Document: WT/DS291/R WT/DS292/R WT/DS293/R Page 867 (a) DS292 (Canada) 7.2524 Canada has stated that if the Panel determin es that parts of the relevant product-specific measures are covered by the TBT Agreement in addition to the SPS Agreement, Canada's claims under the TBT Agreement are to be considered cumulative rather th an alternative.  We note that each of the four product-specific measures challenged by Cana da concerns an approva l procedure which was conducted under Directive 90/220.  In two cases , the relevant procedure was continued under Directive 2001/18 after the repeal of Directive 90/ 220.  We have found that  the relevant approval procedures set out in these Directives are SPS measures within the meaning of Annex A(1) of the
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

(a) DS292 (Canada)
7.2524 Canada has stated that if the Panel determin es that parts of the relevant product-specific
measures are covered by the TBT Agreement in addition to the SPS Agreement, Canada's claims under
the TBT Agreement are to be considered cumulative rather th an alternative. We note that each of the
four product-specific measures challenged by Cana da concerns an approva l procedure which was
conducted under Directive 90/220. In two cases , the relevant procedure was continued under
Directive 2001/18 after the repeal of Directive 90/ 220. We have found that the relevant approval
procedures set out in these Directives are SPS measures within the meaning of Annex A(1) of the
SPS Agreement. We did not determine that parts of the approval procedures set out in the Directives
are not covered by the SPS Agreement. In the light of this, and in view of Article 1.5 of the
TBT Agreement
1670, we have no basis for finding that parts of the relevant approval procedures are
covered by the TBT Agreement in addition to the SPS Agreement. Consequently, we should treat
Canada's claims under Articles 2.1, 2.2, 5.1.2 and 5.2.1, first part, of the TBT Agreement as alternative
claims. Since Canada's alternative claims are rele vant only in the event that we decide that the
relevant product-specific measures are not subject to the SPS Agreement, and since we have found
that these measures are subject to the SPS Agreement (notably Annex C(1)(a) and Article 8), we see
no need to address Canada's alternative claims under Articles 2.1, 2.2, 5.1.2 and 5.2.1, first part, of the
TBT Agreement further.
(b) DS293 (Argentina)
7.2525 Argentina's claim that the product-specific measures it is challenging are inconsistent with the
TBT Agreement is presented in the alternative, in the ev ent the Panel "considers that it should not
analyse Argentina's claim under the SPS Agreement".1671
7.2526 Regarding the product-specific measures describ ed by Argentina as the undue delays in
finalizing consideration of particular applicati ons, we found above that the European Communities
has breached its obligations under Anne x C(1)(a), first clause, of the SPS Agreement and Article 8 of
the SPS Agreement in respect of each of the eight measures concerned. Accordingly, in respect of
these measures, we found that we should analyse Argentina's claim under the SPS Agreement. Since
Argentina's alternative claim under the TBT Agreement is relevant only in the event that we consider
that the relevant product-specific measures should not be analysed under the SPS Agreement, we see
no need to address Argentina's alternative claim under the TBT Agreement further.
7.2527 Regarding the product-specific measures describ ed by Argentina as the suspension by the
European Communities of consideration of, or the fa ilure to consider, particular applications, we
found above that Argentina has not established that the European Communitie s acted inconsistently
with its obligations under Articles 5.1, 5.5, 5.6 or 2.2 of the SPS Agreement in respect of the ten
measures concerned. Thus, we found that the ten measu res are not inconsistent with the provisions of
the SPS Agreement identified by Argentina. However, the relevant findings do not imply that
Argentina's claim that the relevant product-speci fic measures are WTO-inconsistent should not be
analysed under the SPS Agreement. As we have said earlier, the second type of measures challenged
by Argentina in our view is conceptually the same as the type of product-specific measures challenged
by the United States. Our findings above show th at the measures challenged by the United States
could, and in many cases did, give rise to an incons istency with the provisions of Annex C(1)(a), first
clause, and Article 8 of the SPS Agreement. Hence, we consider that Argentina's claim could be

1670 We recall that Article 1.5 states that the provisions of the TBT Agreement do not apply to SPS
measures within the meaning of Annex A(1) of the SPS Agreement.
1671 Argentina's first written submission, paras. 374 and 450.

properly analysed under the SPS Agreement. Since Argentina's alternative claim under the
TBT Agreement is relevant only in the event that we consider that the relevant product-specific
measures should not be analysed under the SPS Agreement, we see no need to address Argentina's
alternative claim under the TBT Agreement further.
(c) Conclusions
7.2528 In the light of the above, the Panel reaches the following 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 product-specific measures which are being
challenged by Canada are inc onsistent with Articles 2.1, 2.2, 5.1.2 and 5.2.1, first
part, of the TBT Agreement. Accordingly, the Panel o ffers no findings under Articles
2.1, 2.2, 5.1.2 or 5.2.1, first part, of the TBT Agreement.

 (ii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communiti es, the Panel concludes that it is not
necessary to make findings on whether th e relevant ten product-specific measures
challenged by Argentina 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. Accordingly, the Panel offers no findings under
Articles 2.1, 2.2, 5.1.1, 5.1.2, 5.2.1, 5.2.2 or 12 of the TBT Agreement.

F. EC
 MEMBER STATE SAFEGUARD MEASURES
1. Introduction
7.2529 The Complaining Parties have made a series of claims concerning measures adopted by
EC member States which allegedly prohibit the im port, use of, or marketing of certain biotech
products. These measures (hereafter "safeguard measures" or "member State measures") were
adopted by EC member States on the basis of Article 16 of Directive 90/220 1672 (later replaced by
Article 23 of Directive 2001/181673) and Article 12 of Regulation 258/97.1674
(a) Safeguard measures in the context of the relevant EC approval procedures
7.2530 Where a biotech product has been approved for Community-wide marketing under
Directives 90/220 or 2001/18, or Regulation 258/97 , member States ordinarily may not prohibit or
restrict trade in, or use of, that product on their r espective territories, provided the conditions attached
to the marketing approval are being met. Ex ceptionally, however, member States may provisionally
adopt safeguard measures which prohibit or restrict trade in, or use of, biotech products which have
been granted Community-wide marketing approval.

1672 Exhibits US-25; CDA-18; ARG-4.
1673 Exhibits US-24; CDA-17; ARG-3.
1674 Exhibits US-26; CDA-19; ARG-5.

7.2531 Pursuant to Article 16 of Directive 90/220, a member State may provisionally restrict or
prohibit the use and or sale of a product in its territory where it has "justifiable reasons to consider
that a product which has been properly notified and has received written consent [...] constitutes a risk
to human health or the environment".
1675 Safeguard measures adopted pursuant to Article 16 of
Directive 90/220 have been maintained and review ed on the basis of Article 23 of Directive 2001/18
since the entry into force of that Directive. Article 23 provides that a safeguard measure may be
adopted where, "as a result of new or additional information made available since the date of the
consent and affecting the environmental risk assessme nt or reassessment of existing information on
the basis of new or additional scientific knowle dge", a member State has "detailed grounds for
considering that a GMO as or in a product [...] cons titutes a risk to human health or the environment
[...]".1676 Finally, Article 12 of Regulation 258/97 provi des that a safeguard measure may be adopted
where, "as a result of new information or a reassess ment of existing information", a member State has
"detailed grounds for considering that the use of a food or a food ingredient complying with this
Regulation endangers human health or the environment [...]".1677
7.2532 The safeguard measures taken pursuan t to Directives 90/220 and 2001/18, or
Regulation 258/97, can be maintained only on a provisional basis, pending a full assessment at
EC level.1678 The member State adopting a safeguard measure must immediately inform the
Commission and other member States of its measure. 1679 Upon notification of the safeguard measure,
the Commission must take a decision with respect to that measure. Such decision will result either in
the modification of the Community-wide marketing approval, or in the termination of the measure.1680
7.2533 According to the procedure laid down in the relevant provisions of Directives 90/220 and
2001/18, and Regulation 258/97 1681, the Commission, when making a decision on a safeguard
measure which has been notified, is assisted for this purpose by the Regulatory Committee 1682 or by
the Standing Committee on Foodstuffs, respectively. 1683 The Commission must submit a draft of the
measure to be taken to the Regulatory Committe e or the Standing Committee on Foodstuffs, which
shall deliver their opinion on the draft within a time-limit which the chairman may lay down
according to the urgency of the matter. 1684 If the draft measure is in accordance with the opinion of
the Regulatory Committee or the Standing Committee on Foodstuffs, the Commission must adopt the
draft measure. However, if the measure is not in accordance with the opinion of the Committee, or if
no opinion is delivered, the Commission must subm it without delay a proposal to the Council of

1675 See supra, footnote 1672.
1676 See supra, footnote 1673.
1677 Supra, footnote 1674.
1678 Article 16(1) of Directive 90/220; Article 23(1), 3 rd paragraph of Directive 2001/18; and
Article 12(1) of Regulation 258/97.
1679 Article 16(1) of Directive 90/220; Article 23(1), 3 rd paragraph of Directive 2001/18; and
Article 12(1) of Regulation 258/97.
1680 Article 21 of Directive 90/220. Under Directive 90/220, such a decision by the Commission must
be taken within a period of three months from the time of notification of the measure. We note that there is no
similar timeframe pursuant to Regulation 258/97.
1681 Details of the procedures for Directives 90/220 and 2001/18, and Regulation 258/97 are described
in section C.
1682 Articles 21 of Directive 90/220 and 30(2) of Directive 2001/18.
1683 Article 13 of Regulation 258/97.
1684 Article 21 of Directive 90/220; Article 30(2) of Directive 2001/18; and Article 13 of
Regulation 258/97. While Article 30(2) of Directive 2001/18 refers to Articles 5, 7 and 8 of Decision 1999/468,
the European Communities notes that these provisions are similar to Article 21 of Directive 90/220 (EC reply to
Panel question No. 84, para. 229).

Ministers on the measure to be taken. The C ouncil must act on the proposal within a period of
three months, failing which the Commission must adopt the proposed measure.
1685
(b) Overview of the specific measures at issue
7.2534 The Complaining Parties make claims with r espect to nine different safeguard measures,
which they allege prohibit the importation or mark eting of various biotech products. The nine
measures were taken by six different member States, namely Austria, France, Germany, Greece, Italy
and Luxembourg. For ease of reference, the safe guard measures are identified hereinafter by the
name of the member State which has adopted th e measure and the product(s) affected by such
measure. Accordingly, the following safeguard measures are at issue in this dispute:
 (1) Austria – T25 maize;
 (2) Austria – Bt-176 maize;
 (3) Austria – MON810 maize;
 (4) France – MS1/RF1 oilseed rape (EC-161);
 (5) France – Topas oilseed rape;
 (6) Germany – Bt-176 maize;
 (7) Greece – Topas oilseed rape;
 (8) Italy – Bt-11 maize (EC-163), MON810 maize, MON809 maize and T25 maize; and
 (9) Luxembourg – Bt-176 maize.

7.2535 The safeguard measures at issue have all been taken pursuant to Article 16 of
Directive 90/220, with the exception of the measure by Italy on Bt-11 maize (EC-163), MON810
maize, MON809 maize and T25 maize, which was adopted on the basis of Article 12 of
Regulation 258/97.
7.2536 Each safeguard measure was notified to the Co mmission by the relevant member State with
evidence allegedly supporting the adoption of the me asure. On the basis of the information provided
by the member State, the Commission requested in each case the opinion of the relevant EC
scientific committee on whether this information cons tituted relevant scientific evidence that would
cause the committee to consider that the product(s) at issue constituted a risk for human health or the
environment. For each safeguard measure at issue, the relevant EC scientific committee reaffirmed its
earlier assessment, or that of a nother EC scientific committee that the relevant products did not
present any risks to human health or the environment. However, the Panel understands that as of the
date of establishment of this Panel, no decision had been taken at Community level with regard to any
of the safeguard measures at issue in this dispute. That is to say, no decision had been taken with
regard to whether the Community-wide marketi ng approval for the releva nt products should be
modified, or whether the safeguard measures at issue should be terminated.
1686
7.2537 The safeguard measures at issue in this dispute were still in force at the time of establishment
of this Panel.1687 However, the European Co mmunities asserts that the safeguard measure adopted by
Italy was repealed by a Decree adopted in October 2004.1688

1685 Article 21 of Directive 90/220; Article 30 of Directive 2001/18; and Article 13(4)(b) of
Regulation 258/97.
1686 According to Canada, the Commission indicated that it had called upon all EC member States with
national measures in place restricting or prohibiting the marketing of EC-approved biotech products to lift or
withdraw those measures. See Exhibits CDA-33 and -34.
1687 EC reply to Panel question No. 101.

(c) Overview of Parties' claims and Panel's approach
7.2538 The United States is challenging all nine safeguard measures at issue in this case, as
mentioned in paragraph 6 above. According to the United States, these safeguard measures are
covered by the SPS Agreement. The United States argues that the safeguard measures violate various
provisions of the SPS Agreement. In particular, the member States have failed to base their measures
on a risk assessment and on scientific principl es pursuant to Articles 5.1 and 2.2 of the
SPS Agreement. Moreover, the member States have applie d arbitrary or unjustifiable distinctions in
their levels of protection against risks that have r esulted in discrimination or a disguised restriction on
international trade pursuant to Articles 5.5 and 2.3 of the SPS Agreement. The United States further
argues that the safeguard measure prohibiting the importation of Topas oilseed rape adopted by
Greece, in addition to violating various provisions of the SPS Agreement, violates Article XI:1 of the
GATT 1994.
7.2539 Canada is challenging five safeguard measures, namely:
 (1) Austria – T25 maize;
 (2) France – MS1/RF1 oilseed rape (EC-161);
 (3) France – Topas oilseed rape;
 (4) Greece – Topas oilseed rape; and
 (5) Italy – Bt-11 maize (EC-163), MON809 maize, MON810 maize and T25 maize.

7.2540 Canada argues that the safeguard measures are SPS measures pursuant to Annex A of the
SPS Agreement, and also affect international trade. Canada argues that the safeguard measures are not
based on a risk assessment, as required by Article 5.1 of the SPS Agreement. Canada further argues
that the safeguard measures violate Article 5.6, since the European Communities’ own regulatory
regime constitutes another measur e, reasonably available taking into account technical and economic
feasibility. Canada argues that the safeguard measur es fail to meet any of the three requirements of
Article 2.2, namely that they 1) be applied to th e extent necessary to protect human, animal or plant
life or health; 2) be based on scientific principles; and 3) not be maintained without sufficient
scientific evidence, except as provided for in paragra ph 7 of Article 5. Consequently Canada argues
that these measures violate Article 2.2. Finally , Canada argues that the safeguard measures are
inconsistent with the European Communities' obligations under Article 5.5 of the SPS Agreement, and
thus by implication, also violate Article 2.3.
7.2541 With respect to the Greek safeguard measure, Canada considers that it violates Article XI:1 of
the GATT 1994. Canada further argues that the safeg uard measures are inconsistent with Article III:4
of the GATT 1994. Canada also makes cumulative claims under the TBT Agreement arguing that the
measures constitute technical regulations because th ey establish product specifications. In particular,
Canada argues that the safeguard measures are inc onsistent with Articles 2.1, 2.2 and 2.9 of the
TBT Agreement.
7.2542 Argentina makes claims with respect to six member State measures, as follows:
 (1) Austria – T25 maize;
 (2) Austria – Bt-176 maize;
 (3) Austria – MON810 maize;
 (4) Germany – Bt-176 maize;

1688 See EC reply to Panel question No. 160 and Exhibit EC-166. This was contested by Canada in
their comments on other Parties' responses to Panel question 160, paras. 52-53.

 (5) Italy – MON810 maize, T25 maize, Bt-11 maize (EC-163)
1689; and
 (6) Luxembourg – Bt-176 maize.

7.2543 Argentina argues that the safeguard measures are SPS measures pursuant to Annex A of the
SPS Agreement, and also affect international trade. Ar gentina argues that the safeguard measures are
not based on a risk assessment, as required by Article 5.1 of the SPS Agreement. Argentina further
argues that the safeguard measures violate Artic le 5.6, since the European Communities’ own
regulatory regime constitutes another measure, reaso nably available taking into account technical and
economic feasibility. Argentina argues that the saf eguard measures fail to meet the requirements of
Article 2.2, which requires that a measure be a pplied "only to the extent necessary," while also
requires that it be based on "sufficient scientific evidence." Consequently, the safeguard measures
conflict with Article 2.2, and cannot be justified under the exception of Article 5.7. Finally, Argentina
argues that the safeguard measure s are inconsistent with the Eu ropean Communities' obligations
under Article 5.5 of the SPS Agreement, and thus by implication, also violate Article 2.3.
7.2544 Argentina argues that the safeguard measures are inconsistent with Article III:4 of the
GATT 1994. Argentina also makes alternative claims under the TBT Agreement arguing that the
measures constitute technical regulations because th ey establish product specifications. In particular,
Argentina argues that the safeguard measures are inc onsistent with Articles 2. 1, 2.2 and 2.9 of the
TBT Agreement.
2. Analysis of the safeguard measures in the light of the SPS Agreement
7.2545 Before examining whether the relevant safe guard measures are inconsistent with the
SPS Agreement, as claimed by the Complaining Parties, we must determine whether the
SPS Agreement is applicable to these measures.
(a) Applicability of the SPS Agreement
7.2546 We begin our examination of whether the SPS Agreement is applicable to the relevant
safeguard measures by summarizing the Parties' gene ral positions. In the light of these, we will
outline how we will approach this issue, and subsequently address the applicability of the
SPS Agreement measure-by-measure.
(i) General
7.2547 The United States argues that all the safeguard measures fall within the scope of the
SPS Agreement. The general purpose of the member State measures can be inferred from the text of
the EC legislation on which the measures are based. The overall objective set out in Article 16 of
Directive 90/220 and Article 12 of Regulation 258/97 is the protection of human health and the
environment. Since all measures were based on on e of these provisions, it can be inferred that the
measures were enacted for the purpose of protecti ng human health and the environment. Moreover,
the sanitary or phytosanitary purpose of the member State measures can be found in the measures
themselves, as well as in the justifications offe red by the member States when the measures were
adopted.

1689 In respect of the safeguard measure imposed by Italy, while the complaints by the United States
and Canada refer to four products, i.e., Bt-11 maize (EC-163), MON809 maize, MON810 maize and T25 maize,
the complaint by Argentina refers to only three products, i.e., Bt-11 maize (EC-163), MON810 maize and T25
maize.

7.2548 The United States notes that the European Communities has not contested the fact that each of
the member State measures was adopted at least for some reasons that fall within the scope of the
SPS Agreement. It considers that the fact that the me asures were adopted for some reasons covered
by the SPS Agreement is sufficient to bring those measures within the scope of that Agreement.
Annex A of the SPS Agreement makes it clear that "any measure" applied to protect against one of the
enumerated risks falls within the scope of the Ag reement. Annex A does not state that the measure
needs to be exclusively applied to protect ag ainst only the enumerated risks, nor does the
SPS Agreement state that a measure addressing one of the risks enumerated in Annex A loses its status
as an SPS measure if the adoption of the measure is also supported by other rationales. The United
States notes that in the EC - Hormones case, all parties agreed that the relevant EC Directives fell
within the scope of the SPS Agreement, even though the Directives were not adopted solely to address
alleged effects on human health.
7.2549 Canada argues that the safeguard measures it is challenging fall within the scope of
paragraph 1(a) to (d) of Annex A of the SPS Agreement. Canada notes that the member State
measures are intended to "protect" "human", "animal" or "plant" "life or health", or "to prevent or
limit other damage" within their territories, as can be inferred from the relevant provisions of EC law
on which the measures are based. According to Cana da, this can also be inferred from the measures
themselves, as well as from official statements ma de by government officials in relation to the
passage or adoption of the measures. This evid ence also supports the conclusion that these measures
are designed to protect against "risks arising from" "the entry, establishment or spread" of "pests" or
"disease-causing organisms" or "additives, contaminan ts, toxins or disease-causing organisms" in
"food" or "feedstuffs". Although these terms are not defined in the SPS Agreement, their ordinary
meaning, when read in context and in light of the object and purpose of the SPS Agreement, falls
within the scope of the types of concerns intended to be addressed by the safeguard measures. More
importantly, the text of the measures themselves, as well as the supporting documentation provided at
the time the measures were adopted, demonstrate that the measures are SPS measures.
7.2550 Argentina argues that the purpose of the safeguard measures may be inferred from the
Community legislation under which the measures were adopted. The relevant provisions of EC
Directive 90/220 and Regulation 258/97 clearly indicate that the purpose of the EC legislation is the
"protection of human health and the environment" . Since the EC member States have taken their
measures explicitly on the basis of this legislation, it can be inferred that the measures were imposed
for the purpose of protecting human health or th e environment. The safeguard measures are,
therefore, SPS measures as defined in the SPS Agreement.
7.2551 The European Communities notes that each of the safeguard measures was adopted for
some reasons that fall within the scope of the SPS Agreement, and some reasons that fall outside the
scope of that Agreement. According to the Eu ropean Communities, if a WTO Member acts on the
basis of two different objectives, one of which falls within the scope of the SPS Agreement
 and the
other of which does not, these two measures are in effect different for WTO purposes. Therefore, the
measure or part of the measure adopted for reasons that fall outside the scope of the SPS Agreement
cannot be inconsistent with that Agreement. Only the measure, or part of the measure, adopted for
reasons that fall within the scope of the SPS Agreement require further analysis. This is so even if the
two different objectives sought to be achieved by a measure are reflected in a single document.
7.2552 The Panel recalls that pursuant to Article 1.1 of the SPS Agreement, the Agreement applies to
"all sanitary and phytosanitary measures which may, directly or indirectly, affect international trade".
7.2553 We recall once again that the term "SPS meas ures" is defined in Annex A(1) of the
SPS Agreement as any measure applied:

(a) to protect animal or plant life or h ealth within the territory of the Member
from risks arising from the entry, establishm ent or spread of pests, diseases, disease-
carrying organisms or disease-causing organisms;
(b) to protect human or animal life or he alth within the territory of the Member
from risks arising from additives, contaminants, toxins or disease-causing organisms
in foods, beverages or feedstuffs;
(c) to protect human life or health within the territory of the Member from risks
arising from diseases carried by animals, plants or products thereof, or from the entry,
establishment or spread of pests; or
(d) to prevent or limit other damage with in the territory of the Member from the
entry, establishment or spread of pests.
Sanitary or phytosanitary measures include all relevant laws, decrees, regulations,
requirements and procedures [...].
7.2554 In order to determine whether the SPS Agreement applies to the safeguard measures, the Panel
must therefore determine (1) whether such measur es are "sanitary or phytosanitary measures", or
"SPS measures", as defined in Annex A of the SPS Agreement; and (2) whether these measures may,
directly or indirectly, affect international trade.
7.2555 It is clear from the definition contained in Annex A(1) that one of the elements which
determines whether a particular measure is an SPS measure is the purpose of the measure.
1690 A
measure is an SPS measure if it is applied "to protect " life or health from certain enumerated risks, or
if it is applied "to prevent or limit" certain other damage.
7.2556 In the case at hand, the Complaining Parti es are challenging the maintenance in August 2003
of the relevant safeguard measures. We must ther efore determine whether at that time each of the
relevant safeguard measures served at least one of the purposes identified in the definition contained
in Annex A of the SPS Agreement. In our view, a determination as to whether a particular safeguard
measure was applied in August 2003 for one of the purposes enumerated in Annex A(1) must be made
in the light of the specific circumstances of each case.
7.2557 We note that applicable EC legislation requi red the member States in question to provide
justification for the adoption of their safeguard measures. We think that documents submitted by
these member States by way of justification for the adoption of their measures are relevant to
ascertaining the purposes of these measures.
7.2558 However, we consider that it would not be a ppropriate in this case to limit our inquiry to
determining the purposes for which the safeguard me asures were adopted. To begin with, we recall
that our task in this case is to determine the pur poses for which the relevant safeguard measures were
maintained in August 2003. Furt hermore, Annex A(1) does not refer to measures "adopted" for one
of the enumerated purposes, but, more broadly, to measures "applied" for one of the enumerated
purposes. Moreover, we see nothing in the SPS Agreement which would bar a panel from considering
purposes which were not articulated by the memb er States when they adopted their safeguard

1690 As we have noted above in the context of our discussion of the general de facto moratorium on
approvals, there are other elements which must be met for a measure to constitute an "SPS measure". See supra,
para. 7.456.

measures.
1691 Finally, our approach is consistent with the view expressed by the Appellate Body that
in identifying the purposes of a measure, panels need not seek to determine the subjective intent of the
legislators or regulators who adopted the measure. According to the Appellate Body, the purposes of
a measure may and should rather be ascertained on th e basis of objective considerations, for instance
by examining whether there is an objective relati onship between the stated purposes and the text and
structural features of the relevant measure.1692
7.2559 We recall that the safeguard measures were orig inally adopted on the basis of Article 16 of
Directive 90/220 and Article 12 of Regulation 258/97. Both provisions make it clear that safeguard
measures may be taken in case of a risk, or danger, to human health or the environment. 1693 T h e
Complaining Parties argue that it can be inferred fro m this that the purpose of the safeguard measures
is to protect against risks to human health or the environment. We note that the provisions of the
SPS Agreement reflect similar objectives.
1694 We agree that the fact that the member States have
invoked Article 16 of Directive 90/220 and Article 12 of Regulation 258/97 in support of their
measures may, together with other elements, support the conclusion that these measures are applied to
protect against risks to human health or the envi ronment. However, the mere invocation of, and
reference to, the aforementioned articles does not dem onstrate, in and of itself, that a particular
measure is in fact being applied for the purpose of protecting human health or the environment. Thus,
we think it is necessary to make a separat e assessment of the applicability of the SPS Agreement for
each of the nine safeguard measures at issue.
7.2560 With these considerations in mind, we now turn to examine individually the nine safeguard
measures at issue in this case.

