in the Regulatory
Committee in less than three months.
1541 It may be inferred from this that the Commission could in
principle have submitted a draft measure to the Regulatory Committee well before October 2002.
7.2135 The fact that the Commission could in prin ciple have submitted a draft measure to the
Regulatory Committee before October 2002 does not necessarily mean that the Commission could
have done so in the specific circumstances of this case. We note in this respect that the SCP's
favourable opinion stated that "[t]he applicant should however establish a monitoring plan to identify
unexpected and unusual events and analyse grower e xperiences, in order to develop and implement
any necessary changes in crop management practices in response to the results of monitoring."
1542
However, as with the approval procedures we have considered earlier, there is no evidence that the
Commission or the lead CA ever requested the a pplicant to propose a monitoring plan in accordance
with the SCP's opinion. In January 2003, the a pplicant submitted an updated application, including a
monitoring plan. But this information was submitted at the applicant's initiative, in anticipation of the

1540 See, e.g., Exhibits EC-62/At. 76; EC-65/At. 48.
1541 Exhibit EC-65/Ats. 48 and 51.
1542 Exhibit EC-78+85/At. 90.

entry into force of the new requirements cont ained in Directive 2001/18, and not because the
applicant was requested to address the SCP opinion.
1543 Therefore, there is no reason to believe that
the Commission was waiting for the applicant to put fo rward a monitoring plan, or, indeed, to provide
any of the other additional information submitted by the applicant in January 2003. Consequently, we
do not consider that the SCP's recommendation just ified the Commission's failure to forward a draft
measure to the Regulatory Committee before October 2002
7.2136 We further 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.1544 In March 2001, the lead CA informed the Commission that
it had no objection to the applicant's request. 1545 There is no indication that the Commission opposed
the applicant's request. While the scope of the appl ication 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.
7.2137 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 favour able vote in the Regulatory Committee. 1546 In our assessment,
the Commission's inaction cannot, therefore, be ex cused on the grounds that the approval procedure
concerning GA21 maize could not be completed while Directive 90/220 was still in force.
7.2138 In its earlier findings on the application con cerning GA21 maize, the Panel noted that 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 measure would not achieve the
required qualified majority and that the Commission would then have to complete the procedure by
adopting its draft measure. In the Panel's view, even in this scenario, there was enough time for the
Commission to complete the procedure in question while Directive 90/220 was still in force. But
even if it was doubtful that there would be enou gh time in view of anticipated member State
opposition, the Panel does not consider that this w ould have justified the Commission's failure to
forward a draft measure to the Regulatory Committ ee. The Commission would 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 th e 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, we think the Commission
could not have legitimately invo ked the June 1999 declaration as a justification for not submitting a
draft measure to the Regulatory Committee prior to October 2002.
7.2139 Based on the above considerations, the Panel is of the view that, in the specific circumstances
of this procedure, the time actually taken by th e Commission to prepare and forward a draft measure

1543 Exhibit EC-78+85/At. 94.
1544 Exhibit EC-78+85/At. 91.
1545 Exhibit EC-78+85/At. 92.
1546 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.

to the Regulatory Committee – no draft measure was forwarded between September 2000 and
October 2002 – was unjustifiably long.
7.2140 Regarding DS291, we recall that the United St ates claims that the approval procedure
concerning GA21 maize (EC-78) was unduly delayed because, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and August 2003 and that (ii) the Commission's failure to submit a
draft measure to the Regulatory Committee following the issuance of the SCP's opinion is consistent
with the application of such a moratorium. In the li ght of this, and in the absence of effective rebuttal
by the European Communities, we ag ree with the United States that it is reasonable to infer that the
Commission's inaction was a consequence of the general moratorium on approvals.
7.2141 In view of our conclusion with regard to th e Commission's failure to submit a draft measure
to the Regulatory Committee, we do not go on to ex amine other arguments put forward by the United
States and Argentina in support of their claim under A nnex C(1)(a), first clause , and Article 8 of the
SPS Agreement.
Conclusions

7.2142 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 prepare and forward a draft measure to the Regulatory Committee
once the SCP had issued its opinion – no draft measure was forwarded between
September 2000 and October 2002 – was unj ustifiably 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 the United States' contention that, consistent with the
general moratorium, the European Commun ities failed to consider the application
concerning GA21 maize (EC-78) for final appr oval, and that this resulted in "undue
delay" in the completion of the relevant a pproval procedure. Accordingly, the Panel
concludes that in respect of the approva l procedure concerning GA21 maize (EC-78),
the European Communities has breached its obligations under Annex C(1)(a), first
clause, and Article 8 of the SPS Agreement.

 (ii) DS293 (Argentina)

 With reference to DS293, the Panel reca lls its finding that the time taken by the
Commission to prepare and forward a draft measure to the Regulatory Committee –
no draft measure was forwarded between September 2000 and October 2002 – was
unjustifiably long. In the light of this finding, the Panel concludes that the European
Communities failed to complete the a pproval procedure concerning GA21 maize
(EC-78) without "undue delay", thus breachi ng its obligations under Annex C(1)(a),
first clause, and Article 8 of the SPS Agreement.

(xviii) MON810 x GA21 maize (EC-82)
7.2143 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning MON810 x GA21 maize has been unduly delayed.
7.2144 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 s upport the application for this product.
1547 The applicant
responded in August 2001 to all requests, exce pt for a scientifically unjustified study on the
nutritional composition of milk fro m dairy cows fed this product. 1548 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. 1549 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. 1550 None of these studies identified anything that would provide
any basis for the concern raised by the member State.
7.2145 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.
7.2146 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. 1551 No further action was taken on this application for over 18 months, until the
applicant volunteered to update the appli cation under Directive 2001/18 on 16 January 2003. 1552 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.1553
7.2147 The United States also points out that the application concerning MON810 x GA21 maize is
one of nine applications identified by the United States which have been pending at the member State

1547 Exhibit EC-82/At. 8.
1548 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.
1549 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).
1550 Exhibit EC-82/Ats. 2 and 5.
1551 Exhibit EC-82/At. 18.
1552 Exhibit EC-82/At. 20.
1553 Exhibit EC-82/At. 21.

level for an average of three years and ten months. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
MON810 x GA21 maize is undue. The United States subm its, in addition, that before the European
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were
undertaken and completed in less than three years.
7.2148 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".
1554
7.2149 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.
7.2150 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.
7.2151 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.
7.2152 The Panel commences its analysis with the alleged delay at member State level.
Delay at member State level
7.2153 We recall that the lead CA (Spain) in Nove mber 1999 requested additional information from
the applicant. The applicant did not provide the information requested until August 2001. A
translation into Spanish of the documents subm itted in the August 2001 response was provided to the
Spanish CA in January 2002. The United States ha s pointed out that the applicant did not comply

1554 The European Communities refers to the United States' response to question 47 of the Panel, table
in Annex I.

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.
7.2154 It was only in April 2002 that the Spanish National Biosafety Committee completed its
review of the January 2002 Spanish translation of the applicant's documents. The National Biosafety
Commission concluded that it still needed the results of feeding studies on cows, and other
information.
1555 However, there is no indication in the r ecord that a further re quest for information
was ever sent to the applicant prior to the repeal of Directive 90/220 in October 2002.
7.2155 According to the European Communities, the failure of the lead CA to forward the application
concerning MON810 x GA21 maize to the Commission prior to the date of repeal of Directive 90/220
is justified 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 prod uct, GA21 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.
7.2156 We recall that the Spanish CA in May 1999 had given a favourable assessment to the
application concerning GA21 maize (EC-78) and forw arded that application to the Commission.
When the application concerning MON810 x GA21 ma ize was submitted, the application concerning
GA21 maize (EC-78) was under assessment at Community level. Furthermor e, in September 2000
the SCP also issued a favourable opinion on the application concerning GA21 maize (EC-78).1556 It is
therefore not clear to us why the 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 unable to
proceed due to the failure of the European Communities to approve the GA21 maize (EC-78) parent.
7.2157 As a general matter, it may be correct to say , as the European Communities does, 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 context 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 asse ssment of GA21 maize (EC-78), even though that
assessment appears to have been confirmed by the SCP, they could have raised an objection on that
basis to Spain's assessment of MON810 x GA21 ma ize and the assessment of that application would
then also have been "concluded" at Community level.
7.2158 For these reasons, it is not apparent to us that the Spanish CA needed to keep the application
at the member State level in order to avoid th e possibility of conflicting assessments of GA21 maize,
and we therefore do not consider that the fact that one of the parental lines was still pending justified
Spain in not completing its assessment of the application concerning MON810 x GA21 maize.
7.2159 We note that after receiving a translation of the additional information requested from the
applicant, it was incumbent on the Spanish CA either to seek further clarifications or to complete its
assessment within the 90-day period provided for in Directive 90/220. As indicated, the National
Biosafety Commission did not complete its review of the information until two and a half months
later. Moreover, there is no evidence that the Spanish CA requested additional or missing information
once the National Biosafety Commission had completed its review of the applicant's documents. Nor

1555 Exhibit EC-82/At. 18.
1556 Exhibit EC-78+85/At. 90.

did the Spanish CA complete its assessment after receiving further advice from the National Biosafety
Commission in April 2002.
7.2160 We recognize that, by April 2002, the date of repeal of Directive 90/220 was approaching.
However, we note that in another approval proced ure, the Spanish CA forwarded questions from the
National Biosafety Commission as late as mid-June 2002.
1557 Moreover, even if the lead CA had
taken another two or three mont hs to complete its assessment 1558, we think that there was still enough
time for the other member States to review the lead CA's assessment report within 60 days following
the circulation of the assessment report and, in the absence of objections, for the lead CA to give its
consent to the placing on the market of MON810 x GA21 maize.1559
7.2161 Taking account of the aforementioned elements, we see no justification for the lead CA's
failure, after receiving further advice from the Na tional Biosafety Commission in April 2002, to
follow up with the applicant to seek more information or additional clarifications, or for the lead CA's
failure to complete its assessment in April 2002 or soon thereafter. We therefore are not convinced
that the lead CA could not have proceeded more promptly than it did.
7.2162 Based on the above considerations, the Panel concludes that the time taken by the lead CA for
its assessment of the application concerning MON810 x GA21 maize – notably the time taken by the
lead CA between January and October 2002 – was unjustifiably long.
7.2163 In addition, we recall that the United States claims that the approva l procedure concerning
MON810 x GA21 maize was unduly delayed because, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and A ugust 2003 and that (ii) the failu re of Spain to complete its
assessment of the application concerning MO N810 x GA21 maize prior to the repeal of
Directive 90/220 is consistent with the application of such a moratorium. In the light of this, and in
the absence of effective rebuttal by the European Communities, we agree with the United States that it
is reasonable to infer that Spain's conduct was a consequence of the general moratorium on approvals.
7.2164 In view of our conclusion with regard to the time taken by Spain for its assessment, we do not
go on to examine other arguments put forward by the United States in support of its claim under
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.

1557 Exhibit EC-75/At. 13.
1558 We note, however, that by April 2002 the 90-day period envisaged in Directive 90/220 for a lead
CA assessment had already been exceeded.
1559 We note that Spain could have considered that fo r as long as Directive 90/220 was still in force,
there was no realistic prospect that the Group of Five countries and the Commission would allow the final
approval of the application in question. However, the Pa nel does not consider that this would have justified
Spain's failure to complete its assessment prior to the date of repeal of Directive 90/220. Spain might have
anticipated opposition from the Group of Five countries on the basis of their June 1999 declaration. As pointed
out above, notwithstanding this declaration, the Group of Five countries retained the freedom under EC law to
approve applications. The same is true for the Commission, which had not issued a declaration comparable to
that of the Group of Five countries.

Conclusion

7.2165 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that the time taken by the lead
CA for its assessment of the applicatio n concerning MON810 x GA21 maize was
unjustifiably long, and that it can reasonably be inferred from surrounding
circumstances that the l ead CA's conduct was a consequence of the general
moratorium on approvals. Based on these findings, the Panel accepts the United
States' contention that, consistent with the general moratorium, the European
Communities failed to consider the app lication concerning MON810 x GA21 maize
for final approval, and that this resulted in "undue delay" in the completion of the
relevant approval procedure. Accordingly, the Panel concludes that in respect of the
approval procedure concerning MON810 x GA21 maize, the European Communities
has breached its obligations under Annex C(1 )(a), first clause, and Article 8 of the
SPS Agreement.

(xix) RR sugar beet (EC-88)
7.2166 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning RR sugar beet has been unduly delayed.
7.2167 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 l ead CA (Belgium) declined to forward the
application to the Commission. The United States argues that although the applicant provided
answers to all of the questions raised by the lead CA, the lead CA failed to complete its review.
7.2168 The United States also points out that the appli cation concerning RR sugar beet is one of nine
applications identified by the United States which ha ve been pending at the member State level for an
average of three years and ten months. The United States contends in this respect that although time
alone is not dispositive, in the light of the acknow ledgement by EC officials of the existence of a
moratorium on approvals, this de lay in completing the approval procedure concerning RR sugar beet
is undue. The United States submits, in addition, th at before the European Communities adopted its
moratorium, all approval procedures under Directiv e 90/220 were undertaken and completed in less
than three years.
7.2169 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.
7.2170 The Panel commences its analysis with the alleged delay at member State level.
Delay at member State level

7.2171 We recall that 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 qu estions on agricultural practices, molecular

characterization, toxicology, allerg enicity, and food/feed equivalence.
1560 The applicant provided
responses to some of these questions in July 1999. 1561 Other questions were answered in December
1999.1562
7.2172 In October 1999 the lead CA requested additional information on gene tr ansfer in digestive
tracts.1563 The applicant provided such information in January 2000. 1564 We asked the experts
advising us whether the information regarding a llergenicity, molecular characterization and gene
transfer in digestive tracts requested by the lead CA was necessary to ensure that conclusions of the
safety assessment were valid. Dr. Nutti stated that the 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.1565
7.2173 In February 2000, the lead CA requested missi ng bibliographical references. The applicant
provided the relevant referenc es in February and March 2000. 1566 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.1567
7.2174 In November 2000, the lead CA requested fu rther clarifications regarding molecular
characterization and allergenicity of "event '77'". 1568 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 safet y assessment were valid. Dr. Nutti emphasized that
the information "for allergenicity was not necessar y 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.1569 The applicant apparently did not provide the requested information.
7.2175 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.
1570 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. 1571 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.

1560 Exhibit EC-88/Ats. 8 and 9.
1561 Exhibit EC-88/At. 10.
1562 Exhibit EC-88/At. 13.
1563 Exhibit EC-88/At. 12.
1564 Exhibit EC-88/At. 15.
1565 Annex H, Dr. Nutti's response to Panel Question 42.
1566 Exhibit EC-88/Ats. 17-21.
1567 Exhibit EC-88/At. 22.
1568 Exhibit EC-88/At. 27.
1569 Annex H, Dr. Nutti's response to Panel Question 43.
1570 Exhibit EC-88/At. 29.
1571 Exhibit EC-88/At. 30.

7.2176 We begin our examination of the lead CA's assessment of the application under
Directive 90/220 by recalling that the applicant di d not respond to the lead CA's November 2000
request for additional information.
1572 It would therefore appear that after November 2000 the lack of
progress of the application under Directive 90/220 is a ttributable to the applicant. The focus of our
examination is therefore on the lead CA's conduct prior to the November 2000 request.
7.2177 We note in this respect that by the end of March 2000 the applicant had provided all
additional information requested by the lead CA. Moreover, there is no indication that the Biosafety
Advisory Council had been asked for further scientif ic input either before or after March 2000.
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. As
indicated previously, notably in the case of the clarifications sought concerning allergenicity, Dr.
Nutti questioned the need for the info rmation that was requested. Even ignoring this, we note that 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.
7.2178 Furthermore, even assuming arguendo that the lead CA could not have finished its
assessment between March 2000, when the applicant provided all additional information requested by
the lead CA, and the end of July 2000, when the applicant voluntarily submitted additional
information, and accepting, again arguendo, that the lead CA required some time to review the July
2000 information, we recall that the November 2000 request came more than seven months after the
applicant had provided all information requested by the lead CA. We are not persuaded that the
completion of the review of the March and July 2000 information required more than twice the
maximum 90-day period envisaged in Directive 90/ 220 for the entire assessment by a lead CA. We
note in this connection that by November 2000, Be lgium had already far exceeded the 90-day period
provided for in Directive 90/220.
7.2179 Moreover, the seven-month delay after March 2000 could not, in our view, be excused on the
basis that there was insufficient time to comple te the approval procedure concerning RR sugar beet
while Directive 90/220 was still in force. Direc tive 90/220 was not repealed until October 2002.
There was thus enough time for the other member States to review the lead CA's assessment report
within 60 days following the circulation of the assessment report and, in the absence of objections, for
the lead CA to give its consent to the placing on the market of RR sugar beet.
1573
7.2180 Taking account of the aforementioned elements, we consider that, even assuming that the lead
CA's November 2000 request for additional informati on was justified, the lead CA could have sought
that information earlier than it did. We also cons ider that the lead CA should have done so, as we
think that by November 2000 the lead CA should ha ve been able to resolve all other outstanding
scientific or technical issues.

1572 The lead CA in January 2001 reminded the applicant of its November 2000 request for information.
Exhibit EC-88/At. 29.
1573 We note that Belgium could have considered that for as long as Directive 90/220 was still in force,
there was no realistic prospect that the Group of Five countries and the Commission would allow the final
approval of the application in question. However, the Pane l does not consider that this would have justified the
seven-month delay after March 2000. Belgium might ha ve anticipated opposition from the Group of Five
countries on the basis of their June 1999 declaration. However, as poin ted out above, notwithstanding this
declaration, the Group of Five countries retained the freedom under EC law to approve applications. The same
is true for the Commission, which had not issued a declaration comparable to that of the Group of Five
countries.

7.2181 Based on the above considerations, the Panel concludes that the time taken by the lead CA for
its assessment of the application concerning RR suga r beet – notably the time taken by the lead CA
between March and November 2000 – was unjustifiably long.
7.2182 In addition, we recall that the United States claims that the approval procedure concerning RR
sugar beet was unduly delayed because, due to the moratorium, the European Communities failed to
consider the application in question for final appr oval. In this respect, we note our earlier findings
that (i) a general de facto moratorium on approvals was in e ffect in the European Communities
between June 1999 and August 2003 and that (ii) the time taken by Belgium to complete its
assessment is consistent with the application of such a moratorium. In the light of this, and in the
absence of effective rebuttal by th e European Communities, we agree with the United States that it is
reasonable to infer that Belgium's conduct was a consequence of the general moratorium on
approvals.
7.2183 In view of our conclusion with regard to the time taken by Belgium for its assessment, we do
not go on to examine other arguments put forward by the United States in support of its claim under
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Conclusion

7.2184 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that the time taken by the lead
CA for its assessment of the application concerning RR sugar beet was unjustifiably
long, and that it can reasonably be inferred from surrounding circumstances that the
lead CA's conduct was a consequence of the general moratorium on approvals. Based
on these findings, the Panel accepts the United St ates' contention that, consistent with
the general moratorium, the European Comm unities failed to consider the application
concerning RR sugar beet for final approval, and that this resulted in "undue delay" in
the completion of the relevant approval pro cedure. Accordingly, the Panel concludes
that in respect of the approval procedur e concerning RR sugar beet, the European
Communities has breached its obligations under Annex C(1)(a), first clause, and
Article 8 of the SPS Agreement.