1691 This does not mean, however, that we need to accept at face value assertions of purposes which are
implausible in the light of all relevant circumstances.
1692 See, e.g ., Appellate Body Reports, Japan – Alcoholic Beverages II , pp. 27-28 (including the
statement that "[i]t is irrelevant that protectionism was no t an intended objective if the particular tax measure in
question is nevertheless, to echo Article III:1 [of the GATT 1994], "applied to imported or domestic products so
as to afford protection to domestic production. This is an issue of how the measur e in question is applied");
Chile – Alcoholic Beverages , paras. 62 and 71-72; and US – Offset Act (Byrd Amendment), para. 259. While
these Appellate Body reports discussed claims under WTO agreements other than the SPS Agreement, the logic
followed by the Appellate Body in these reports is applicable, in our view, to the issue we are considering here.
1693 Article 16 of Directive 90/220: "1. Where a Member State has justif iable reasons to consider that a
product which has been properly notified and has received written consent under this Directive constitutes a risk
to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product
on its territory. It shall immediately inform the Commission and the other Member States of such action and
give reasons for its decision. 2. A decision shall be taken on the matter within three months in accordance with
the procedure laid down in Article 21."
Article 12 of Regulation 258/97: "1. Where a Memb er State, as a result of new information or a
reassessment of existing information, has detailed grounds for considering that the use of a food or a food
ingredient complying with this Regulation endangers human health or the environment, that Member State may
either temporarily restrict or suspend the trade in and use of the food or food ingredient in question in its
territory. It shall immediately inform the other Member States and the Commission thereof, giving the grounds
for its decision. 2. The Commission shall examine the grounds referred to in paragraph 1 as soon as possible
within the Standing Committee for Foodstuffs; it shall ta ke the appropriate measures in accordance with the
procedure laid down in Article 13. The Member State which took the decision referred to in paragraph 1 may
maintain it until the measures have entered into force."
1694 See e.g. Preamble for protection of human health; relevant ecological and environmental conditions
to be taken into account in assessment of risks pursuant to Article 5.2 of the SPS Agreement.

(ii) Austria – T25 maize
7.2561 We begin with the safeguard measure applied by Austria on T25 maize. We recall that the
product at issue was approved by the Commission for placing on the market in April 1998.
1695 I n
April 2000, Austria adopted an ordinance to prohibit commercialisation of T25 maize on its
territory.1696 Austria's safeguard measure, which was taken on the basis of Article 16 of
Directive 90/220, was notified to the Commission in May 2000.1697
Is the Austrian safeguard measure on T25 maize an SPS measure?
7.2562 We start with the issue of whether the Austri an safeguard measure on T25 maize is an SPS
measure. In order to make this determination, we need to consider two distinct elements, namely:
(1) the purpose of the measure; and (2) the form and nature of the measure.
Purpose of the safeguard measure
7.2563 We first consider the issue of the purpose of th e safeguard measure. Before turning to the
arguments of the Parties on this issue, we recall that we must determine whether the purpose of the
safeguard measure falls within one of the categories of purposes set out in Annex A(1) of the
SPS Agreement.
7.2564 The United States notes that among the reasons set out to prohibit T25 maize, Austria cited
the failure by the European Commissi on, at the time it approved the product, to set forth "protection
for ecologically sensitive regions." According to the United States, a measure based on such
justification is an SPS measure because it is app lied "to protect animal life or health" from
"disease-causing organisms"; or "to prevent or limit [...] damage" from the "spread of pests".
7.2565 Canada notes that Austria sought to justify its ban on T25 maize on the grounds that pollen
from the genetically modified variety could spread to fields containing non-biotech maize, giving rise
to a risk of genetic transfer and the development of herbicide resistance in other species. Austria also
cited the absence of a monitoring programme on the long-term effects of genetically altered plants,
particularly in relation to the protection of ecol ogically sensitive regions, and the need for further
testing of possible long-term ecological effects. Si nce these concerns relate to potential risks arising
from T25 maize acting as a "pest" in relation to its surrounding environment, Canada argues that the
Austrian safeguard measure is an SPS measure within the meaning of Annex A(1) of the
SPS Agreement.
7.2566 Argentina argues that the purpose of the safeguard measures may be inferred from the
Community legislation under which the bans were adopted, and that the relevant provisions of EC
Directive 90/220 and Regulation 258/97 clearly indicate that the purpose of the EC legislation is the
"protection of human health and the environment" . Since the EC member States have taken their
measures explicitly on the basis of this legislation, it can be inferred that the measures were imposed

1695 Commission Decision 98/293.
1696 We note that the text of the ordinance provides fo r an exception in cases where the product is to be
immediately re-exported after handling and repackaging. Regulation No. 120, Federal Ministry for Social
Protection and Generations, Ordinance issued on 28 April 2000 prohibiting the commercialization of the
genetically altered corn Zea Mays L. T25 in Austria, approved by the European Commission on 22 April 1998
under Decision 98/293, Federal Gazette, vol. 2000, 28 April 2000 (Exhibits EC-160/At. 3_trans; CDA-76;
US-53).
1697 Exhibit EC-160/At. 3_trans.

for the purpose of protecting human health or th e environment. The safeguard measures are,
therefore, SPS measures as defined in the SPS Agreement.
7.2567 The European Communities asserts that the main reasons for which the Austrian measure
affecting T25 maize was adopted and maintained include, inter alia , horizontal gene transfer;
antibiotic resistance; effects on non-target organisms; persistence and invasiveness in agricultural and
natural habitats; development of resistance; out-crossing; undesirable effects on management
practices; biodiversity; monitoring; labelling; co-existence; and human and animal health.
1698
7.2568 In examining the purposes for which Austria's safeguard measure on T25 maize is applied, the
Panel will first consider the documents notified by Austria to the Commission in support of its
safeguard measure. We note that Austria provided a justification for its safeguard measure in a
document entitled " Reasons for the decision of the Republic of Austria to prohibit the placing on the
market of GM maize line T25 [...]" (hereafter the "Reasons document").
7.2569 In the Reasons document, Austria argued th at the product had not been examined under
realistic conditions of the use of the herbic ide and of corresponding agricultural practices.
 1699 Austria
noted in this regard that neither the applicant' s application seeking approval for the placing on the
market of T25 maize nor the approval decision of the Commission foresaw a monitoring programme.
In particular, Austria considered that special me asures monitoring the spread of pollen to surrounding
fields cultivated with conventional maize were miss ing. Austria further criticized the lack of a
monitoring programme regarding the long-term effects of biotech plants and herbicides especially
because of the fact that the conditions attached to the approval of T25 maize for Community-wide
marketing did not foresee the protection of envi ronmentally sensitive areas. An additional reason
cited by Austria in support of its safeguard measu re was that regional ecological aspects were not
differentiated. Austria pointed out in this regard that the use of herbicide resistant plants such as
T25 maize in areas of unavoidable applications of herbicides seemed to be useful, if good agricultural
practices minimized the danger of the development of resistance in other species. Austria argued,
however, that since mountain ecosystems are susceptib le to accelerated soil erosion and rapid loss of
habitat and genetic diversity, the use of herbicide resistant plants such as T25 maize in these areas
should only take place after further investigati ons of possible long-term and secondary ecological
effects.
7.2570 A document submitted by Austria to the Commission for an Experts Meeting held in Brussels
in January 2004 (hereafter the "January 2004 docum ent") also sheds light on the reasons for which
Austria is applying its safeguard measure on T25 maize. 1700 In this document, Austria states that it
adopted a safeguard measure because: (a) the e nvironmental risk assessment was considered as
insufficient, as it had not taken into account an integr ated point of view of the use of herbicides under
realistic conditions 1701; and (b) possible long term effects and ecological aspects had not been
scientifically assessed. In addition to these reasons, Au stria cited other, more general concerns which
in its view justify the precautionary approach embodi ed in Austria's safeguard measure. Specifically,
Austria pointed out that the allergological and toxicological risk assessment concerning EC-approved
biotech products such as T25 maize had been inadequa te. Austria also noted that pending the report
of the Working Group on antibiotic resistance mark er genes set up by the European Communities in

1698 Exhibit EC-155.
1699 Exhibit EC-160/At. 3_trans.
1700 Exhibit EC-158/At. 30.
1701 It is not clear to the Panel if Austria is referrin g to a specific environmental risk assessment, and if
so, which assessment.

accordance with Directive 2001/18, products containi ng such genes, including T25 maize, should not
be placed on the market.
7.2571 Finally, we note that Austria's reasons for adopting the safeguard measure on T25 maize are
also discussed in a letter addressed to the Commissi on in February 2004 by the Austrian Federal
Minister for Health and Women. In that letter, Austria rejected a request by the Commission for the
withdrawal of Austria's safeguard measure. In this context, Austria recalled that "[t]he crucial factors
in the case of [the decision concerning] maize T25 were the absence of a supervisory programme and
of an examination of the use of herbicide and agricultural practice.
 Both are related to the
consideration of regional ecological characteris tics and the protection of ecologically sensitive
areas."1702 Austria also reiterated its concern a bout inadequacies in the allergological and
toxicological risk assessment concerning biotech products, such as T25 maize, which were submitted
for approval under Directive 90/2201703 and/or Regulation 258/97. Furthermore, Austria noted that it
could not withdraw its safeguard me asure on T25 maize in view of the fact that a coherent regulatory
solution to the problem of coexistence had not yet been found.
7.2572 Based on the foregoing, we consider that at the time of review by the Panel, Austria applied
its safeguard measure on T25 maize to address concerns about:1704
 (1) the spread of pollen to cultivated surrounding fields (co-existence);
 (2) long-term ecological effects in environmentally sensitive areas;
 (3) allergenicity and toxicity; and
 (4) the development of antibiotic resistance.

7.2573 The European Communities asserts that Austri a's safeguard measure on T25 maize is also
applied in view of concerns about labelling . This concern was not articulated by Austria in the
documents discussed by us above. Furthermore, th e European Communities has neither substantiated
nor explained its assertion. In the light of this, we are not persuaded that Austria is applying its
safeguard measure also to address the additional concern identified by the European Communities.
7.2574 Having determined the purposes for which Austri a applied its safeguard measure at the time
of review by the Panel, we now go on to assess whether these purposes fall within one of the
categories of purposes which according to Annex A(1) characterize an SPS measure. To that end, we
will consider one by one each of the above-noted purposes of Austria's safeguard measure.
Spread of pollen to cultivated surrounding fields (co-existence)
7.2575 We begin with the purpose of preventing the spread of pollen to surrounding areas cultivated
with conventional maize. We observe that Austri a does not claim that its safeguard measure on T25
maize is intended to prevent environmental eff ects associated with out-crossing between T25 maize
and conventional maize. Rather, Austria emphasize s the need for "special measures monitoring the
possible – mostly regarded as safe – spread of polle n to fields in the surroundings cultivated with
conventional maize".
1705 As Austria in this statement explicitly notes the lack of compelling safety

1702 Exhibit EC-158/At. 31_trans.
1703 The document submitted by Austria actually refers to Regulation 2001/18, which appears to be an
error.
1704 We note that some of these concerns were artic ulated by Austria in documents which post-date the
date of establishment of this Panel. However, we see no grounds for considering that these plausible concerns
did not underlie the safeguard measure at issue already in August 2003.
1705 Exhibit EC-160/At. 3, p. 4.

concerns, we understand this statem ent to refer to concerns over the possible loss of economic value
to farmers, who due to the existence of unwanted, out-crossed plants in th eir fields, can no longer
market their crops as non-GM crops.
7.2576 In Section VII.C we have found that the term "o ther damage" as it appears in Annex A(1)(d)
includes economic damage which arises from the entry, establishment or spread of pests and which is
not a consequence of damage to the life or health of animals or plants. We also found that plants
growing where they are undesired can be consider ed as "pests". This includes cross-breeds between
GM maize and conventional maize which grow in a conventional maize field.
7.2577 In view of these findings, we consider that Au stria's safeguard measure on T25 maize, to the
extent it is applied to prevent economic damage re sulting from the entry, establishment or spread of
cross-breeds between T25 and conventional maize in cultivated surrounding maize fields, falls within
the scope of Annex A(1)(d) of the SPS Agreement.
Long-term ecological effects in environmentally sensitive areas
7.2578 The Panel turns now to the next objective st ated by Austria for prohibiting the placing on the
market of T25 maize, namely, Austria's concerns over long-term ecological effects. Austria includes
in this category of concerns secondary ecological effects. The Panel understands the term "secondary
ecological effects" to refer to indirect environmen tal effects which might be caused by the cultivation
of T25 maize.
7.2579 In Section VII.C we have addressed concerns that GM plants might crowd out or eliminate
other plants, due to a potential competitive advantage, invasiveness or persistence, thus affecting the
genetic diversity of remaining pl ant populations and putting at risk the survival of certain plant
species. In relation to these concerns, we stated that to the extent a measure is applied to avoid this
kind of adverse effect, it can be considered a measure covered by Annex A(1)(a), as it would be
applied "to protect [...] plant life or health [… ] from risks arising from the entry, establishment or
spread" of GM plants qua "pests".
7.2580 We further found that to the extent that GM plan ts may result in changes in plant populations,
this may increase or decrease the food available for particular animal populations and thus enhance, or
detract from, the fitness and health of these animal populations, which in turn may have a deleterious
effect on the life or health of plants, e.g., by affecting their ability to reproduce. We stated that, by
causing harm to the health of animals or other plan ts in this way, GM plants would act as "pests"
within the meaning of Annex A(1)(a), and that to th e extent a measure is applied to avoid this kind of
adverse effect, it can be considered a measure covered by Annex A(1)(a).
7.2581 We also found that Annex A(1)(a) covers measures applied to protect animal or plant life or
health from risks arising directly or indirectly fro m the entry, establishment or spread of cross-breeds
with undesired traits (such as herbicide resistance) resulting from transfer of genetic material from a
GM plant.
7.2582 Moreover, we addressed potential risks to the en vironment, including to farmland wildlife,
resulting from a change in weed control practices (the application of a herbicide where none was used
before the increased application of a herbicide, or the application of a different, more harmful
herbicide). We said that to the extent a measure is applied to avoid adverse effects on the life or
health of animals or plants which arise from the management techniques associated with GMOs, such
a measure falls within the scope of Annex A(1)(a), in that it can be viewed as a measure applied to

protect the life or health of animals or plants from risks arising indirectly from the entry,
establishment or spread of weeds qua "pests".
7.2583 Finally, we found that to the extent a measure seeks to avoid adverse effects of GMOs on the
environment other than adverse effects on animal or plant life or health, including on geochemical
processes, such a measure can be considered to be covered by Annex A(1)(d), inasmuch as it can be
viewed as a measure which is applied to prevent or limit "other damage" from the entry, establishment
or spread of "pests". As noted earlier, the GMOs themselves or cross-breeds of GM plants might
qualify as the relevant pests, or other plants or animals might become pests as a result of the release of
GMOs into the environment. Furthermore, we said that to the extent that a measure is applied to
avoid adverse effects arising from the management techniques associated with GMOs other than
damage to the life or health of animals or plants, that measure can be considered as a measure applied
to prevent or limit "other damage" resulting indirec tly from the entry, establishment or spread of
weeds qua "pests".
7.2584 In view of the above findings, we consider that Austria's safeguard measure on T25 maize, to
the extent it is applied to avoid potential long-te rm ecological effects of the release into the
environment of T25 maize, falls within the scope of Annex A(1)(a) and (d) of the SPS Agreement.
Allergenicity and toxicity
7.2585 We turn now to Austria's stated concern regard ing potential risks of allergenicity and toxicity
associated with T25 maize.
7.2586 In Section VII.C we have found that Annex A( 1)(b) covers measures applied to protect the
life or health of humans or animals (not including target organisms) from risks arising from toxins
produced in GM plants which are foods or feedstuffs. Furthermore, we found that to the extent that a
measure seeks to protect humans and animals from a llergenic effects of GM plants used as or in
foods, that measure can be considered to be a me asure applied to protect human or animal life or
health from risks arising from toxins produced in GM plants which are foods or feedstuffs and, as
such, would fall within the scope of Annex A(1)(b).
7.2587 We also recall our view that if interaction w ith, and exposure to, GMOs other than as or in a
food produced allergenic effects in persons, the GMOs in question could be considered "pests" within
the meaning of Annex A(1). We therefore found that to the extent that a measure seeks to avoid the
entry, establishment or spread of allergenic GM plants, that measure can be considered to be a
measure applied to protect human life or health fro m risks arising from the entry, establishment or
spread of GM plants qua "pests". As such, it would fall within the meaning of Annex A(1)(c).
7.2588 In view of the above findings, we consider that Austria's safeguard measure on T25 maize, to
the extent it is applied to protect from potential a llergenic and toxicologic effects associated with T25
maize, falls within the scope of Annex A(1)(b) and (c) of the SPS Agreement.
Development of antibiotic resistance
7.2589 We turn finally to the purpose of managing potentia l risks associated with the transfer of the
bla-ampicillin resistance gene to bacteria of the int estine of humans or animals due to consumption of
T25 maize. We recall our discussion in Section VI I.C regarding antibiotic resistance marker genes
(ARMG). More particularly, we recall that in our vi ew, the concern relates to the potential transfer to
pathogens of ARMG present in certain GMOs, a nd the possible resulting decrease in effectiveness of

medical treatments involving specific antibiotics whic h might pose a risk to the life or health of
animals infected with the resistant pathogen.
7.2590 In Section VII.C we have found that Annex A(1)(a) covers measures applied to protect animal
life or health from risks arising from the entry, est ablishment or spread of disease-causing organisms
which have or might become resistant to antibiotics due to the transfer of ARMG from a GM plant.
Similarly, we found that Annex A(1)(a) covers measu res applied to protect animal life or health from
risks arising from the entry, establishment or spr ead of diseases due to the reduced effectiveness of
antibiotics used to treat the pathogens which have become resistant to these antibiotics through gene
transfer. Furthermore, we found that Annex A(1 )(b) covers measures applied to protect human or
animal life or health from risks arising indirectly, namely via the potential transfer to humans or
animals of marker genes conferring resistance to an tibiotics used in human or veterinary medicine,
from additives in foods or feedstuffs. We recall in this respect that, in our view, ARMGs can be
considered to be additives for the purposes of Annex A(1)(b).
7.2591 In view of the above findings, we consider that Austria's safeguard measure on T25 maize, to
the extent it is applied to avoid risk s associated with the transfer of the bla-ampicillin resistance gene
to bacteria of the intestine of humans or animals due to consumption of T25 maize, falls within the
scope of Annex A(1)(a) and (b) of the SPS Agreement.
Conclusion with regard to the purpose of the safeguard measure
7.2592 In the light of the above considerations, we c onclude that the safeguard measure applied by
Austria with respect to T25 maize qualifies as an SPS measure within the meaning of Annex A(1) as
far as its purpose is concerned.
Form and nature of the safeguard measure
7.2593 We now turn to the issue of the form and nature of the Austrian safeguard measure on
T25 maize. We start by recalling the Parties' arguments on this matter.
7.2594 The United States notes that the Austrian measure is in the form of an "ordinance", which is
defined as "an authoritative decree or command"
1706. The United Stated further notes that a decree is
among the types of measures explicitly mentioned in Annex A(1) of the SPS Agreement.
7.2595 Canada argues that the measure falls within th e scope of "laws, decrees, regulations,
requirements and procedures." As indicated by th e use of the word "include", Annex A provides a
non-exhaustive list of the forms that an SPS measure can take. The Austrian measure takes the form
of an "ordinance", a type of measure which is not among those expressly enumerated in Annex A, but
which is nonetheless legally binding and lawfully promulgated by the central government authorities.
The term ordinance is also defined as synonymous to the word "decree", which is specifically referred
to in Annex A(1).
7.2596 Argentina notes that an "ordinance" is defined as an "authoritative decree or command", and
that a decree is one of the types of measur es specifically mentioned in Annex A of the
SPS Agreement.