(xx) MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape (EC-90)
7.2185 One Complaining Party, Canada, claims that the completion of the separate approval
procedures for MS1/RF1 oilseed rape (EC-89) and MS 1/RF2 oilseed rape have been unduly delayed.
While we are mindful of the fact that Canada is making separate product-specific claims in respect of
the two approval procedures concerning MS1/RF1 o ilseed rape (EC-89) and MS1/RF2 oilseed rape,
in view of the very similar facts of these procedures, we examine the two claims together.
7.2186 Canada argues that the delays in completing the approval procedures for MS1/RF1 oilseed
rape (EC-89) and MS1/RF2 oilseed rape are both excessive and unjustified, and hence undue. The
EC decisions authorizing 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 th e competent authority of France to

the placing on the market" of the products in question
1574, yet in 2003, when the Panel was
established, the lead CA had still failed to give its consent for either product.
7.2187 Canada notes that although the Commission t ook the procedural step of sending a "reasoned
opinion" to France in relation to the withholding of consent for these products on 7 July 1999, the
Commission has not pursued legal proceedings ag ainst France for infringement of European law
before the European Court of Justice. 1575 No explanation has been pr ovided by France for its refusal
to comply with the Commission decisions and Di rective 90/220, nor by the Commission for not
pursuing legal action against France. This is despite the November 2000 judgment of the French
Conseil d'Etat that, without new information concerning the risks associated with MS1/RF1 oilseed
rape (EC-89) and MS1/RF2 oilseed rape, the French Ministry could not call into question the decision
taken by the Commission.1576
7.2188 Canada contends that the length of time it has ta ken, so far, for these applications to move
through the approval system – more than eight y ears – is, by any reasonable standard, "undue" and
therefore a violation of Annex C(1)(a), keeping in mind that the final approval for these products still
has not been given. However, the amount of tim e these applications have languished in the approval
procedure is not the sole reason for Canada's clai m that the delays have been undue. First and
foremost, the European Communities has had in place, since October 1998, an unjustified moratorium
on approvals. Furthermore, the refusal to approve the applications concerning MS1/RF1 oilseed rape
(EC-89) and MS1/RF2 oilseed rape are not based on risk assessments, particularly since both products
were formally approved by the Commission in 1997.
7.2189 The European Communities argues that these products obtained a market authorization by
virtue of Commission decisions of 6 June 1997. The European Communities submits that from the
point of view of EC law, the absence of the fina l consent does not mean that the applicant is not
entitled to place MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape on the market. The
doctrine of "direct effect" in Community law means that the applicant could assert the rights granted
them through the provisions of EC law.1577
7.2190 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
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).
7.2191 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

1574 Article 1(1) of each Decision respectively. Exhibits CDA-48 and -49.
1575 European Commission, GMOs: Commission moves against Luxembourg and France, Commission
Press Release, IP/99/438, Brussels, 7 July 1999 (Exhibit CDA-52). See also European, 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)
1576 European 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] ECR I-01651 (Exhibit CDA-51).
1577 The European Communities refers to European Court of Justice, Leberpfennig, Case 9/70 [1970]
ECR 825.

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.
7.2192 Canada rejects the EC argument that the absence of the final consent does not mean that the
applicant is not entitled to place MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape on the
market. Canada submits that this would require th e applicant to pursue legal proceedings within the
European Communities in order to bring to an e nd the approval procedures. According to Canada,
under these circumstances it is obvious that the Eu ropean Communities has fa iled to complete the
relevant approval procedures under Directive 90/220. The applicant has been unable to market its
products in the European Communities as a result of the failure of France to issue the letters of
consent and the consequent uncertainty regarding th e legal status of the products. Therefore, the
European Communities has failed to "complete" the relevant approval procedures without "undue
delay" in patent violation of Annex C(1)(a) of the SPS Agreement. Moreover, Canada argues that by
failing to complete the approval procedures, the Eu ropean Communities has instituted and maintained
effective product-specific marketing bans for MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed
rape.
7.2193 The Panel begins its analysis by addressing the de lay allegedly caused by France as the lead
CA.
Member State failure to give consent to placing on the market

7.2194 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, which 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 "consent shall be given by the competent authority of France to the
placing on the market" of the oilseed rape products in question.1578
7.2195 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
on the market of the products at issue. Thus, un der Directive 90/220, France did not grant its consent
for more than five years.1579

1578 Exhibits CDA-48 and -49.
1579 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.

7.2196 There is some 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 Directive 2001/18. There is no indication that the applications
concerning MS1/RF1 oilseed rape (EC-89) and MS 1/RF2 oilseed rape were complemented in
accordance with Directive 2001/18.
7.2197 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. 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.
7.2198 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.
7.2199 We must not, and hence do not, express a view on whether the approval procedures conducted
under Directive 90/220 concerning MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape were
"completed" as a matter of EC law.
1580 However, we may express a view on whether these approval
procedures were "completed" within the meaning of Annex C(1)(a), first clause. We have observed
earlier that the verb "complete" as it appears in A nnex C(1)(a), first clause, indicates that approval
procedures are not only to be undertaken, but are also to be finished, or concluded, and that the phrase
"undertake and complete", which also appears in A nnex C(1)(a), first clause, covers all stages of
approval procedures and should be taken as meaning th at approval procedures are to be started and
carried out from beginning to end.1581
7.2200 We do not consider that the European Comm unities finished, or concluded, the approval
procedures concerning MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape, or that the
European Communities carried out these procedures fro m beginning to end. Indeed, Directive 90/220
provides for the granting of the lead CA's written c onsent to the placing on the market as an integral
and last step of the approval procedure.1582 In our view, the fact that 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 does not demonstrate that the relevant
approval procedures have already been "completed " within the meaning of Annex C(1)(a), first

1580 We note that Article 35 of Directive 2001/18 uses the phrase "not [...] completed" in connection
with procedures commenced under Directive 90/220.
1581 See supra, para. 7.1494.
1582 Article 13(4) of Directive 90/220.

clause. Rather, it indicates that, notwithstanding France's failure to finish the procedures, the
Commission decisions may be enforceable vis-à-vis France.
7.2201 Having determined that the a pproval procedures concerning MS 1/RF1 oilseed rape (EC-89)
and MS1/RF2 oilseed rape have not been completed, we now turn to address whether the time taken
by France to grant its written consent is unjustifiably long. The European Communities asserts in this
respect 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).
1583 In considering the EC assertion, we note that we have been provided very little
information on the approval procedures concerni ng MS1/RF1 oilseed rape (EC-89) and MS1/RF2
oilseed rape. In particular, we have seen no ev idence 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 MS 1/RF2 oilseed rape make clear that France
forwarded the application to the Commission with a favourable opinion.
7.2202 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.
1584 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.
7.2203 For 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.
7.2204 The European Communities offered no other explanation for France's prolonged inaction. We
recall in this regard 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. We found earlier that at least as from June 1999
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 prevented these
products from being approved. As we have explained earlier 1585, however, we consider that the
perceived need for new EC rules on labelli ng and traceability does not provide a sufficient
justification for not completing the approval pr ocedures for the products in question and for
preventing their final approval.

1583 The application concerning MS1/RF1 oilseed rape (EC-161) had been submitted to the United
Kingdom and was approved for breeding activities in 1996.
1584 There is nothing in Directive 90/220 which says that 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.
1585 See supra, paras. 7.1511-7.1518.

7.2205 Based on the above considerations, the Panel c oncludes that the time taken by France up to
August 2003, including the time taken after June 1999, for the purpose of giving its written consent to
the placing on the market of MS1/RF1 oilseed rape (EC-89) and MS1/RF2 oilseed rape following the
approval of both applications by the Commission in June 1997 is unjustifiably long.
7.2206 In view of this conclusion, we do not go on to examine other arguments put forward by
Canada in support of its claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Conclusions

7.2207 In the light of the above, the Panel reaches the following conclusions:
 (i) DS292 (Canada) – MS1/RF1 oilseed rape (EC-89)

 With reference to DS292, the Panel recalls its findings that the time taken by France
to give its written consent for the placing on the market of MS1/RF1 oilseed rape
(EC-89) following its approval by the Commission in June 1997 – no consent was
given between June 1997 and August 2003 – was unjustifia bly long. Based on these
findings, the Panel accepts Canada's contention that the European Communities failed
to "consider or approve, without undue de lay" the application concerning MS1/RF1
oilseed rape (EC-89), and that it consequent ly did not complete the relevant approval
procedure without "undue delay". Accordingly, the Panel concludes that in respect of
the approval procedure concerning MS1/RF1 oilseed rape (EC-89), the European
Communities has breached its obligations under Annex C(1)(a), first clause, and
Article 8 of the SPS Agreement.

 (ii) DS292 (Canada) – MS1/RF2 oilseed rape (EC-90)

 With reference to DS292, the Panel recalls its findings that the time taken by France
to give final consent for the placing on the market of MS1/RF2 oilseed rape following
its approval by the Commission in June 1997 – no consent was given between June
1997 and August 2003 – was unjus tifiably long. Based on these findings, the Panel
accepts Canada's contention that the Europ ean Communities failed to "consider or
approve, without undue delay" the application concerning MS1/RF2 oilseed rape, and
that it consequently did not complete the relevant approval procedure without "undue
delay". Accordingly, the Panel concludes that in respect of the approval procedure
concerning MS1/RF2 oilseed rape, the Eu ropean Communities has breached its
obligations under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.

(c) Novel Foods – Applications s ubmitted under Regulation 258/97

7.2208 We now turn to examine the approva l procedures which were conducted under
Regulation 258/97 for the applications identified by the Complaining Parties. Before embarking on
an examination of individual approval procedures, however, we should briefly address certain issues
presented by the application of Annex C(1)(a), fi rst clause, to approval procedures conducted under
Regulation 258/97.

(i) Application of Annex C(1)(a), first clause, to approval procedures conducted under
Regulation 258/97
7.2209 We have found earlier that the approval procedure set out in Regulation 258/97, to the extent
it is applied to check and ensure the fulfilment of the requirement that novel foods not present a
danger for the consumer, constitutes an "approval pro cedure" within the meaning of Annex A(1) of
the SPS Agreement. On the other hand, we found that to th e extent the same approval procedure is
applied to check and ensure the fulfilment of the requirements that novel foods not mislead the
consumer and that they not be nutritionally disadvantageous for the consumer, that procedure is not an
"approval procedure" within the meaning of Annex A(1) of the SPS Agreement.
7.2210 Under Regulation 258/97, once an application for the approval of a novel food product is
submitted, the fulfilment of the aforementioned three requirements is to be checked through one
single approval procedure. Regulation 258/97 also envisages that if an application does not meet one
of three requirements, the relevant food product may not be placed on the market. We recall that the
Complaining Parties did not challenge Regulati on 258/97 as such, and thus did not question the
European Communities' decision to conduct one si ngle approval procedure to check all three
requirements and to grant approvals only in cases where applications comply with all three
requirements.
7.2211 It follows from the design of Regulation 258/97 that in the event there is a delay in the
processing of an application due to the need to ch eck the fulfilment of the requirement that novel
foods not mislead the consumer, or that they not be nutritionally disadvantag eous for the consumer,
that delay would also affect the SPS approval procedure conducted for the same application, i.e., the
procedure applied to check and ensure the fulfilmen t of the requirement that novel foods not present a
danger for the consumer. In other words, the SPS a pproval procedure would be delayed if, and to the
extent that, there was a delay in the non-SPS approval procedure.
7.2212 We have previously stated that, in our view, Annex C(1)(a), first clause, requires that SPS
approval procedures be undertaken and completed with no unjustifiable loss of time. In the context of
Regulation 258/97, the issue thus arises whether a delay caused by the need to check the fulfilment of,
e.g., the non-SPS requirement that novel foods not be nutritionally disadvantageous for the consumer
should be considered to constitute, ipso facto, unjustifiable loss of time.
7.2213 In addressing this issue, we recall that the Complaining Parties did not challenge or question
the fact that Regulation 258/97 provides that fo r each application a single procedure is to be
conducted, leading to a single approval. We consid er that, in these circumstances, a delay in the SPS
approval procedure should not be viewed as "undue" merely because it arose from the need to check
the fulfilment of one of the two non-SPS re quirements contained in Regulation 258/97, e.g., the
requirement that novel foods not be nutritionally disadvantageous for the consumer. Indeed, if it were
otherwise, a situation might arise where the European Communities would have to complete the
procedure with a substantive decision on the applic ation concerned even if it had not yet been able
adequately to determine whether the application meets the requirement that the novel food product not
be nutritionally disadvantageous for the consumer. The European Communities might thus have to
approve a novel food product the consumption of wh ich is nutritionally disadvantageous for the
consumer, and this even though the Complaining Par ties never questioned the fact that in accordance
with Regulation 258/97 the requirement that a prod uct not be nutritionally disadvantageous must be
fulfilled before a product is approved.
7.2214 While we thus do not consider that, in the speci fic circumstances of this case, a delay in the
SPS approval procedure should be treated as "undue " merely because it arose from the need to check

the fulfilment of one of the two non-SPS requirement s contained in Regulation 258/97, it is our view
that for instance if the time taken to check th e fulfilment of one of those non-SPS requirements
exceeded the time that is required to do so, the r esulting delay in the SPS approval procedure would
be at least partly "undue".
7.2215 In view of the above considerations, we think that for the purposes of our examination of the
relevant approval procedures in the light of Annex C(1)(a), first clause, we need not, and hence do
not, make specific findings on whether any delays in a relevant approval procedure arose from the
need to check the fulfilment of the SPS requireme nt that novel foods not present a danger for the
consumer or whether they arose from the need to check the fulfilment of the non-SPS requirements
that novel foods not mislead the c onsumer and that they not be nu tritionally disadvantageous for the
consumer. In the circumstances of this case, either type of delays would be relevant to an inquiry
under Annex C(1)(a), first clause.
7.2216 As an additional, but separate, matter, we should recall that the Regulation 258/97
applications covering foods or food ingredients wh ich contain or consist of GMOs are subject to
Article 9 of Regulation 258/97 which provides that the Commission 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]". As
we have said earlier, it would seem to follow from Ar ticle 9 that if the applicant did not submit an
environmental risk assessment, a Regulation 258/ 97 application could not be approved by the
Commission unless a Directive 90/220 application concerning the same biotech product had
previously been approved. We observe in this cont ext that it would in our view be contrary to the
requirements of Annex C(1)(a), first clause, fo r the European Communiti es to proceed with a
Regulation 258/97 procedure at a delayed pace merely because of delays which have occurred, or are
anticipated to occur, in a para llel Directive 90/220 (or Directive 2001/18) procedure concerning the
same biotech product, provided that further pr ogress in the Regulation 258/97 procedure is still
possible. In other words, we consider that the European Communities must proceed as far as possible
with a Regulation 258/97 proce dure as promptly as possible, unless the applicant requests that the
Regulation 258/97 procedure proceed more slowly, or that it not proceed faster or further, than a
parallel Directive 90/220 (or Directive 2001/18) pr ocedure. In the case of the Regulation 258/97
applications at issue in this dispute, we are not aware of the existence of such a request by an
applicant or of a situation where no further progr ess in the relevant Regula tion 258/97 procedure was
possible.
7.2217 Finally, we recall that in Section VII.D we have addressed whether the reason for the general
EC moratorium on final approvals could have provided a justificati on for delays which might have
occurred as a result of that moratorium. These earlier observations are relevant and applicable also to
our examination of the Regulation 258/97 approval procedures identified by the Complaining Parties.
7.2218 With these general observations in mind, we now proceed with the examination of the
individual complained against.
(ii) GA21 maize (food) (EC-91)
7.2219 Two Complaining Parties, the United States and Argentina, claim that the completion of the
approval procedure concerning GA21 maize (food) has been unduly delayed.
7.2220 The United States argues that the application concerning GA21 maize (food) under
Regulation 257/98 was delayed first at the member St ate level in that the lead CA (the Netherlands)

took at least 10 months more than required to co mplete its initial assessment. Subsequently, the SCF
failed to consider the application for 11 months , and later delayed issuing its assessment for 11
months without explanation. Finally, following the positive assessment of the SCF, the Commission
failed to submit a draft decision to the Regulatory Committee for approval of this product prior to the
establishment of the Panel. The United States cons iders these delays to be unwarranted and thus
undue.
7.2221 The United States observes that this product was under consideration by the lead CA between
the submission of the application in July 1998 an d the lead CA's opinion in January 2000. In
February 1999, the lead CA requested the appli cant to perform a further study on compositional
analysis, and the applicant provided its response in October 1999. Therefore, of the total 18 months
during which this product was considered at the member State level, only 8 were used by the
applicant to answer questions.
7.2222 The United States points out that the applica tion was forwarded to the Commission on 21
January 2000. The official member State cons ultation period was over by April 2000. The United
States notes that the Commission asked the SCF for an opinion on 18 May 2000. However, it was
eleven months later that the SCF contacted the applicant for the first time, asking for additional
information.
1586 Within less than one month, the appl icant provided answers to all questions. 1587 It
took a further 11 months for the SCF to issue an opinion on 27 February 2002. 1588 Hence the
application was delayed for 17 months at the Co mmunity level before the SCF rendered its positive
opinion on 27 February 2002. In its opinion, the SCF concluded that the data submitted, including the
two whole food studies, were "sufficient for evaluation" 1589 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 and derived products from conventional maize
lines."1590
7.2223 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. 1591 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."1592
7.2224 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

1586 Exhibit EC-91/At. 39.
1587 Exhibit EC-91/At. 40.
1588 The current revised regulatory framework recognizes that a period of six months is an achievable
timeframe for the EC's Scientific Authority (EFSA GMO Panel) to come to an opinion. Regulation (EC)
No. 1829/2003, Article 6.1.
1589 Exhibit EC-91/At. 43, pp. 11-12.
1590 Exhibit EC-91/At. 43.
1591 Exhibit EC-91/At. 44.
1592 Exhibit EC-91/At. 44.

feed as well as the labelling of GM products".
1593 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
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.
1594 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.
7.2225 The United States submits, in addition, that the application concerning GA21 maize (food) is
one of five applications identified by the Un ited States which are pending at Commission level and
which, as of the date of establishment of the Pane l, have been pending for an average of four years
and six months. The United States contends in this respect that although time alone is not dispositive,
in the light of the acknowledgement by EC official s of the existence of a moratorium on approvals,
this delay in completing the approval procedure concerning GA21 maize (food) is undue. The United
States submits, in addition, that before the European Communities adopted its moratorium, all
approval procedures under Directive 90/220 were undertaken and completed in less than three years.
7.2226 Argentina argues that consideration of the a pplication for GA-21 maize (food) under
Regulation 258/97 dragged on for a total of 5 years and 2 months without a definitive response.
Argentina further contends that the chronologies provided by the European Communities verify the
numerous opportunities in which information additional to what is necessary for appropriate control,
inspection and approval procedures was required from the applicant. Argentina contends that 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 indi cates that the application was withdrawn in
September 2003 because no progress had been made since 27 February 2002.
7.2227 The European Communities argues that the 18 months spent at member State level were due
to the incompleteness of the dossi er initially submitted and to the need for additional scientific
data.1595 The dossier was circulated at the Community level in January 2000, as required by the
regulation. Many member States requested additional information and raised questions, several raised
objections mainly on grounds of insufficient data on molecular characterisation and on compositional
analysis (substantial equivalence). In May 2000, the Commission requested the opinion of the SCF.
The SCF found that the dossier did not contain sufficient information concerning substantial
equivalence and toxicity testing, and had to requ est the relevant information from the applicant. 1596
The SCF finally issued its opinion February 2002.
7.2228 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

1593 Exhibit EC-91/At. 45, p. 1.
1594 Exhibit EC-91/At. 45, p. 2.
1595 Exhibit EC-91/At. 1-6.
1596 See Request of 24 April 2001 (Exhibit EC-91/At. 17).

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.
7.2229 In relation to Regulation 258/97, the European Communities contends that in terms of risk
management it became clear in 1999 that there woul d have to be new legislation addressing issues
such as labelling and traceability, and also the deve lopment and validation of detection methods. In
relation to the application concerning GA21 maiz e (food), the European Communities submits that
the SCF's opinion did not address sufficiently all rele vant elements. The elements which determined
the insufficiency of the SCF's opinion related to th e issues of validation of detection 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 not es that in view of the pending
legislative proposal for "Food and Feed", in June 2002 the applicant committed on a voluntary basis
to providing detection and validation methods for its product in collaboration with the Joint Research
Centre of the Commission (hereafter the "JRC").
7.2230 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.
7.2231 The Panel begins its analysis by addressing the Comm ission's failure up to August 2003 to
submit a draft measure to the Regulatory Committee.
Failure by the Commission to submit a draft measure to the Regulatory Committee

7.2232 We recall that the SCF issued a positive evaluati on of this application in February 2002.
Following the issuance of the SCF opinion, the Commission did not submit a draft measure to the
Regulatory Committee at any point up to August 2003. The United States a nd Argentina argue that
the Commission should have prepared and submitt ed a draft measure to the Regulatory Committee
shortly after the issuance of the SCF opinion.
7.2233 The record shows that some two months after the issuance in February 2002 of the favourable
opinion by the SCF Instead, on 23 April 2002, the applicant informed the Commission that it was no
longer seeking to obtain approval to place on the ma rket unprocessed GA21 maize grain for food use.
The applicant explained that this food use would be subject to Directive 90/220
1597, and noted that the
progress of the application concerning GA21 maize (EC-78) under Directive 90/220 had been
suspended for some time. The applicant was hoping that this move would enable the application
under Regulation 258/97 to proceed immediately.1598

1597 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]".
1598 Exhibit EC-91/At. 44.

7.2234 The record further shows that more than a month later, on 5 June 2002, the Commission
services met with the applicant. According to a Commission report about the meeting, the
Commission indicated at the meeting that "it wo uld be desirable that a [draft measure on the
application] would take into account in an appr opriate manner the legislative developments with
respect to the authorization of GM food an d feed as well as the labelling of GM products".
1599
Specifically, the Commission sought voluntary commitments with regard to the labelling of foods and
food ingredients derived from GA21 maize as well as with regard to detection methods and reference
materials.
7.2235 At the June 2002 meeting, the applicant agr eed to provide additional information and
materials, including a detection method, so as to provide a basis for traceability, as envisaged in the
new EC rules proposed by the Commission. The Co mmission's report of the meeting notes in this
regard that the Commission might present a draft measure to the Regulatory Committee in November
2002, provided that a validated detection method was av ailable by then. At the time of establishment
of the Panel, the question of the validation of the detection method had not yet been resolved, and so
by August 2003 no draft measure had been forwarded to the Regulatory Committee.
7.2236 The record of the approval procedure concerning GA21 maize (food) does not contain any
evidence to show that the Commission in this procedure launched inter- service consultations on a
draft measure after the issuance in February 2002 of the favourable opinion by the SCF. This
contrasts with the record of other approva l procedures which contains such evidence. 1600 Therefore,
we cannot assume that inter-service consultations were launched on a draft measure on GA21 maize
(food).
7.2237 Indeed, it appears that the Commission preferred first to explore whether the applicant would
be willing to provide certain add itional information, or to make certain additional commitments, on
the basis of proposals for new EC legislation. Wh ile we accept that the applicant's response could
have had an impact on the kind of draft measure on which the Commission would launch inter-service
consultations, this circumstance would not explain why the Commission waited for more than three
months after the issuance of the SCF opinion before approaching the applicant.
7.2238 Since the Commission was seeking voluntary comm itments, it was possible that the applicant
would reject the Commission's request in its entir ety. Had the applicant done so, the Commission
would have delayed the procedure by more th an three months, as the Commission would have
launched inter-service consultations only at that point.
7.2239 The record contains no information which sugg ests that June 2002 was the earliest date on
which the Commission could have sought the releva nt voluntary commitments. Indeed, the European
Communities itself stated in relation to Regulation 258/ 97 that in terms of risk management it became
clear in 1999 that there would have to be new legislation addressing issues such as labelling and
traceability, and also the development and validation of detection methods. In the light of this, we fail
to see why it would not have been possible for th e Commission to explore the possibility of voluntary
commitments with the applicant already in March 2002 rather than only in June 2002. Indeed, the
Commission had circulated proposals for appropriate EC legislation as early as July 2001. Had the
applicant said no to the Commission's request, this would have disposed of the issue.
7.2240 In fact, it is clear from the record that the applicant showed little interest in undertaking
additional commitments with regard to labe lling. However, the applicant did accept the

1599 Exhibit EC-91/At. 45.
1600 See, e.g., Exhibits EC-62/At. 76; EC-65/At. 60.

Commission's request to provide reference material and a detection method which was to be validated
by the Joint Research Centre of the Commission. It appears to us from the record that the applicant
accepted this request on the basis of the Commi ssion proposals for new legislation, since the
European Parliament was apparently scheduled to debate the proposals only in July 2002. This
supports our view that the Commission could have s ought this particular commitment prior to June
2002.
7.2241 The Commission's report of the June 2002 mee ting indicates that the Commission expected
"no particular problem with respect to the validation. However, the availability of reference material
has not been discussed."
1601 It is clear from this statement that the Commission was aware that
relevant material might or might not have been available, and that it was therefore possible that the
applicant would require time to put together releva nt data and material. Moreover, as this approval
procedure shows, a material transfer agreement need ed to be reached before any materials would be
transferred. Finally, the Commission in its repor t of the June 2002 meeting made clear that it would
not forward a draft measure to the Regulatory Committee until a detection method had been validated.
Therefore, had the applicant been made aware of the Commission's request earlier, the detection
method could have been validated sooner, and a draf t measure would also have been submitted to the
Regulatory Committee sooner.
7.2242 Taking account of the foregoing elements, we c onsider that for the purposes of exploring the
possibility of the applicant undertaking voluntary commitments, the Commission could, and should,
have approached the applicant soon after the issuance of the SCF opinion (or before) rather than more
than three months later.
7.2243 Based on the above considerations, the Panel is of the view that, in the specific circumstances
of this procedure, the time taken by the Commission to prepare and forward a draft measure to the
Regulatory Committee – and in particular the time taken by the Commission to explore the possibility
of the applicant undertaking voluntary commitments – was unjustifiably long.
7.2244 Regarding DS291, we recall that the United St ates claims that the approval procedure
concerning GA21 maize (food) was unduly delayed because, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and August 2003 and that (ii) the Commission's failure to submit a
draft measure to the Regulatory Committee meeti ng concerning GA21 maize (food) prior to August
2003 is consistent with the application of such a mo ratorium. In the light of this, and in the absence
of effective rebuttal by the European Communitie s, we agree with the United States that it is
reasonable to infer that the Commission's conduct was a consequence of the general moratorium on
approvals.
7.2245 In view of our conclusion with regard to th e Commission's failure to submit a draft measure
to the Regulatory Committee, we do not go on to ex amine other arguments put forward by the United
States and Argentina in support of their claim under A nnex C(1)(a), first clause , and Article 8 of the
SPS Agreement.

1601 Exhibit EC-91/At. 45.

Conclusions

7.2246 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 prepare a draft measure to be submitted to the Regulatory Committee
– and in particular the time taken to explore the possibility of the applicant
undertaking voluntary commitments – was unjustifiably long, and that it can
reasonably be inferred from surrounding circumstances that the Commission's
conduct was a consequence of the general moratorium on approvals. Based on these
findings, the Panel accepts the United States' contention that, consistent with the
general moratorium, the European Commun ities failed to consider the application
concerning GA21 maize (food) for final appr oval, and that this resulted in "undue
delay" in the completion of the relevant a pproval procedure. Accordingly, the Panel
concludes that in respect of the appr oval procedure concerning GA21 maize (food),
the European Communities has breached its obligations under Annex C(1)(a), first
clause, and Article 8 of the SPS Agreement.

 (ii) DS293 (Argentina)

 With reference to DS293, the Panel reca lls its finding that the time taken by the
Commission to prepare a draft measure to be submitted to the Regulatory Committee
– and in particular the time taken to explore the possibility of the applicant
undertaking voluntary commitments – was unjus tifiably long. In the light of this
finding, the Panel concludes that the Eur opean Communities failed to complete the
approval procedure concerning GA21 maiz e (food) without "undue delay", thus
breaching its obligations under Annex C(1)(a ), first clause, and Article 8 of the
SPS Agreement.

(iii) Bt-11 sweet maize (food) (EC-92)
7.2247 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning the Bt-11 sweet maize (food) has been unduly delayed.
7.2248 The United States submits that the processing of this application had been delayed at the
Commission stage of the process, as the Commission had refused to forward a draft measure to the
Regulatory Committee as is required to complete the approval process, and the request remained
blocked as of then.
7.2249 The United States also points out that the app lication concerning Bt-11 sweet maize (food) is
one of five applications identified by the Un ited States which are pending at Commission level and
which, as of the date of establishment of the Pane l, have been pending for an average of four years
and six months. The United States contends in this respect that although time alone is not dispositive,
in the light of the acknowledgement by EC official s of the existence of a moratorium on approvals,
this delay in completing the approval procedure co ncerning Bt-11 sweet maize (food) is undue. The
United States submits, in addition, that before th e European Communities adopted its moratorium, all
approval procedures under Directive 90/220 were undertaken and completed in less than three years.

7.2250 The European Communities notes that, after the lead CA sent its initial assessment report to
the Commission in May 2000, four member States raised objections and several more requested
additional information, relating mainly to the antibio tic resistance marker used (PAT protein) and to
the toxicity studies done in relation to this protein as well as to molecular characterization.
7.2251 The Commission requested the opinion of the SCF in December 2000. The SCF requested
further data which the applicant only supplied in Febr uary 2002. The SCF issued its opinion in April
2002, stating that on the basis of the information supplied in the application and further material
supplied by the applicant in response to queries ra ised by member States and in the light of the
published literature, it was to be c oncluded that Bt-11 sweet maize (f ood) was as safe for human food
use as its conventional counterparts.
7.2252 According to the European Communities, in view of the pending legislative proposal on
"Food and Feed", the applicant, on a voluntary basis, 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 and the method provided by the applicant perfo rmed very poorly in a pre-validation study.
The applicant delivered a proper method and all the necessary materials only by July 2003. The JRC
finalized the validation method in October 2003.
7.2253 In November 2003, the Commission submitted a draft measure to the Regulatory Committee.
At member States' request, however, the Commission di d not ask for a formal vote, given that several
member States considered that the scientific questions they had formulated earlier on the basis of their
conflicting national scientific evaluations were s till open, and others were still awaiting further
scientific risk assessments of their national scientific committees. Between October and early
December 2003, three new risk assessments were issued by the member States, all of which conflicted
with the SCF opinion.
7.2254 Finally, the Commission asked for the formal vot e on its draft measure. However, the draft
measure did not obtain a qualified majority in th e Regulatory Committee, nor subsequently in the
Council. The draft measure was adopted by the Commission on 19 May 2004.
7.2255 With regard to the period of time taken by the Commission before requesting the SCF for an
opinion, the United States maintains that when the application was first evaluated at the Community
level in 2000, member States objected on the basis not of scientific grounds, but the general
moratorium. The United States cites, as an exam ple, that Denmark's Agriculture and Fisheries
Council recalled "[i]n August 2000, Denmark submitte d an objection to the approval of Bt-11 maize
in respect of the novel food regulation with refe rence to the declaration approved by Denmark,
France, Italy, Greece and Luxembourg on the suspension of new GMO licenses (the moratorium
declaration), which was made at the Council me eting (environment) on 24-25 June 1999. The
objection included a reference to the fact that, pending the approval of a regulation that would
guarantee the labelling and effective tracing of GMOs and products derived from them, the
moratorium countries would block any new licens es for the cultivation and marketing of GMOs."
1602
Also in August 2000, France cited the yet to be im plemented food and feed regulations as a reason for
withholding support for Bt-11 sweet maize (food), c hoosing to disregard comprehensive scientific
findings and instead continue the moratorium on biotech reviews.1603

1602 Exhibit EC-92/At. 80.
1603 Exhibit EC-92/At. 23, p.2.

7.2256 According to the United States, there is no sci entific basis for the requests from Austria,
France and Greece for additional long-term animal feeding studies given the results of the
compositional analyses, and the fact that feeding studies conducted on Bt-11 field maize had been
provided along with simulated digestibility studies, and acute toxicity tests.
1604 Greece had
acknowledged that these latter studies "showed not a single adverse effect in the dosage tested." 1605
Furthermore, Greece did not identify, with any specifi city, any deficiencies in the data provided, nor
any reason to believe that these proteins would beha ve any differently than any other protein would
spontaneously develop new or different toxic prop erties or would otherwise interact with other
components of the food. Instead, Greece merely noted that "the in vitro methodology to study
degradability of Btk and PAT proteins can be improved", but failed to specify how.
7.2257 The key difference between sweet and field maize being that sweet maize has a higher
amount of natural sugars, the United States maintains th at there is no reason to believe that this fact
alone would render the results of the safety assessme nts conducted on the field maize inapplicable to
this product. Nonetheless, Austria, Greece a nd the United Kingdom also argued that additional
compositional and safety data were necessary to est ablish the equivalence between Bt-11 sweet maize
(food) and Bt-11 field maize. Austria summarily rejected the applicant's reliance on the risk
assessments conducted by the lead CA and the SCP on Bt-11 field maize, on the grounds that this
evidence "cannot be considered adequate since sweet maize and field maize have different component
spectrums."1606 Greece required "analyses for all the parameters" (especially for amino acids, fatty
acids, anti-nutrients and secondary plant substances) for both the Bt-11 sweet maize (food) and Bt-11
field maize, without identifying any unique prope rty that would make the Bt-11 sweet maize (food)
behave differently than all of the data indicated was likely. 1607 Even though the United Kingdom
acknowledged that "it is accepted that the protein [in sweet maize] is the same as in the field maize", it
nevertheless objected on the grounds that studies rela ting to the expression of the introduced genes in
sweet maize were necessary. 1608 No further explanation was provided for rejecting the results of the
safety data conducted on the parent field maize.
7.2258 The United States observes that these concerns were discounted by the SCF. Indeed, the SCF
noted that "the distinction between the results for the sweet maize and field maize is not relevant to
the assessment as long as the appropriate corresponding non-modified maize is used as control".1609
7.2259 With regard to the period after the positive asse ssment of the SCF in April 2002, the United
States notes that the European Communities attempts to justify delays in the processing of the Bt-11
application by claiming that "[b]etween October and early December 2003 [after the SCF positive
opinion], three new risks assessment were issued by the Member States, all of which conflicted with
the SCF opinion".
1610 These risk assessments we re supposedly provided by Austria, Belgium and
France. The United States maintain s that the EC contention is unsupported by the record. No risk
assessments were submitted during that time peri od, according to the European Communities' own
chronology. None of the documents submitted duri ng that time period contain any purported risk
assessments conducted by France, Austria, or Belgium. At the 10 November 2003 meeting of the

1604 The applicant had referenced the whole food feeding studies it had performed on Bt-11 field maize
in its submission of 28 November 1998. The European Communities did not provide the original submission of
6 April 1998 for processed products of sweet maize.
1605 Exhibit EC-92/At. 28.
1606 Exhibit EC-92/At. 25.
1607 Exhibit EC-92/At. 28.
1608 Exhibit EC-92/At. 22.
1609 Exhibit EC-92/At. 53, section 3.10.
1610 Responses by the European Communities to the questions posed by the Panel on 3 June 2004,
Response to Question 1.

Regulatory Committee,
1611 only a comment was provided by France, not a risk assessment. 1612 At the
Regulatory Committee meeting on 8 December 2003, Austria 1613, Belgium 1614 and France 1615
submitted written declarations to their votes. But none of these was a risk as sessment. Rather, when
the Regulatory Committee failed to obtain a qualified majority, it was because certain member States
objected due to the proposed new traceability an d labelling regulations (which did not become
effective until April 2004).1616
7.2260 The Panel begins its analysis by addressing the Comm ission's failure up to August 2003 to
submit a draft measure to the Regulatory Committee.
Failure by the Commission to submit a draft measure to the Regulatory Committee
7.2261 We recall that the SCF issued a positive eval uation of this application in April 2002.
Following the issuance of the SCF opinion, the Commission did not submit a draft measure to the
Regulatory Committee at any point up to August 20 03, although subsequently it did submit a draft
measure to the Regulatory Committee which was on the Committee's agenda in November 2003. The
United States argues that the Commission should have prepared and submitted a draft measure to the
Regulatory Committee shortly after the issuance of the SCF opinion in April 2002.
7.2262 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".
1617
7.2263 More specifically, the report of the meeting addresses the issue of " [d]etection methods,
traceability, reference materials [and] identification". According to th e report, the applicant "agree[d]
to provide" the necessary information and ma terials to the JRC in a timely manner. 1618 There is
nothing in the record which indicates that this "a greement" from the applicant was not voluntary. The
report notes that a draft measure might be presente d to the Regulatory Committee in November 2002,
provided that a validated detection method was availabl e by then. At the time of establishment of the

1611 Exhibit EC-92/At. 67.
1612 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.
1613 Exhibit EC-92/At. 71.
1614 Exhibit EC-92/At. 73.
1615 Exhibit EC-92/At. 72.
1616 Exhibit EC-92/Ats. 67 ("Finally, several 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 and76.
1617 Exhibit EC-92/At. 54.
1618 Ibid.

Panel, the question of the validation of the detec tion method had not yet been resolved, and so by
August 2003 no draft measure had been forwarded to the Regulatory Committee.
7.2264 The record of the approval procedure concerning Bt-11 sweet maize (food) does not contain
any evidence to show that the Co mmission in this procedure launched inter-service consultations on a
draft measure after the issuance in April 2002 of th e favourable opinion by the SCF. This contrasts
with the record of other approval pr ocedures which contains such evidence.
1619 Therefore, we cannot
assume that inter-service consultations were la unched on a draft measure on Bt-11 sweet maize
(food).
7.2265 Indeed, it appears that the Commission preferred first to explore whether the applicant would
be willing to provide certain add itional information, or to make certain additional commitments, on
the basis of proposals for new EC legislation. Wh ile we accept that the applicant's response could
have had an impact on the kind of draft measure on which the Commission would launch inter-service
consultations, this circumstance would not explain why the Commission waited for more than a
month and a half after the issuance of the SCF opinion before approaching the applicant.
7.2266 Since the Commission was seeking voluntary comm itments, it was possible that the applicant
would reject the Commission's request in its entir ety. Had the applicant done so, the Commission
would have delayed the procedure by more than a month and a half, as the Commission would have
launched inter-service consultations only at that point.
7.2267 The record contains no information which sugg ests that June 2002 was the earliest date on
which the Commission could have sought the releva nt voluntary commitments. Indeed, the European
Communities itself stated in relation to Regulation 258/ 97 that in terms of risk management it became
clear in 1999 that there would have to be new legislation addressing issues such as labelling and
traceability, and also the development and validation of detection methods. In the light of this, we fail
to see why it would not have been possible for th e Commission to explore the possibility of voluntary
commitments with the applicant earlier than only in June 2002. Indeed, the Commission had
circulated proposals for appropriate EC legislation as early as July 2001. Had the applicant said no to
the Commission's request, this would have disposed of the issue.
7.2268 In fact, the applicant did accept the Commission's request to provide reference material and a
detection method which was to be validated by th e Joint Research Centre of the Commission. It
appears to us from the record that the applicant accepted this request on the basis of the Commission
proposals for new legislation, since the European Pa rliament was apparently scheduled to debate the
proposals only in July 2002. This supports our vi ew that the Commission could have sought this
particular commitment prior to June 2002.
7.2269 As we have noted earlier in the context of the approval procedure concerning GA21 maize
(food), we have reason to believe that in seeking th e provision by the applicant of a detection method,
the Commission was aware that relevant reference ma terial might or might not have been available,
and that it was therefore possible that the applican t would require time to put together relevant data
and material. Moreover, as the European Communities itself points out, the amount of data and
material and the circumstances of their submission to the JRC needed to be agreed upon. Finally, the
Commission in its report of the June 2002 meeting made clear that it would not forward a draft
measure to the Regulatory Committee until a detection method had been validated. Therefore, had the
applicant been made aware of the Commission's request earlier, the detection method could have been

1619 See, e.g., Exhibits EC-62/At. 76; EC-65/At. 60.

validated sooner, and a draft measure would also have been submitted to the Regulatory Committee
sooner.
7.2270 In our view, since the Commission sought the provision of a detection method on a voluntary
basis, the Commission could even have approached the applicant prior to the issuance of the SCF
opinion in April 2002. The applicant would then have had the opportunity to make sure that reference
material and other documents and materials relevant to the validation of a detection method were
available if and when the Commission sought their tr ansmission. Indeed, we note that in the approval
procedure concerning NK603 maize (food), work on method validation was undertaken even before
the Commission had sought a scientific opinion of the EFSA.
1620
7.2271 Taking account of the foregoing elements, we c onsider that for the purposes of exploring the
possibility of the applicant undertaking voluntary commitments, the Commission could, and should,
have approached the applicant either before or s oon after the issuance of the SCF opinion rather than
more than a month and a half later.
7.2272 Based on the above considerations, the Panel is of the view that, in the specific circumstances
of this procedure, the time taken by the Commission to prepare and forward a draft measure to the
Regulatory Committee – and in particular the time taken by the Commission to explore the possibility
of the applicant undertaking voluntary commitments – was unjustifiably long.
7.2273 In addition, we recall that the United States claims that the approva l procedure concerning
Bt-11 sweet maize (food) was unduly delayed because, due to the moratorium, the European
Communities failed to consider the application in ques tion for final approval. In this respect, we note
our earlier findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and August 2003 and that (ii) the Commission's failure to submit a
draft measure to the Regulatory Committee meeting concerning Bt-11 sweet maize (food) prior to
August 2003 is consistent with the a pplication of such a moratorium. In the light of this, and in the
absence of effective rebuttal by th e European Communities, we agree with the United States that it is
reasonable to infer that the Commission's conduct was a consequence of the general moratorium on
approvals.
7.2274 In view of our conclusion with regard to th e Commission's failure to submit a draft measure
to the Regulatory Committee, we do not go on to ex amine other arguments put forward by the United
States and Argentina in support of their claim under A nnex C(1)(a), first clause , and Article 8 of the
SPS Agreement.
Conclusion

7.2275 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel reca lls its findings that the time taken by the
Commission to prepare a draft measure to be submitted to the Regulatory Committee
– and in particular the time taken to explore the possibility of the applicant
undertaking voluntary commitments – was unjustifiably long, and that it can
reasonably be inferred from surrounding circumstances that the Commission's
conduct was a consequence of the general moratorium on approvals. Based on these

1620 Exhibit EC-96/At. 34, as well as entries concerning 20 February 2003 and 31 March 2003.

findings, the Panel accepts the United States' contention that, consistent with the
general moratorium, the European Commun ities failed to consider the application
concerning Bt-11 sweet maize (food) for final approval, and that this resulted in
"undue delay" in the completion of the relevant approval procedure. Accordingly, the
Panel concludes that in respect of the approval procedure concerning Bt-11 sweet
maize (food), the European Communiti es has breached its obligations under
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.