1706The New Shorter Oxford English Dictionary , L. Brown (ed.) (Clarendon Press, 1993), Vol. I,
p. 2017.

7.2597 The Panel recalls that the second paragraph of Anne x A(1) addresses the form and nature of
measures which may qualify as SPS measures. In r espect of the form of SPS measures, we have
indicated earlier in this report that the referenc e in the second paragraph to "laws, decrees [and]
regulations" should not be taken to prescribe a part icular legal form and that SPS measures may in
principle take many different legal forms. Furthermore, in respect of the nature of SPS measures, we
have indicated earlier that the reference in the same paragraph to "requirements" is broad and
unqualified. Hence, both an authorization to mark et a particular product and a ban on the marketing
of a particular product may be considered as "re quirements". The second example would constitute a
negative requirement.
7.2598 We note that the Austrian safeguard measure on T25 maize was implemented by Austria
through an ordinance to prohibit commercializati on of T25 maize on its territory. Annex A(1) does
not specifically refer to "ordinances". As we have pointed out, this fact alone does not necessarily
mean that Austria's safeguard measure is not an SPS measure, since no specific legal form is
prescribed. Austria's ordinance clearly is a measure attributable to the Austrian Government. It is
also not in dispute that the ordinance is legally binding. We therefore consider that, for the purposes
of Annex A(1), the Austrian ordinance may be assim ilated to measures adopted in the form of "laws",
"decrees" or "regulations".
7.2599 In respect of the nature of the Austrian m easure, we note that the ordinance prohibits the
marketing of T25 maize. As indicated above, we are of the view that a prohibition on the marketing
of a particular product (within a particular terr itory) may be considered a "requirement" for the
purposes of Annex A(1).
7.2600 We therefore conclude that the safeguard measure taken by Austria with respect to T25 maize
qualifies as an SPS measure within the meaning of Annex A(1) as far as its form and nature are
concerned.
Conclusion
7.2601 We have now considered Austri a's safeguard measure on T25 ma ize in terms of its purpose,
its form and its nature. In relation to each of these issues, we have found that Austria's measure
satisfies the definition of the term "SPS measure" set out in Annex A(1). In the light of this, we come
to the conclusion that the safeguard measure taken by Austria with respect to T25 maize constitutes an
"SPS measure" within the meaning of Annex A(1).
7.2602 At this juncture, we could go on and address the question of whether, in view of its multiple
purposes, the Austrian safeguard measure could be considered to embody more than one SPS
measure. However, neither the Complaining Par ties nor the European Communities have argued that
to the extent any of the safeguard meas ures at issue falls to be assessed under the SPS Agreement, it
should be deemed to constitute more than one SPS measure. In their submissions to the Panel, the
Parties treated the relevant safe guard measures as constituting one SPS measure each. In the light of
this, like the Parties, we will treat the Austri an safeguard measure as constituting one single SPS
measure. We will revisit this issue, however, if our disposition of the relevant claims under the
SPS Agreement (and, where appropriate, any implementi ng action to be taken in view of our
disposition of particular claims) we re to depend on, and be affected by, whether we treat the Austrian
safeguard measure as constituting a single SPS measure or as embodying more than one SPS measure.

Effect on international trade

7.2603 We now turn to the issue of whether Austria's safeguard measure on T25 maize is a measure
that may affect international trade, and that is therefore subject to the provisions of the
SPS Agreement. We recall that according to Article 1.1 of the SPS Agreement, the SPS Agreement
applies to all SPS measures which "may, directly or indirectly, affect international trade."
Accordingly, for Austria's safeguard measu re on T25 maize to be subject to the SPS Agreement, it
must be a measure which may, directly or indirectly, affect international trade. We recall the Parties'
arguments on this matter.
7.2604 The United States argues that the measure adopted by Austria prohibits the "placing on the
market" of T25 maize, thereby effectively blocking the importation of the product.
7.2605 Canada argues that the measure prohibits commer cialization of T25 maize and bans its
importation, except where the imported product is "immediately" exported "after possible handling
and repackaging" in Austria. Since the measure effectively blocks market access for the targeted
biotech product, it clearly affects international trade.
7.2606 Argentina notes that since the safeguard measure prev ents access of T25 maize to Austria,
resulting in the absence of imports of this product, the measure can be said to affect international
trade.
7.2607 The Panel notes that pursuant to Article 1.1 of the SPS Agreement, it is not necessary to
demonstrate that an SPS measure has an actual effect on trade. Article 1.1 merely requires that an
SPS measure "may, directly or indirectly, affect international trade".
7.2608 Austria's decision to apply a safeguard measure on T25 maize is contained in the text of the
Ordinance that entered into force on 29 April 2000. 1707 According to the text of the Ordinance,
Austria's decision prohibits the placing on the Austri an market of T25 maize. In our understanding,
the prohibition applies also to imports of T25 maize from outside the European Communities.1708
7.2609 In view of the fact that Austria's safeguard me asure prohibits imports of T25 maize, we have
no difficulty concluding that the safeguard measure by Austria is an SPS measure which may affect
international trade within the meaning of Article 1.1 of the SPS Agreement and, as such, is subject to
the provisions of the SPS Agreement.
Overall conclusions
7.2610 In the light of the above, the Panel reaches the following overall conclusions:
(a) DS291 (United States)
(b) With reference to DS291, and having regard to the arguments and evidence presented
by the United States and the European Co mmunities, the Panel concludes that the
Austrian safeguard measure on T25 maize is an SPS measure within the meaning of
Annex A(1) and Article 1.1 of the SPS Agreement.

1707 Exhibit EC-160/At. 3.
1708 We note that this is subject to an exception for imported T25 maize that is immediately exported
after handling and repackaging in Austria.

(c) DS292 (Canada)
(d) With reference to DS292, and having regard to the arguments and evidence presented
by Canada and the European Communities, the Panel concludes that the Austrian
safeguard measure on T25 maize is an SPS measure within the meaning of
Annex A(1) and Article 1.1 of the SPS Agreement.
(e) DS293 (Argentina)
(f) With reference to DS293, and having regard to the arguments and evidence presented
by Argentina and the European Communities, the Panel concludes that the Austrian
safeguard measure on T25 maize is an SPS measure within the meaning of
Annex A(1) and Article 1.1 of the SPS Agreement.
(iii) Austria – Bt-176 maize
7.2611 We now turn to the safeguard measure applied by Austria on Bt-176 maize. We recall that
the application for placing on the market of this product was initially submitted to France.
1709 The
product was authorized by the EC Commission in 1996. 1710 Austria adopted an Ordinance to prohibit
the sale of Bt-176 maize on its territory in February 1997 on the basis of Article 16 of
Directive 90/220.
1711 Austria notified its Decision to the Commission on 14 February 1997.
Is the Austrian safeguard measure on Bt-176 maize an SPS measure?
7.2612 We start with the issue of whether the Austrian safeguard measure on Bt-176 maize is an
SPS measure. In order to make this determination, we need to consider two distinct elements,
namely: (1) the purpose of the measure; and (2) the form and nature of the measure.
Purpose of the safeguard measure
7.2613 We first consider the issue of the purpose of th e safeguard measure. Before turning to the
arguments of the Parties on this issue, we recall that we must determine whether the purpose of the
safeguard measure falls within one of the categories of purposes set out in Annex A(1) of the
SPS Agreement.
7.2614 The United States recalled that in its decision to adopt the measure, Austria noted its concern
with regard to the effect of Bt toxin on non-target organisms and the potential transfer of antibiotic
resistant genes to humans and animals. Accordin g to the United States, a measure based on such
justification is an SPS measure be cause it is applied "to protect animal life or health" from "disease-
causing organisms"; "to protect human life or health" from "toxins" or "disease-causing organisms in
foods"; or "to prevent or limit [...] damage" from the "spread of pests".
7.2615 Argentina argued that the purpose of the safegua rd measures may be inferred from the
Community legislation under which the bans were adopted, and that the relevant provisions of EC
Directive 90/220 and Regulation 258/97 clearly indicate that the purpose of the EC legislation is the
"protection of human health and the environment" . Since the EC member States have taken their
measures explicitly on the basis of this legislation, it can be inferred that the measures were imposed

1709 C/F/94/11-03.
1710 Commission Decision 97/98 (Exhibits US–97; ARG–37).
1711 Regulation No. 45 of the Federal Ministry for Consumer Health and Protection, 13 February 1997.

for the purpose of protecting human health or th e environment. The safeguard measures are,
therefore, SPS measures as defined in the SPS Agreement.
7.2616 The European Communities argues that the main reasons for which the measure was
adopted and maintained include, inter alia, horizontal gene transfer; antibiotic resistance; effects on
non-target organisms; toxicity or allergenicity; persistence and invasiveness in agricultural and natural
habitats; development of resistance; out-crossi ng; undesirable effects on management practices;
biodiversity; monitoring; labelling; co-existence; and human and animal health.
1712
7.2617 In examining the purposes for wh ich Austria's safeguard measure on Bt-176 maize is applied,
the Panel will first consider the document notified by Austria to the Commission in support of its
safeguard measure in February 1997, hereafter referred to as Austria's "Reasons document". 1713 In
the Reasons' document, Austria stated that "new scientific results have questioned the present
scientific possibility of a conclusive evaluation of the mechanism of gene transfer, as well as the
development of resistance to Bt toxin. Accordi ngly, possible risks are very hard to assess and should
be avoided at the present state of the scientific discussion." 1714 Austria considered that, in the case of
Bt-176 maize, approving the product despite the un certainties regarding both the ampicillin resistance
as well as the resistance against the Bt toxin wi thout any legally binding resistance management
programme was in conflict with the principle of precaution. 1715 In particular, Austria noted that
evidence on "the impact of a potential gene transfer of the bla-gene/b-lactamase and potential
induction of resistance in bacteria on the therapy of humans and animals with antibiotics remains not
fully conclusive."1716
7.2618 We note that Austria also notified the Commission in May 1997 of the results of two studies
concerning the possible adverse effects on th e environment due to the cultivation of Bt maize.1717 In
the cover letter, Austria states that "[...] these studies prove that pests may evolve ( sic) resistance
against Bt toxins much faster than previously expected, due to the fact that transgenic crops producing
insecticidal proteins from Bt [...] are being grown commercially."1718
7.2619 Furthermore, in the cover letter addressed to th e Commission at the time of notification of the
measure, Austria indicated that it maintained its position that "the labelling laid down in the
Commission's decision is insufficient", and that "[ c]onsumers should be informed precisely about the
fact that this product has been genetically modified."1719
7.2620 The January 2004 document submitted by Austria to the Commission also sheds light on the
reasons for which Austria is applying its safeguard measure on Bt-176 maize. 1720 In this document,
Austria states that it adopted its safeguard me asure regarding Bt-176 maize because: "(a) [t]he
transgenic maize line contains the ampicillin-resi stance gene including its bacterial regulatory
sequences. The probability of gene transfer of a functional bla-construct into bacteria – even though
it is considered low – has to be taken into account for the risk assessment, because the spreading of
antibiotic resistance is unacceptable; and (b) [t]he environmental risk assessment has been considered

1712 Exhibit EC-155.
1713 Exhibit EC-158/At. 7.
1714 Ibid, p. 5.
1715 Ibid.
1716 Exhibit EC-158/At. 7 p. 6.
1717 Exhibit EC-158/At. 10. The two studies referred to by Austria are contained in
Exhibits EC-158/At. 11-12.
1718 Exhibit EC-158/At. 10.
1719 Exhibit EC-158/At. 7.
1720 Exhibit EC-158/At. 30.

as insufficient: the possible unintended effects of the Bt-toxin on non-target organisms and the
possible resistance-development in insects, e.g. the European corn borer, has not been thoroughly
assessed".
1721 In addition to these reasons, Austria cited other, more general concerns which in its
view justify the precautionary approach embodied in Austria's safeguard measure. Specifically,
Austria pointed out that the allergological and toxicological risk assessment concerning EC-approved
biotech products such as Bt-176 maize had been inadequate. Austria also noted that pending the
report of the EC working group on antibiotic resistance marker genes established pursuant to
Directive 2001/18, products containing such genes, including Bt-176 maize, should not be placed on
the market.
7.2621 We note that Austria's concerns for adopting a safeguard measure on Bt-176 maize are also
discussed in a letter addressed to the Commission in February 2004 by the Austrian Federal Minister
for Health and Women. In that letter, Austri a rejected a request by the Commission for the
withdrawal of Austria's safeguard measure. In this context, Austria recalled that "[t]he Austrian
decision concerning Bt-176 maize was based on hea lth doubts regarding the ampicillin-resistant gene
(bla) with a bacterial promoter and the possible r esistance formation of insects to the bacillus
thuringiensis (Bt) protein. There was also a la ck of clarity regarding the ecological effects of
herbicide resistance and inadequate designation."
1722 Austria also reiterated its concern about
inadequacies in the allergological and toxicological risk assessment concerning biotech products, such
as Bt-176 maize, which were submitted fo r approval under Directive 90/220 and/or
Regulation 258/97. Furthermore, Austria noted that it could not withdraw its safeguard measure on
T25 maize in view of the fact that a coherent re gulatory solution to the problem of co-existence had
not yet been found. The Austrian letter notes in th is respect that in June 2003 a resolution had been
approved in the Austrian parliament calling on th e Austrian Federal Government to refrain from
approving new GM plants, especially in relation to their cultivation, until a coherent solution was
found on this issue.
7.2622 Based on the foregoing, we consider that at the time of review by the Panel, Austria applied
its safeguard measure on Bt-176 maize to address concerns about:1723
(1) the transfer of the bla-ampicillin resistance gene to bacteria of the intestine of humans
and animals;
(2) the development of resistance to Bt toxin in insects;
(3) effects on non-target organisms;
(4) environmental effects of herbicide resistance;
(5) co-existence;
(6) allergenicity and toxicity; and
(7) insufficient labelling.

7.2623 Having determined the purposes for which Austri a applied its safeguard measure at the time
of review by the Panel, we now go on to assess whether these purposes fall within one of the
categories of purposes which according to Annex A(1) characterize an SPS measure. To that end, we
will consider one by one each of the above-noted purposes of Austria's safeguard measure.

1721 Exhibit EC-158/At. 30, p. 2.
1722 Exhibit EC-158/At. 31_trans.
1723 We note that some of these concerns were artic ulated by Austria in documents which post-date the
date of establishment of this Panel. However, we see no grounds for considering that these plausible concerns
did not underlie the safeguard measure at issue already in August 2003.

Transfer of the bla-ampicillin resistance gene to bacteria of the intestine of
humans or animals
7.2624 The Panel begins with Austria's stated con cern regarding the potential transfer of the
bla-ampicillin resistance gene to bacteria of the int estine of humans or animals due to consumption of
Bt-176 maize. The concern identified by Austria with regard to Bt-176 is similar to that identified by
Austria with regard to its safeguard measur e on T25 maize, discussed above. We recall our
discussion in Section VII.C regarding antibiotic resist ance marker genes, and in particular our view
that the concern relates to the potential transfer to pathogens of ARMG present in certain GMOs, and
the possible resulting decrease in effectiveness of medical treatments involving specific antibiotics
which might pose a risk to the life or health of animals infected with the resistant pathogen.
7.2625 In Section VII.C we have found that Annex A(1)(a) covers measures applied to protect animal
life or health from risks arising from the entry, est ablishment or spread of disease-causing organisms
which have or might become resistant to antibiotics due to the transfer of ARMG from a GM plant.
Similarly, we found that Annex A(1)(a) covers measu res applied to protect animal life or health from
risks arising from the entry, establishment or spr ead of diseases due to the reduced effectiveness of
antibiotics used to treat the pathogens which have become resistant to these antibiotics through gene
transfer. Furthermore, we found that Annex A(1 )(b) covers measures applied to protect human or
animal life or health from risks arising indirectly, namely via the potential transfer to humans or
animals of marker genes conferring resistance to an tibiotics used in human or veterinary medicine,
from additives in foods or feedstuffs. We recall in this respect that, in our view, ARMGs can be
considered to be additives for the purposes of Annex A(1)(b).
7.2626 Thus, consistent with the Panel's reasoning above in the context of Austria's safeguard
measure on T25 maize, we consider that Austria's saf eguard measure on Bt-176 maize, to the extent it
is applied to avoid potential risks associated with the transfer of the bla-ampicillin resistance gene to
bacteria of the intestine of humans or animals, fall s within the scope of Annex A(1)(a) and (b) of the
SPS Agreement.
Development of resistance to Bt toxin in insects
7.2627 We turn now to another objective stated by Austria for prohibiting the placing on the market
of Bt-176 maize, namely the managing of pote ntial risks associated with the development of
resistance to Bt toxin in both target and non-ta rget insects. We understand the concern identified by
Austria to be that resistance in insects to Bt toxin may develop due to frequent exposure to this
pesticide (the Bt toxin) and that the development of high levels of resistance in insect populations
might require the application of a pesticide where none was used before, the increased application of a
pesticide, or the application of more harmful pestic ides, to control the resistant populations and that
this might have adverse effects on the environment.
7.2628 We recall our analysis in Section VII.C regardi ng the development of pesticide-resistance in
target organisms. We found that resistant target organisms (insects) could be regarded as "pests"
within the meaning of Annex A(1), inasmuch as they present a risk to animal, plant or human life or
health or result in other damage. We further determined that risks to animal or plant life or health, or
other damage to the environment, resulting from a ch ange in pesticide use may be viewed as arising
indirectly from the entry, establishment or spread of resistant target organisms
qua relevant pest. We
found that to the extent that a measure seeks to a void such risks and damage, it can be considered to
be covered by Annex A(1)(a) and (d) of the SPS Agreement.

7.2629 In view of the above findings, we consider th at Austria's safeguard measure on Bt-176 maize,
to the extent it is applied to protect from potential risks associated with the development of resistance
to Bt toxin in insects due to the cultivation of Bt- 176 maize, falls within the scope of Annex A(1)(a)
and (d) of the SPS Agreement.
Effects on non-target organisms
7.2630 We now consider Austria's stated objective of managing risks associated with potential effects
on non-target organisms, other than risks associated with the development of resistance in insects as
addressed above. As we noted earlier, we understa nd "non-target" organisms to mean plants and
animals (including insects) which are not themselves the organisms farmers seek to control or
eliminate through the cultivation of GM crops, but wh ich are affected by the cultivation of the GM
crop, including through consumption of the GM plants or components thereof (e.g., pollen).
7.2631 We recall our conclusions in Section VII.C that a GM crop that is eaten by animals can be
considered to be a "food" for that animal. This would include, for example, pollen of the GM crop
which is consumed by insects and GM plants consum ed by non-target insects, deer, rabbits or other
wild fauna. As we previously noted, a poisonous s ubstance, such as the Bt toxin, which is produced
by a GM crop could qualify as a "toxin" within the meaning of Annex A(1)(b). We determined on
that basis that measures applied to protect the lif e or health of animals (not including target
organisms) from risks arising from toxin produced in GM plants are covered by Annex A(1)(b).
7.2632 Moreover, we indicated in Section VII.C our view that if a GM plant produces a poisonous
substance which could adversely affect the health of non-target organisms, even if the non-target
organisms do not eat the GM plant, e.g. through exposure other than through ingestion of food, the
GM plant could be considered a "pest" within the meaning of Annex A(1)(a). Thus, a measure
applied to protect from risks arising from such exposur e to GM plants would, in our view, fall within
the scope of Annex A(1)(a).
7.2633 In addition, in Section VII.C we concluded that to the extent that GM plants may result in
changes in animal or plant populations, this may in crease or decrease the food available for particular
non-target animal populations and thus alter the f itness and health of these animal populations, which
may in turn lead to further deleteri ous effects on the life or health of animals or other plants. We also
recall our conclusion that by causing harm to the hea lth of animals or other plants in this way, GM
plants would act as "pests" within the meaning of Annex A(1), and that to the extent a measure is
applied to avoid this kind of adverse effect, it can be considered a measure covered by Annex A(1)(a).
Furthermore, we found that Annex A(1)(a) covers me asures applied to protect animal or plant life or
health from risks arising directly or indirectly fro m the entry, establishment or spread of cross-breeds
with undesired traits (such as insecticidal traits) r esulting from transfer of genetic material from a GM
plant.
7.2634 In view of these findings, we consider that Austria's safeguard measure on Bt-176 maize, to
the extent it is applied to avoid potential risks to the health of non-target organisms from the
consumption of Bt-176 maize, falls with in the scope of Annex A(1)(b) of the SPS Agreement.
Furthermore, to the extent that Austria's safeguard measure is applied to avoid other potential risks to
the life or health of non-target organisms aris ing directly or indirectly from Bt-176 maize ( i.e., risks
unrelated to the ingestion of Bt-176 maize as food), it falls within the scope of Annex A(1)(a) of the
SPS Agreement

Environmental effects of herbicide resistance
7.2635 Another concern raised by Austria concerns the environmental effects of herbicide resistance.
We understand this to be a concern about the enviro nmental effects of Bt-176 maize which contains a
herbicide resistance marker gene.
7.2636 In Section VII.C we have found that cro ss-breeds between conventional and GM plants,
including herbicide-resistant plants, could be rega rded as "pests" for the purposes of Annex A(1), to
the extent they have undesired introduced traits (such as herbicide resistance) and harm animal or
plant life or health or result in other damage. We have determined on that basis that measures applied
to protect animal or plant life or health from risks arising directly ( e.g., through changes in selective
advantage) from the entry, establishment or spread of cross-breeds with undesired traits resulting from
the transfer of genetic material from a GM plan t fall within the scope of Annex A(1)(a), while
measures applied to prevent "other damage" to the environment from the entry, establishment or
spread of cross-breeds fall within the scope of Annex A(1)(d).
7.2637 In addition, we recall that one possible concer n arising from cross-breeds that have acquired
herbicide resistance is that they may lead to the n eed for an increased use of the same herbicides, or
different, more toxic herbicides, to control the resistan t weeds. We determined that risks to animal or
plant life or health, or other damage to the envir onment, resulting from a change in pesticide use may
be viewed as arising indirectly from the entry, establishment or spread of cross-breeds qua relevant
pest. We deduced from this that measures applie d to avoid such indirect adverse effects on the
environment fall within the scope of Annex A(1)(a) and (d).
7.2638 Furthermore, in Section VII.C we have found that to the extent a measure is applied to avoid
adverse effects on the life or health of animals or plants which arise from particular management
(weed control) practices associated with GMOs, in cluding herbicide resistant GMOs, such a measure
falls within the scope of Annex A(1)(a), in that it can be viewed as a measure applied to protect the
life or health of animals or plants from risks arisi ng indirectly from the entry, establishment or spread
of weeds qua "pests". Similarly, we said that to the exte nt that a measure is applied to avoid adverse
environmental effects arising from management (weed control) practices associated with GMOs other
than damage to the life or health of animals or plants, that measure can be considered as a measure
applied to prevent or limit "other damage" resulting i ndirectly from the entry, establishment or spread
of weeds qua "pests" and would thus also be covered by Annex A(1)(d).
7.2639 In view of our findings above, we consider th at Austria's safeguard measure on Bt-176 maize,
to the extent it is applied to avoid risks to the environment arising from herbicide resistance, falls
within the scope of Annex A(1)(a) and (d) of the SPS Agreement.
Co-existence
7.2640 We now turn to Austria's stated concern about co-existence. We understand this to be a
concern that farmers cultivating conventional mai ze might experience a loss of economic value of
their crop due to the existence of unwanted geneti cally modified maize plants in their fields
(contamination). The loss would result from the ci rcumstance that the farmers might no longer be
able to market their crops as non-GM crops.
7.2641 In Section VII.C we have found that the term "o ther damage" as it appears in Annex A(1)(d)
includes economic damage which arises from the entry, establishment or spread of pests and which is
not a consequence of damage to the life or health of animals or plants. We also found that plants
growing where they are undesired can be consider ed as "pests". Such plants include cross-breeds

between GM maize and conventional maize which grow in a conventi onal maize field as a result of
pollen dispersal. Such plants further include GM maize plants growing in a conventional maize field
as a result of unintentional dispersal of GM seed. Thus, we consider that to the extent Austria's
safeguard measure on Bt-176 maize is applied to prevent economic damage resulting from the
contamination of conventional maize due to the entr y, establishment or spread of Bt-176 maize (via
dispersal of GM seed), or of cross-breeds be tween Bt-176 maize and conventional maize (via
dispersal of GM pollen), in cultivated conventi onal maize fields, it falls within the scope of
Annex A(1)(d) of the SPS Agreement.
7.2642 In view of the above findings, we consider th at Austria's safeguard measure on Bt-176 maize,
to the extent it is applied to prevent or limit da mage from the possible cont amination of conventional
maize by Bt-176 maize, falls within the scope of Annex A(1)(d) of the SPS Agreement.
Allergenicity and toxicity
7.2643 We now turn to Austria's stated concern rega rding the potential risks of allergenicity and
toxicity associated with Bt-176 maize. We recall our analysis related to allergens and toxins in
Section VII.C and our analysis of this concern in the context of Austria's safeguard measure on T25
maize.
7.2644 In particular, we recall that in Section VII.C we have found that to the extent that a measure
seeks to protect humans and animals from allergenic effects of GM plants used as or in foods or
feedstuffs, that measure can be considered to be a measure applied to protect human or animal life or
health from risks arising from toxins produced in GM plants which are foods or feedstuffs and, as
such, would fall within the scope of Annex A(1)(b ). We furthermore recall our view that if
interaction with, and exposure to, GMOs other than as or in a food or feedstuff produced allergenic
effects in persons, the GMOs in question could be considered "pests" within the meaning of
Annex A(1)(c).
7.2645 Consistent with our reasoning a bove, we consider that Austria's safeguard measure on Bt-176
maize, to the extent it is applied to avoid potential a llergenic or toxic effects, falls within the scope of
Annex A(1)(b) and (c) of the SPS Agreement.
Insufficient labelling
7.2646 Finally, we turn to Austria's stated concern regarding insufficient labelling of Bt-176 maize.
We recall that Austria considered that "the labelling laid down in the Commission's decision is
insufficient" and that "[c]onsumers should be info rmed precisely about the f act that this product has
been genetically modified."
1724 The Commission's decision to which Austria refers stipulates that the
label of each package of seeds of Bt-176 maize is to indicate that the product "protects itself against
corn borers", and that it "has increased tolera nce to the herbicide glufosinate-ammonium". 1725 The
preamble to the decision further notes that there were no safety grounds for mentioning on the label
that the product has been obtained by genetic modifica tion techniques. Thus, it appears that contrary
to the Commission, Austria wanted the label to indicate the presence of GMOs, in addition to
providing the information the Commission required to be indicated on the label of each package of
seeds.

1724 Exhibit EC-158/At. 7.
1725 Exhibits US-97; ARG-37.

7.2647 We note that Austria stated that the explicit identification of the presence of GMOs which it
was seeking would be for the information of consumers of Bt-176 maize. We also note, however, that
Austria's letter to the Commission states that Aust ria's safeguard measure on Bt-176 maize is taken in
accordance with Article 16 of Directive 90/220. To recall, Article 16 provides that member States
may take safeguard measures in cases where there are justifiable reasons to consider that an approved
biotech product constitutes a risk to human health or the environment. Article 16 does not authorize a
member State to restrict or prohibit the use and/or sale of an approved biotech product merely because
a labelling requirement specified in the written con sent for the placing on the market of that biotech
product does not ensure consumers' freedom of choice (with regard to the consumption of GM
products vs. non-GM products).
7.2648 Since Austria specifically claimed to be acting in accordance with the provisions of Article 16
of Directive 90/220, we consider that Austria's re ference to consumer information should be read in
the light of, and together with, Austria's referen ce to Article 16. Indeed, in our view, Austria's
argument that consumers should be explicitly informed about the presence of GMOs can be
understood as an argument that identification of the presence of a GMO would help protect notably
from unanticipated adverse effects on human health which might arise from the consumption of
Bt-176 maize.
1726 As we have indicated in Section VII.C, explicit identification of the presence of a
GMO alerts and sensitises users of a product containing or consisting of a GMO to the possibility that
any observed adverse effects of the product on human health might be attributable to the presence of a
GMO as opposed to other factors. In view of th e foregoing elements, we consider that Austria's
concern about insufficient labelling reflects a concern about risks to consumer health arising from the
consumption of Bt-176 maize.
7.2649 This interpretation of Austria's labelling c oncern is consistent with the provisions of
Directive 90/220. While Directive 90/220 does not requi re a statement on a label to the effect that a
GMO is present in a product, it does not state that such a requirement may not be imposed as part of
the conditions attached to the written consent to pl acing on the market. Furthermore, we recall that
Directive 2001/18 requires labelling to indicate the presence of GMOs. We find in Section VII.C that
this requirement could be presume d to be applied to protect human health and the environment from
possible unanticipated effects of GMOs. Thus, our interpretation of Austria's labelling concern is
consistent with the kind of general labelling requirement whic h was subsequently imposed by
Directive 2001/18.
7.2650 We refer to our analysis in Section VII.C of labelling to indicate the presence of GMOs. As
noted in that section, we are of the view that la belling to indicate the presence of GMOs imposed for
the purpose of protecting human health from unantici pated effects of GMOs falls within the scope of
Annex A(1)(b) or (c) of the SPS Agreement, depending on what the adverse effects would be.
7.2651 In view of our findings above, we consider th at Austria's safeguard measure on Bt-176 maize,
to the extent it is applied to avoid adverse effect s on human health (due to the potential transfer of
ARMG to gut bacteria and possible allergenicity and toxicity) which in Austria's view were not
adequately avoided by the labelli ng requirements imposed by the Commission, falls within the scope
of Annex A(1)(b) and (c) of the SPS Agreement.

1726 In view of Austria's reference to "consumers", we are assuming that Austria was concerned with
unanticipated adverse effects on human health from consumption of Bt-176 maize, and not with other adverse
effects on human health, on animals or on the environment.

Conclusion with regard to the purpose of the safeguard measure
7.2652 In the light of the above considerations, we c onclude that the safeguard measure applied by
Austria with respect to Bt-176 maize qualifies as an SPS measure within the meaning of Annex A(1)
as far as its purpose is concerned.
Form and nature of the measure
7.2653 We now turn to the issue of the form and nature of Austria's safeguard measure on
Bt-176 maize.
7.2654 We note that the arguments presented by the United States and Argentina regarding the form
and nature of Austria's safeguard measure on Bt-176 maize are the same as for Austria's safeguard
measure on T25 maize.
7.2655 Thus, as in the case of Austria's safeguard measure on T25 maize we conclude that the
safeguard measure applied by Austria with r espect to Bt-176 maize qualifies as an SPS measure
within the meaning of Annex A(1) as far as its form and nature are concerned.
Conclusion
7.2656 We have now considered Aust ria's safeguard measure on Bt -176 maize in terms of its
purpose, its form and its nature. In relation to each of these issues, we have found that Austria's
measure satisfies the definition of the term "SPS measur e" set out in Annex A(1). In the light of this,
we come to the conclusion that the safeguard measu re taken by Austria with respect to Bt-176 maize
constitutes an "SPS measure" within the meaning of Annex A(1).
7.2657 At this juncture, we could go on and address the question of whether, in view of its multiple
purposes, the Austrian safeguard measure could be considered to embody more than one SPS
measure. However, neither the United States, nor Argentina or the European Communities have
argued that to the extent any of the safeguard measures at issue falls to be assessed under the
SPS Agreement, it should be deemed to constitute more th an one SPS measure. In their submissions
to the Panel, the Parties treated the relevant safeguard measures as constituting one SPS measure each.
In the light of this, like the Parties, we will tr eat the Austrian safeguard measure as constituting one
single SPS measure. We will revisit this issue, howe ver, if our disposition of the relevant claims
under the SPS Agreement (and, where appropriate, any implementing action to be taken in view of our
disposition of particular claims) we re to depend on, and be affected by, whether we treat the Austrian
safeguard measure as constituting a single SPS measure or as embodying more than one SPS measure.
Effect on international trade

7.2658 We now turn to the issue of whether Austria's safeguard measure on Bt-176 maize is a
measure that may affect international trade, and th at is therefore subject to the provisions of the
SPS Agreement. We recall that according to Article 1.1 of the SPS Agreement, the SPS Agreement
applies to all SPS measures which "may, directly or indirectly, affect international trade."
Accordingly, for Austria's safeguard measu re on Bt-176 maize to be subject to the SPS Agreement, it
must be a measure which may, directly or indirectly, affect international trade. We recall the Parties'
arguments on this matter.
7.2659 The United States argues in this regard that the measu re adopted by Austria prohibits the
"placing on the market" of Bt-176 maize, thereby effectively blocking the importation of the product.

7.2660 Argentina notes that since the safeguard measure prevents access of Bt-176 maize to Austria,
resulting in the absence of imports of this product, the measure can be said to affect international
trade.
7.2661 The Panel notes that the arguments of the parties regarding the effects on trade of Austria's
safeguard measure on Bt-176 maize are essentially the same as their arguments with respect to
Austria's measure on T25 maize. We recall our reas oning and conclusions with respect to Austria's
safeguard measure on T25 maize in paragraphs 7. 2603-7.2609 above. In view of the fact that
Austria's measure prohibits imports of Bt-176 maize, we have no difficulty concluding that Austria's
safeguard measure is an SPS measure which may a ffect international trade within the meaning of
Article 1.1 of the SPS Agreement and, as such, is subject to the provisions of the SPS Agreement.
Overall conclusions

7.2662 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Co mmunities, the Panel concludes that the
Austrian safeguard measure on Bt-176 maiz e is an SPS measure within the meaning
of Annex A(1) and Article 1.1 of the SPS Agreement.

 (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 the Austrian
safeguard measure on Bt-176 maize is an SPS measure within the meaning of
Annex A(1) and Article 1.1 of the SPS Agreement.

(iv) Austria – MON810 maize
7.2663 We now turn to the safeguard measure applied by Austria on MON810 maize. We recall that
the application for placing on the market of this product was initially submitted to France.
1727 The
product was authorized for all uses by the European Commission in 1998. 1728 In June 1999, Austria
adopted an Ordinance to prohibit the sale of MON810 maize on its territory pursuant to Article 16 of
Directive 90/220.1729
Is the Austrian safeguard measure on MON810 maize an SPS measure?
7.2664 We start with the issue of whether the Austri an safeguard measure on MON810 maize is an
SPS measure. In order to make this determination, we need to consider two distinct elements,
namely: (1) the purpose of the measure; and (2) the form and nature of the measure.

1727 C/F/95/12-02.
1728 Commission Decision 98/294.
1729 Regulation No. 175, Federal Ministry for Women's Issues and Consumer Protection, Ordinance
issued on 10 June 1999 prohibiting the entry of MON810 maize into Austria.

Purpose of the safeguard measure
7.2665 We first consider the issue of the purpose of th e safeguard measure. Before turning to the
arguments of the parties on this issue, we recall that we must determine whether the purpose of the
safeguard measure falls within one of the categories of purposes set out in Annex A(1) of the
SPS Agreement.
7.2666 The United States notes that in its decision to adopt a safeguard measure to prohibit
MON810 maize, Austria referred to the adverse effect s of Bt toxin on non-target organisms. Austria
also expressed a concern that insects could develop r esistance to the Bt toxin, thus becoming more
difficult to manage and control.
1730 According to the United Stat es, a measure based on such
justification is an SPS measure be cause it is applied "to protect animal life or health" from "disease-
causing organisms"; "to protect human life or health" from "toxins" or "disease-causing organisms in
foods"; or "to prevent or limit [...] damage" from the "spread of pests".
7.2667 Argentina argued that the purpose of the safegua rd measures may be inferred from the
Community legislation under which the bans were adopted, and that the relevant provisions of EC
Directive 90/220 and Regulation 258/97 clearly indicate that the purpose of the EC legislation is the
"protection of human health and the environment" . Since the EC member States have taken their
measures explicitly on the basis of this legislation, it can be inferred that the measures were imposed
for the purpose of protecting human health or th e environment. The safeguard measures are,
therefore, SPS measures as defined in the SPS Agreement.
7.2668 The European Communities argues that the main reasons for which the measure was
adopted and maintained include, inter alia, horizontal gene transfer; antibiotic resistance; effects on
non-target organisms; toxicity or allergenicity; development of resistance; biodiversity; monitoring;
labelling; co-existence; and human and animal health.
1731
7.2669 In examining the purposes for which Austri a's safeguard measure on MON810 maize is
applied, the Panel will first consider the document notified by Austria to the Commission in support
of its safeguard measure, hereafter referred to as Austria's Reasons document. In this document,
Austria notes that its objections regarding th e assessment of MON810 maize concern the possible
unintended effects of the Bt toxin on non-target organisms, and the possible development of Bt
resistance in insects, such as the European corn borer.1732
7.2670 The concerns of Austria with respect to MON810 maize are further identified in a
January 2004 document as follows: "(a) [a] risk assessment on indirect and long term effects of the Bt
toxin is missing; and (b) [t]he environmental risk assessment has been considered as insufficient: the
possible unintended effects of the Bt-toxin on non-target organisms and the possible
resistance-development in insects [ ...] has not been thoroughly assessed". 1733 In addition to these
reasons, Austria cited other, more general concer ns which in its view justify the precautionary
approach embodied in Austria's safeguard measur e. Specifically, Austria pointed out that the
allergological and toxicological risk assessment concerning EC-approved biotech products such as
MON810 maize had been inadequate. Austria also not ed that pending the report of the EC Working
Group on antibiotic resistance marker genes (ARMG), biotech products containing such genes, such
as MON810 maize, should not be placed on the market.

1731 Exhibit EC-155.
1732 Exhibit EC-159/At. 3_trans., pages 5-6.
1733 Exhibit EC-159/At. 30, p. 2.

7.2671 We note that Austria's concerns for adop ting a safeguard measure with regard to
MON810 maize are also discussed in a letter addresse d to the Commission in February 2004 by the
Austrian Federal Minister for Health and Women. In this letter, Austria rejected a request by the
Commission that Austria withdraw its safeguard measure . In this context, Austria recalled that "[t]his
prohibition on cultivation was issued in the light of scientific discoveries concerning the effects of the
bacillus thuringiensis (Bt) protein, which is directed at insects, on monarch butterflies in the US and
other non-target organisms. In addition, Austria re ferred to the question of resistance formation, as in
the case of Bt-176 maize."
1734 Austria also reiterated its c oncern about inadequacies in the
allergological and toxicological risk assessment concerning biotech products, such as
MON810 maize, which were submitted for approval under Directive 90/220 and/or
Regulation 258/97. Furthermore, Austria noted that it could not withdraw its safeguard measure on
MON810 maize in view of the fact that a coherent regulatory solution to the problem of co-existence
had not yet been found. The Austrian letter notes in this respect that in June 2003 a resolution had
been approved in the Austrian parliament calling on the Austrian Federal Government to refrain from
approving new GM plants, especially in relation to their cultivation, until a coherent solution was
found on this issue.
7.2672 Based on the foregoing, we consider that at the time of review by the Panel, Austria applied
its safeguard measure on MON810 maize to address concerns about:1735
 (1) the effects on non-target organisms, including indirect and long-term effects;
 (2) the development of resistance to Bt toxi n in insects, including indirect and long-term
effects of insect resistance;
 (3) allergenicity and toxicity;
 (4) the development of antibiotic resistance; and
 (5) co-existence.

7.2673 The European Communities asse rts that Austria's safeguard measure on MON810 maize is
also applied in view of concerns about labelling. This concern was not articulated by Austria in the
documents discussed by us above. Furthermore, th e European Communities has neither substantiated
nor explained its assertion. In the light of this, we are not persuaded that Austria is applying its
safeguard measure to address this concern asserted by the European Communities.
7.2674 Having determined the purposes for which Austri a applied its safeguard measure at the time
of review by the Panel, we now go on to assess whether these purposes fall within one of the
categories of purposes which according to Annex A(1) characterize an SPS measure. To that end, we
will consider one by one each of the above-noted purposes of Austria's safeguard measure.
Effects on non-target organisms, including indirect and long-term effects
7.2675 We turn first to Austria's stated concern regarding the potential effects on non-target
organisms associated with MON810 maize. We re call our analysis related to effects on non-target
organisms in Section VII.C and our analysis of th is concern in the context of Austria's safeguard
measure on Bt-176 maize.

1734 Exhibit EC-158/At. 31.
1735 We note that some of these concerns were artic ulated by Austria in documents which post-date the
date of establishment of this Panel. However, we see no grounds for considering that these plausible concerns
did not underlie the safeguard measure at issue already in August 2003.

7.2676 We recall our conclusions in Section VII.C that a GM crop that is eaten by animals can be
considered to be a "food" for that animal. This would include, for example, pollen of the GM crop
which is consumed by insects and GM plants consum ed by non-target insects, deer, rabbits or other
wild fauna. As we previously noted, a poisonous s ubstance, such as the Bt toxin, which is produced
by a GM crop could qualify as a "toxin" within the meaning of Annex A(1)(b). We determined on
that basis that measures applied to protect the lif e or health of animals (not including target
organisms) from risks arising from toxin, produced in GM plants are covered by Annex A(1)(b).
7.2677 Moreover, in Section VII.C we indicated our view that if a GM plant produces a poisonous
substance which could adversely affect the health of non-target organisms, even if the non-target
organisms do not eat the GM plant, e.g. through exposure other than th rough ingestion of food (such
as contact with the leaves of a GM plant), the GM plant could be considered a "pest" within the
meaning of Annex A(1)(a). Thus, a measure applie d to protect from risks arising from such exposure
to GM plants would, in our view, fall within the scope of Annex A(1)(a).
7.2678 In addition, in Section VII.C we concluded that to the extent that GM plants may result in
changes in animal or plant populations, this may in crease or decrease the food available for particular
non-target animal populations and thus alter the f itness and health of these animal populations, which
may in turn lead to further deleteri ous effects on the life or health of animals or other plants. We also
recall our conclusion that by causing harm to the hea lth of animals or other plants in this way, GM
plants would act as "pests" within the meaning of Annex A(1), and that to the extent a measure is
applied to avoid this kind of adverse effect, it can be considered a measure covered by Annex A(1)(a).
Furthermore, we found that Annex A(1)(a) covers me asures applied to protect animal or plant life or
health from risks arising directly or indirectly fro m the entry, establishment or spread of cross-breeds
with undesired traits (such as insecticidal traits) r esulting from transfer of genetic material from a GM
plant.
7.2679 In view of the above findings, we consider that Austria's safeguard measure on MON810
maize, to the extent it is applied to avoid po tential adverse effects on non-target organisms of
MON810 maize, falls within the scope of Annex A(1)(a) and (b) of the SPS Agreement.
Development of resistance to Bt toxin in insects, including indirect and long-
term effects of insect resistance
7.2680 We turn now to Austria's stated concern regard ing the potential development of resistance to
Bt toxin in insects associated with MON810 maize. We understand the concern identified by Austria
to be that resistance in insects to Bt toxin may de velop due to frequent exposure to this pesticide (the
Bt toxin) and that the development of high levels of resistance in insect populations might require the
application of a pesticide where none was used before , the increased application of a pesticide, or the
application of more harmful pesticides to control the resistant populations.
7.2681 We recall our analysis in Section VII.C regardi ng the development of pesticide-resistance in
insects. We found that resistant target organisms (insects) could be regarded as "pests" within the
meaning of Annex A(1), inasmuch as they present a ri sk to animal, plant or human life or health or
result in other damage. We further determined that risks to animal or plant life or health, or other
damage to the environment, resulting from a cha nge in pesticide use may be viewed as arising
indirectly from the entry, establishment or spread of resistant target organisms qua relevant pest. We
found that to the extent that a measure seeks to a void such risks and damage, it can be considered to
be covered by Annex A(1)(a) and (d) of the SPS Agreement.

7.2682 In view of the above findings, we consider that Austria's safeguard measure on MON810
maize, to the extent it is applied to avoid potentia l risks associated with the development of resistance
to Bt toxin in insects due to the cultivation of MON810 maize, falls within the scope of
Annex A(1)(a) and (d) of the SPS Agreement.
Allergenicity and toxicity
7.2683 We turn now to Austria's stated concern rega rding the potential risks of allergenicity and
toxicity associated with MON810 maize. We recall our analysis related to allergens and toxins in
Section VII.C and our analysis of this concern re lated to Austria's safeguard measures on T25 maize
and Bt-176 maize.
7.2684 In particular, we recall that in Section VII.C we have found that to the extent a measure seeks
to protect humans and animals from allergenic effects of GM plants used as or in foods, that measure
can be considered to be a measure applied to protect human or animal life or health from risks arising
from toxins produced in GM plants which are foods or feedstuffs and, as such, would fall within the
scope of Annex A(1)(b). We furthermore recall our view that if interaction with, and exposure to,
GMOs other than as or in a food produced allergen ic effects in persons, the GMOs in question could
be considered "pests" within the meaning of Annex A(1)(c).
7.2685 Consistent with our reasoning above, in the contex t of the case before us, we consider that
Austria's safeguard measure on MON810 maize, to the extent it is applied to avoid potential allergenic
or toxic effects of MON810 mai ze, falls within the scope of Annex A(1)(b) and (c) of the
SPS Agreement.
Development of antibiotic resistance
7.2686 We turn finally to Austria's stated concern regarding the presence in MON810 maize of an
antibiotic resistance marker gene (ARMG) and the po ssible development of antibiotic resistance. We
understand this to be a concern about a potential tr ansfer of the ARMG present in MON810 maize to
bacteria of the intestine of humans or animals due to consumption of MON810 maize. We recall our
discussion in Section VII.C regarding ARMG, and in pa rticular our view that this concern relates to
the potential transfer to pathogens of ARMG pr esent in certain GMOs, and the possible resulting
decrease in effectiveness of medical treatments i nvolving specific antibiotics which might pose a risk
to the life or health of animals infected with the resistant pathogen.
7.2687 In Section VII.C we have found that Annex A(1)(a) covers measures applied to protect animal
life or health from risks arising from the entry, est ablishment or spread of disease-causing organisms
which have or might become resistant to antibiotics due to the transfer of ARMG from a GM plant.
Similarly, we found that Annex A(1)(a) covers measu res applied to protect animal life or health from
risks arising from the entry, establishment or spr ead of diseases due to the reduced effectiveness of
antibiotics used to treat the pathogens which have become resistant to these antibiotics through gene
transfer. Furthermore, we found that Annex A(1 )(b) covers measures applied to protect human or
animal life or health from risks arising indirectly, namely via the potential transfer to humans or
animals of marker genes conferring resistance to an tibiotics used in human or veterinary medicine,
from additives in foods or feedstuffs. We recall in this respect that, in our view, ARMGs can be
considered to be additives for the purposes of Annex A(1)(b).
7.2688
Thus, in view of our findings above, we c onsider that Austria's safeguard measure on
MON810 maize, to the extent it is applied to a void potential risks associated with the presence in
MON810 maize of an ARMG, falls within the scope of Annex A(1)(a) and (b) of the SPS Agreement.