(iv) LL soybeans (food) (EC-93)
7.2276 Two Complaining Parties, the United States and Argentina, claim that the completion of the
approval procedure concerning LL soybeans (food) has been unduly delayed.
7.2277 The United States submits that the lead CA (Belgium) refused to forward the application for
LL soybeans (food) for consideration at the Community level.
7.2278 The United States also points out that the application concerning LL soybeans (food) is one of
four applications identified by the United States wh ich have been pending at the member State level
for an average of three and one half years. The Un ited States contends in this respect 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 LL soybeans
(food) is excessive and unjustified a nd, hence, undue. The United States submits, in addition, that
before the European Communities adopted its moratorium, all approval procedures under
Directive 90/220 were undertaken and completed in less than three years.
7.2279 Argentina claims that as of the date of Argentina's first written submission the application
was delayed at the member State level for 5 years and 8 months without a final decision on its
approval. Argentina asserts that the European Communities neither processed the application nor
conducted the required risk assessment. Argentina argu es that there is no scientific justification for
the delay, as the "initial reports" were not prepared.
7.2280 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.
1621 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. 1622 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.
7.2281 The European Communities submits that the United States and Argentina choose to ignore the
fact that the applicant failed to provide the additi onal information that was requested by the lead CA
in April 1999, and by Greece and Italy in June and July 1999. According to the European
Communities, all three requests for additional in formation remained mostly unanswered. The
European Communities also notes that on 6 July 2004, the applicant withdrew its application.

1621 Exhibit EC-93/At. 11.
1622 Exhibit EC-93/Ats. 16 and 17.

7.2282 The Panel commences its analysis with the alleged delay at member State level.
Delay at member State level

7.2283 We note that contrary to what the European Communities asserts, the application concerning
LL soybeans (food) was with the Belgian CA as of ea rly December 1998, and not only as of February
1999.1623 On 8 December 1998, the Belgian Genera l Food Inspectorate requested the Belgian
Biosafety Council to prepare a first evaluation report within 90 days of referral of the file.
7.2284 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.1624
7.2285 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. 1625 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.
1626
7.2286 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 informati on referred to in the letter of April 1999. 1627 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 aforementioned two requests for additional
information.1628 The record indicates that as of August 2003, the applicant had still not fully replied to
the first request relating to substantial equivalence. 1629 It appears that the applicant responded to the
first request concerning the presence of PAT DNA and PA T protein in derived soya products, but it is
not clear when.1630
7.2287 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

1623 Exhibit EC-93/Ats. 1 and 3.
1624 Exhibit EC-93/At. 11.
1625 Ibid.
1626 Annex H, Dr. Nutti's response to Panel Question 48.
1627 Exhibit EC-93/At. 14.
1628 Exhibit EC-93/At. 13.
1629 Exhibit EC-93/At. 25.
1630 Ibid.

were justified.
1631 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. 1632 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.1633
7.2288 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. 1634 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.
7.2289 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.1635
7.2290 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.
7.2291 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. As al so noted, the part of the request which remained
unresolved, notwithstanding the applicant's undertaki ng to provide the relevant information, was
made known to the applicant already after the De cember 1998 meeting. It also appears that the
responses which were given by the applicant in r esponse to the April 1999 request were not provided
in a timely manner. Furthermore, the record s uggests 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.
7.2292 In the light of the foregoing elements, and in particular the fact that the applicant did not
provide information it apparently undertook to provid e and otherwise failed to respond to requests for
information which were not explic itly challenged, we are not pers uaded by the United States' and

1631 Annex H, Dr. Nutti's response to Panel Question 49.
1632 Exhibit EC-93/At. 21.
1633 Exhibit EC-93/At. 22.
1634 Annex H, Dr Nutti's responses to Panel Question 50.
1635 Exhibit EC-93/At. 25.

Argentina's assertion that the time taken by Belgium up to August 2003 to assess the application
concerning LL soybeans was unjustifiably long.
7.2293 In view of our conclusion with regard to the time taken by Belgium for its assessment, we go
on to examine other arguments put forward by the United States and Argentina in support of their
claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Total amount of time taken since submission of application

7.2294 The United States and Argentina also put forward the argument that the total amount of time
during which the application concerning LL soybeans (food) was pending is excessive and
unjustified. The application concerning LL soybeans (food) was first submitted for approval at the
end of November 1998. This means that as of August 2003, the approval procedure had been pending
for four years and nine months.
7.2295 We agree with the United States and Argentina that, in absolute terms, this is a long period of
time for an initial assessment. Howeve r, as we have explained earlier, the mere identification of the
total amount of time during which an application has been pending does not demonstrate, in and of
itself, that the time taken was unjustifiably long.
7.2296 The United States argues that that before there was an EC moratorium, approval procedures
used to be completed in less than three years. Even if the United States were correct, however, it must
be remembered that the Europ ean Communities assesses applicati ons on a case-by-case basis. Thus,
the fact that the approval procedure concerning LL soybeans (food) was not completed in less than
three years in our view does not demonstrate that it was not justifiable for the European Communities
to take more time to process that particular application.
7.2297 The United States further argues that in the light of the acknowledgement by EC officials of
the existence of a moratorium on approvals, the fact that the application in question lingered at the
member State level for well over four years demonstr ates the existence of undue delay. We recall in
this respect our finding that the record suppor ts the conclusion that the European Communities
applied a de facto moratorium on approvals as of June 1999. At that time, the application concerning
LL soybeans (food) had already been pending for almo st seven months. Thus, some of the total time
taken cannot be explained by the moratorium. Moreover, the mere fact that a general moratorium was
in effect does not necessarily imply that a particular application was affected by it. The United States
itself has repeatedly stated that "the moratorium wa s a decision by the EC not to move products to a
final decision in the approval process" and that "c ertain progress in the process, short of a final
decision, is not the least bit inconsiste nt with a moratorium on final approvals".
1636 Therefore, by
itself, the fact that a moratorium on approvals w as in effect between June 1999 and August 2003 is
not sufficient to demonstrate that the period of time during which the application concerning LL
soybeans (food) was pending as of August 2003 reflects a failure on the part of the lead CA to
complete the relevant approval procedure without undue delay.
7.2298 Accordingly, the Panel is unable to accept the United States' and Argentina's assertion that the
total period of time during which the application concerning LL soybeans (food) had been pending as
of August 2003 demonstrates that the time taken was unjustifiably long.

1636 See, e.g., US second written submission, para. 51 (emphasis in original).

Conclusions

7.2299 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that it has not been established
that the time taken by the lead CA for its initial assessment of the application
concerning LL soybeans (food) was unjustifiably long, or that the total period of time
during which the application concerning LL soybeans (food) had been pending as of
August 2003 demonstrates that the time taken by the European Communities was
unjustifiably long. Based on these findings , the Panel is unable to accept the United
States' contention that, consistent with the general moratorium, the European
Communities failed to consider the app lication concerning LL soybeans (food) for
final approval, and that this resulted in "undue delay" in the completion of the
relevant approval procedure. Accordingly, the Panel concludes that in respect of the
approval procedure concerning LL soybeans (food), the United States has failed to
establish that the European Communiti es has breached its obligations under
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.

 (ii) DS293 (Argentina)

 With reference to DS293, the Panel recalls its findings that it has not been established
that the time taken by the lead CA for its initial assessment of the application
concerning LL soybeans (food) was unjustifiably long, or that the total period of time
during which the application concerning LL soybeans (food) had been pending as of
August 2003 demonstrates that the time taken by the European Communities was
unjustifiably long. In the light of these findings, the Panel concludes that in respect
of the approval procedure concerning LL soybeans (food), Argentina has failed to
establish that the European Communiti es has breached its obligations under
Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.

(v) MON810 x GA21 maize (food) (EC-94)
7.2300 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning MON810 x GA21 maize (food) has been unduly delayed.
7.2301 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.
7.2302 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
1637 and was notified in 1998 on the basis of an opi nion of substantial equivalence as required
under Regulation 258/97 in 1998.1638 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]."
1639 At the time of establishment of the
Panel, the approval of GA21 maize (food) under Regulation 258/97 had not yet been granted.
7.2303 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. 1640 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.
7.2304 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.
1641 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.
7.2305 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. 1642 The lead CA also
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

1637 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).
1638 Exhibit US-132.
1639 Exhibit EC-94/At. 11.
1640 Exhibit EC-94/At. 12.
1641 Exhibit EC-82/At. 9.
1642 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).

transgenic parental lines.
1643 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.
7.2306 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. 1644 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." 1645 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.
7.2307 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).
7.2308 The United States submits, in addition, that the application concerning MON810 x GA21
maize (food) is one of four applications identifie d by the United States which have been pending at
the member State level for an average of three and one half years. The United States contends in this
respect that although time alone is not dispositive, in the light of the acknowledgement by EC officials
of the existence of a moratorium on approvals, this delay in completing the approval procedure
concerning MON810 x GA21 maize (food) is undue. The United States further argues that before the
European Communities adopted its moratorium, a ll approval procedures under Directive 90/220 were
undertaken and completed in less than three years.
7.2309 The European Communities argues that the lead CA requested additional information from
the applicant in July 2000, and that that 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. The request was made on valid grounds. Therefore, the delay caused by it cannot be
considered "undue." The European Communities adds that issues such as mo lecular characterization
of inserted DNA from transgenic parent lines, th e determination of fla nking DNA or compositional
analysis, still remain unaddressed. Furthermore, 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.
7.2310 The Panel commences its analysis with the alleged delay at member State level.

1643 Exhibit EC-94/At. 2.
1644 Exhibit EC-94/At. 10.
1645 Ibid.

Delay at member State level

7.2311 We recall that although the application was su bmitted on 29 February 2000, the record shows
that the first contact by the lead CA to request additional information from the applicant occurred only
on 17 July 2000 1646, i.e., more than four and a half months after receipt of the application. The
response to the July 2000 request for information was provided by the applicant only on 15 February
2002. Subsequently, there was a further, five-mont h delay before the lead CA followed up with the
applicant to request additional information on 2 July 2002. Finally, we note that no information has
been provided regarding any action on this app lication 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.
7.2312 The United States contends that the lengthy dela y caused by the applicant due to the time it
took to respond to the July 2000 request for info rmation occurred, in part, because there was no
justification for requesting the relevant data. In our earlier findings, we observed that the experts
expressed the view that whereas some of the inform ation requested by the lead CA was not necessary
to ensure the validity of the safety assessment, othe r requested information was indeed needed. We
also previously noted the disagreement of the European Communities with the views expressed by the
experts regarding the need for the data requested.
7.2313 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 could not provide a
justification for the time taken by the lead CA fo r its assessment of the application both before and
after the July 2000 request for information.
7.2314 In examining the issue of the time taken by th e lead CA before and after the July 2000
request, we first recall that Regulation 258/97 provi des that the lead CA should complete its initial
assessment within three months of receipt of an ap plication which contains the necessary information.
We recognize that the question of whether or not the lead CA complied with the three-month deadline
stipulated in Regulation 258/97 is not dispositive, per se, of whether the European Communities met
its WTO obligation to complete its approval procedures without undue delay. This said, in the Panel's
view, the deadline set forth in Regulation 258/97 provides a useful indicator to guide the Panel's
analysis. The three-month deadline is binding and a pplies to all relevant applications submitted under
Regulation 258/97. It may therefore be assumed that the EC legislator set this binding deadline in
such a way as to make it possible for the CAs of all member States to assess even complex
applications within the prescribed deadline.
7.2315 We first turn to consider the time taken by th e lead CA before forwarding its initial request
for information of July 2000. We note that when the Commission circulated notice of this application
to all member States, it indicated that the initial assessment was to be completed by the lead CA by 16
June 2000 at the latest.
1647 However, by 16 June 2000, the l ead CA not only had not completed its
initial assessment, but it apparently had not even iden tified any need for further information. It was
not until one full month after the deadline circulated by the Commission that the lead CA forwarded
an initial request for information.
7.2316 The European Communities asserts that all of th e time taken by the lead CA was necessary to
resolve scientific and technical issues, but provides no specific justification for the time taken by the
lead CA up to July 2000. Even if it were accepted that in this procedure the lead CA could not have

1646 Exhibit EC-94/At. 12.
1647 Exhibit EC-94/At. 5.

met the mid-June deadline circulated by the Commission, this would not imply that the lead CA could
not have requested missing information much sooner, rather than a full month after the date on which
it should have completed its entire initial assessment.
7.2317 We note that three member States submitted substantive comments or requests for further data
prior to July 2000.
1648 However, Regulation 258/97 does not require the lead CA to await comments
from other member States, let alone possible r esponses thereto from the applicant, prior to
undertaking its initial assessment.
7.2318 We have previously pointed out that the Netherlands 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. However, in this instance, we are
not convinced that the Dutch CA's conduct reflects a precautionary approach. Indeed, we are not
convinced that the Dutch CA could not have id entified any need for additional information and
forward an appropriate request for information to the applicant sooner than it did even while
following a precautionary approach.
7.2319 We now turn to the time taken by the lead CA after it had received the applicant's response to
its initial request for information of July 2000. As we indicated above, four and a half months lapsed
between the receipt of the information requested in July 2000 and the next request, in July 2002, for
additional information. Thus, the lead CA took more time to assess the additi onal information than it
should have used, in accordance with Regulation 258/97, to complete its entire initial assessment.
7.2320 As with the time taken by the lead CA up to th e first request for information, the European
Communities asserts that the time taken by the l ead CA up to the second request for information was
necessary to resolve scientific and technical issues. However, the European Communities provides no
specific justification for why the lead CA required mo re than four and a half months to complete its
consideration of the responses provided and to identify short-comings. It is pertinent to note in this
respect that the information provided by the app licant in response to the July 2000 request was 34
pages long. Given this, and in the absence of a specific justification offered by the European
Communities, we are not convinced that the lead CA could not have evaluated much sooner than it
did whether additional information was still needed. We also consider that the Dutch CA could have
forwarded its July 2002 request for additional informa tion to the applicant at a much earlier date even
while following a precautionary approach.
7.2321 In relation to the time taken by the lead CA both before and after the July 2000 request for
information, we note, as an additional matter, the European Communities argument that the
assessment of a hybrid product such as MON810 x GA21 maize cannot be concluded as long as the
assessment of one of its parental lines is still open. Thus, the European Communities appears to argue
that the time taken by the lead CA to assess the application concerning MON810 x GA21 maize
(food) is justified 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, GA21 maize (food).
7.2322 It is correct that between February 2000 and July 2002, the application concerning GA21
maize (food) was still being evaluated at Community level. However, the record does not indicate
that the Dutch CA ever stated that it was unabl e to proceed due to the failure of the European
Communities to approve the GA21 maize (food) parent . Moreover, we recall that it was the same
Dutch CA which assessed the application concerning GA21 maize (food) and which in late January
2000 forwarded it to the Commission with a favourable assessment. Therefore, we see no reason why

1648 Exhibit EC-94/Ats. 9-11.

the Dutch 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.
7.2323 As a general matter, it may be correct to say , as the European Communities does, 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 context of the assessment of the hybrid. At any rate, the Dutch CA c ould not have "concluded"
the assessment of the application concerning MON810 x GA21 maize (food) completely on its own.
If other member States had concerns with the Dutch assessment of the application concerning GA21
maize (food) (even though that assessment was confir med by the SCP in early 2002), they could have
raised an objection on that basis to the Dutch assessment of the application concerning MON810 x
GA21 maize (food) and the assessment of that app lication would then have been "concluded" at
Community level.
7.2324 For these reasons, it is not apparent to us that the Dutch CA needed to keep, or would have
been justified in keeping, the application at the me mber State level in order to avoid the possibility of
conflicting assessments of MON810 x GA21 maize (food), and we therefore do not consider that the
fact that one of the parental lines was still pending justified the Netherlands in not completing its
assessment of the application concerning MON810 x GA21 maize (food).
7.2325 Taking account of all of the aforementioned elem ents, we consider that upon receipt of the
original application and subsequently upon on receipt of the information requested by it in July 2000,
the lead CA could, and should, have determined more promptly that additional information was
needed and could, and should, have forwarded appropriate requests to the applicant more promptly.
7.2326 Based on the above considerations, we therefore conclude that the time taken by the lead CA
for its assessment of the application concer ning MON810 x GA21 maize (food) was unjustifiably
long.
7.2327 In addition, we recall that the United States claims that the approva l procedure concerning
MON810 x GA21 maize (food) was unduly delayed becau se, due to the moratorium, the Netherlands
failed to consider the application in question for fi nal approval. In this respect, we note our earlier
findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and A ugust 2003 and that (ii) the tim e taken by the Netherlands for
its initial assessment of MON810 x GA21 maize (food) 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 that it is reasonable to infer that the Netherlands'
conduct was a consequence of the general moratorium on approvals.
7.2328 In view of our conclusion with regard to th e time taken by the Netherlands for its initial
assessment, we do not go on to examine other argumen ts put forward by the United States in support
of its claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Conclusion

7.2329 In the light of the above, we reach the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that the time taken by the lead
CA for its assessment of the applicatio n concerning MON810 x GA21 maize was

unjustifiably long, and that it can reasonably be inferred from surrounding
circumstances that the l ead CA's conduct was a consequence of the general
moratorium on approvals. Based on these findings, the Panel accepts the United
States' contention that, consistent with the general moratorium, the European
Communities failed to consider the app lication concerning MON810 x GA21 maize
(food) for final approval, and that this resu lted in "undue delay" in the completion of
the relevant approval procedure. Accordingl y, the Panel concludes that in respect of
the approval procedure concerning MON810 x GA21 maize (food), the European
Communities has breached its obligations under Annex C(1)(a), first clause, and
Article 8 of the SPS Agreement.

(vi) Bt-1507 maize (food) (EC-95)
7.2330 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning Bt-1507 maize (food) has been unduly delayed.
7.2331 The United States argues that the lead CA (Netherlands ) refused to forward this application
to the Commission, thereby unduly delaying its consideration for approval.
7.2332 The United States also points out that the application concerning Bt-1507 maize (food) is one
of four applications identified by the United Stat es which have been pending at the member State
level for an average of three and one half years. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
Bt-1507 maize (food) is undue. The United States subm its, in addition, that before the European
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were
undertaken and completed in less than three years.
7.2333 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 characterization, and event-specific detection methods. The lead
CA finalized the initial assessment report in Novemb er 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.
7.2334 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.
7.2335 The Panel notes that the United States' claim is based on an alleged delay at member State
level.