Co-existence
7.2689 We now turn to Austria's stated concern about co-existence. We understand this to be a
concern that farmers cultivating conventional mai ze might experience a loss of economic value of
their crop due to the existence of unwanted geneti cally modified maize plants in their fields
(contamination). The loss would result from the ci rcumstance that the farmers might no longer be
able to market their crops as non-GM crops.
7.2690 In Section VII.C we have found that the term "o ther damage" as it appears in Annex A(1)(d)
includes economic damage which arises from the entry, establishment or spread of pests and which is
not a consequence of damage to the life or health of animals or plants. We also found that plants
growing where they are undesired can be consider ed as "pests". Such plants include cross-breeds
between GM maize and conventional maize which grow in a conventi onal maize field as a result of
pollen dispersal. Such plants further include GM maize plants growing in a conventional maize field
as a result of unintentional dispersal of GM seed. Thus, we consider that to the extent Austria's
safeguard measure on MON810 maize is applied to prevent economic damage resulting from the
contamination of conventional maize due to the entry, establishment or spread of MON810 maize (via
dispersal of GM seed), or of cross-breeds be tween MON810 maize and conventional maize (via
dispersal of GM pollen), in cultivated conventi onal maize fields, it falls within the scope of
Annex A(1)(d) of the SPS Agreement.
7.2691 In view of the above findings, we consider that Austria's safeguard measure on MON810
maize, to the extent it is applied to prevent or limit damage from the possible contamination of
conventional maize by MON810, falls within the scope of Annex A(1)(d) of the SPS Agreement.
Conclusion with regard to the purpose of the safeguard measure
7.2692 In the light of the above considerations, we c onclude that the safeguard measure applied by
Austria with respect to MON810 maize qualifie s as an SPS measure within the meaning of
Annex A(1) as far as its purpose is concerned.
Form and nature of the measure
7.2693 We now turn to the issue of the form and nature of Austria's safeguard measure on
MON810 maize.
7.2694 We note that the arguments presented by the United States and Argentina regarding the form
and nature of Austria's safeguard measure on MON810 maize are the same as for Austria's safeguard
measure on T25 maize.
7.2695 Thus, as in the case of Austria's safeguard measure on T25 maize we conclude that the
safeguard measure applied by Austria with resp ect to MON810 maize qualifies as an SPS measure
within the meaning of Annex A(1) as far as its form and nature are concerned.
Conclusion
7.2696 We have now considered Austria's safeguard measure on MON810 maize in terms of its
purpose, its form and its nature. In relation to each of these issues, we have found that Austria's
measure satisfies the definition of the term "SPS measur e" set out in Annex A(1). In the light of this,
we come to the conclusion that the safeguard measure taken by Austria with respect to
MON810 maize constitutes an "SPS measure" within the meaning of Annex A(1).

7.2697 At this juncture, we could go on and address the question of whether, in view of its multiple
purposes, the Austrian safeguard measure could be considered to embody more than one SPS
measure. However, neither the United States nor Argentina or the Eu ropean Communities have
argued that to the extent any of the safeguard measures at issue falls to be assessed under the
SPS Agreement, it should be deemed to constitute more th an one SPS measure. In their submissions
to the Panel, the Parties treated the relevant safeguard measures as constituting one SPS measure each.
In the light of this, like the Parties, we will tr eat the Austrian safeguard measure as constituting one
single SPS measure. We will revisit this issue, howe ver, if our disposition of the relevant claims
under the SPS Agreement (and, where appropriate, any implementing action to be taken in view of our
disposition of particular claims) we re to depend on, and be affected by, whether we treat the Austrian
safeguard measure as constituting a single SPS measure or as embodying more than one SPS measure.
Effect on international trade

7.2698 We now turn to the issue of whether Aust ria's safeguard measure on MON810 maize is a
measure that may affect international trade, and th at is therefore subject to the provisions of the
SPS Agreement. We recall that according to Article 1.1 of the SPS Agreement, the SPS Agreement
applies to all SPS measures which "may, directly or indirectly, affect international trade."
Accordingly, for Austria's safeguard measu re on MON810 maize to be subject to the SPS Agreement,
it must be a measure which may, directly or indir ectly, affect international trade. We recall the
Parties' arguments on this matter.
7.2699 The United States argues that the measure adopted by Austria prohibits the "placing on the
market" of MON810 maize, thereby effectively blocking the importation of the product.
7.2700 Argentina notes that since the safeguard measure prevents access of MON810 maize to
Austria, resulting in the absence of imports of this product, the measure can be said to affect
international trade.
7.2701 The Panel notes that the arguments of the parties regarding the effects on trade of Austria's
safeguard measure on MON810 maize are essentially th e same as their arguments with respect to
Austria's safeguard measure on T25 maize. We reca ll our reasoning and conclusions with respect to
Austria's measure on T25 maize in paragraphs 7.2603-7. 2609 above. In view of the fact that Austria's
safeguard measure prohibits imports of MON810 mai ze, we have no difficulty concluding that the
safeguard measure by Austria is an SPS measure which may affect international trade within the
meaning of Article 1.1 of the SPS Agreement and, as such, is subject to the provisions of the
SPS Agreement.
Overall conclusions
7.2702 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Co mmunities, the Panel concludes that the
Austrian safeguard measure on MON810 maize is an SPS measure within the
meaning of Annex A(1) and Article 1.1 of the SPS Agreement.

 (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 the Austrian
safeguard measure on MON810 maize is an SPS measure within the meaning of
Annex A(1) and Article 1.1 of the SPS Agreement.

(v) France – MS1/RF1 oilseed rape (EC-161)
7.2703 We now turn to the safeguard measure applied by France on MS1/RF1 oilseed rape (EC-161).
We recall that the application for placing on the market, growing and obtaining seeds of this oilseed
rape was initially submitted to the United Kingdom.
1736 The product was authorized by the
Commission in February 1996 for cultivation and placing on the market. 1737 In November 1998,
France adopted a Decree suspending commercializa tion of MS1/RF1 oilseed rape (EC-161) on its
territory for a period of two years. 1738 The period of application of the French safeguard measure on
MS1/RF1 oilseed rape (EC-161) was extended twice, namely in July 20011739 and July 2003.1740
Is the French safeguard measure on MS1/RF1 oilseed rape (EC-161) an SPS measure?
7.2704 We start with the issue of whether the Fren ch safeguard measure on MS1/RF1 oilseed rape
(EC-161) is an SPS measure. In order to make this determination, we need to consider two distinct
elements, namely: (1) the purpose of the measure; and (2) the form and nature of the measure.
Purpose of the safeguard measure
7.2705 We first consider the issue of the purpose of th e safeguard measure. Before turning to the
arguments of the Parties on this issue, we recall that we must determine whether the purpose of the
safeguard measure falls within one of the categories of purposes set out in Annex A(1) of the
SPS Agreement.
7.2706 The United States notes that according to the SCP, France justified the ban based on its
"concern over the environmental impact of genetic e scape" and the "spread of herbicide tolerance" to
other plants. This justification indicates that the French measures are sanitary and phytosanitary
measures as they are applied "to protect [...] plan t life or health" from the "spread of pests" and
"prevent or limit other damage" from the "spread of pests".

1736 C/UK/94/M1/1.
1737 Commission Decision 96/158, 6 February 1996.
1738 France, Ministry of Agriculture and Fishing, Decree of 16 November 1998 involving suspension of
the commercialisation of genetically modified colza by virtue of Article 16 of Directive 90/220/European
Communities of 23 April 1990, pursuant to Decision 96/15 8 of 6 February 1996, Official Journal, No. 267, 18
November 1998, at 17379 (Exhibits US-60; CDA-68).
1739 France, Ministry of Agriculture and Fishing, Decree of 26 July 2001 regarding suspension of the
sale of genetically modified colza by virtue of Artic le 16 of Directive 90/220/European Communities of 23
April 1990, pursuant to Decision 96/158/European Co mmunities of 6 February 1996, Official Journal,
30 August 2001 at 13903 (Exhibit CDA-70).
1740 France, Ministry of Agriculture, Food, Fisheries and Rural Affairs, Order of 25 July 2003
suspending the marketing of genetically modified rapeseed pursuant to Article 23 of
Directive 2001/18/European Communities of 12 March 2001, Official Journal, 14 August 2003 at 14061
(Exhibit CDA-71).

7.2707 Canada notes that the French safeguard measure against MS1/RF1 oilseed rape (EC-161) is
predicated on concerns that its release into th e environment may have detrimental effects on the
surrounding plant life or health. More specifically , France indicated that it was concerned about
genetic escape from the biotech varieties, leading to the transfer of herbicide resistance through
hybridization with wild oilseed rape varieties. In essence, the concerns of France were related to
potential risks arising from the release into the e nvironment of the biotech oilseed rape varieties
because of their alleged potential to function as a pest in relation to the surrounding environment, and
in particular, to out-cross with wild species of oilseed rape.
7.2708 The European Communities argues that the main reasons for which the measure was
adopted and maintained include, inter alia , persistence and invasiveness in agricultural and natural
habitats; development of resistance; out-crossing; undesirable effects of management practices;
biodiversity; monitoring; labelling; co-existence; and human and animal health.
7.2709 In examining the purposes for which France's measure on MS1/RF1 oilseed rape (EC-161) is
applied, the Panel will first consider the document notified by France to the Commission in
November 1998 which sets out the reasons for suspending the placing on the market of
MS1/RF1 oilseed rape (EC-161) for an initial period of two years (hereafter the "Reasons
document").
1741
7.2710 In the Reasons document, France justifies its safeguard measure on MS1/RF1 oilseed rape
(EC-161) on the basis of alleged risks to the envi ronment. In particular, France was concerned with
the potential dissemination of the herbicide-tolerance gene into the environment through hybridisation
with other plant species, as well as among different varieties of oilseed rape. France notes that while
experimental platforms have been set up to measu re and quantify on an agronomic scale the extent
and consequences of gene flows in various species, including oilseed rape, knowledge in this area is
still fragmented. It further notes that the agricultura l practices at issue must be considered in the
broader context of their global impact on the environment.
7.2711 We note that France's decision to extend the a pplication of its safeguard measure suspending
the placing on the market of MS1/RF1 oilseed rape (EC-161) in July 2001
1742 and July 2003 1743 was
based on opinions from the French "Commission du Génie biomoléculaire" (hereafter the
"Biomolecular Engineering Committee" or "BEC"), delivered in February 2001
1744 and July 2003 1745
respectively, at the request of th e French authorities. In its February 2001 opinion, the BEC invokes
the need to pursue scientific expe riments with a view to complete current scientific knowledge and to
validate risk management options for the cultivatio n of GM oilseed rape that could limit potential
adverse effects on the environment. In particular, the BEC opinion points to the need to obtain
additional information on the effects of pollen disp ersal from oilseed rape plants and the role of

en marché sur le territoire français de colza génétiquement modifié tolérant aux herbicides, en application de
l'environnement" sets out the reasons for France's safeguard measures on MS1/RF1 oilseed rape and Topas
oilseed rape (Exhibits EC-161/At. 2 and EC-162/At. 5).
1742 The Panel notes that this decision adopted by France on 26 July 2001 to suspend the placing on the
market of MS1/RF1 for a period of two years, was not submitted to the Panel.
1743 The safeguard measure was renewed on the basis of Article 23 of Directive 2001/18 (Exhibits
EC-161/At. 3 and EC-161/At. 5).
1744 It is not clear to the Panel whether this opinion of the BEC was submitted as evidence by the
European Communities. We note that the documents contained in Exhibits EC-161/At. 7 and EC-161/At. 8,
which seem to be translations of the document contained in EC-161/At. 6, are not dated.
1745 Exhibit EC-161/At. 9.

insects in its transport, as well as the effects of pers istence of oilseed rape plants resulting from seed
dispersal during transportation and pollenisation of neighbouring oilseed rape plants. The opinion
further indicates that modalities for management are necessary in order to limit the direct and indirect
effects of re-growth of oilseed rape in the case of herbicide tolerance, and that large scale experiments
are necessary in order to validate such modalities.
7.2712 In its July 2003 opinion, the BEC pointed to the existence of new elements of information,
including, inter alia, with respect to the issues of pollen di spersal, characterization of inter-specific
hybrids and re-growth. The BEC considered that these new elements of information required further
analysis in order to determine whether they put into question the conclusions of the February 2001
opinion, on which the decision to maintain the safeguard measure on MS1/RF1oilseed rape (EC-161)
was based.
1746 To this end, the BEC recommended the organization of a scientific workshop to take
stock of ongoing research and to eventually iden tify modalities for the management of genetically
modified oilseed rape. 1747
7.2713 We note that France further elaborated on its c oncerns with respect to MS1/RF1 oilseed rape
(EC-161) in a Note addressed to the Commission in July 2003 regarding the extension of the
safeguard measure. In this Note, France recalls th at the decision to apply a safeguard measure on
MS1/RF1 oilseed rape (EC-161) is based on the pot ential risk of contamination of conventional
oilseed rape by genetically modified oilseed rape.1748
7.2714 A further informal Note was provided by France to the Commission after the establishment of
the Panel. 1749 The Note recalls the concerns underlying, inter alia , the safeguard measure on
MS1/RF1 oilseed rape (EC-161) , including those rela ting to the environmental consequences of gene
transfer to other plants and the economic conseque nces of contamination (co-existence issue). The
Note indicates that the BEC was to hold a sci entific workshop in November 2003 and that the
safeguard measure on MS1/RF1 oilseed rape (EC-161) might be withdrawn if after the workshop the
BEC provided favourable scientific advice on the outstanding concerns. Looking ahead, the Note
concludes that the maintenance of the safeguard m easure at issue was justified at the time by the
precautionary principle, pending a clearer and more complete scientific picture. The Note goes on to
state, however, that the safeguard measure would in any event not be withdrawn before the entry into
force of the new EC regulations on labelling and traceability as well as on GM food and feed.
7.2715 Finally, we note that the BEC delivered an opinion in February 2004 based on the conclusions
of a scientific workshop held in November 2003.
1750 The opinion concludes that the cultivation of
MS1/RF1 oilseed rape (EC-161) does not present any direct risk for the environment, but that
modalities are nonetheless required to manage indirect ecological risks, which are related to practices
associated with the cultivation of MS1/RF1 oilseed rape (EC-161).
7.2716 Based on the foregoing, we consider that at the time of review by the Panel, France applied its
safeguard measure to address concerns about:
 (1) transfer of the herbicide-tolerance gene to adventitious flora;

1746 Exhibit EC-161/At. 9. See also Exhibit EC-161/At. 5.
1747 Ibid.
1748 Exhibit EC-161/At. 3.
1749 Exhibit EC-161/At. 4. While the document is not dated, we note that it makes reference to the
proceedings before this Panel, thus suggesting that the document was circulated after the establishment of the
Panel.
1750 Exhibit EC-161/At. 10.

 (2) adverse effects on the environment, including from persistence and management
practices associated with the cultivation of MS1/RF1 oilseed rape (EC-161); and
 (3) contamination of conventional oilseed rape by genetically modified oilseed rape.

7.2717 The European Communities asserts that France's safeguard measure on MS1/RF1 oilseed rape
(EC-161) is also applied in view of concerns about labelling, but provides no substantiation or
explanation of this assertion. The labelling con cern asserted by the European Communities was not
articulated by France in any of th e documents discussed by us above which date from before the date
of establishment of this Panel. However, as we have pointed out, after the establishment of the Panel,
France in an informal Note to the Commission ma de reference to the new EC regulation on labelling
and traceability as well as to the new EC regulation on GM food and feed. These regulations contain
new labelling requirements. Nevertheless, for the re asons which follow, we ar e not persuaded that it
can be inferred from this post-2003 reference to labelling that France in August 2003 applied its
safeguard measure on MS1/RF1 oilseed rape (EC-161) to address concerns about labelling.
7.2718 To begin with, we recall that according to the No te the relevant safeguard measure is justified
by the precautionary principle, pending a clearer a nd more complete scientific picture. Insufficient
labelling is not claimed as a separate justification. Indeed, the Note indicates that in July 2003 France
extended its safeguard measure for one year on the basis of scientific advice received from the BEC in
July 2003. Moreover, the reference to labe lling is made in a forward-looking context, i.e., in the
context of a discussion of the "way ahead".
1751 It is clear from the Note that France at the time was
waiting for further advice from the BEC (in the wake of the November 2003 scientific workshop to be
held by the BEC) which it said could lead to th e withdrawal of the safeguard measure if the
outstanding concerns were satisfactorily addressed by the BEC. The Note states, however, that even
if the BEC were to offer favourable scientific a dvice, France would not withdraw its safeguard
measure prior to the entry into force of the new EC regulations. We consider that it may be
appropriate to infer from this statement that in case of favourable advice from the BEC following the
November 2003 workshop, concerns about labe lling would be the reason for maintaining the
safeguard measure.1752 But we do not think that it may be properly inferred from this forward-looking
statement that concerns about labelling were a reaso n for applying the relevant safeguard measure in
August 2003, when France was still waiting for the results of the November 2003 scientific workshop
and subsequent scientific advice from the BEC. In the light of this, as indicated, we are not persuaded
that France at the time of review by the Panel was applying its safeguard measure to address concerns
about labelling as asserted by the European Communities.
7.2719 Having determined the purposes for which France applied its safeguard measure at the time of
review by the Panel, we now go on to assess whether these purposes fall within one of the categories
of purposes which according to Annex A(1) character ize an SPS measure. To that end, we will
consider one by one each of the above-noted purposes of France's safeguard measure.
Transfer of the herbicide-tolerance gene to adventitious flora
7.2720 We turn first to France's stated objective for prohibiting the placing on the market of
MS1/RF1 oilseed rape (EC-161) due to concerns ove r the transfer of the herbicide-tolerance gene
contained in MS1/RF1 oilseed rape (EC-161) to adventitious flora. We understand this to be
essentially a concern about the potential environmenta l impacts associated with gene transfer from

1751 The Note uses the French word "perspectives".
1752 We note in this context that the Note in question is an informal note which bears no official
letterhead nor a date or signature which would allow us to confirm that the views expressed in the Note are
attributable to, and expressed on behalf of, France.

MS1/RF1 oilseed rape (EC-161) to adventitious flor a, and in particular about the environmental
impacts of the possible development of herbicide resistant weeds.
7.2721 We recall our finding in Section VII.C that cro ss-breeds between conventional and GM plants
could be regarded as "pests" for the purposes of A nnex A(1), to the extent they have undesired
introduced traits (such as herbicide resistance) and ha rm animal or plant life or health or result in
other damage. We have determined on that basis th at measures applied to protect animal or plant life
or health from risks arising directly ( e.g., through changes in selective advantage) from the entry,
establishment or spread of cross-breeds with undesi red traits resulting from the transfer of genetic
material from a GM plant fall within the scope of Annex A(1)(a), while measures applied to prevent
"other damage" to the environment from the entry, est ablishment or spread of cross-breeds fall within
the scope of Annex A(1)(d).
7.2722 In addition, we recall that one possible concer n arising from cross-breeds that have acquired
herbicide resistance is that they may lead to the n eed for an increased use of the same herbicides, or
different, more toxic herbicides, to control the resistan t weeds. We determined that risks to animal or
plant life or health, or other damage to the envir onment, resulting from a change in pesticide use may
be viewed as arising indirectly from the entry, establishment or spread of cross-breeds qua relevant
pest. We deduced from this that measures applie d to avoid such indirect adverse effects on the
environment fall within the scope of Annex A(1)(a) and (d).
7.2723 Consistent with our reasoning above, we cons ider that France's safeguard measure on
MS1/RF1 oilseed rape (EC-161), to the extent it is applied to avoid risks to the environment
associated with the transfer of the herbicide-to lerance gene contained in MS1/RF1 oilseed rape
(EC-161) to adventitious flora, and in particular th e development of resistance in weeds, falls within
the scope of Annex A(1)(a) and (d) of the SPS Agreement.
Adverse effects on the environment, including from persistence and
management practices associated with the cultivation of MS1/RF1 oilseed
rape
7.2724 We turn now to the next objective stated by France for prohibiting the placing on the market
of MS1/RF1 oilseed rape (EC-161), namely, France' s concerns over potential adverse effects on the
environment, including the environmental effects of persistence resulting from seed dispersal during
transportation and of management techniques associated with the cultivation of MS1/RF1 oilseed rape
(EC-161).
7.2725 In Section VII.C we have found that to the ex tent a measure is app lied to avoid adverse
effects on plant life or health that might arise if GM plants crowd out or eliminate other plants due to
a potential competitive advantage, invasiveness or pe rsistence, such a measure would be covered by
Annex A(1)(a), as it would be applied "t o protect [...] plant life or health [… ] from risks arising from
the entry, establishment or spread" of GM plants qua "pests".
7.2726 In Section VII.C we also found that to the exte nt that GM plants may result in changes in
plant populations, this may increase or decrease th e food available for particular animal populations
and thus enhance, or detract from, the fitness and health of these animal populations, which in turn
may have a deleterious effect on the life or health of plants, e.g., by affecting their ability to
reproduce. We state that, by causing harm to the health of animals or other plants in this way, the GM
plants would act as "pests" within the meaning of Annex A(1), and that to the extent a measure is
applied to avoid this kind of adverse effect, it can be considered a measure covered by Annex A(1)(a).

7.2727 Moreover, we stated that to the extent a measure is applied to avoid adverse effects on the life
or health of animals or plants which arise from particular management (weed control) practices
associated with GMOs, such a measure falls within the scope of Annex A(1)(a), in that it can be
viewed as a measure applied to protect the life or health of animals or plants from risks arising
indirectly from the entry, establishment or spread of weeds qua "pests".
7.2728 Finally, we found that to the extent a measure seeks to avoid adverse effects of GMOs on the
environment other than adverse effects on animal or plant life or health, such a measure can be
considered to be covered by A nnex A(1)(d), inasmuch as it can be viewed as a measure which is
applied to prevent or limit "other damage" from th e entry, establishment or spread of "pests". As
noted earlier, the GMOs themselves might qualify as th e relevant pest, or other plants or animals
might become pests as a result of the release of GM Os into the environment. Furthermore, we said
that to the extent that a measure is applied to avoid adverse environmental effects arising from
management (weed control) practices associated with GMOs other than damage to the life or health of
animals or plants, that measure can be considered as a measure applied to prevent or limit "other
damage" resulting indirectly from the entr y, establishment or spread of weeds qua "pests" and would
thus also be covered by Annex A(1)(d).
7.2729 Consistent with our reasoning above, we cons ider that France's safeguard measure on
MS1/RF1 oilseed rape (EC-161), to the extent it is applied to avoid adverse effects on the
environment, including from management practic es associated with the cultivation of MS1/RF1
oilseed rape (EC-161), falls within the scope of Annex A(1)(a) and (d) of the SPS Agreement.
Contamination of conventional oilseed rape by genetically modified oilseed
rape
7.2730 We finally address France's concern with regard to the risk of contamination of conventional
oilseed rape by genetically modified oilseed rape, i.e., MS1/RF1 oilseed rape (EC-161).
7.2731 We have already addressed France's concern a bout the possible transfer of the introduced
herbicide-tolerance gene from MS1/RF1 oilseed ra pe to adventitious flor a, which includes gene
transfer from MS1/RF1 oilseed rape to different sp ecies (resulting in inter-specific hybrids), but also
includes gene transfer to wild or cultivated conventional oilseed rape. Thus, for the reasons which we
have outlined above, we consider that to the exte nt France's safeguard measure on MS1/RF1 oilseed
rape is applied to avoid adverse environmental e ffects arising from the contamination of conventional
oilseed rape by MS1/RF1 oilseed rape due to gene transfer from MS1/RF1 oilseed rape to
conventional oilseed rape, it falls within the scope of Annex A(1)(a) and (d) of the SPS Agreement.
7.2732 In our understanding, France's concern about contamination of conventional oilseed rape is
also a concern that farmers cultivating conventiona l oilseed rape might experience a loss of economic
value of their crop due to the existence of unwanted genetically modified oilseed rape plants in their
fields. The loss would result from the circumstance that the farmers might no longer be able to
market their crops as non-GM crops. Even if Fr ance's concern about contamination were understood
in this way, however, France's safeguard measure would, in our view, fall within the scope of
Annex A(1) of the SPS Agreement.
7.2733 We recall in this regard that in Section VII. C we found that the term "other damage" as it
appears in Annex A(1)(d) includes economic damage which arises from the entry, establishment or
spread of pests and which is not a consequence of da mage to the life or health of animals or plants.
We also found that plants growing where they are undesired can be considered as "pests". Such plants
include cross-breeds between GM oilseed rape a nd conventional oilseed rape which grow in a

conventional oilseed rape field as a result of pollen dispersal. Such plants further include GM oilseed
rape plants growing in a conventio nal oilseed rape field as a result of unintentional dispersal of GM
seed. Thus, we consider that to the extent Fr ance's safeguard measure on MS1/RF1 oilseed rape
(EC-161) is applied to prevent economic damage resulting from the contamin ation of conventional
oilseed rape due to the entry, establishment or spre ad of MS1/RF1 oilseed rape (via dispersal of GM
seed), or of cross-breeds between MS1/RF1 oilseed ra pe and conventional oilseed rape (via dispersal
of GM pollen), in cultivated conventional oilseed rape fields, it falls within the scope of
Annex A(1)(d) of the SPS Agreement.
7.2734 In view of the above findings, we consider that France's safeguard measure on MS1/RF1
oilseed rape (EC-161), to the extent it is applied to avoid adverse effects arising from the possible
contamination of conventional oilseed rape by MS1/ RF1 oilseed rape (EC-161), falls within the scope
of Annex A(1)(a) and (d) of the SPS Agreement.
Conclusion with regard to the purpose of the safeguard measure
7.2735 In the light of the above considerations, we c onclude that the safeguard measure applied by
France with respect to MS1/RF1 oilseed rape (EC-161) qualifies as an SPS measure within the
meaning of Annex A(1) as far as its purpose is concerned.
Form and nature of the measure
7.2736 We now turn to the issue of form and nature of France's safeguard measure on
MS1/RF1 oilseed rape (EC-161). We start by recalling the Parties' arguments on this matter.
7.2737 The United States argues that the measure is in the form of a "decree" from the French
Minister of Agriculture and Fishing, which is among the types of measures explicitly mentioned in
Annex A(1) of the SPS Agreement.
7.2738 Canada argues that the French measure is in the form of a "decree", one of the types of
measures expressly enumerated in Annex A(1) of the SPS Agreement.
7.2739 The Panel recalls that the second paragraph of Anne x A(1) addresses the form and nature of
measures which may qualify as SPS measures. In r espect of the form of SPS measures, we have
indicated earlier in this report that the referenc e in the second paragraph to "laws, decrees [and]
regulations" should not be taken to prescribe a part icular legal form and that SPS measures may in
principle take many different legal forms.
1753 Furthermore, in respect of the nature of SPS measures,
we have indicated earlier that the reference in th e same paragraph to "requirements" is broad and
unqualified. Hence, both an authorization to mark et a particular product and a ban on the marketing
of a particular product may be considered "re quirements". The second example would constitute a
negative requirement.
7.2740 We note that the French safeguard measure on MS1/RF1 oilseed rape (EC-161) was
implemented through a decree to prohibit commer cialisation of MS1/RF1 oilseed rape (EC-161).
Annex A(1) specifically refers to "decrees". We therefore consider that, for the purposes of
Annex A(1), the French decree is an SPS measure in respect of the form of the measure.
7.2741 In respect of the nature of the French measure, we note that the decree prohibits the marketing
of MS1/RF1 oilseed rape (EC-161). As indicated above, we are of the view that a prohibition on the

1753 See supra, para. 7.1334.

marketing of a particular product (within a particular territory) may be considered a "requirement" for
the purposes of Annex A(1).
7.2742 We therefore conclude that the safeguard meas ure taken by France with respect to MS1/RF1
oilseed rape qualifies as an SPS measure within the meaning of Annex A(1) as far as its form and
nature are concerned.
Conclusion
7.2743 We have now considered France's safeguard measure on MS1/RF1 oilseed rape (EC-161) in
terms of its purpose, its form and its nature. In relation to each of these issues, we have found that
France's measure satisfies the definition of the term "SPS measure" set out in Annex A(1). In the light
of this, we come to the conclusion that the safe guard measure applied by France with respect to
MS1/RF1 oilseed rape (EC-161) constitutes an "SPS measure" within the meaning of Annex A(1).
7.2744 At this juncture, we could go on and address the question of whether, in view of its multiple
purposes, the French safeguard measure could be co nsidered to embody more than one SPS measure.
However, neither the United States nor Canada or the European Communities have argued that to the
extent any of the safeguard measures at issue falls to be assessed under the SPS Agreement, it should
be deemed to constitute more than one SPS measure. In their submissions to the Panel, the Parties
treated the relevant safeguard measures as constituting one SPS measure each. In the light of this, like
the Parties, we will treat the French safeguard measure as constituting one single SPS measure. We
will revisit this issue, however, if our di sposition of the relevant claims under the SPS Agreement
(and, where appropriate, any implementing action to be taken in view of our disposition of particular
claims) were to depend on, and be affected by, wh ether we treat the French safeguard measure as
constituting a single SPS measure or as embodying more than one SPS measure.
Effect on international trade

7.2745 We now turn to the issue of whether France 's safeguard measure on MS1/RF1 oilseed rape
(EC-161) is a measure that affects in ternational trade, and that is therefore subject to the provisions of
the SPS Agreement. We recall that according to Article 1.1 of the SPS Agreement, the SPS Agreement
applies to all SPS measures which "may, directly or indirectly, affect international trade."
Accordingly, for France's safeguard measure on MS1/ RF1 oilseed rape (EC-161) to be subject to the
SPS Agreement, it must be a measure which may, directly or indirectly, affect international trade. We
recall the Parties' arguments on this matter.
7.2746 The United States argues that the measure adopted by France prohibits the "placing on the
market" of MS1/RF1 oilseed rape (EC-161), thereby effectively blocking the importation of the
product.
7.2747 Canada argues that the measure suspends commercialization of MS1/RF1 oilseed rape
(EC-161), as well as prohibiting its importation on the French territory. Since the measure effectively
blocks market access for the targeted biotech product, it clearly affects international trade.
7.2748 The Panel notes that the arguments of the parties regarding the effects on trade of France's
safeguard measure on MS1/RF1 oilseed rape (EC-161) are essentially the same as their arguments
with respect to Austria's safeguard measure on T2 5 maize. We recall our reasoning and conclusions
with respect to Austria's measure on T25 maize in paragraphs 7.2603-7.2609 above. Therefore, in
view of the fact that France's safeguard measure prohibits imports of MS1/RF1 oilseed rape (EC-161),
we have no difficulty concluding that the safeguard measure applied by France is an SPS measure

which may affect international trade within the meaning of Article 1.1 of the SPS Agreement and, as
such, is subject to the provisions of the SPS Agreement.
Overall conclusions

7.2749 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Co mmunities, the Panel concludes that the
French safeguard measure on MS1/RF1 o ilseed rape (EC-161) is an SPS measure
within the meaning of Annex A(1) and Article 1.1 of the SPS Agreement.

 (ii) 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 the French
safeguard measure on MS1/RF1 oilseed rape (EC-161) is an SPS measure within the
meaning of Annex A(1) and Article 1.1 of the SPS Agreement.

(vi) France – Topas oilseed rape
7.2750 We now turn to the safeguard measure applie d by France on Topas oilseed rape. We recall
that the application for placing on the market, gr owing and obtaining seeds of this oilseed rape was
initially submitted to the United Kingdom.
1754 The product was authorized by the European
Commission in April 1998. 1755 In November 1998, France adopted a Decree suspending the placing
on the market of Topas oilseed rape for a period of two years. 1756 This Decision, which was taken on
the basis of Article 16 of Directive 90/220, was notified to the Commission in May 1999. The period
of application of the French safeguard measure on Topas oilseed rape was extended twice, namely in
July 20011757 and July 2003.1758
Is the French safeguard measure on Topas oilseed rape an SPS measure?
7.2751 We start with the issue of whether the French safeguard measure on Topas oilseed rape is an
SPS measure. In order to make this determination, we need to consider two distinct elements,
namely: (1) the purpose of the measure; and (2) the form and nature of the measure.

1754 C/UK/95/M5/1.
1755 Commission Decision 98/291, April 1998.
1756 France, Ministry of Agriculture and Fishing, Decree of 16 November 1998 involving suspension of
the commercialization of genetically modified colza by virtue of Article 16 of Directive 90/220 of 23 April
1990, pursuant to Decision 98/291 of 22 April 1998, Official Journal, 18 November 1998, at 17379 (Exhibit
CDA-64).
1757 France, Ministry of Agriculture and Fishing, Decree of 26 July 2001 regarding suspension of the
sale of genetically modified colza by virtue of Artic le 16 of Directive 90/220/European Communities of 23
April 1990, pursuant to Decision 96/158/European Co mmunities of 6 February 1996, Official Journal,
30 August 2001 at 13903 (Exhibit CDA-70).
1758 France, Ministry of Agriculture, Food, Fisheries and Rural Affairs, Order of 25 July 2003
suspending the marketing of genetically modified rapeseed pursuant to Article 23 of
Directive 2001/18/European Communities of 12 March 2001, Official Journal, 14 August 2003 at 14061
(Exhibit CDA-71).

Purpose of the safeguard measure
7.2752 We first consider the issue of the purpose of th e safeguard measure. Before turning to the
arguments of the Parties on this issue, we recall that we must determine whether the purpose of the
safeguard measure falls within one of the categories of purposes set out in Annex A(1) of the
SPS Agreement.
7.2753 The United States notes that according to the SCP, France justified the ban based on its
"concern over the environmental impact of genetic e scape" and the "spread of herbicide tolerance" to
other plants. This justification indicates that the French measures are sanitary and phytosanitary
measures as they are applied "to protect [...] plan t life or health" from the "spread of pests" and
"prevent or limit other damage" from the "spread of pests".
7.2754 Canada notes that the French safeguard measure ag ainst Topas oilseed rape is predicated on
concerns that its release into the environment may have detrimental effects on the surrounding plant
life or health. More specifically, France indicated that it was concerned about genetic escape from the
biotech varieties, leading to the transfer of he rbicide resistance through hybridization with wild
oilseed rape varieties. In essence, the concerns of France were related to potential risks arising from
the release into the environment of the biotech oil seed rape varieties because of their alleged potential
to function as a pest in relation to the surrounding en vironment, and in particular, related wild species
of oilseed rape.
7.2755 The European Communities argues that the main reasons for which the measure was
adopted and maintained include, inter alia , persistence and invasiveness in agricultural and natural
habitats; development of resistance; out-crossi ng; undesirable effects on management practices;
biodiversity; monitoring; labelling; co-existence; and human and animal health.
7.2756 The Panel observes that the French decisions to suspend the placing on the market of
Topas oilseed rape identify exactly the same purposes for this safeguard measure at the time of review
by the Panel as those invoked by France with resp ect to its safeguard measure on MS1/RF1 oilseed
rape.
1759 Thus, based on the relevant information provided by the Parties, we consider that at the time
of review by the Panel, France applied its safe guard measure on Topas oilseed rape to address
concerns about:
 (1) transfer of the herbicide-tolerance gene to adventitious flora;
 (2) adverse effects on the environm ent, including from persistence; and
 (3) contamination of conventional oilseed rape by genetically modified oilseed rape.

7.2757 The European Communities asserts that France's safeguard measure on Topas oilseed rape is
also applied in view of concerns about labelling, but provides no substantiation or explanation of this
assertion. The labelling concern asserted by the European Communities was not articulated by France
in any of the relevant documents which date from be fore the date of establishment of this Panel.
However, after the establishment of the Panel, Fr ance in an informal Note to the Commission made
reference to the new EC regulation on labelling an d traceability as well as to the new EC regulation
on GM food and feed.
1760 We have already examined this docum ent in the context of our analysis of
the French safeguard measure on MS1/RF1 oilseed rape. Since the document also concerns the
French safeguard measure on Topas oilseed rape, our earlier analysis is applicable to the safeguard

1759 We note, however, that unlike MS1/RF1 oilseed rape, Topas oilseed rape was not approved for
cultivation. It was approved for import, storage and processing.
1760 Exhibit EC-161/At. 4.

measure on Topas oilseed rape as well. Thus, for the reasons we have outlined earlier in
paragraph 7.2718, we are not persuaded that it can be inferred from the post-2003 reference to
labelling in the French Note that France in A ugust 2003 applied its safeguard measure on Topas
oilseed rape to address concerns about labelling.
7.2758 Having determined the purposes for which France applied its safeguard measure at the time of
review by the Panel, we now go on to assess whether these purposes fall within one of the categories
of purposes which according to Annex A(1) character ize an SPS measure. To that end, we will
consider one by one each of the above-noted purposes of France's safeguard measure.
Transfer of the herbicide-tolerance gene to adventitious flora
7.2759 Considering first France's stated objective for prohibiting the placing on the market of Topas
oilseed rape due to concerns over the transfer of the herbicide-tolerance gene contained in Topas
oilseed rape to adventitious flora, we recall our analysis of this concern in the context of our
discussion of France's safeguard measure on MS1/RF1 oilseed rape.
7.2760 Consistent with our reasoning there, we consid er that France's safeguard measure on Topas
oilseed rape, to the extent it is applied to avoid risks associated with the tr ansfer of the herbicide-
tolerance gene contained in Topas oilseed rape to adventitious flora, and in particular the development
of resistance in weeds due to cultivation of Topas oilseed rape, falls within the scope of
Annex A(1)(a) and (d) of the SPS Agreement.
Adverse effects on the environment, including from persistence
7.2761 We turn now to the next objective stated by France for prohibiting the placing on the market
of Topas oilseed rape, namely, France's concerns over potential adverse effects on the environment,
including the environmental effects of pers istence resulting from seed dispersal during
transportation.
1761 We recall our analysis of this concern in the context of our discussion of France's
safeguard measure on MS1/RF1 oilseed rape.
7.2762 Consistent with our reasoning there, we consid er that France's safeguard measure on Topas
oilseed rape, to the extent it is applied to avoi d adverse effects on the environment, including from
persistence, falls within the scope of Annex A(1)(a) and (d) of the SPS Agreement.
Contamination of conventional oilseed rape by genetically modified oilseed
rape
7.2763 We address finally France's concern with regard to the risk of contamination of conventional
oilseed rape by genetically modified oilseed rape. We recall in this regard our analysis of this concern
in the context of our discussion of France's safeguard measure on MS1/RF1 oilseed rape.
7.2764 Consistent with our reasoning there, we consid er that France's safeguard measure on Topas
oilseed rape, to the extent it is applied to avoi d adverse environmental or economic effects arising
from the possible contamination of conventional oilseed rape by Topas oilseed rape, falls within the
scope of Annex A(1)(a) and (d) of the SPS Agreement.

1761 Since Topas oilseed rape was not approved for cu ltivation, our analysis in the context of MS1/RF1
oilseed rape relating to the adverse environmental effect s resulting from management practices associated with
the cultivation of MS1/RF1 oilseed rape is not applicable here.

Conclusion with regard to the purpose of the safeguard measure
7.2765 In the light of the above considerations, we therefore conclude that the safeguard measure
applied by France with respect to Topas oilseed rape qualifies as an SPS measure within the meaning
of Annex A(1) as far as its purpose is concerned.
Form and nature of the measure
7.2766 We now turn to the issue of the form and nature of France's safeguard measure on
Topas oilseed rape. We note that the Parties have made the same arguments with respect to France's
safeguard measure on Topas oilseed rape as for Fr ance's safeguard measure on MS1/RF1 oilseed rape
(EC-161).
7.2767 Consistent with our analysis with respect to France's safeguard measure on MS1/RF1 oilseed
rape (EC-161), we conclude that France's safeguard measure on Topas oilseed rape qualifies as an
SPS measure within the meaning of Annex A(1) as far as its form and nature are concerned.
Conclusion
7.2768 We have now considered France's safeguard m easure on Topas oilseed rape in terms of its
purpose, its form and its nature. In relation to each of these issues, we have found that France's
measure satisfies the definition of the term "SPS measur e" set out in Annex A(1). In the light of this,
we come to the conclusion that the safeguard measure applied by France with respect to Topas oilseed
rape constitutes an "SPS measure" within the meaning of Annex A(1).
7.2769 At this juncture, we could go on and address the question of whether, in view of its multiple
purposes, the French safeguard measure could be co nsidered to embody more than one SPS measure.
However, neither the United States nor Canada or the European Communities have argued that to the
extent any of the safeguard measures at issue falls to be assessed under the SPS Agreement, it should
be deemed to constitute more than one SPS measure. In their submissions to the Panel, the Parties
treated the relevant safeguard measures as constituting one SPS measure each. In the light of this, like
the Parties, we will treat the French safeguard measure as constituting one single SPS measure. We
will revisit this issue, however, if our di sposition of the relevant claims under the SPS Agreement
(and, where appropriate, any implementing action to be taken in view of our disposition of particular
claims) were to depend on, and be affected by, wh ether we treat the French safeguard measure as
constituting a single SPS measure or as embodying more than one SPS measure.
Effect on international trade

7.2770 We now turn to the issue of wh ether France's safeguard measure on Topas oilseed rape is a
measure that affects international trade, and that is therefore subject to the provisions of the
SPS Agreement. We recall that according to Article 1.1 of the SPS Agreement, the SPS Agreement
applies to all SPS measures which "may, directly or indirectly, affect international trade."
Accordingly, for France's safeguard measure on Topas oilseed rape to be subject to the
SPS Agreement, it must be a measure which may, directly or indirectly, affect international trade. We
recall the Parties' arguments on this matter.
7.2771 The United States argues that the measure adopted by France prohibits the "placing on the
market" of Topas oilseed rape, thereby effectively blocking the importation of the product.

7.2772 Canada argues that the measure suspends commercialization of Topas oilseed rape, and
prohibits its importation on the French territory. Si nce the measure effectively blocks market access
for the targeted biotech product, it clearly affects international trade.
7.2773 The Panel notes that the arguments of the parties regarding the effects on trade of France's
safeguard measure on Topas oilseed rape are essentia lly the same as their arguments with respect to
Austria's safeguard measure on T25 maize. We reca ll our reasoning and conclusions with respect to
Austria's measure on T25 maize in paragraphs 7.2603- 7.2609 above. Therefore, in view of the fact
that France's safeguard measure prohibits imports of Topas oilseed rape, we have no difficulty
concluding that the safeguard measure applied by France is an SPS measure which may affect
international trade within the meaning of Article 1.1 of the SPS Agreement and, as such, is subject to
the provisions of the SPS Agreement.
Overall conclusions

7.2774 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Co mmunities, the Panel concludes that the
French safeguard measure on Topas oilseed rape is an SPS measure within the
meaning of Annex A(1) and Article 1.1 of the SPS Agreement.

 (ii) 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 the French
safeguard measure on Topas oilseed rape is an SPS measure within the meaning of
Annex A(1) and Article 1.1 of the SPS Agreement.