Delay at member State level

7.2336 We recall that the application concerning Bt-1507 maize (food) was submitted on 15 February
2001. However, the first request for additional information from the lead CA was made only on
28 June 2001, i.e., almost four and a half months followi ng receipt of the application. Although the
applicant apparently provided a partial response in November 2001, it appears that it did not provide
all of the information requested until 12 February 2003. Following the twenty-month period taken by
the applicant to provide all the in formation requested, in March 2003, the lead CA requested further
clarifications, which were provide d in May 2003. In June 2003, the lead CA posed questions in
relation to the applicant's May 2003 reply. The ap plicant provided answers by 9 July 2003. 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.
7.2337 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
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 conclusions of the safety assessment were valid. We recall that the
experts considered that some of the information requested by the lead CA in June 2001 was not
necessary to ensure the validity of the safety assessment for Bt-1507 maize (food). This included
some of the information which was not provided by the applicant until February 2003.
7.2338 Even if we were to accept that all of the inform ation requested by the lead CA in June 2001
was necessary to ensure the validity of the safety assessment, this could not provide a justification for
the time taken by the lead CA for its assessment of the application before the June 2001 request for
information. We recall that the application con cerning Bt-1507 maize (food) had been under review
in the Netherlands for more than four and a half months before the Dutch CA forwarded its June 2001
request for information.
7.2339 In examining the issue of the time taken by the lead CA before the June 2001 request, we first
recall that Regulation 258/97 provides that the lead CA should complete its initial assessment within
three months of receipt of an application which contains the necessary information. We recognize
that the question of whether or not the lead CA co mplied with the three-month deadline stipulated in
Regulation 258/97 is not dispositive, per se , of whether the European Communities met its WTO
obligation to complete its approval procedures without undue delay. This said, in the Panel's view,
the deadline set forth in Regulation 258/97 provides a useful indicator to guide the Panel's analysis.
The three-month deadline is binding and appli es to all relevant app lications submitted under
Regulation 258/97. It may therefore be assumed that the EC legislator set this binding deadline in
such a way as to make it possible for the CAs of all member States to assess even complex
applications within the prescribed deadline.
7.2340 We note that by the time the lead CA forwarded its first request for information at the end of
June 2001, the lead CA had already exceeded the three-month period envisaged in Regulation 258/97
by a month and a half, yet it was far from completing its initial assessment. The European
Communities asserts that all of the time taken by th e lead CA was necessary to resolve scientific and
technical issues, but provides no specific justification for the time taken by the lead CA up to the end
of June 2001. Even if it were accepted that in th is procedure the lead CA could not have completed
its initial assessment within the th ree-month period provided for in Regulation 258/97, this would not
imply that the lead CA could not have requested missing information much sooner. Given the three-
month maximum assessment period envisaged in Regulation 258/97, and lacking a specific
justification by the European Communities, we are not convinced that the lead CA could not have
evaluated much more promptly than it did whether additional information was still needed.

7.2341 We have previously pointed out that the Netherlands 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. However, in this instance, we are
not convinced that the Dutch CA's conduct reflects a precautionary approach. Indeed, we are not
convinced that the Dutch CA could not have id entified any need for additional information and
forwarded an appropriate request for information to the applicant sooner than it did even while
following a precautionary approach.
7.2342 Taking account of all of the aforementioned elem ents, we consider that upon receipt of the
original application, the lead CA could, and shou ld, have determined more promptly that additional
information was needed and could, and should, have forwarded an appropriate request to the applicant
more promptly.
7.2343 Based on the above considerations, we thus conc lude that the time taken by the lead CA for
its assessment of the application concerning Bt-1507 maize (food) – and in particular the time taken
by the lead CA before forwarding its first request for additional information – was unjustifiably long.
7.2344 In addition, we recall that the United States claims that the approva l procedure concerning
Bt-1507 maize (food) was unduly delayed because, due to the moratorium, the Netherlands failed to
consider the application in question for final appr oval. In this respect, we note our earlier findings
that (i) a general de facto moratorium on approvals was in e ffect in the European Communities
between June 1999 and August 2003 and that (ii) the failure of th e Netherlands to complete the initial
assessment of the application concerning Bt-1507 ma ize (food) by August 2003 is consistent with the
application of such a moratorium. In the light of this, and in the absence of effective rebuttal by the
European Communities, we agree with the United St ates that it is reasonable to infer that the
Netherlands failure to complete its initial asse ssment by August 2003 was a consequence of the
general moratorium on approvals.
7.2345 In view of our conclusion with regard to th e time taken by the Netherlands for its initial
assessment, we do not go on to examine other argumen ts put forward by the United States in support
of its claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
Conclusion

7.2346 In the light of the above, we reach the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that the time taken by the lead
CA for its assessment of the application concerning Bt-1507 maize (food) –
particularly the time taken prior to the lead CA's initial request for additional
information – was unjustifiably long, and that it can reasonably be inferred from
surrounding circumstances that the lead CA's conduct was a consequence of the
general moratorium on approvals. Base d on these findings, the Panel accepts the
United States' contention that, consistent w ith the general moratorium, the European
Communities failed to consider the appli cation concerning Bt-1507 maize (food) for
final approval, and that this resulted in "undue delay" in the completion of the
relevant approval procedure. Accordingly, the Panel concludes that in respect of the
approval procedure concerning Bt-1507 maize (food), the European Communities has
breached its obligations under Annex C(1)(a ), first clause, and Article 8 of the
SPS Agreement.

(vii) NK603 maize (food) (EC-96)
7.2347 Two Complaining Parties, the United States and Argentina, claim that the completion of the
approval procedure concerning NK603 maize (food) has been unduly delayed.
7.2348 The United States argues that although the application concerning NK603 maize (food)
eventually received a positive assess ment from the lead CA (Netherlands), this product 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 three and a half months were used by the applicant to provide additional
information; the lead CA used the remaining fourteen and a half months.
7.2349 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.
1649 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
food safety. The United States observes that the ap plicant nevertheless conducted the requested test,
which identified no adverse effects.
7.2350 The United States further argues that once the application had reached the Community level
Austria filed an objection in respect of the application for NK603 maize (food) on the grounds that not
only acute but also sub-chronic, mutagenic, repr oductive and ecotoxic effects of the protein (EPSPS)
should be studied. However, Austria failed to discuss the results of the acute studies, or to provide an
explanation of why the proteins in this product would behave differently than all available data
indicate is likely. The United States submits that given that EPSPS proteins are commonly found in a
wide variety of food sources which have a long history of safe use, the available information
regarding the enzyme function of the protein, lack of homology to toxic proteins based on
bioinformatics searches, and lack of acute oral toxi city when administered to mice at high doses, the
additional toxicological testing for the EPSPS prot ein that Austria demanded is unfounded and
unreasonable. Such testing exceeds Codex Alimentarius guidelines,
1650 as well as the European
Communities' own Scientific Committee Guidance Docu ment for the Risk Asse ssment of Genetically
Modified Plants and Derived Food and Feed (March 2003).
7.2351 The United States submits, in addition, that the application concerning NK603 maize (food) is
one of five applications identified by the Un ited States which are pending at Commission level and
which, as of the date of establishment of the Pane l, have been pending for an average of four years
and six months. The United States contends in this respect that although time alone is not dispositive,
in the light of the acknowledgement by EC official s of the existence of a moratorium on approvals,
this delay in completing the approval procedur e concerning NK603 maize (food) is undue. The

1649 Exhibit EC-96/At. 7.
1650 The United States refers to Codex Alimentarius, "Guideline for the Conduct of Food Safety
Assessment of Foods Derived from Recombinant-DNA Plants", CAC/GL 45-2003, paras. 37, 38.

United States submits, in addition, that before th e European Communities adopted its moratorium, all
approval procedures under Directive 90/220 were undertaken and completed in less than three years.
7.2352 Argentina argues that NK603 maize (food) was stalled at various stages of the approval
process under Regulation 258/97. Argentina notes that the assessments performed by the lead CA and
subsequently the EFSA concluded th at there was no evidence of risk to human health or life.
Therefore, it is clear that the delays by the lead CA to complete its initial assessment and forward this
application to the Commission were not justified.
7.2353 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 eighteen m onths 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.
7.2354 The European Community further notes that th e Commission circulated the dossier to all
member States in January 2003. Three member Stat es raised objections and several others requested
additional information. The European Comm unities points out in this connection that
Regulation 258/97, in general term s, provided an adequate framework for a risk assessment for GM
food products. However, in terms of risk management, it became cl ear in 1999 that there would have
to be new legislation addressing some issues su ch as labelling and traceability, and also the
development and validation of de tection methods. The application concerning NK603 maize (food)
was partially affected by this situation as it had reached the Community level and the stage of risk
management considerations. Thus, it was considered necessary to require the validation of a detection
method as a pre-condition for marketing approval. This was done on the basis of a voluntary
agreement with the applicant. These detection methods were validated for NK603 maize (food) and
the decision-making process was launched immediately after.
7.2355 The Panel commences its analysis with the alleged delay at member State level.
Delay at member State level

7.2356 We recall that the applicant first submitted the a pplication 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. However, the first request for
additional information from the lead CA was made onl y in December 2001, more than four and a half
months later. In August 2002, five months after the applicant supplied the information requested by
the lead CA, the lead CA's advisory body, th e Dutch Health Council's Committee on the Safety
Assessment of Novel Foods, finished its assess ment report. It was not until November 2002,
however, that the lead CA forwarded its assessment report to the Commission.
7.2357 It is clear from the foregoing that the December 2001 request for information led to delay in
the consideration of this application inasmuch as the applicant took more than three months and a half
to respond to the request. We asked the experts advising us for their views on the necessity of the
information requested by the lead CA in December 2001 to ensure that the conclusions of the safety
assessment were valid. We recall the view expressed by one of the experts that the request in question
was not necessary to ensure the validity of the safety assessment.
7.2358 However, even accepting that the information requested by the lead CA in December 2001
was appropriate to ensure the validity of the safet y assessment, this could not provide a justification

for the time taken by the lead CA to assess the ap plication. 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.
1651 Moreover, once the applicant
had provided information in response to the Dutc h CA's December 2001 request for information, the
Health Council's Committee on the Safety Assessment of Novel Foods still took more than four
months to complete its initial assessment report. Wh ile 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.
7.2359 In examining the issue of the time taken by th e lead CA for its assessment of the application
concerning NK603 maize (food), we first recall that Regulation 258/97 provides that the lead CA
should complete its initial assessment within three months of receipt of an application which contains
the necessary information. We recognize that the question of whether or not the lead CA complied
with the three-month deadline stipulated in Regulation 258/97 is not dispositive, per se, of whether
the European Communities met its WTO obligation to complete its approval procedures without
undue delay. This said, in the Panel's view, the deadline set forth in Regulation 258/97 provides a
useful indicator to guide the Panel's analysis. Th e three-month deadline is binding and applies to all
relevant applications s ubmitted under Regulation 258/97 . It may therefore be assumed that the EC
legislator set this binding deadlin e in such a way as to make it possible for the CAs of all member
States to assess even complex applications within the prescribed deadline.
7.2360 We first turn to consider the time taken by th e lead CA before forwarding its initial request
for information of December 2001. We note that by the time the lead CA forwarded its first request
for information, the lead CA had already ex ceeded the three-month period envisaged in
Regulation 258/97 by more than four months, ye t it was far from completing its initial assessment. 1652
The European Communities asserts that all of the tim e taken by the lead CA was necessary to resolve
scientific and technical issues, but provides no specifi c justification for the time taken by the lead CA
up to December 2001. Even if it were accepted that in this procedure the lead CA could not have
completed its initial assessment within the three-month period provided for in Regulation 258/97, this
would not imply that the lead CA could not have requested missing information much sooner. Given
the three-month maximum assessment period envisage d in Regulation 258/97, and lacking a specific
justification by the European Communities, we are not convinced that the lead CA could not have
evaluated much more promptly than it did whether additional information was still needed.
7.2361 We have previously pointed out that the Netherlands 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. However, in this instance, we are
not convinced that the Dutch CA's conduct reflects a precautionary approach. Indeed, we are not
convinced that the Dutch CA could not have id entified any need for additional information and
forwarded an appropriate request for information to the applicant sooner than it did even while
following a precautionary approach.
7.2362 Taking account of the aforementioned elements, we consider that upon receipt of the original
application, the lead CA could, and should, ha ve determined more promptly that additional
information was needed and could, and should, have forwarded an appropriate request to the applicant
more promptly.

1651 The application had been under re view for more than four months after receipt of copies of the
cited literature and data. These copies were not requeste d by the lead CA until two months after receipt of the
application.
1652 Even if it were considered that a complete app lication was only available as of the end of July
2001, the lead CA would still have exceeded the three-month period by more than four and a half months.

7.2363 We now turn to consider the time taken by the lead CA to complete and forward its
assessment report. To recall, five months after the applicant supplied the information requested by the
lead CA in December 2001, the lead CA's scientific advisory body in August 2002 finished its
assessment report. However, the lead CA did no t forward its assessment report to the Commission
until November 2002, i.e., for more than two and a half months.
7.2364 While accepting that the advisory body's assessment report needed to be adopted by the Dutch
CA, we recall that in accordance with Regulation 2 58/96 the Dutch CA was required to complete its
entire initial assessment within no more than three months. Given this, and lacking a specific
justification by the European Communities, we are not convinced that the Dutch CA could not have
adopted the report in question much sooner than it did in the case of the application concerning
NK603 maize (food).
7.2365 Thus, based on the above considera tions, we conclude that the time taken by the lead CA for
its assessment of the application concerning NK603 maize (food) – and in particular the time taken by
the lead CA before forwarding its first request for additional information as well as the time taken by
the lead CA to forward its completed assessment report – was unjustifiably long.
7.2366 In addition, we recall that the United States claims that the approva l procedure concerning
NK603 maize (food) was unduly delayed because, due to the moratorium, the European Communities
failed to consider the application in question for fi nal approval. In this respect, we note our earlier
findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and August 2003 and that (ii) the time taken by the Netherlands to
complete its initial assessment of the application concerning NK603 ma ize (food) is consistent with
the application of such a moratorium. In the light of this, and in the absence of effective rebuttal by
the European Communities, we agr ee with the United States that it is reasonable to infer that the
Netherlands' conduct was a consequence of the general moratorium on approvals.
7.2367 In view of our conclusion with regard to th e time taken by the Netherlands for its initial
assessment, we do not go on to examine other arguments put forward by the United States and
Argentina in support of their claim under Annex C(1)(a), first clause, and Article 8 of the
SPS Agreement.
Conclusions

7.2368 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that the time taken by the lead
CA for its assessment of the application concerning NK603 maize (food) –
particularly the time taken by the lead CA before forwarding its first request for
additional information as well as the time taken by the lead CA to forward its
completed assessment report – was unjustifia bly long, and that it can reasonably be
inferred from surrounding circumstances that the lead CA's conduct was a
consequence of the general moratorium on approvals. Based on these findings, the
Panel accepts the United States' contenti on that, consistent with the general
moratorium, the European Communities failed to consider the application concerning
NK603 maize (food) for final approval, and that this resulted in "undue delay" in the
completion of the relevant approval procedure. Accordingly, the Panel concludes that
in respect of the approval procedure c oncerning NK603 maize (food), the European

Communities has breached its obligations under Annex C(1)(a), first clause, and
Article 8 of the SPS Agreement.

 (ii) DS293 (Argentina)

 With reference to DS293, the Panel recalls its finding that the time taken by the lead
CA for its assessment of the application concerning NK603 maize (food) –
particularly the time taken by the lead CA before forwarding its first request for
additional information as well as the time taken by the lead CA to forward its
completed assessment report – was unjustifiably long. In the light of this finding, the
Panel concludes that the European Comm unities failed to complete the approval
procedure concerning NK603 maize (food) with out "undue delay", thus breaching its
obligations under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.

(viii) RR sugar beet (food) (EC-102)
7.2369 One Complaining Party, the United States, claims that the completion of the approval
procedure concerning RR sugar beet (food) has been unduly delayed.
7.2370 The United States argues that the lead CA (Netherlands) refused to forward the application to
the Commission and that this resulted in undue delay.
7.2371 The United States also points out that the app lication concerning RR suga r beet (food) is one
of four applications identified by the United Stat es which have been pending at the member State
level for an average of three and one half years. The United States contends in this respect that
although time alone is not dispositive, in the light of the acknowledgement by EC officials of the
existence of a moratorium on approvals, this dela y in completing the approval procedure concerning
RR sugar beet (food) is undue. The United States s ubmits, in addition, that before the European
Communities adopted its moratorium, all a pproval procedures under Directive 90/220 were
undertaken and completed in less than three years.
7.2372 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.
7.2373 The Panel commences its analysis with the alleged delay at member State level.
Delay at member State level

7.2374 We recall that the applicant submitted the app lication concerning RR sugar beet (food) to the
lead CA on 3 November 1999. However, the first request for additional information from the lead CA
was made only on 24 March 2000, almost five mont hs later. The applicant responded one month
later. In May 2000, the lead CA requested furthe r information. That information was provided on 7
December 2000. On 16 May 2001, after review ing the additional information provided by the
applicant in December 2000, the lead CA requested further information. The lead CA indicated that it
was not yet fully satisfied with the information pr ovided by the applicant concerning the likelihood of
specific protein formation. In addition, menti oning recent studies which had shown that "unintended
effects on GMOs" were possibly caused by transformati on 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".
1653 No specific study was cited in this regard. There is no indication in the
evidence before us that the applicant responded to the requests from the lead CA for further
information prior to August 2003.
7.2375 We sought the advice of the experts assisting us regarding whether the additional information
requested by the lead CA in May 2001 was necessar y to ensure that the conclusions of the safety
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".1654
7.2376 Even accepting that contrary to the views of Dr. Nutti the information requested in May 2001
was necessary to ensure the validity of the safety assessment, this would not provide a justification for
the time taken by the lead CA before initially requesting additional information in March 2000
(almost five months), and the time taken to revi ew the information received in December 2000 (five
months).
7.2377 In examining the issue of the time taken by th e lead CA for its assessment of the application
concerning RR sugar beet (food), we first recall that Regulation 258/97 provides that the lead CA
should complete its initial assessment within three months of receipt of an application which contains
the necessary information. We recognize that the question of whether or not the lead CA complied
with the three-month deadline stipulated in Regulation 258/97 is not dispositive, per se, of whether
the European Communities met its WTO obligation to complete its approval procedures without
undue delay. This said, in the Panel's view, the deadline set forth in Regulation 258/97 provides a
useful indicator to guide the Panel's analysis. Th e three-month deadline is binding and applies to all
relevant applications s ubmitted under Regulation 258/97 . It may therefore be assumed that the EC
legislator set this binding deadlin e in such a way as to make it possible for the CAs of all member
States to assess even complex applications within the prescribed deadline.
7.2378 We first turn to consider the time taken by th e lead CA before forwarding its initial request
for information of March 2000. We note that by the time the lead CA forwarded its first request for
information, the lead CA had already exceed ed the three-month period envisaged in
Regulation 258/97 by almost two months, yet it w as far from completing its initial assessment. The
European Communities asserts that all of the time taken by the lead CA was necessary to resolve
scientific and technical issues, but provides no specifi c justification for the time taken by the lead CA
up to March 2000. Even if it were accepted that in this procedure the lead CA could not have
completed its initial assessment within the three-month period provided for in Regulation 258/97, this
would not imply that the lead CA could not have requested missing information much sooner. Given
the three-month maximum assessment period envisage d in Regulation 258/97, and lacking a specific
justification by the European Communities, we are not convinced that the lead CA could not have
determined much more promptly than it did whether additional information was still needed.
7.2379 We have previously pointed out that the Netherlands 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. However, in this instance, we are
not convinced that the Dutch CA's conduct reflects a precautionary approach. Indeed, we are not

1653 Exhibit EC-102/At. 32.
1654 Annex H, paras. 775 and 778.

convinced that the Dutch CA could not have id entified any need for additional information and
forwarded an appropriate request for information to the applicant sooner than it did even while
following a precautionary approach.
7.2380 Taking account of the aforementioned elements, we consider that upon receipt of the original
application, the lead CA could, and should, ha ve determined more promptly that additional
information was needed and could, and should, have forwarded an appropriate request to the applicant
more promptly.
7.2381 We now turn to consider the time taken by the lead CA taken to review the information
received in December 2000. To recall, more than five months after the applicant supplied the
information requested by the lead CA in May 2000, the lead CA requested further information on
protein analysis and a semi-chronic oral toxicity study on rats in order to "to rule out possible
undesirable effects". Regarding protein analysis, the lead CA indicated that it was not yet fully
satisfied with the information previously provided by the applicant. Regarding the requested toxicity
study, the lead CA mentioned recent studies whic h had shown that "unintended effects on GMOs"
were possibly caused by transformation of plant cells . However, as noted, no specific study was cited
in this regard.
7.2382 Since it is not clear from the record what recen t studies the lead CA was referring to, we have
no basis on which to determine whether the lead CA could, and should, have put forward its request
for a toxicity study earlier than it did.
7.2383 With regard to protein analysis, we note th at the European Communities provides no specific
justification for why the lead CA required more th an five months to identify a need for yet more
information. In the absence of a specific jus tification by the European Communities, we are not
convinced that the lead CA could not have eval uated much sooner than it did whether additional
information on protein analysis was still needed. We are also of the view that the Dutch CA could
have requested supplementary information on prot ein analysis at a much earlier date even while
following a precautionary approach.
7.2384 Taking account of the aforementioned elements, we consider that the lead CA could, and
should, have determined more pr omptly that additional informati on was needed on protein analysis
and could, and should, have forwarded an appropriate request to the applicant more promptly.
7.2385 Thus, based on the above considera tions, we conclude that the time taken by the lead CA for
its assessment of the application concerning RR sugar beet (food) – and in particular the time taken by
the lead CA before forwarding its first request for additional information as well as the time taken by
the lead CA to review the information received in December 2000 and to put forward a new request
for information – was unjustifiably long.
7.2386 In addition, we recall that the United States claims that the approva l procedure concerning
NK603 maize (food) was unduly delayed because, due to the moratorium, the European Communities
failed to consider the application in question for fi nal approval. In this respect, we note our earlier
findings that (i) a general de facto moratorium on approvals was in effect in the European
Communities between June 1999 and August 2003 and that (ii) the time taken by the Netherlands to
complete its initial assessment of the application co ncerning RR sugar beet (food) is consistent with
the application of such a moratorium. In the light of this, and in the absence of effective rebuttal by
the European Communities, we agr ee with the United States that it is reasonable to infer that the
Netherlands' conduct was a consequence of the general moratorium on approvals.