(vii) Germany – Bt-176 maize
7.2775 We now turn to the safeguard measure applied by Germany on Bt-176 maize. We recall that
the application for placing on the market of this product was initially submitted to France.
1762 The
product was authorized by the European Commission in 1996. 1763 Germany informed the
Commission of its decision to restrict the authorization for the placing on the market of Bt-176 maize
in a letter dated 2 March 2000.
1764 Germany amended its original decision on Bt-176 maize by a
further decision adopted on 31 March 2000. 1765 This amended decision suspends the placing on the
market of Bt-176 maize and its progeny in German y, unless cultivation is intended for research and

1762 C/F/94/11-03.
1763 Commission Decision 97/98 (Exhibits US-97; ARG-37).
1764 The letter is from the Robert Koch Institute (Exhibit EC-158/At. 19_trans).
1765 Exhibits US-65; ARG-13.

testing purposes in certain specified areas.
1766 This decision was notified to the Commission in
April 2000.1767
Is the German safeguard measure on Bt-176 maize an SPS measure?
7.2776 We start with the issue of whether Germany' s safeguard measure on Bt-176 maize is an SPS
measure. In order to make this determination, we need to consider two distinct elements, namely: (1)
the purpose of the measure; and (2) the form and nature of the measure.
Purpose of the safeguard measure
7.2777 We first consider the issue of the purpose of th e safeguard measure. Before turning to the
arguments of the Parties on this issue, we recall that we must determine whether the purpose of the
safeguard measure falls within one of the categories of purposes set out in Annex A(1) of the
SPS Agreement.
7.2778 The United States notes that the concerns expressed by Germany with regard to
Bt-176 maize include the effect of Bt toxin on non-target organisms, the development of insect
resistance to Bt toxin, and the transfer of antibio tic resistant genes to humans and animals. On the
basis of these justifications, the United States argue s that the German safeguard measure is an SPS
measure, as it is applied to "protect animal lif e or health" from "disease-causing organisms"; or
"protect human life or health" from "toxins" or "d isease-causing organisms in foods"; or "to prevent
or limit [...] damage" from the "spread of pests".
7.2779 Argentina argued that the purpose of the safeguard measures may be inferred from the
Community legislation under which the bans were adopted, and that the relevant provisions of EC
Directive 90/220 and Regulation 258/97 clearly indicate that the purpose of the EC legislation is the
"protection of human health and the environment" . Since the EC member States have taken their
measures explicitly on the basis of this legislation, it can be inferred that the measures were imposed
for the purpose of protecting human health or th e environment. The safeguard measures are,
therefore, SPS measures as defined in the SPS Agreement.
7.2780 The European Communities argues that the main reasons for which the measure was
adopted and maintained include, inter alia, horizontal gene transfer; antibiotic resistance; effects on
non-target organisms; toxicity or allergenicity; persistence and invasive ness in agricultural and
natural habitats; development of resistance; out-crossing; undesirable effects on management
practices; biodiversity; monitoring; labelling; co-existence; and human and animal health.
7.2781 The Panel notes that Germany sets out its reasons for adopting the safeguard measure on
Bt-176 maize in a letter to the Commission dated 4 April 2000.
1768 In this document, Germany refers
to recent laboratory investigations and relevant studies with insect species which suggest that the
ingestion of pollen from maize plants expressing Bt-toxin may produce harmful effects in non-target

1766 The prohibition did not apply in the case of cultivation intended for research and testing purposes
in the following areas: effects on target or non-target organisms, the development of resistance, counter
measures to resistance development, horizontal or ve rtical gene transfer, ecological assessments or the
enhancement of agronomic and plant protection knowledge for practical application.
1767 The amended decision was notified to the Commission on 4 April 2000 (Exhibit EC-158/At. 21),
and again on 28 April 2000 with the relevant scientific evidence considered by Germ any in the context of the
adoption of its safeguard measure (Exhibits EC-158/At. 23-29).
1768 Exhibit EC-158/At. 21. The Panel notes that the concerns of Germany with respect to
Bt-176 maize are also outlined in the letter of 31 March 2000 (Exhibit US-65).

insects through their absorption of the Bt-toxin.
1769 Germany notes that in the case of unrestricted
cultivation, resistance to Bt toxin may develop in maize pests and non-target organisms, thereby
impeding the applicability of Bt toxin as a pesticide. Other studies reported that Bt toxin enters the
soil from the roots of genetically modified maize plants. Germany submits that these studies suggest
that if cultivation is unrestricted, the presence of Bt toxin could have adverse effects on living
organisms in the soil. Finally, Germany notes th at the cultivation of a transgenic variety with
antibiotic-resistant genes might increase the deve lopment of antibiotic resistance following the
ingestion of the gene by humans and animals.
7.2782 Based on the foregoing, we consider that at the time of review by the Panel, Germany applied
its safeguard measure on Bt-176 maize to address concerns about:
 (1) effects on non-target organisms;
 (2) the development of resistance to Bt toxin in insects;
 (3) possible adverse effects of the Bt toxin in the soil; and
 (4) the transfer of the bla-ampicillin resistance gene to bacteria of the intestine of humans
and animals.

7.2783 The European Communities asserts that Germ any's safeguard measure on Bt-176 maize is
also applied in view of concerns about labelling and co-existence. These asserted concerns were not
articulated by Germany in the documents discus sed by us above. Furthermore, the European
Communities has neither substantiate d nor explained its assertion. In the light of this, we are not
persuaded that Germany is applying its safeguard measure to address these additional concerns
identified by the European Communities.
7.2784 Having determined the purposes for which Germany applied its safeguard measure at the time
of review by the Panel, we now go on to assess whether these purposes fall within one of the
categories of purposes which according to Annex A(1) characterize an SPS measure. To that end, we
will consider one by one each of the above-noted purposes of Germany's safeguard measure.
Effects on non-target organisms
7.2785 We begin our analysis with the purpose of ma naging potential risks associated with effects on
non-target organisms.
7.2786 We refer to our conclusions in Section VII.C th at a GM crop that is eaten by animals can be
considered to be a "food" for that animal. This would include, for example, pollen of the GM crop
which is consumed by insects and GM plants consum ed by non-target insects, deer, rabbits or other
wild fauna. As we previously noted, a poisonous s ubstance, such as the Bt toxin, which is produced
by a GM crop could qualify as a "toxin" within the meaning of Annex A(1)(b).
1770 We determined on
that basis that measures applied to protect the lif e or health of animals (not including target
organisms) from risks arising from toxins produced in GM plants are covered by Annex A(1)(b).
7.2787 Moreover, we indicate in Section VII.C our vi ew that if a GM plant produces a poisonous
substance which could adversely affect the health of non-target organisms, even if the non-target
organisms do not eat the GM plant, e.g. through exposure other than through ingestion of food, the
GM plant could be considered a "pest" within the meaning of Annex A(1)(a). Thus, a measure

1769 It is noted, however, that adve rse effects are not expected in respect of the specified cultivation
purposes if the quantity sown is limited to 12 tonnes per year in a cultivation area limited to 500 hectares.
1770 We recall our view that the term "toxin" as it appears in Annex A(1)(b) includes allergens.

applied to protect from risks arising from such exposur e to GM plants would, in our view, fall within
the scope of Annex A(1)(a).
7.2788 In addition, in Section VII.C we conclude that to the extent that GM plants may result in
changes in animal or plant populations, this may in crease or decrease the food available for particular
non-target animal populations and thus alter the f itness and health of these animal populations, which
may in turn lead to further deleteri ous effects on the life or health of animals or other plants. We also
recall our conclusion that by causing harm to the hea lth of animals or other plants in this way, GM
plants would act as "pests" within the meaning of Annex A(1), and that to the extent a measure is
applied to avoid this kind of adverse effect, it can be considered a measure covered by Annex A(1)(a).
Furthermore, we found that Annex A(1)(a) covers me asures applied to protect animal or plant life or
health from risks arising directly or indirectly fro m the entry, establishment or spread of cross-breeds
with undesired traits (such as insecticidal traits) r esulting from transfer of genetic material from a GM
plant.
7.2789 Consistent with our reasoning above, we c onsider that Germany's safeguard measure on
Bt-176 maize, to the extent it is applied to avoid potential risks to the health of non-target organisms
from the consumption of Bt-176 maize, falls within the scope of Annex A(1)(b) of the
SPS Agreement. Furthermore, to the extent that Germany's safeguard measure is applied to avoid
other potential adverse effects on non-target organism s arising from Bt-176 maize, it falls within the
scope of Annex A(1)(a) of the SPS Agreement.
Development of resistance to Bt toxin in insects
7.2790 Turning next to the concern regarding the devel opment of resistance to Bt toxins in insects,
we refer to our analysis of this type of concern in Section VII.C and in the context of our discussion of
Austria's safeguard measure on Bt-176 maize above.
7.2791 We refer to our analysis in Section VII.C re garding the development of pesticide-resistance
in target organisms. We found that resistant targ et organisms (insects) could be regarded as "pests"
within the meaning of Annex A(1), inasmuch as they present a risk to animal, plant or human life or
health or result in other damage. We further determined that risks to animal or plant life or health, or
other damage to the environment, resulting from a ch ange in pesticide use may be viewed as arising
indirectly from the entry, establishment or spread of resistant target organisms qua relevant pest. We
found that to the extent that a measure seeks to a void such risks and damage, it can be considered to
be covered by Annex A(1)(a) and (d) of the SPS Agreement.
7.2792 Consistent with our reasoning above, we c onsider that Germany's safeguard measure on
Bt-176 maize, to the extent it is applied to prot ect from risks associated with the development of
resistance to Bt toxin in insects due to the cultiv ation of Bt-176 maize, falls within the scope of
Annex A(1)(a) and (d) of the SPS Agreement.
Possible adverse effects of the Bt toxin in the soil
7.2793 We turn next to Germany's concern related to the possible adverse effects of the Bt toxin in
the soil. We understand Germany's concern to be about adverse effects on living organisms in the
soil.
7.2794 In Section VII.C, we found that the phrase "anima l and plant" in Annex A(1) covers also soil
microfauna or –flora. In addition, we found that to the extent that GM plants might affect the life or
health of non-target soil microfauna or –flora, they could be considered as "pests" in the sense of

Annex A(1). Thus, to the extent Germany's safegua rd measure is applied to address concerns that
Bt-176 maize might affect the life or health of non-target soil microfauna or –flora, it can, in our view,
be considered to be a measure applied to protect th e life or health of soil microfauna or –flora from
risks arising from the entry, establishment or spread of a Bt-producing GM plant qua "pest" within the
meaning of Annex A(1)(a) of the SPS Agreement.
7.2795 Consistent with our reasoning above, we c onsider that Germany's safeguard measure on
Bt-176 maize, to the extent it is applied to avoid ri sks associated with adverse effects of the Bt toxin
on living organisms in the soil, falls within the scope of Annex A(1)(a) of the SPS Agreement.
Transfer of the bla-ampicillin resistance gene to bacteria of the intestine of
humans or animals
7.2796 We turn finally to Germany's stated con cern regarding the potential transfer of the bla-
ampicillin resistance gene to bacteria of the int estine of humans or animals due to consumption of
Bt-176 maize. With respect to the transfer of antib iotic resistance marker ge nes to the intestine of
humans or animals, we note that the Parties' argum ents are the same as those made in relation to
Austria's safeguard measures on T25 maize and Bt- 176 maize. We refer to our discussion in Section
VII.C regarding ARMG. More particularly, we reca ll that, in our view, the concern relates to the
potential transfer to pathogens of ARMG present in certain GMOs, and the possible resulting decrease
in effectiveness of medical treatments involving specific antibiotics which might pose a risk to the life
or health of animals infected with the resistant pathogen.
7.2797 In Section VII.C we found that Annex A(1)(a) covers measures applied to protect animal life
or health from risks arising from the entry, estab lishment or spread of disease-causing organisms
which have or might become resistant to antibiotics due to the transfer of ARMG from a GM plant.
Similarly, we found that Annex A(1)(a) covers measu res applied to protect animal life or health from
risks arising from the entry, establishment or spr ead of diseases due to the reduced effectiveness of
antibiotics used to treat the pathogens which have become resistant to these antibiotics through gene
transfer. Furthermore, we found that Annex A(1 )(b) covers measures applied to protect human or
animal life or health from risks arising indirectly, namely via the potential transfer to humans or
animals of marker genes conferring resistance to an tibiotics used in human or veterinary medicine,
from additives in foods or feedstuffs. We recall in this respect that, in our view, ARMGs can be
considered to be additives for the purposes of Annex A(1)(b).
7.2798 Consistent with our reasoning above, we c onsider that Germany's safeguard measure on
Bt-176 maize, to the extent it is applied to a void risks associated with the transfer of the bla-
ampicillin resistance gene from Bt-176 maize to bacter ia in the intestine of humans or animals, falls
within the scope of Annex A(1)(a) and (b) of the SPS Agreement.
Conclusion with regard to the purpose of the safeguard measure
7.2799 In the light of the above considerations, we c onclude that the safeguard measure applied by
Germany with respect to Bt-176 maize qualifies as an SPS measure within the meaning of
Annex A(1) as far as its purpose is concerned.
Form and nature of the measure
7.2800 We now turn to the issue of the form a nd nature of Germany's safeguard measure on
Bt-176 maize. We start by recalling the arguments of the Parties on this matter.

7.2801 The United States argues that the measure was in the form of a "notice" from the government
agency with responsibility for the regulation of biot ech products. Through this "notice", the German
Government "ordered" suspension of the approva l for commercialization of Bt-176 maize on the
German territory. The word "order" is defined as "a n authoritative direction", which is similar to the
definition of "regulation". A "regulation" is among the types of measures explicitly mentioned in
Annex A(1).
7.2802 Argentina notes that the measure was implemented by means of an amendment notice
suspending the entry of Bt-176 maize. The measure has the same binding nature as a law, regulation,
order or requirement.
7.2803 The Panel recalls that the second paragraph of Anne x A(1) addresses the form and nature of
measures which may qualify as SPS measures. In r espect of the form of SPS measures, we have
indicated earlier in this report that the referenc e in the second paragraph to "laws, decrees [and]
regulations" should not be taken to prescribe a part icular legal form and that SPS measures may in
principle take many different legal forms.
1771 Furthermore, in respect of the nature of SPS measures,
we have indicated earlier that the reference in th e same paragraph to "requirements" is broad and
unqualified. Hence, both an authorization to mark et a particular product and a ban on the marketing
of a particular product may be considered "re quirements". The second example would constitute a
negative requirement.
7.2804 We note that the German safeguard measure on Bt-176 maize was implemented through a
decision by the Robert Koch Institute, the competen t German authority, to prohibit commercialization
of Bt-176 maize on the German territory. Annex A(1) does not specifically refer to "decisions". As
we have pointed out, this fact alone does not nece ssarily mean that Germany's safeguard measure is
not an SPS measure, since no specific legal form is prescribed. Germany's decision clearly is a
measure attributable to the German Government. It is also not in dispute that the decision is legally
binding. We therefore consider that, for the pur poses of Annex A(1), the German decision may be
assimilated to measures adopted in the form of "laws", "decrees" or "regulations".
7.2805 In respect of the nature of the German meas ure, we note that the decision prohibits the
marketing of Bt-176 maize. As indicated above, we are of the view that a prohibition on the
marketing of a particular product (within a particular territory) may be considered a "requirement" for
the purposes of Annex A(1).
7.2806 We therefore conclude that the safeguard measu re taken by Germany with respect to Bt-176
maize qualifies as an SPS measure within the meaning of Annex A(1) as far as its form and nature are
concerned.
Conclusion
7.2807 We have now considered Germany's safeguard measure on Bt-176 maize in terms of its
purpose, its form and its nature. In relation to each of these issues, we have found that Germany's
measure satisfies the definition of the term "SPS measur e" set out in Annex A(1). In the light of this,
we come to the conclusion that the safeguard measure applied by Germany with respect to
Bt-176 maize constitutes an "SPS measure" within the meaning of Annex A(1).
7.2808 At this juncture, we could go on and address the question of whether, in view of its multiple
purposes, the German safeguard measure could be considered to embody more than one SPS measure.

1771 See supra, footnote 1753.

However, neither the United States nor Argentina or the European Communities have argued that to
the extent any of the safeguard measures at issue falls to be assessed under the SPS Agreement, it
should be deemed to constitute more than one SPS measure. In their submissions to the Panel, the
Parties treated the relevant safe guard measures as constituting one SPS measure each. In the light of
this, like the Parties, we will treat the German safeguard measure as constituting one single SPS
measure. We will revisit this issue, however, if our disposition of the relevant claims under the
SPS Agreement (and, where appropriate, any implementi ng action to be taken in view of our
disposition of particular claims) we re to depend on, and be affected by, whether we treat the German
safeguard measure as constituting a single SPS measure or as embodying more than one SPS measure.
Effect on international trade

7.2809 We now turn to the issue of whether German y's safeguard measure on Bt-176 maize is a
measure that affects international trade, and that is therefore subject to the provisions of the
SPS Agreement. We recall that according to Article 1.1 of the SPS Agreement, the SPS Agreement
applies to all SPS measures which "may, directly or indirectly, affect international trade."
Accordingly, for Germany's safeguard meas ure on Bt-176 maize to be subject to the SPS Agreement,
it must be a measure which may, directly or indir ectly, affect international trade. We recall the
Parties' arguments on this matter.
7.2810 The United States argues that the measure adopted by Germany suspends the approval for
commercialization of Bt-176 maize, thereby effectiv ely blocking the importation of the product. The
measure as such therefore affects international trade.
7.2811 Argentina notes that since the safeguard measure prevents access of Bt-176 maize to
Germany, resulting in the absence of imports of this product, the measure can be said to affect
international trade.
7.2812 The Panel notes that the arguments of the parties regarding the effects on trade of Germany's
safeguard measure on Bt-176 maize are essentially th e same as their arguments with respect to
Austria's safeguard measure on T25 maize. We reca ll our reasoning and conclusions with respect to
Austria's measure on T25 maize in paragraphs 7.2603- 7.2609 above. Therefore, in view of the fact
that Germany's safeguard measure prohibits im ports of Bt-176 maize, we have no difficulty
concluding that the safeguard measure applied by Germany is an SPS measure which may affect
international trade within the meaning of Article 1.1 of the SPS Agreement and, as such, is subject to
the provisions of the SPS Agreement.
Overall conclusions
7.2813 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Co mmunities, the Panel concludes that the
German safeguard measure on Bt-176 maize is an SPS measure within the meaning
of Annex A(1) and Article 1.1 of the SPS Agreement.

 (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 the German
safeguard measure on Bt-176 maize is an SPS measure within the meaning of
Annex A(1) and Article 1.1 of the SPS Agreement.

(viii) Greece – Topas oilseed rape
7.2814 We now turn to the safeguard measure applied by Greece with respect to Topas oilseed rape.
We recall that the application for placing on the ma rket of this product was initially submitted to the
United Kingdom.
1772 The product was approved for import and processing by the European
Commission in April 19981773, and Greece adopted its safeguard measure to prohibit imports of Topas
oilseed rape pursuant to Article 16 of Directive 90/220 in September 1998.1774
Is the Greek safeguard measure on Topas oilseed rape an SPS measure?
7.2815 We start with the issue of whether the Greek safeguard measure on Topas oilseed rape is an
SPS measure. In order to make this determination, we need to consider two distinct elements,
namely: (1) the purpose of the measure; and (2) the form and nature of the measure.
Purpose of the safeguard measure
7.2816 We first consider the issue of the purpose of th e safeguard measure. Before turning to the
arguments of the Parties on this issue, we recall that we must determine whether the purpose of the
safeguard measure falls within one of the cate gories of purposes set out in Annex A (1) of the
SPS Agreement.
7.2817 The United States notes that according to the SCP, Greece justified its safeguard measure on
the basis of its concern for "genetic escape" a nd the consequences it could have on agriculture, the
natural environment of Greece and c onsumer health. Concerns regarding "genetic escape" relate to
adverse effects from the transfer of the herbicide tolerant gene to other plants or to consuming
organisms. According to the United States, the Gree k measure is an SPS measure, as it is applied to
protect "plant life or health" from the "spread of pests"; to protect "human life or health" from
"contaminants" or "disease-causing organisms in food"; or "to prevent or limit other damage" from
the "spread of pests".
7.2818 Canada notes that the Greek safeguard measure was predicated on concerns that release into
the environment of Topas oilseed rape may have a detrimental effect on the surrounding plant life or
health. More specifically, Greece indicated that it was concerned about genetic escape from the
biotech varieties, leading to the transfer of he rbicide resistance through hybridization with wild
oilseed rape varieties. In essence, the concerns of Greece were related to potential risks arising from
the release into the environment of the biotech oil seed rape varieties because of their alleged potential
to function as a "pest" in relation to the surroundi ng environment, and in particular, related wild
species of oilseed rape.

1772 C/UK/95/M5/1.
1773 Commission Decision 98/291 (Exhibits US-97; CDA-61).
1774 Greece, Minister of Environment, Regional Planning and Public Works, Prohibition of seeds of the
genetically-modified rape-plant line bearing reference number C/UK/95/M5/1, Government Gazette, 1008,
25 September 1998, at 11941 (Exhibits CDA-72; US-69).

7.2819 The European Communities argues that the main reasons for which the measure was
adopted and maintained include, inter alia , persistence and invasiveness in agricultural and natural
habitats; development of resistance; out-crossi ng; undesirable effects on management practices;
biodiversity; monitoring; labelling; co-existence; and human and animal health.
7.2820 The Panel notes that the Ministerial decision adopted by the Greek authorities on
8 September 1998 prohibiting imports of Topas oilseed rape refers, without el aboration, to potential
"risks for the natural environment of Greece".
1775 Greece provided the justification for its safeguard
measure in a Note addressed to the Commission on 3 November 1998.1776
7.2821 In this document, Greece indicated that alt hough the consent for Topas oilseed rape was not
given for cultivation, the seeds could nonetheless escape into the environment during transport and
grow into viable plants. Greece notes that since oilseed rape is capable of out-crossing and giving
fertile hybrids with wild Brassica species, the release into the environment of oilseed rape could
therefore generate hybrid plants bearing the gluf osinate tolerance gene. The Greek climate would
permit the spreading not only of vol unteer oilseed rape plants, but al so of their hybrids with wild
related species in both the agricultural and th e natural environment, with unpredictable
consequences.1777 Greece further notes that in Greece some of the wild plant varieties at issue are
collected and consumed as food. Greece points out in this regard that if out-crossing were to confer
on these wild plant varieties the herbicide resistance trait, the consequences of the consumption of
these varieties would be unpredictable.
7.2822 Furthermore, in a letter form the Greek au thorities to the Commission dated March 2004 1778
Greece highlights concerns about gene flow through pollen transfer to wild related species. This letter
also notes that the maintenance of the safeguard me asure at issue is justified by the precautionary
principle, until new scientific information was av ailable regarding risks to human health and the
environment.
7.2823 Finally, we note that a memorandum was provided by Greece to the Commission in
March 2004.1779 It recalls the concerns underlying the safeguard measure on Topas oilseed rape,
including those relating to the harm for wildlif e and the environment and possible problems for
consumers and farmers, specifically related to possible consumption of hybrids from outcrosses of
Topas oilseed rape and wild plant species and th e potential difficulties associated with managing
herbicide tolerant weeds arising from these types of outcrosses. The memorandum concludes that the
maintenance of the safeguard measu re at issue is justified by the precautionary principle, pending
complete scientific proof of the existence and seri ousness of risks. The memorandum also states that
the issue of co-existence is not relevant in the case of the oilseed rape since its import by Greece, if it
were allowed, would be for the use of the product for oil extraction and not for cultivation.
7.2824 Based on the foregoing, we consider that at the time of review by the Panel, Greece applied
its safeguard measure to address concerns about:
 (1) adverse environmental effects of hybridisation and out-crossing;
 (2) adverse environmental effects of volunteer Topas oilseed rape plants; and
 (3) consumer health.