7.2387 In view of our conclusion with regard to th e time taken by the Netherlands for its initial
assessment, we do not go on to examine other argumen ts put forward by the United States in support
of its claim under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
7.2388 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.
Conclusion

7.2389 In the light of the above, the Panel reaches the following overall conclusion:
 (i) DS291 (United States)

 With reference to DS291, the Panel recalls its findings that the time taken by the lead
CA for its assessment of the application concerning RR sugar beet (food) –
particularly the time taken by the lead CA before forwarding its first request for
additional information as well as the time taken by the lead CA to review the
information received in December 2000 and to put forward a new request for
information – was unjustifiably long, and that it can reasonably be inferred from
surrounding circumstances that the lead CA's conduct was a consequence of the
general moratorium on approvals. Base d on these findings, the Panel accepts the
United States' contention that, consistent w ith the general moratorium, the European
Communities failed to consider the application concerning RR sugar beet (food) for
final approval, and that this resulted in "undue delay" in the completion of the
relevant approval procedure. Accordingly, the Panel concludes that in respect of the
approval procedure concerning RR sugar beet (food), the European Communities has
breached its obligations under Annex C(1)(a ), first clause, and Article 8 of the
SPS Agreement.

(d) Summary of the Panel's conclusions

7.2390 In view of the large number of approval pro cedures reviewed, it is useful to summarize in
table form the Panel's conclusions on the Complain ing Parties' claim that the European Communities
has failed to complete the relevant approval pro cedures without undue delay and hence has breached
its obligations under Annex C(1)(a), first clause, and Article 8 of the SPS Agreement.
7.2391 We should recall that most of the conclusions id entified in the table are relevant to only one
or two of the three complaints we are examining. Our preceding analysis identifies which of these
conclusions are applicable to which complaint(s).

 Approval procedures examined by the Panel
Panel's conclusions on
asserted "undue delay"
(X: unduly delayed,
9: not unduly delayed)
1 Falcon oilseed rape X
2 MS8/RF3 oilseed rape X
3 RR fodder beet X
4 Bt-531 cotton X
5 RR-1445 cotton X
6 Transgenic potato 9
7 Liberator oilseed rape X
8 Bt-11 maize (EC-69) X
9 RR oilseed rape (EC-70) X
10 LL soybeans (EC-71) X
11 LL oilseed rape 9
12 BXN cotton X
13 Bt-1507 maize (EC-74) X
14 Bt-1507 maize (EC-75) X
15 NK603 maize X
16 GA21 maize (EC-78) X
17 MON810 x GA21 maize X
18 RR sugar beet X
19 MS1/RF1 oilseed rape (EC-89) X
20 MS1/RF2 oilseed rape X
21 GA21 maize (food) X
22 Bt-11 sweet maize (food) X
23 LL soybeans (food) 9
24 MON810 x GA21 maize (food) X
25 Bt-1507 maize (food) X
26 NK603 maize (food) X
27 RR sugar beet (food) X
Total: X: 24
9:3

10. Consistency of the with Article 8 and Annex C(1)(a), second
clause, of the SPS Agreement
7.2392 Argentina claims that the product-specific measure s identified by it are inconsistent with the
European Communities' obligatio ns under Article 8 and Annex C(1)(a), second clause, of the
SPS Agreement.
7.2393 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."
7.2394 Annex C(1)(a), second clause, 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:

(a) such procedures are undertaken and completed [...] in no less favourable
manner for imported products than for like domestic products[.]"
7.2395 Argentina argues that Annex C(1)(a), second clau se, establishes an obligation to avoid
discriminatory treatment. Members must not differentiate the treatment granted to an imported
product and to a like domestic product. Argentina submits that in the present case a comparison
should be made between the manner in which the EC approval system has been applied in the case of
biotech products and the manner in which it has been applied in the case of novel non-biotech
products. Specifically, Argentina points to Regulation 258/97 which it says defines a procedure that
does not differ in terms of implementation between th e two products. According to Argentina, undue
delays have, however, occurred only in the treatment of biotech products. Furthermore, Argentina
identifies another instance of less favourable treatment of biotech products. In the view of Argentina,
prior to 1998, the European Communities granted approvals for the marketing of biotech products,
whereas it has not done so since, as a consequence of the general de facto moratorium on approvals.
7.2396 The European Communities argues that the differences in treatment alleged by Argentina
between biotech products and novel non-biotech pro ducts, and between biotec h products before and
after the "moratorium", have nothing to do with the national treatment obligation set forth in
Annex C(1)(a), second clause. According to the European Communities, a national treatment issue
would arise if the European Communities in the a pplication of its approval system treated imported
biotech products differently from domestic biot ech products. The European Communities submits
that this is not the case as all products are being tr eated equally, irrespective of their origin. The
European Communities considers, therefore, that Argentina has failed to est ablish an inconsistency
with Annex C(1)(a), second clause.
7.2397 The Panel notes that Argentina relies on the allege d inconsistency of the with Annex C(1)(a), second clause, to ma ke consequential claims of inconsistency under
Article 8. Accordingly, we will begin our anal ysis with the claims under Annex C(1)(a), second
clause, before turning to Article 8.
(a) Annex C(1)(a), second clause
7.2398 We note that in accordance with the lead-in to Annex C(1) the provisions of Annex C(1)(a)
apply "with respect to any procedur e to check and ensure the fulfilm ent 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 provisions of Annex C(1), which include those of Annex C(1)(a).
Therefore, the European Communities was and is required under the provisions of Annex C(1)(a) to
"undertake and complete" the approval procedures set out in Directives 90/220 and 2001/18 as well as

Regulation 258/97 (to the extent it is an SPS m easure) "in no less favourable manner for imported
products than for like domestic products".
7.2399 Argentina is challenging alleged undue delays in completing the consideration and processing
of specified applications. In our view, the type of measure challenged by Argentina could
conceivably constitute, or lead to, a breach of the European Communities' obligations under
Annex C(1)(a), second clause, and it can therefore be examined in the light of the provisions of
Annex C(1)(a), second clause. Since Argentina seeks to establish an inconsistency with Article 8 on
the basis of an alleged inconsiste ncy with Annex C(1)(a), second clause, this conclusion applies also
to Article 8.
7.2400 In order to establish an inc onsistency with Annex C(1)(a), second clause, Argentina must
establish (i) that imported products have been tr eated in a "less favourable manner" than domestic
products in respect of the undertaking and comple tion of approval procedures, and (ii) that the
imported products which are allege d to have been treated less favourably are "like" the domestic
products which are alleged to have been treated mo re favourably. If either one of these two elements
is not met, that is, if imported products have not been treated "less favourably" than the domestic
products to which they are being compared, or if these domestic products are not "like" the relevant
imported products, Argentina's claim of inconsistency must fail. In the circumstances of this case, we
find it appropriate to begin our analysis with the fi rst element. Thus, we will examine first whether
Argentina has demonstrated that imported products have been treated in a "less favourable manner"
than domestic products in respect of the undertaking and completion of approval procedures.
7.2401 We note the phrase "in no less favourable manner". It is clear from this phrase that
Annex C(1)(a), second clause, lays down a natio nal treatment obligation. National treatment
obligations are found in numerous WTO agreements . Moreover, the relevant provisions often use
similar language. The Appellate Body has confirme d that, in such circumstances, the jurisprudence
on a national treatment provision in one WTO agreem ent may be useful in interpreting a national
treatment provision in another WTO agreement.
1655 In the present case, we find it useful to look to
the jurisprudence on Articles III:1 and III:4 of the GATT 1994 for appropriate interpretative guidance.
7.2402 Article III:1 provides:1656
"The contracting parties recognize that intern al taxes and other internal charges, and
laws, regulations and requirements affecting the internal sale, offering for sale,
purchase, transportation, distribution or use of products, and internal quantitative
regulations requiring the mixture, processing or use of products in specified amounts
or proportions, should not be applied to impor ted or domestic products so as to afford
protection to domestic production."
7.2403 Article III:4 provides in relevant part:
"The products of the territory of any contr acting party imported into the territory of
any other contracting party shall be accord ed treatment no less favourable than that
accorded to like products of national origin in respect of all laws, regulations and
requirements affecting their internal sale, offering for sale, purchase, transportation,
distribution or use."

1655 Appellate Body Report, US – Section 211 Appropriations Act, para. 242.
1656 Ad Note omitted.

7.2404 In EC – Asbestos, the Appellate Body had this to say on the term "less favourable treatment"
as it appears in Article III:4:
"[...] there is a second element [in addition to the 'likeness' of the products being
'compared] that must be established before a measure can be held to be inconsistent
with Article III:4. [...] A complaining Memb er must [...] establish that the measure
accords to the group of 'like' imported products 'less favourable treatment' than it
accords to the group of 'like' domestic products. The term 'less favourable treatment'
expresses the general principle, in Article III:1, that internal regulations 'should not be
applied … so as to afford protection to domestic production'. If there is 'less
favourable treatment' of the group of 'like' imported products, there is, conversely,
'protection' of the group of 'like' domest ic products. However, a Member may draw
distinctions between products which have b een found to be 'like', without, for this
reason alone, according to the group of 'like' imported products 'less favourable
treatment' than that accorded to the group of 'like' domestic products. In this case, we
do not examine further the interpretation of the term 'treatment no less favourable' in
Article III:4, as the Panel's findings on this issue have not been appealed or, indeed,
argued before us."
1657
7.2405 Subsequently, in Dominican Republic – Import and Sale of Cigarettes , the Appellate Body
again addressed the meaning of the phrase "less favourable treatment", stating that:
"[T]he existence of a detrimental [com petitive] effect on a given imported product
resulting from a measure does not necessarily imply that this measure accords less
favourable treatment to imports if the detrim ental effect is explained by factors or
circumstances unrelated to the foreign origin of the product, such as the market share
of the importer in this case."
1658
7.2406 We recognize that Annex C(1)(a), second clause, does not use the phrase "treatment no less
favourable", but the phrase "in no less favourable manner". In our view, there is, however, a close
conceptual similarity between these two phrases, a nd the textual difference between them does not,
therefore, render inapposite appropriate reliance on the Appellate Body's interpretation of the phrase
"treatment no less favourable" as it appears in Article III:4.
7.2407 We also recognize that Annex C(1) to the SPS Agreement does not contain a provision
analogous to Article III:1 of the GATT 1994. But the fact that Article III:4 expresses a general
principle which is explicitly spelt out in Article III:1 does not necessarily mean that a similar general
principle cannot be implicit in Annex C(1)(a), seco nd clause. Indeed, we consider that a central
purpose of the provisions of Annex C(1)(a), second clause, is precisely to prevent Members from
applying their approval procedures in a manne r which would afford protection to domestic
production. This view is consis tent with Article 2.3 of the SPS Agreement, which is part of the
context of Annex C(1)(a). The second sentence of Article 2.3, which would appear to be applicable to
approval procedures, provides that SPS measures "s hall not be applied in a manner which would
constitute a disguised restriction on international trade". Thus, we do not think that the absence in
Annex C(1) of an analogue to Article III:1 should prevent us from being guided by the Appellate
Body's interpretation of the phrase "treatment no less favourable".

1657 Appellate Body Report, EC – Asbestos, para. 100 (emphasis in original).
1658 Appellate Body Report, Dominican Republic – Import and Sale of Cigarettes, para. 96.

7.2408 Reading Annex C(1)(a), second clause, in the lig ht of the jurisprudence on Article III:4, we
consider that in undertaking and completing its ap proval procedures, a Member may, in principle,
differentiate between products that have been found to be like because this would not, by itself, mean
that the relevant approval procedures have been undertaken or completed in less favourable manner
for the group of like imported products than for th e group of like domestic products. In particular, a
mere showing that a Member has undertaken or completed a particular approval procedure in a
manner which is unfavourable for a given imported product would not be sufficient to establish a "less
favourable manner" of undertaking or completing approval procedures if the relevant Member's
conduct is explained by factors or circumstances unrelated to the foreign origin of the product.
7.2409 With these considerations in mind, we now turn to analyse Argentina's arguments.
Argentina's first argument is that the Europ ean Communities has undertaken approval procedures
under Regulation 258/97 in less favourable manner fo r the biotech products which are the subject of
the challenged by Arge ntina than for like novel non-biotech products.
Argentina asserts that undue delays have occurre d only in the processing of applications concerning
biotech products.
7.2410 We note that it is not entirely clear from Arge ntina's submissions which approval procedures
are at issue. We understand Argentina to refer to the procedures set out in Articles 4, 6, 7 and 8 of
Regulation 258/97. These procedures apply in the same way to biotech products as they do to novel
non-biotech products. These procedures also apply equally to imported a nd domestic products.
Finally, we note that we have previously determ ined that these procedures constitute an approval
procedure within the meaning of Annex C. Therefore, in undertaking and completing these
procedures, the European Communities must comply with Annex C(1)(a), second clause.
7.2411 Turning to the merits of Argentina's argument , we observe, initially, that Argentina has not
provided factual information about the processing of applications concerning those novel non-biotech
products which Argentina considers to be like the biot ech products at issue. At any rate, even if it
were the case, as Argentina seems to assert, that the processing of applications concerning the relevant
imported biotech products ( e.g., imported biotech maize) has been unduly delayed, while the
processing of applications concerning the corresponding domestic non-biotech varieties ( e.g.,
domestic novel non-biotech maize) has not been unduly delayed, this would not be sufficient, in and
of itself, to raise a presumption that the procedur es envisaged in Regulation 258/97 have been applied
in less favourable manner for the group of like importe d products than for the group of like domestic
products. Argentina does not assert that the processi ng of applications con cerning relevant domestic
biotech products (e.g., domestic biotech maize) has not been unduly delayed, or that the processing of
applications concerning correspondi ng imported non-biotech varieties ( e.g., imported novel non-
biotech maize) has been unduly delayed. In other words, Argentina is not alleging that the manner of
processing applications under Regulation 258/97 has differed depending on the origin of the products.
In these circumstances, it is not self-evident th at the alleged less favourable manner of processing
applications concerning the rele vant imported biotech products ( e.g
., imported biotech maize) is
explained by the foreign origin of these products rather than, for instance, a perceived difference
between biotech products and novel no n-biotech products in terms of the required care in their safety
assessment, risk for the consumer, etc. Argentin a has not adduced argument and evidence sufficient
to raise a presumption that the alleged less favourable treatment is explained by the foreign origin of
the relevant biotech products.
7.2412 In the light of the above, we find that Ar gentina has not established that the approval
procedures set out in Regulation 258/97 have been undertaken or completed in a less favourable
manner for imported products than for domestic products.

7.2413 Argentina's second argument is that after 1998 the European Communities has applied its
approval procedures in a less favourable manner for the biotech products which are the subject of the
 challenged by Argentina than for like biotech products before 1998. More
particularly, Argentina submits that after 1998 und ue delays have occurred in the processing of
applications under the relevant approval procedures. The year 1998 is the year in which, in
Argentina's view, the European Communities began applying its general de facto moratorium on
approvals.
7.2414 We understand Argentina's second argu ment to relate to the approval procedures contained in
Directives 90/220 and 2001/18 as well as Regulation 258/97. Directives 90/220 and 2001/18 as well
as Regulation 258/97 apply equally to imported and domestic biotech pr oducts. We have previously
determined that these pieces of legislation contai n approval procedures within the meaning of
Annex C. Therefore, in undertaking and comp leting these approval procedures, the European
Communities was and is required to comply with Annex C(1)(a), second clause. We note that
Directive 2001/18 is formally and, to some extent, substantively different from Directive 90/220.
Argentina appears to assume that the obligation laid down in Anne x C(1)(a), second clause, applies
not only in situations where imported and domestic products are dealt with under one and the same
approval procedure, but also in situations wher e like products are dealt with under formally or
substantively different approval procedures. For the purposes of our analysis of Argentina's
argument, we are prepared to proceed on the basis of this assumption, but we do not make a finding in
this regard.
7.2415 It seems to us that Argentina wishes to argue, in effect, that approval procedures were applied
in less favourable manner for relevant imported biotech products after 1998 than for like domestic
biotech products before 1998. Even if this were co rrect as a factual matter, however, this would not
be sufficient, in and of itself, to raise a presump tion that the approval procedures at issue have been
applied in less favourable manner for the group of li ke imported products than for the group of like
domestic products. Argentina asserts that after 1998 applications concerning the relevant biotech
products were processed in less favourable manner, i rrespective of whether they were of foreign or
domestic origin, and that before 1998 applicati ons concerning biotech products were processed in
more favourable manner, irrespective of whether they were of foreign or domestic origin. Thus, it is
not Argentina's contention that there has been a di fference, before and after 1998, in the manner in
which the European Communities has processed applications concerning imported biotech products
and the manner in which it has processed applicati ons concerning domestic biotech products. It is
therefore not obvious that the alleged less favour able manner of conducting approval procedures for
the relevant imported biotech products after 1998 is explained by the foreign origin of these products
rather than by other factors or circumstances, such as a different perception of risks associated with
biotech products, etc. Argentina has not adduc ed argument and evidence sufficient to raise a
presumption that the alleged less favourable treatment is explained by the foreign origin of the
relevant biotech products.
7.2416 Additionally, we note that one of the conse quences of accepting Argentina's second argument
would be that Members could not consistently w ith Annex C(1)(a), second clause, elect to conduct
their approval procedures in a less favourable manner for all subject products regardless of their
origin, e.g., in response to new scientif ic evidence suggesting that th e risks associated with the
products subject to the approval requirement had pr eviously been underestimated. In our view, it
would be unreasonable to interpret Annex C(1)(a ), second sentence, so as to produce such an
outcome.
7.2417 In the light of the above, we are not persuaded by Argentina's argument that the European
Communities has undertaken and completed its approva l procedures in a less favourable manner for

imported products than for domestic products by processing applicati ons concerning biotech products
in a less favourable manner after 1998 than before 1998.
7.2418 Since we have found that Argentina has not de monstrated to our satisfaction that imported
products have been processed in a "less favourable manner" than domestic products in respect of the
undertaking and completion of approval procedures, th ere is no need to go on to examine whether the
imported products which Argentina alleges have been treated less favourably are "like" the domestic
products which Argentina alleges have been treated more favourably.
7.2419 Based on all of the above considerations, we c onclude that Argentina has failed to establish
its product-specific claims under Annex C(1)(a), second clause.
(b) Article 8
7.2420 Turning to Argentina's claims under Article 8, we recall that Argentina seeks to establish an
inconsistency with Article 8 on the basis of an alleged inconsistency with Annex C(1)(a), second
clause. We have determined that Argentina has failed to establish its claims under Annex C(1)(a),
second clause. Under the approach followed by Argen tina, this means that its claims under Article 8
have not been established either.
(c) Overall conclusion
7.2421 In the light of the above, the Panel reaches the following conclusion:
 (i) 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 in respect of which the Panel is
making findings have resulted in the Eur opean Communities acting inconsistently
with its obligations under Annex C(1)(a), second clause, of the SPS Agreement and,
consequently, with its obligations under Article 8 of the SPS Agreement.

11. Consistency of the with Article 8 and Annex C(1)(b) of the
SPS Agreement
7.2422 The United States and Argentina claim that the identified by them
are inconsistent with the European Communities' obligations under Article 8 and Annex C(1)(b) of
the SPS Agreement.
7.2423 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."

7.2424 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[.]"
7.2425 As we have noted earlier, Annex C(1)(b) essen tially sets out five separate, but related,
obligations to be observed by Members in the ope ration 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.

7.2426 The United States argues that under the relevant – the product-
specific moratoria – the European Communities does not allow its approval procedures to proceed to
conclusion. As such, the product-specific morato ria are inconsistent with each of the related
procedural obligations in Annex C(1)(b) and, consequently, with Article 8 as well.
7.2427 Regarding the first obligation (publication or communication of processing period), the
United States submits that although the applicable EC approval legislation contains processing
periods, under the product-specific moratoria those processing periods are not followed. Instead, the
European Communities has imposed an indefinite de lay. However, since the European Communities
does not acknowledge the product-specific moratoria, the standard processing period is not published,
and the anticipated processing period is not communicated to the applicant.
7.2428 Regarding the second obligation (completeness of documentation), the United States argues
that under the product-specific moratoria the European Communities does not promptly examine
documentation and inform the applicant of all defici encies. To the contrary, applications under the
applicable EC legislation are stalled, without e xplanation. More specifically, the United States

submits that in the Bt-531 cotton, RR-1445 cotton, MS1/RF1 oilseed rape (EC 89) and MS1/RF2
oilseed rape applications, the applicant was not in formed in a precise and complete manner of all
deficiencies. To the contrary, when the Regulator y Committee fails to approve an application by
qualified majority vote, or when the Commission enters into inter-service consultations rather than
sending an application on to the Council, the ap plicant is given no explanation, and thus no
opportunity to correct any deficiencies. The same is true when, as for the oilseed rape products, the
lead member State fails to take the final step of placing the product on the market.
7.2429 Regarding the third obligation (transmission of results), the United States argues that under
the product-specific moratoria results of procedures ar e not promptly communicated to applicants so
that corrective action may be taken. Instead, app lications are stalled in the approval process without
explanation. More specifically, the United States submits that in the Bt-531 cotton, RR-1445 cotton,
MS1/RF1 oilseed rape (EC 89) and MS1/RF2 oil seed rape applications, the applicant was not
informed in a precise and complete manner of all de ficiencies. To the cont rary, when the Regulatory
Committee fails to approve an application by qualif ied majority vote, or when the Commission enters
into inter-service consultations rather than sending an application on to the Council, the applicant is
given no explanation, and thus no opportunity to corr ect any deficiencies. The same is true when, as
for the oilseed rape products, the l ead member State fails to take the final step of placing the product
on the market.
7.2430 Regarding the fourth obligation (processing of deficient applications), the United States
argues that under the product-specific moratoria the European Communities does not proceed as far as
practicable in the approval process. Instead, applications are stalled in the approval process.
7.2431 Regarding the fifth obligation (explanation of delay), the United States argues that under the
product-specific moratoria delays are not explained. To the contrary, the European Communities does
not even inform applicants of the existence of the general moratorium.
7.2432 Argentina argues that Annex C(1)(b) stipulates obliga tions of publication and notification of
the applicant and requires the competent bodies of Members to perform their obligations "promptly"
and to explain "any delay". Argentina considers that the undue delay which has been caused by the
European Communities in the specific approval pro cedures identified by it is inconsistent with
Article 8 and Annex C(1)(b). Argentina submits that the European Communities has not ensured
compliance with the requirements of Annex C(1)(b ) because in some cases the relevant EC entity did
not promptly determine whether the documentati on was complete (second obl igation), and in other
cases did not inform the applicant of the results of the procedure (thi rd obligation) or of the current
stage of the procedure (fifth obligation). Argentina ar gues in this regard that it has demonstrated that,
for instance, in the approval procedure concerni ng GA21 maize (EC-78) the applicant was still
waiting for a definitive answer with respect to its a pplication after more than five years. Finally,
Argentina submits that a violation of the provisions of Annex C simultaneously represents a violation
of Article 8.
7.2433
 The European Communities submits that the United States and Argentina have offered a
mere assertion that the European Communities h as not done what it is required to do under the
different obligations contained in Annex C(1)(b). Argentina has offered no evidence in support of its
allegations. The United States also considers it suffi cient simply to allege that applications were
stalled in the approval process and gives no explanations. However, it is a complaining party's burden
to establish a prima facie case. In any event, the detailed ch ronologies of individual approval
procedures and other documents submitted by the European Communities demonstrate that the
allegations of the United States are unfounded.

7.2434 Regarding the United States' claim that no st andard processing periods have been published
for the "product-specific morato ria", the European Communities ar gues that these "moratoria" are
individual applications subject to their own particular facts. In the European Communities' view, it is
difficult to see how a "standard" processing period othe r than the one laid down in the legislation
could be set out for these applications collectively.
7.2435 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). Therefore, in respect of the approval procedures set out in the aforementioned
Directives and Regulation, the European Communi ties was and is required to comply with the
provisions of Annex C(1)(a).
7.2436 We recall that the United States is challe nging the alleged failure by the European
Communities to consider particular applications for final approval. We have observed in this regard
that this is essentially a challenge to the applicati on by the European Communities of a particular way
of operating the relevant EC appr oval procedures. We also recall that Argentina is challenging
alleged undue delays in completing the consideration and processing of specified applications.
7.2437 In our view, the type of measure challenge d by the United States and Argentina could
conceivably constitute, or lead to, a breach of EC obligations under Annex C(1)(b), and it can
therefore be examined in the light of the provisi ons of Annex C(1)(b). Since the United States and
Argentina seek to establish an inconsistency with Article 8 on the basis of an alleged inconsistency
with Annex C(1)(b), this conclusion applies also to Article 8.
7.2438 In view of the fact that the United States' and Argentina's claim under Article 8 is in the
nature of a consequential claim, we will begin our analysis with the claims under Annex C(1)(b).
(a) First obligation in Annex C(1)(b) (publication or communication of processing period)
7.2439 Only the United States has presented arguments in relation to the first obligation contained in
Annex C(1)(b). Specifically, the United States puts forward two main arguments. The first argument
is that as a result of the European Communities' fa ilure to consider the relevant applications for
approval, the European Communities did not foll ow 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 period was not published.
7.2440 We agree with the European Communities that th e first obligation in Annex C(1)(b) does not,
and logically cannot, require the European Comm unities to publish a "standard" processing period for
every individual approval procedure undertaken by it. The processing period to be published is the
period which is intended to be the norm for a ll approval procedures of a particular type, e.g., the
approval procedures envisaged in Directive 2001/18 for the placing on the market of biotech products.
This follows from the word "standard", which in th e specific context of the first obligation should be
understood as meaning "normal".
1659 However, we do not understand the United States to argue that

1659 The dictionary defines "standard" as "[o]f a pr escribed or normal size, amount, quality, etc.". The
New Shorter Oxford English Dictionary, L. Brown (ed.) (Clarendon Press, 1993), Vol. II, p. 3028. The French

the European Communities should have published a standard processing period for each individual
approval procedure conducted by it.
7.2441 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. Even if we were to
accept that what has to be publishe d in accordance with the first obligation in Annex C(1)(b) is the
"effective" standard processing period, the mere fact that the European Communities in one particular
approval procedure might not have followed the published standard processing period would not, by
itself, justify the conclusion that there was a new and unpublished effec tive "standard" processing
period. A single departure from the published st andard processing period in our view does not
demonstrate the existence of a new "standard" processing period.
1660 In any event, even if there was a
new standard processing period, the fact that it wa s unpublished would not be a consequence of the
failure by the European Communities to consider the relevant application for final approval. In other
words, it would not be a consequence of the product- specific measure at issue. Rather, it would be a
consequence of a separate and independent failure by the European Communities to publish the new
standard processing period.
7.2442 In the light of this, we conclude that the United States has failed to establish its product-
specific claims under the first obligation contained in Annex C(1)(b), insofar as these claims are based
on the requirement to publish the standard processing period of each procedure.
7.2443 The United States' second argument in support of its claim under Annex C(1)(b) is that since
the European Communities does not acknowledge its failu re to consider the relevant applications for
approval, the anticipated processing period is not communicated to the applicants. We note that
pursuant to Annex C(1)(b) the anticipated processing period is to be communicated to the applicant
"upon request". The United States has provided no ev idence 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 becaus e of a deliberate failure to consider the relevant
applications for approval. Moreover, we do not think that the failure by the European Communities to
consider particular applications for final approva l necessarily resulted in the European Communities
not communicating to applicants the anticipated processing periods upon request. Indeed, in our
view, the fact that the European Communities may have prevented a partic ular approval procedure
from proceeding to conclusion would not have made it impossible for the European Communities to
communicate to the applicant the anticipated processing period upon request, as required by
Annex C(1)(b).
7.2444 In the light of this, we conclude that the United States has failed to establish its product-
specific claims under the first obligation contained in Annex C(1)(b), insofar as these claims are based
on the requirement to communicate to applicants the anticipated processing period.
(b) Second obligation in Annex C(1)(b) (completeness of documentation)
7.2445 Concerning the second obligation contained in Annex C(1)(b), both the United States and
Argentina have presented arguments. We begin our analysis with the United States' arguments.

("la durée normale") and Span ish ("el período normal de tramitación") versions of the SPS Agreement support
this interpretation.
1660 We recall that the measures at issue are indivi dual , and not the product-
specific measures collectively or the general moratorium on approvals.

7.2446 The United States argues that as a result of the Eu ropean Communities' failure to consider the
relevant applications for approval, the Eur opean Communities did not promptly examine the
completeness of documentation and inform applicants of any deficiencies. The United States has
identified individual approval procedures whic h it believes support its claim under the second
obligation.
7.2447 Among the applications referred to by the United States are those concerning MS1/RF1
oilseed rape (EC 89) and MS1/RF2 oilseed rape. We have determined above that there are twenty-
five on which the Unite d States is seeking findings. However, the
applications concerning MS1/RF1 oilseed rape (EC 89) and MS1/RF2 oilseed rape are not part of
these twenty-five measures. We are therefore not entitled to make product-specific findings on these
two applications concerning oilseed rape.
7.2448 The United States also refers to the app lications concerning Bt-531 cotton and RR-1445
cotton. They are among the applications which are the subject of product-specific claims put forward
by the United States. In relation to these app lications, the United States argues that when the
Regulatory Committee failed to approve them by a qualified majority vote, or when the Commission
entered into inter-service consultations after the Regulatory Committee vote, the applicant was given
no explanation, and thus no opportunity to correct a ny deficiencies. As an initial matter, we note that
the second obligation in Annex C(1)(b) applies when a "competent body" "receives" an application.
In our view, the competent body receiving the a pplications concerning Bt-531 and RR-1445 cotton
was the lead member State to whic h these applications were submitte d for initial assessment, not the
Regulatory Committee or the Commission at the post-Regulatory Committee stage.
7.2449 In any event, the United States has not demonstr ated that either the Regulatory Committee or
the Commission identified deficiencies in the docum entation submitted by the applicant and did not
inform the applicant thereof in a precise and comp lete manner. We recall that in the case of the
application concerning Bt-531 cotton, three member States made written statements in support of their
votes in the Regulatory Committee in February 1999, and that the applicant provided additional
information more than two years after the Regul atory Committee meeting and the launching by the
Commission of inter-service consultations. The United States has not shown that any of the member
State statements identified deficiencies in the doc umentation submitted by the applicant. We have
found earlier that none of the member State statemen ts specifically called for the provision of the
additional information and that there is no indi cation that the applicant submitted the additional
information in response to the written statements. We also recall our earlier finding that there is no
evidence to suggest that the Commission was waiting for the additional information provided by the
applicant and for that reason did not submit a draf t measure to the Council. We therefore do not
consider that the additional information provided by the applicant addressed "deficiencies" which had
been identified by the Regulatory Committee or the Commission.
7.2450 Regarding the application concerning RR-1445 cott on, we note that as in the case of the
application concerning Bt-531 cotton, a number of member States made written statements in support
of their votes in the Regulatory Committee in Febr uary 1999. The United States has not shown that
any of these statements identified deficiencies in the documentation submitted by the applicant.
Moreover, we have found earlier that the record of the consultation of the Regulatory Committee does
not contain any indication of a request to the appli cant for further information. In fact, no further
information was provided subsequent to the Regul atory Committee vote. Finally, the United States
itself points out in a different context that not hing in the record indi cates that the Commission
communicated any scientific concerns to the appl icant or identified any shortcomings in the
application following the Regulatory Committee vote. We therefore consider that the United States
has not demonstrated that either the Regulatory Committee or the Commission identified deficiencies

in the documentation submitted by the applicant and did not inform the applicant thereof in a precise
and complete manner.
7.2451 By way of an additional consideration, we not e that the failure by the European Communities
to consider particular applications for final a pproval did not necessarily result in the European
Communities not examining promptly the comple teness of documentation and not informing
applicants of any deficiencies. Indeed, in our view, the fact that the European Communities may have
prevented a particular approval procedure from pr oceeding to conclusion w ould not have made it
impossible for the European Communities to exam ine the completeness of the documentation or
inform the applicant of deficiencies in the documentation submitted, as required by Annex C(1)(b).
1661
7.2452 In the light of the above considerations, we c onclude that the United States has failed to
establish its product-specific claims under the second obligation contained in Annex C(1)(b).
7.2453 Argentina submits that the European Comm unities has not ensured compliance with the
requirements of Annex C(1)(b) because in some c ases the relevant EC entity did not promptly
determine whether the documentation was complete. Argentina has failed specifically to identify
these "cases" and has not demonstrated that in these cases the competent body found deficiencies in
the documentation submitted by the applicant and did not inform the applicant thereof in a precise and
complete manner.
7.2454 In the light of this, we conclude that Arge ntina has failed to establish its product-specific
claims under the second obligation contained in Annex C(1)(b).
(c) Third obligation in Annex C(1)(b) (transmission of results)
7.2455 With regard to the third obligation contained in Annex C(1)(b), both the United States and
Argentina have presented arguments. We begin our analysis with the United States' arguments.
7.2456 The United States argues that as a result of the Eu ropean Communities' failure to consider the
relevant applications for approval, the Europ ean Communities did not promptly communicate the
results of procedures to applicants so that correc tive action could be taken if necessary. The United
States has identified individual approval procedures which it believes support its claim under the third
obligation. Among the applications referred to by the United States are those concerning MS1/RF1
oilseed rape (EC 89) and MS1/RF2 oilseed rape. We have already determined that we are not entitled
to make product-specific findings on the two applications concerning oilseed rape.
7.2457 The United States also refers to the app lications concerning Bt-531 cotton and RR-1445
cotton. They are among the challenged by the United States. In relation to
these approval procedures, the United States argues that when the Regulatory Committee failed to
approve them by a qualified majority vote, or when the Commission entered into inter-service
consultations after the Regulatory Committee vote, th e applicant was given no explanation, and thus
no opportunity to correct any deficiencies.
7.2458 We note at the outset that when the applications concerning Bt-531 and RR-1445 cotton
reached the Regulatory Committee stage, they were subject to Directive 90/220. It is clear from
Article 21 of Directive 90/220 that the role of th e Regulatory Committee is to assist the Commission
in its decision-making by delivering opinions on draft measures proposed by the Commission. The

1661 We note in this regard that certain progress in the approval process is not inconsistent with a
deliberate failure by the European Communities to move a particular application to final decision.

Regulatory Committee cannot by itself take decisions on applications. Moreover, Directive 90/220
does not provide for the applicant to be given an explanation of the vote.
1662 Indeed, we have noted
earlier that there is no publicly available record of Regulatory Committee votes. The European
Communities has pointed out in this regard that Regulatory Committee votes have no external legal
effect and cannot, therefore, be challenged under EC law. 1663 Thus, there is no "corrective action"
which can be taken by the applicant in response to an unfavourable Regulatory Committee vote. For
all these reasons, we are not persuaded that a vote in the Regulatory Committee can be considered a
"result of the procedure" within the meaning of the third obligation contained in Annex C(1)(b). In
our view, the Regulatory Committee vote is rather a "s tage of the procedure" of which the applicant
must be informed upon request in accordance with the fifth obligation in Annex C(1)(b).
7.2459 We believe that the same is true for inter-ser vice consultations held by the Commission prior
to the submission of a draft measure to the Coun cil. Such consultations are a "stage of the
procedure", not a "result of the procedure". At any rate, the outcome of such consultations is a draft
measure to be transmitted to the Council for action, not a decision on an application.
7.2460 Based on the preceding considerations, we find that the Regulatory Committee votes and the
opening of inter-service consultations by the Co mmission in the approval procedures concerning
Bt-531 and RR-1445 cotton were not "results" whic h the European Communities was required to
transmit to the applicant.
7.2461 More generally, we note that the failure by the European Communities to consider particular
applications for final approval meant that no final results were achieved. Thus, there were no final
results which could have been communicated to applicants as required by the third obligation in
Annex C(1)(b).
1664
7.2462 In the light of the above, we conclude that the United States has failed to establish its product-
specific claims under the third obligation contained in Annex C(1)(b).
7.2463 Argentina submits that the European Comm unities has not ensured compliance with the
requirements of Annex C(1)(b) because in some c ases the relevant EC entity did not inform the
applicant of the results of the procedure. Arge ntina has failed specifically to identify these "cases"
and has not demonstrated that in these cases there were "results" which needed to be transmitted to the
applicants. We note that Argentina has referred to the fact that in the approval procedure concerning
GA21 maize (EC-78), the applicant was still waiting fo r a definitive answer regarding its application
after more than five years. We recall in this rega rd that the third obligation in Annex C(1)(b) requires
the competent body to "transmit" 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. Thus, the third
obligation applies in situations where results have been reached.1665 Argentina's example is one where
no final results have been reached yet. Since no results have been reached, none could be transmitted

1662 It is important to recall in this context that the United States is not alleging that Directive 90/220 is,
as such, WTO-inconsistent.
1663 In support of its statement, the European Commun ities refers to the jurisprudence of the European
Court of First Instan ce, case T-326/99, Nancy Fern Olivieri v. Commission and EMEA , decision of
18 December 2003, paras. 51 et seq.
1664 As is clear from the discussion of the approval procedures concerning Bt-531 and RR-1445 cotton,
the United States has failed to establish that "results" other than the final results of the relevant procedures had
to be transmitted to the relevant applicants and that those results were not transmitted to them.
1665 We note that the requirement in Annex C(1)(a), first clause, that approval procedures be
"completed" without undue delay serves to ensure that "results" are reached.

to the applicant. In our view, the example of the approval procedure concerning GA21 maize (EC-78)
does not, therefore, assist Argentina in establishing an inconsistency with the third obligation.
7.2464 In the light of this, we conclude that Arge ntina has failed to establish its product-specific
claims under the third obligation contained in Annex C(1)(b).
(d) Fourth obligation in Annex C(1)(b) (processing of deficient applications)
7.2465 Only the United States has presented arguments in relation to the fourth obligation contained
in Annex C(1)(b). The United States argues that as a result of the European Communities' failure to
consider the relevant applicati ons for approval, the European Co mmunities did not proceed as far as
practicable in the approval process.
7.2466 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 a decision
by the European Communities not to consider the relevant applicati on for final approval. Moreover,
we do not think that the failure by the European Co mmunities to consider particular applications for
final approval necessarily resulted in the European Communities not proceeding as far as practicable
with procedures if applicants so requested. I ndeed, in our view, the fact that the European
Communities may have prevented a particular a pproval procedure from proceeding to conclusion
would not have made it impossible for the Europ ean Communities to proceed as far as practicable
with that procedure upon request, as required by Annex C(1)(b).
1666
7.2467 In the light of this, we conclude that the United States has failed to establish its product-
specific claims under the fourth obligation contained in Annex C(1)(b).
(e) Fifth obligation in Annex C(1)(b) (explanation of delay)
7.2468 Regarding the fifth obligation contained in Annex C(1)(b), both the United States and
Argentina have presented arguments. We begin our analysis with the United States' arguments.
7.2469 The United States argues that as a result of the Eu ropean Communities' failure to consider the
relevant applications for approval, delays were not explained. 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 a pplicant making such a request, or of a relevant
EC entity denying an explanation of any delay b ecause of a deliberate failure by the European
Communities to consider the relevant application fo r approval. Moreover, we do not think that the
failure by the European Communities to consider pa rticular applications for final approval necessarily
resulted in the European Communities not informing applicants of the stage of procedures and not
explaining any delays, if applicants so requested. Indeed, in our view, the fact that the European
Communities may have prevented a particular a pproval procedure from proceeding to conclusion
would not have made it impossible for the European Communities to inform applicants of the stage of
procedures and explain any delays, as required by Annex C(1)(b).
7.2470 In the light of this, we conclude that the United States has failed to establish its product-
specific claims under the fifth obligation contained in Annex C(1)(b).

1666 We note in this regard that certain progress in the approval process is not inconsistent with a
deliberate failure by the European Communities to move a particular application to final decision.

7.2471 Argentina submits that the European Comm unities has not ensured compliance with the
requirements of Annex C(1)(b) because in some c ases the relevant EC entity did not inform the
applicant of the current stage of the procedure. Argentina has failed specifically to identify these
"cases" and has not demonstrated that the relevant applicants requested information about the stage of
the procedure and were denied such information.
7.2472 In the light of this, we conclude that Arge ntina has failed to establish its product-specific
claims under the fifth obligation contained in Annex C(1)(b).
(f) Article 8
7.2473 Turning now to the United States' and Argentina' s claims under Article 8, we recall that the
United States and Argentina seek to establish an inconsistency with Article 8 on the basis of an
alleged inconsistency with Annex C(1)(b). We have determined that the United States and Argentina
have failed to establish their claims under Annex C(1)(b). Under the approach followed by the United
States and Argentina, this means that their claims under Article 8 have not been established either.
(g) Overall conclusions
7.2474 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 th e in respect of
which the Panel is making findings have resulted in the European Communities
acting inconsistently with its oblig ations under Annex C(1)(b) of the SPS Agreement
and, consequently, with its obligations under Article 8 of the SPS Agreement.

 (ii) 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 in respect of which the Panel is
making findings have resulted in the Eur opean Communities acting inconsistently
with its obligations under Annex C(1)(b) of the SPS Agreement and, consequently,
with its obligations under Article 8 of the SPS Agreement.

12. Consistency of the with Article 8 and Annex C(1)(c) of the
SPS Agreement
7.2475 Argentina claims that the product-specific measure s identified by it are inconsistent with the
European Communities' obligations under Article 8 and Annex C(1)(c) of the SPS Agreement.
7.2476 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."
7.2477 Annex C(1)(c) 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:

(c) information requirements are limited to what is necessary for appropriate
control, inspection and approval procedures, including for approval of the use of
additives or for the establishment of tolerances for contaminants in food, beverages or
feedstuffs[.]"
7.2478 Argentina submits that the European Communities act ed inconsistently with the provisions
of Annex C(1)(c) by delaying the examination of th e relevant applications and by requiring excessive
submissions under the terms of subsequent legislat ion. Regarding the submission of information
under the terms of subsequent legislation, Argen tina points out that the European Communities has
invoked requirements contained in subsequent legislation as grounds for not processing applications.
According to Argentina, this is clear from the f act that applications submitted under Directive 90/220
had to be resubmitted under Directive 2001/18 even in cases where the procedures had already been
in progress under the old Directive for three years. Argentina also points out that there were
numerous requests for additional information in the approval procedures which are the subject of its
product-specific claims under Annex C(1)(c). Finally, Argentina argues that a violation of the
provisions of Annex C simultaneously represents a violation of Article 8.
7.2479 The European Communities argues that delays do not fall within the scope of application of
Annex C(1)(c). Regarding information requireme nts, the European Communities submits that the
question of which information requirements are necess ary is a question of standards set forth in the
SPS Agreement itself. The European Communities also argues that Argentina should have attacked
Directive 2001/18 if it considered the requirement to resubmit an updated dossier upon entry into
force of Directive 2001/18 to be inconsistent with the SPS Agreement.
7.2480 The Panel notes that in accordance with the lead-in to Annex C(1) the provisions of
Annex C(1)(c) 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)(c). Therefore, in respect of the approval procedures set out in the aforementioned
Directives and Regulation, the European Communi ties was and is required to comply with the
provisions of Annex C(1)(c).
7.2481 We note that Argentina relies on the alleged in consistency of the re levant with Annex C(1)(c) to make consequentia l claims of inconsistency under Article 8.
Accordingly, we will begin our analysis with the claims under Annex C(1)(c).

(a) Annex C(1)(c)
7.2482 We recall that the product-specific measure s which Argentina says give rise to an
inconsistency with Annex C(1)(c ) are undue delays caused by the European Communities in the
consideration of particular applications. Arge ntina asserts that the European Communities has
breached its obligations under Annex C(1)(c) by de laying the completion of the relevant approval
procedures. We are not persuaded by this asserti on. In our view, the failure by the European
Communities to complete particular approval procedures without undue delay did not itself impose, or
lead to the imposition of, information requirements which were not necessary. We therefore fail to
see how the measures challenged by Argentina could be considered to give rise to an inconsistency
with Annex C(1)(c). At any rate, Argentina h as not identified specific information requirements
which were imposed on applicants in the relevant approval procedures, nor has it explained why any
such requirements were not necessary for appropriate approval procedures.
7.2483 Argentina also asserts that the European Co mmunities has breached its obligations under
Annex C(1)(c) by requiring excessive submissions unde r the terms of subsequent legislation. Here
again, we must recall that the which Argentina is challenging are undue
delays caused by the European Co mmunities in the consideration of particular applications. The
failure by the European Communities to complete particular approval procedures without undue delay
did not impose a requirement on applicants to provi de information based on legislation not yet in
force, nor did it cause such a requirement to be imposed. Likewise, the European Communities'
failure to complete particular approval procedures without undue delay did not require applicants to
update their applications in accordance with the provisions of Directive 2001/18 once that
Directive had entered into force. Nor did that failure cause such a requirement to be imposed.
1667 We
are therefore unable to agree with Argentina that the European Communities has breached its
obligations under Annex C(1)(c) by requiring excessive submissions under the terms of subsequent
legislation. In any event, Argentina has not e xplained why the submissions it referred to were
"excessive" and thus not necessary.
7.2484 We note Argentina's argument that there were numerous requests for additional information
in the approval procedures which are the subject of its claims under Annex C(1)(c). It is sufficient to
note in this regard that if Argentina was of the vi ew that some or all of these requests for additional
information constitute information requirements and that these requirements were not limited to what
was necessary, it should have challenged these requests.
7.2485 In the light of the above, we conclude that Argentina has failed to establish its product-
specific claims under Annex C(1)(c).
(b) Article 8
7.2486 Turning to Argentina's claims under Article 8, we recall that Argentina seeks to establish an
inconsistency with Article 8 on the basis of an a lleged inconsistency with A nnex C(1)(c). We have
determined that Argentina has failed to establish its claims under Annex C(1)(c). Under the approach
followed by Argentina, this means that its claims under Article 8 have not been established either.

1667 As pointed out by the European Communities, the requirement to update applications in accordance
with the provisions of Directive 2001/18 flows from Artic le 35 of that Directive. Argentina does not challenge
Article 35 as such.

(c) Overall conclusion
7.2487 In the light of the above, the Panel reaches the following conclusion:
 (i) 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 in respect of which the Panel is
making findings have resulted in the Eur opean Communities acting inconsistently
with its obligations under Annex C(1)(c) of the SPS Agreement and, consequently,
with its obligations under Article 8 of the SPS Agreement.

13. Consistency of the with Article 8 and Annex C(1)(e) of the
SPS Agreement
7.2488 Argentina claims that the product-specific measure s identified by it are inconsistent with the
European Communities' obligations under Article 8 and Annex C(1)(e) of the SPS Agreement.
7.2489 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."
7.2490 Annex C(1)(e) 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:

(e) any requirements for control, in spection and approval of individual
specimens of a product are limited to what is reasonable and necessary[.]"
7.2491 Argentina argues that the detailed requirements of Directive 2001/18 and of its predecessor,
Directive 90/220, as well as of Regulation 258/97 do not seem to meet the criteria of "reasonableness
and necessity". Moreover, the European Communities has failed to exercise the authority granted to it
by the aforementioned legislation, and that failure to act cannot be deemed reasonable or necessary.
Furthermore, when Directive 2001/18 came into force, no consideration was given to the newly
submitted applications, nor were those applications approved which had already been submitted under
the predecessor Directive. Argentina further s ubmits that the application of the European
Communities' approval procedures is not limited to what is reasonable and necessary for the approval
of biotech products.
7.2492 The European Communities argues that to the extent that Argentina's argument relates to
the EC approval legislation itself, there is no reas on to respond as the legislation is not a measure at
issue. Furthermore, Argentina offers no support fo r its assertion that the application of the European
Communities' approval procedures is not limited to what is reasonable and necessary for the approval

of biotech products. The European Communities submits, therefore, that Argentina has not
established a prima facie case.
7.2493 The Panel notes that Argentina relies on the allege d inconsistency of the relevant product-
specific measures with Annex C(1)(e) to make conseque ntial claims of inconsis tency under Article 8.
Accordingly, we will begin our analysis with the claims under Annex C(1)(e).
(a) Annex C(1)(e)
7.2494 We note that Annex C(1)(e) imposes limita tions on any requirements for approval of
"individual specimens of a product" (emphasis added). The challenged by
Argentina do not concern "individual specimens" of biotech products. They concern specific biotech
products for which marketing approval has been so ught. We also recall that the which Argentina says give rise to an in consistency with Annex C(1)(e) are undue delays
caused by the European Communities in the consider ation of particular applications. It is not
apparent to us that the European Communities' failure to complete approval procedures concerning
particular biotech products without undue dela y imposed, or led to the imposition of, any
requirements for the approval of individual specimens of the relevant biotech products. We therefore
fail to see how the measures challenged by Argen tina could be considered to give rise to an
inconsistency with Annex C(1)(e).
7.2495 In the light of this, we conclude that Arge ntina has failed to establish its product-specific
claims under Annex C(1)(e).
7.2496 To the extent Argentina is seeking to challe nge requirements contained in the EC approval
legislation, we agree with the European Communitie s that the relevant legislation is not a measure
within our terms of reference.
(b) Article 8
7.2497 Turning to Argentina's claims under Article 8, we recall that Argentina seeks to establish an
inconsistency with Article 8 on the basis of an a lleged inconsistency with A nnex C(1)(e). We have
determined that Argentina has failed to establish its claims under Annex C(1)(e). Under the approach
followed by Argentina, this means that its claims under Article 8 have not been established either.
(c) Overall conclusion
7.2498 In the light of the above, the Panel reaches the following conclusion:
 (i) 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 in respect of which the Panel is
making findings have resulted in the Eur opean Communities acting inconsistently
with its obligations under Annex C(1)(e) of the SPS Agreement and, consequently,
with its obligations under Article 8 of the SPS Agreement.

14. Consistency of the with Article III:4 of the GATT 1994
7.2499 Canada and Argentina claim that the European Communities has acted inconsistently with its
obligations under Article III:4 of the GATT 1994 in r espect of the they are
challenging. We recall that the United States did not present claims under the GATT 1994.
7.2500 Article III:4 of the GATT 1994 provides in relevant part:
"The products of the territory of any contr acting party imported into the territory of
any other contracting party shall be accord ed treatment no less favourable than that
accorded to like products of national origin in respect of all laws, regulations and
requirements affecting their internal sale, offering for sale, purchase, transportation,
distribution or use."
7.2501 Canada argues that the failure of the European Communities to consider or approve, without
undue delay, the four applications of specific inter est to Canada falls within the scope of the GATT
1994 and is inconsistent with the European Commun ities' obligations under Article III:4. According
to Canada, the measures at issue are "laws, re gulations or requirement s laws, regulations or
requirements affecting the internal sale, offering for sale, purchase, and distribution" of the biotech
products concerned; the biotech products subject to the are "like"
domestically-grown non-biotech counterparts in the li ght of the criteria put forth by the Appellate
Body; and the imported biotech products concerned ar e accorded treatment less favourable than that
accorded like non-biotech products of national origin . Canada submits that, for these reasons, the
measures at issue constitute a violation of the Eu ropean Communities' national treatment obligations
under Article III:4.
7.2502 Argentina argues that the suspension of considera tion of, or the failure to consider, the
particular applications of interest to Argentina is inconsistent with Ar ticle III:4 of the GATT 1994,
because it gives less favourable treatment to biotech products than to non-biotech products. Argentina
argues that the inconsistencies re sult from the fact that (i) biotech and non-biotech products are "like
products", (ii) the suspension of consideration of, or the failure to consider, the particular applications
are "requirements affecting the sale, offering sale, purchase, transport, distribution and use of products
on the domestic market", and (iii) the suspension of consideration of, or the failure to consider, the
particular applications has modified the conditions of competition in the relevant market to the
detriment of imported products.
7.2503 The European Communities argues that there is no violation of Article III:4 of the GATT
1994 with regard to the ch allenged by Canada and Argentina. This is
because: (i) the measures challenged by Canada and Argentina are alleged delays in dealing with
specific requests for approval within a specified timeframe, and these measures are not in themselves
"laws, regulations or requirements" as provided fo r by Article III:4 of the GATT 1994; (ii) imported
products are not accorded less favourable treatment than like domestic products, as there is no
discrimination between relevant imported biotech products and same biotech products cultivated or
processed domestically, which are the only "like products" to the imported biotech products
concerned.
7.2504 The
Panel will analyse Canada's and Argentina's claim separately.

(a) DS292 (Canada)
7.2505 In relation to DS292, we recall that we have al ready reached the conclusion that the failure by
the European Communities to consider or appr ove, without undue delay, the four particular
applications identified by Canada has given rise to a breach of the European Communities' obligations
under Annex C(1)(a), first clause, of the SPS Agreement and, consequently, its obligations under
Article 8 of the SPS Agreement. In these circumstances, we see no need to examine, and offer
additional findings on, whether the relevant measures are also inc onsistent with Article III:4.
Accordingly, we exercise judicial economy with regard to Canada's claim under Article III:4.

(b) DS293 (Argentina)
7.2506 In relation to DS293, we begin our analysis with the applications concerning Bt-531 cotton
and RR-1445 cotton which Argentina says have yet to be approved under Regulation 258/97.
(i) affecting the approval of Bt-531 cotton and RR-1445 cotton under
Regulation 258/97
7.2507 Argentina challenges under Article III:4 the susp ension of consideration of, or failure to
consider, applications concerning Bt-531 cott on and RR-1445 cotton which were allegedly submitted
for "approval"1668 under Regulation 258/97.
7.2508 We recall that in respect of the same allege d Argentina presented a
claim under Article 5.1 of the SPS Agreement. In the context of our analysis of that claim, we have
pointed out that we have seen no evidence that applications concerning Bt-531 cotton and RR-1445
cotton were submitted for approval under Regulati on 258/97, and we therefore found that Argentina
has failed to meet its burden of demonstrating the existence of a suspension of consideration of, or
failure to consider, Bt-531 cotton and RR-1445 cotton for approval under Regulation 258/97. As the
existence of these product-specifi c measures has not been demonstrated, we cannot but reject
Argentina's claim that the Europ ean Communities has acted inconsistently with its obligations under
Article III:4 in relation to these alleged measures.
(ii) Other challenged by Argentina
7.2509 We now turn to address the remaining eight in respect of which the
Panel has decided to make findings.
7.2510 Argentina claims that the alleged suspension of consideration of, or the failure to consider, the
relevant eight applications is inconsistent with Article III:4 of the GATT 1994 because it resulted in
less favourable treatment being accorded to the biot ech products which are the subject of the eight
applications than to like non-biotech products.
7.2511 Argentina submits that the alleged suspension of consideration of, or the failure to consider,
an application for the approval of a biotech produc t constitutes a "requirement" affecting the sale,
offering for sale, etc. within the meaning of Artic le III:4. For the purposes of our analysis, we are
willing to proceed on the assumption that the alleged suspension of consideration of, or the failure to
consider, an application constitutes a "requirement" within the meaning of Article III:4. Moreover,
we initially focus our analysis on the "no less favourable treatment" obligation contained in
Article III:4, rather than on the "like products" el ement. We recall in this connection that the

1668 Argentina's first written submission, paras. 201-202.

Appellate Body in EC – Asbestos and Dominican Republic – Impor t and Sale of Cigarettes made
statements in relation to the meaning of the ph rase "no less favourable treatment" in Article III:4.
1669
We find these statements to be relevant to th e type of measures challenged by Argentina under
Article III:4.
7.2512 Argentina contends that, as a result of the a lleged suspension of consideration of, or the
failure to consider, the relevant eight applica tions, the European Comm unities has accorded "less
favourable treatment" to the biotech products which ar e the subject of the eight applications than to
like non-biotech products. More particularly, Argen tina considers that the measures at issue have
modified the conditions of competition in the EC market to the detriment of imported biotech
products. Argentina notes in this regard that as a result of the alleged suspension of consideration of,
or the failure to consider, the relevant eight appli cations the biotech products which are the subject of
these applications were not approved.
7.2513 In considering Argentina's contention, the first thing to be observed is that Argentina has not
provided specific factual information about the tr eatment accorded by the European Communities to
the non-biotech products which Argentina considers to be like the biotech products at issue. It
appears to be Argentina's contention, however, that these non-biotech products may be marketed in
the European Communities, whereas the relevant biotech products may not be marketed.
7.2514 At any rate, even if it were the case that, as a result of the measures challenged by Argentina,
the relevant imported biotech products cannot be marketed, while corresponding domestic non-
biotech products can be marketed, in accordance with the aforementioned statements by the Appellate
Body this would not be sufficient, in and of itself, to raise a presumption that the European
Communities accorded less favourable treatment to the group of like imported products than to the
group of like domestic products. We note that Argentina does not assert that domestic biotech
products have not been less favourably treated in th e same way as imported biotech products, or that
the like domestic non-biotech varieties have been more favourably treated than the like imported non-
biotech varieties. In other words, Argentina is not alleging that the treatment of products has differed
depending on their origin. In these circumstances, it is not self-evident that the alleged less
favourable treatment of imported biotech products is explained by the foreign origin of these products
rather than, for instance, a perceived difference be tween biotech products and non-biotech products in
terms of their safety, etc. In our view, Argentin a has not adduced argument and evidence sufficient to
raise a presumption that the alleged less favourable treatment is explained by the foreign origin of the
relevant biotech products.
7.2515 In the light of the above, we find that Argentina has not established that, as a result of the
alleged suspension of consideration of, or the failure to consider, the relevant eight applications, the
European Communities has accord ed "less favourable treatment" to imported products than to
domestic products.
7.2516 Since we have found that Argentina has not de monstrated to our satisfaction that imported
products have been treated "less favourably" than domestic products, there is no need to go on to
determine whether the challenged measures in fact constitute "requirements" within the meaning of
Article III:4, and whether the imported products which Argentina alleges have been treated less
favourably are "like" the domestic products whic h Argentina alleges have been treated more
favourably. Our finding on the "no less favourable treatment" obligation necessarily implies that
Argentina has failed to establish its claim under Arti cle III:4 with regard to the eight in question.

1669 We have reproduced the relevant statements at paras. 7.2404 and 7.2405 above.

(c) Conclusions
7.2517 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS292 (Canada)

 With reference to DS292, and having re gard to the arguments and evidence presented
by Canada and the European Communities, the Panel concludes that it is not
necessary to make findings on whether the which are being
challenged by Canada are inconsistent with Article III:4 of the GATT 1994.
Accordingly, the Panel offers no findings under Article III:4.

 (ii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communities, the Panel concludes that Argentina has
not established that the in respect of which the Panel is
making findings have resulted in the Eur opean Communities acting inconsistently
with its obligations under Article III:4 of the GATT 1994.

15. Consistency of the with the TBT Agreement
7.2518 The Panel now turns to address Canada's and Ar gentina's claims of inconsistency under the
TBT Agreement. We recall that the United States did not present claims under the TBT Agreement.
7.2519 Canada considers that the product-specific measure s it is challenging are SPS measures and
that, as such, they are not subject to the requirements of the TBT Agreement. Canada argues,
however, that if the Panel decides that the produc t-specific measures at issue are not SPS measures,
then Canada submits, in the alternative, that th ese measures are subject to the requirements of the
TBT Agreement. More particularly, Canada's alternativ e claim is that the relevant measures are
inconsistent with Articles 2.1, 2.2, 5.1.2 and 5.2.1, first part, of the TBT Agreement.
7.2520 Furthermore, Canada states that to the extent that the Panel determines that parts of the
measures at issue are covered by the TBT Agreement in addition to the SPS Agreement, Canada's TBT
claims are to be considered cumulative rather than alternative, vis-à-vis its SPS claims.
7.2521 Argentina considers that the Panel should examin e the Argentina
is challenging under the SPS Agreement. However, if the Panel concludes that it should not analize
Argentina's claim under the SPS Agreement, Argentina submits, in the alternative, that the product-
specific measures at issue are subject to the requirements of the TBT Agreement. More particularly, in
Argentina's view the relevant measures are inconsistent with Articles 2.1, 2.2, 5.1.1, 5.1.2, 5.2.1, 5.2.2
and 12 of the TBT Agreement.
7.2522 The European Communities considers that, given the reasons on which the relevant product-
specific measures are based, they fall in part within the scope of the SPS Agreement
 and in part
outside the scope of the SPS Agreement. However, the European Comm unities rejects the alternative
claims by Canada and Argentina that the releva nt they are challenging are
inconsistent with the TBT Agreement.
7.2523 The Panel will analyse Canada's and Argentina's claims separately.