1775 Exhibit EC-162/At. 4_trans.
1776 Ibid.
1777 Ibid.
1778 Exhibit EC-162/At. 6.
1779 Exhibit EC-162/At. 7.

7.2825 The European Communities asserts that Greece's safeguard measure on Topas oilseed rape is
also applied in view of concerns about labelling and co-existence. These asserted concerns were not
articulated by Greece in the documents discussed by us above. Furthermore, the European
Communities has neither substantiate d nor explained its assertion. In the light of this, we are not
persuaded that Greece is applyi ng its safeguard measure to a ddress these additional concerns
identified by the European Communities.
7.2826 Having determined the purposes for which Greece applied its safeguard measure at the time
of review by the Panel, we now go on to assess whether these purposes fall within one of the
categories of purposes which according to Annex A(1) characterize an SPS measure. To that end, we
will consider one by one each of the above-noted purposes of Greece's safeguard measure.
Adverse environmental effects of hybridisation and out-crossing
7.2827 We begin with Greece's stated purpose of mana ging risks associated with the environmental
impacts of hybridisation and out-crossing. We r ecall that the documentation reviewed by the Panel
with respect to the Greek safeguard measure on Topas oilseed rape highlighted concerns regarding the
potential loss of seeds during transportation, which co uld result in the establishment of viable biotech
oilseed rape in the environment a nd potential hybridisation with other Brassicae. The Panel
understands this concern to be related, inter alia, to potential out-crossing between Topas oilseed rape
plants and unmodified plants, and the introduction of herbicide resistance in the out-crossed plants.
7.2828 We refer to our finding in Section VII.C th at cross-breeds between conventional and GM
plants could be regarded as "pests" for the purposes of Annex A(1), to the extent they have undesired
introduced traits (such as herbicide resistance) and ha rm animal or plant life or health or result in
other damage. We have determined on that basis th at measures applied to protect animal or plant life
or health from risks arising directly ( e.g., through changes in selective advantage) from the entry,
establishment or spread of cross-breeds with undesi red traits resulting from the transfer of genetic
material from a GM plant fall within the scope of Annex A(1)(a), while measures applied to prevent
"other damage" to the environment from the entry, est ablishment or spread of cross-breeds fall within
the scope of Annex A(1)(d).
7.2829 In addition, we recall that one possible concer n arising from cross-breeds that have acquired
herbicide resistance is that they may lead to the n eed for an increased use of the same herbicides, or
different, more toxic herbicides, to control the resi stant cross-breeds. We determined that risks to
animal or plant life or health, or other damage to the environment, resulting from a change in pesticide
use may be viewed as arising indirectly from th e entry, establishment or spread of cross-breeds qua
relevant pest. We deduced from th is that measures applied to avoid such indirect adverse effects on
the environment fall within the scope of Annex A(1)(a) and (d).
7.2830 Consistent with our findings above, we consider that Greece 's safeguard measure on Topas
oilseed rape, to the extent it is applied to avoid ri sks to the environment associated with the transfer of
the herbicide-tolerance gene contained in Topas oilsee d rape to wild related species, and in particular
the development of resistance in these wild hybrid plants, falls within the scope of Annex A(1)(a) and
(d) of the SPS Agreement.

Adverse environmental effects of volunteer Topas oilseed rape plants
7.2831 We next turn to Greece's concerns about other adverse environmental effects, notably adverse
environmental effects of volunteer Topas oilseed rape plants which are the result of accidental
dispersal of Topas oilseed rape seeds during transportation.
7.2832 In Section VII.C we found that to the extent a measure is applied to avoid adverse effects on
plant life or health, including adverse effects on ge netic diversity, that might arise if volunteer GM
plants crowd out or eliminate other plants due to a potential competitive advantage, invasiveness or
persistence, such a measure would be covered by Annex A(1)(a), as it would be applied "to protect
[...] plant life or health [… ] from risks arising from the entry, est ablishment or spread" of GM plants
qua "pests".
7.2833 In Section VII.C we also found that to the extent that volunteer GM plants may result in
changes in plant populations, this may increase or decrease the food available for particular animal
populations and thus enhance, or detract from, the fitness and health of these animal populations,
which in turn may have a deleterious e ffect on the life or health of plants, e.g., by affecting their
ability to reproduce. We stated that, by causing harm to the health of animals or other plants in this
way, the GM plants would act as "pests" within th e meaning of Annex A(1), and that to the extent a
measure is applied to avoid this kind of adverse effect, it can be considered a measure covered by
Annex A(1)(a).
7.2834 Finally, we found that to the extent a measure seeks to avoid adverse effects of GM plants on
the environment other than adverse effects on animal or plant life or health, such a measure can be
considered to be covered by A nnex A(1)(d), inasmuch as it can be viewed as a measure which is
applied to prevent or limit "other damage" from th e entry, establishment or spread of "pests". As
noted earlier, the GM plants themselves might qualify as the relevant pest, or other plants or animals
might become pests as a result of the release of GMOs into the environment.
7.2835 Consistent with our findings above, we consider that Greece 's safeguard measure on Topas
oilseed rape, to the extent it is applied to av oid adverse effects on the environment arising from
volunteer Topas oilseed rape plants, falls within the scope of Annex A(1)(a) and (d) of the
SPS Agreement.
Consumer health
7.2836 Turning last to Greece's stated concern regarding the potential risks to consumer health
associated with Topas oilseed rape, we recall that Greece expressed concern with respect to consumer
health, since some wild varieties of oilseed rape are apparently consumed in Greece as food.
Specifically, Greece noted that if out-crossing were to confer on these wild plant varieties the
herbicide resistance trait, the consequences of the consumption of these varieties would be
unpredictable. We understand this c oncern to be related to potential adverse health effects associated
with the consumption of GM material or the consumption of proteins produced through the expression
of modified genes, in hybrids of conventional oilseed rape and Topas oilseed rape.
7.2837 In Section VII.C we found that Annex A(1) c overs food safety risks which might potentially
arise from the consumption of GM foods, namely, ri sks to human life or health from the presence in
food of additives, contaminants, toxins (includi ng allergens) or disease-causing organisms. More
particularly, we found that genes intentionally added for a technological purpose to GM plants that are
eaten or being used as an input in processed foods can be considered "additives" in foods within the
meaning of Annex A(1)(b). We also recall our finding that substances wh ich are produced through

the unintended expression of modified plant gen es may be considered "contaminants" within the
meaning of Annex A(1)(b). Finally, we recall our finding that a poisonous substance which is
produced during the metabolism or growth of a plant, including allergens, could qualify as a "toxin"
within the meaning of Annex A(1)(b). Therefore, we consider that potential risks to human health
associated with consumption of hybrids of GM an d conventional cultivated or wild plants can be
considered to be risks associated with "additives" , "contaminants" or "toxins" in foods within the
meaning of Annex A(1)(b). Measures applied to protect from such food safety risks can thus be
considered to fall within the scope of Annex A(1)(b).
7.2838 Greece did not specify the nature of the potentia l adverse health effects associated with the
consumption of cross-breeds between Topas oilseed rape and wild oilseed rape. Hence, we cannot
determine whether Greece's concern relates to the presence in hybrids of additives, contaminants or
toxins (including allergens). However, in the ab sence of any information suggesting otherwise, there
are no grounds for believing that Greece's concern abou t consumer health does not relate to any of the
aforementioned types of risks potentially associated with the consumption of GM foods.
7.2839 Thus, consistent with our findings above, we consider that Greece's safeguard measure on
Topas oilseed rape, to the extent it is applied to avoid risks to consumer h ealth associated with the
consumption of cross-breeds between Topas oilsee d rape and wild oilseed rape, or food products
derived therefrom, falls within the scope of Annex A(1)(b) of the SPS Agreement.
Conclusion with regard to the purpose of the safeguard measure
7.2840 In the light of the above considerations, we therefore conclude that the safeguard measure
applied by Greece with respect to Topas oilseed ra pe qualifies as an SPS measure within the meaning
of Annex A(1) as far as its purpose is concerned.
Form and nature of the measure
7.2841 We now turn to the issue of the form and nature of Greece's safeguard measure on
Topas oilseed rape. We start by recalling the arguments of the Parties on this matter.
7.2842 The United States argues that the measure is in the form of a ministerial decision, which is
synonymous with the term "regulation", which is one of the types of measure explicitly mentioned in
Annex A(1) of the SPS Agreement.
7.2843 Canada argues that the measure falls within the scope of "laws, decrees, regulations,
requirements and procedures." As indicated by th e use of the word "include", Annex A provides a
non-exhaustive list of the forms that an SPS measure can take. The Greek measure is in the form of a
"ministerial decision". Although this form of measu re is not explicitly mentioned in Annex A, it can
be equated to a regulation or othe r form of subordinate legislation, if legally binding and lawfully
promulgated by the central government authorities.
7.2844 The Panel recalls that the second paragraph of Anne x A(1) addresses the form and nature of
measures which may qualify as SPS measures. In r espect of the form of SPS measures, we have
indicated earlier in this report that the referenc e in the second paragraph to "laws, decrees [and]
regulations" should not be taken to prescribe a part icular legal form and that SPS measures may in
principle take many different legal forms. Furthermore, in respect of the nature of SPS measures, we
have indicated earlier that the reference in the same paragraph to "requirements" is broad and
unqualified. Hence, both an authorization to mark et a particular product and a ban on the marketing

of a particular product may be considered "re quirements". The second example would constitute a
negative requirement.
7.2845 We note that Greece's safeguard measure on Topas oilseed rape was implemented through a
ministerial decision to prohibit commercialization of Topas oilseed rape on the Greek territory.
Annex A(1) does not specifically refer to "ministerial decisions". As we have pointed out, this fact
alone does not necessarily mean that Greece's safe guard measure is not an SPS measure, since no
specific legal form is prescribed. Greece's decision clearly is a measure attributable to the Greek
Government. It is also not in dispute that the decisi on is legally binding. We therefore consider that,
for the purposes of Annex A(1), the Greek decisi on may be assimilated to measures adopted in the
form of "laws", "decrees" or "regulations".
7.2846 In respect of the nature of the Greek measu re, we note that the decision prohibits the
marketing of Topas oilseed rape. As indicated a bove, we are of the view that a prohibition on the
marketing of a particular product (within a particular territory) may be considered a "requirement" for
the purposes of Annex A(1).
7.2847 We therefore conclude that the safeguard measure taken by Greece with respect to Topas
oilseed rape qualifies as an SPS measure within the meaning of Annex A(1) as far as its form and
nature are concerned.
Conclusion
7.2848 We have now considered Greece's safeguard measure on Topas oilseed rape in terms of its
purpose, its form and its nature. In relation to each of these issues, we ha ve found that Greece's
measure satisfies the definition of the term "SPS measur e" set out in Annex A(1). In the light of this,
we come to the conclusion that the safeguard measure applied by Greece with respect to
Topas oilseed rape constitutes an "SPS measure" within the meaning of Annex A(1).
7.2849 At this juncture, we could go on and address the question of whether, in view of its multiple
purposes, the Greek safeguard measure could be cons idered to embody more than one SPS measure.
However, neither the United States nor Canada or the European Communities have argued that to the
extent any of the safeguard measures at issue falls to be assessed under the SPS Agreement, it should
be deemed to constitute more than one SPS measure. In their submissions to the Panel, the Parties
treated the relevant safeguard measures as constituting one SPS measure each. In the light of this, like
the Parties, we will treat the Greek safeguard measure as constituting one single SPS measure. We
will revisit this issue, however, if our di sposition of the relevant claims under the SPS Agreement
(and, where appropriate, any implementing action to be taken in view of our disposition of particular
claims) were to depend on, and be affected by, whether we treat the Greek safeguard measure as
constituting a single SPS measure or as embodying more than one SPS measure.
Effect on international trade

7.2850 We now turn to the issue of whether Greece's safeguard measure on Topas oilseed rape is a
measure that affects international trade, and that is therefore subject to the provisions of the
SPS Agreement. We recall that according to Article 1.1 of the SPS Agreement, the SPS Agreement
applies to all SPS measures which "may, directly or indirectly, affect international trade."
Accordingly, for Greece's safeguard measure on Topas oilseed rape to be subject to the
SPS Agreement, it must be a measure which may, directly or indirectly, affect international trade. We
recall the Parties' arguments on this matter.

7.2851 The United States argues that the measure adopted by Greece prohibits the "importation" of
Topas oilseed rape. The measure as such therefore affects international trade.
7.2852 Canada argues that the measure prohibits the importation of Topas oilseed rape on the Greek
territory. Since the measure effectively blocks market access for the targeted biotech product, it
clearly affects international trade.
7.2853 The Panel notes that the arguments of the parties regarding the effects on trade of Greece's
safeguard measure on Topas oilseed rape are essentia lly the same as their arguments with respect to
Austria's safeguard measure on T25 maize. We reca ll our reasoning and conclusions with respect to
Austria's measure on T25 maize above. Therefore, in view of the fact that Greece's safeguard
measure prohibits imports of Topas oilseed rape, we have no difficulty concluding that the safeguard
measure applied by Greece is an SPS measure wh ich may affect international trade within the
meaning of Article 1.1 of the SPS Agreement and, as such, is subject to the provisions of the
SPS Agreement.
Overall conclusions

7.2854 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Co mmunities, the Panel concludes that the
Greek safeguard measure on Topas oilseed rape is an SPS measure within the
meaning of Annex A(1) and Article 1.1 of the SPS Agreement.

 (ii) 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 the Greek
safeguard measure on Topas oilseed rape is an SPS measure within the meaning of
Annex A(1) and Article 1.1 of the SPS Agreement.

(ix) Italy – T25 maize, MON810 maize, MON809 maize, Bt-11 maize (EC-163)
7.2855 We now turn to the Italian safeguard measu re applied on T25 maize, MON810 maize,
MON809 maize and Bt-11 maize (EC-163). We recall that the applications for placing on the market
of these products were originally submitted to the United Kingdom.
1780 The products were authorized
by the European Commission under the simplified aut horization procedure set out in Article 3(4) of
Regulation 258/97.1781 By Decree of the President of the Council of Ministers dated 4 August 2000
(hereafter "the Decree"), Italy adopted a measure pursuant to Article 12 of Regulation 258/97 to
suspend the commercialisation and use on its territory of T25 maize, MON810 maize,
MON809 maize and Bt-11 maize (EC-163).1782

1780 Exhibit EC-163.
1781 Commission Decision 98/292 (Exhibits CDA-80; ARG-35).
1782 Italy, President of the Council of Ministers, Precautionary suspension of the commercialisation and
utilization of certain transgenic products [Bt-11 ma ize (EC-163), MON810 maize, MON809 maize and T25

Is the Italian safeguard measure on T 25 maize, MON810 maize, MON809 maize and
Bt-11 maize (EC-163) an SPS measure?
7.2856 We start with the issue of whether the Italian safeguard measure on T25 maize,
MON810 maize, MON809 maize and Bt-11 maize (EC-163) is an SPS measure 1783. In order to make
this determination, we need to consider two distinct elements, namely: (1) the purpose of the
measure; and (2) the form and nature of the measure.
Purpose of the safeguard measure
7.2857 We first consider the issue of the purpose of th e safeguard measure. Before turning to the
arguments of the Parties on this issue, we recall that we must determine whether the purpose of the
safeguard measure falls within one of the cate gories of purposes set out in Annex A (1) of the
SPS Agreement.
7.2858 The United States notes that according to the SCF, one of the documents provided by Italy
suggested that the herbicide tolerant biotech produc ts Bt-11 maize and T25 maize could have adverse
effects on consuming animals. The United States also notes that with respect to the products
protected by Bt toxin (Bt-11, MON810 maize, M ON809 maize), Italy cited another report which
raised the issue of "occupational allerg[ies] to Bt bacterium spores in farmers using Bt pesticides".
Based on these justifications, the Italian measure is an SPS measure, given that it is applied "to protect
[...] animal life or health" from "contaminants, toxi ns or disease-causing organisms" in "feedstuffs";
or "to protect human life or health" from "toxins" in "foods".
7.2859 Canada notes that the Italian measure was predicated on concerns about the finding of
substantial equivalence of T25 maize, MON810 ma ize, MON809 maize and Bt-11 maize (EC-163) to
existing foodstuffs pursuant to Article 3(4) of Regul ation 258/97. Canada argues that these concerns
were triggered by laboratory tests which indicated that the products in question contained proteins
derived from genetic modification at levels ranging from 0.04 to 30 parts per million.1784
7.2860 Argentina argued that the purpose of the safeguard measures may be inferred from the
Community legislation under which the bans were adopted, and that the relevant provisions of EC
Directive 90/220 and Regulation 258/97 clearly indicate that the purpose of the EC legislation is the
"protection of human health and the environment" . Since the EC member States have taken their
measures explicitly on the basis of this legislation, it can be inferred that the measures were imposed
for the purpose of protecting human health or th e environment. The safeguard measures are,
therefore, SPS measures as defined in the SPS Agreement.
7.2861 The European Communities argues that the main concerns with regard to T25 maize were,
inter alia , horizontal gene transfer; antibiotic resistance; effects on non-target organisms;
persistence and invasiveness in agricultural and na tural habitats; development of resistance;
out-crossing; undesirable effects on management prac tices; biodiversity; monitoring; labelling;
co-existence; and human and animal health. With regard to MON810 maize, the concerns related to,
inter alia, horizontal gene transfer; antibiotic resistance; effects on non-target organisms; toxicity or

maize] in the national territory, acco rding to Article 12 of Regulation (European Communities) No. 258/97,
4 August 2000, Official Gazette, 8 August 2000, 184 (Exhibit EC-157/At. 1).
1783 In respect of the safeguard measure imposed by Italy, while the complaints by the United States
and Canada refer to four products, i.e., Bt-11 maize (EC-163), MON809 maize, MON810 maize and T25 maize,
the complaint by Argentina refers to only three products, i.e., Bt-11 maize (EC-163), MON810 maize and T25
maize.
1784 Exhibit CDA-86.

allergenicity; development of resistance; biodivers ity; monitoring; labelling; co-existence; and
human and animal health. Finally, with rega rd to MON809 maize and Bt-11, the European
Communities asserts that the concerns of Italy relate to, inter alia, toxicity and allergenicity;
biodiversity; monitoring; labelling; co-existence; and human and animal health.
7.2862 The Panel notes that the Italian Decree sets out the reasons for Italy's decision to suspend the
trade in and use of transgenic foodstuffs.
1785 In the Decree, Italy notes its concerns with respect to the
simplified procedure under Regulation 258/97 pursuant to which the products at issue were authorized
by the Commission. In particular, Italy points to th e ambiguity of the term "substantial equivalence"
in Article 3(4) of Regulation 258/97. In a letter addressed to the Commission before the adoption of
the safeguard measure, the Italian authorities express ed their concern with the assessment carried out
as part of the simplified procedure to evaluate whether a particular product is "substantially
equivalent" to existing equivalent foods or food ingredients, in terms of its potential risks to human
health or the environment. 1786 Similar concerns were also expressed in a subsequent letter addressed
by the Italian Health Minister to the President of the European Commission and the Health and
Consumer Protection Commissioner on 5 June 2000. 1787 The Decree further states that since it had
been established that residues of modified compone nts remain in the four products, the information
available from the simplified procedure was also in adequate with regard to the risks arising from
"environmental release" of the GMOs in question, or their products.
7.2863 The reasons set out in the Italian Decree ar e further based on opinions from the Italian
Consiglio Superiore di Sanità (hereafter the "Superior Council of Health") and the Istituto Superiore
di Sanità (hereafter the "Superior Institute of Health") . We note that the opinion of the Superior
Council of Health of 16 December 1999 was not submitte d to the Panel. However, according to the
text of the Decree, the Superior Council of Health calls in its opinion for specific research to be
undertaken on the consequences of genetic modifi cations before novel foods tuffs are placed on the
market.1788
7.2864 The opinion of the Superior Institute of Health dated 28 July 2000, which is also mentioned in
the Italian Decree, addresses the concept of "substan tial equivalence" in the context of the product
applications.1789 In particular, the opinion identifies shortc omings in the original applications with
respect to the data required to support the establishm ent of substantial equivalence of the product to
its conventional counterpart. 1790 In this respect, the Superior Ins titute of Health notes that the maize
products in question contain levels of protein de riving from the genetic modifications ranging from
0.04 to 30 parts per million and that, therefore, th e foodstuff has been permanently affected by the
modified elements. Italy observes in the Decree that even though the Superior Institute of Health
concluded that there were no apparent risks to the health of humans or livestock from the
consumption of derivatives of the biotech products, there were inadequacies in the risk assessment
procedures.1791

1785 See supra, footnote 1782.
1786 The Decree refers to a letter from the Italian Health Minister to the European Health and Consumer
Protection Commissioner dated 23 December 1999, which is referenced internally as document
No. 100/338.7/13126. On the basis of this reference num ber, the Panel notes that this letter is one of the
translated documents submitted by the European Communities in Exhibit EC-157/At. 2_trans.
1787 Exhibit EC-157/At. 2_trans.
1788 See supra, footnote 1782.
1789 We note that this opinion from the Superior Institute of Health is one of the translated documents
provided by the European Communities in Exhibit EC-158/At. 2_trans.
1790 Ibid.
1791 See supra, footnote 1782.

7.2865 The opinion of the Superior Institute of Hea lth also raises the issue that the herbicide
glyphosate is metabolised by the herbicide-tolerant biotech plant to a non-toxic metabolite, but that
this metabolite can revert to the parent compound in the gut of test animals. The opinion of the
Superior Institute mentions in this context a r ecently published observation on occupational allergy to
Bt bacterium spores in farmers using Bt pesticides.
1792 Furthermore, the Superior Institute of Health
addresses in its opinion the issue of antibiotic resist ance transfer, but concludes that "[t]he effect on
antibiotic resistance of a possible resistant gene transfer from the GMOs to the components of the
intestinal flora is minimal compared to the prevalence of antibiotic-resistant genes normally present in
the intestinal flora of humans and animals." 1793 Finally, the Institute opinion also indicates that
observations regarding the risk of possible "environm ental release" of the GMOs in question, or of
their products, are unnecessary.
7.2866 Based on the foregoing, we consider that at the time of review by the Panel, Italy applied its
safeguard measure on T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163) to
address concerns about:
 (1) adverse effects on consumer health due to the possibility that the herbicide glyphosate
could revert from its non-toxic metabolite back to its original chemical composition
in the gut of humans
1794; and

 (2) adverse effects on the environment arising from "environmental release" of the GM
plants in question, or of the products derived therefrom.

7.2867 The European Communities asserts that Italy' s safeguard measure on T25 maize, MON810
maize, MON809 maize and Bt-11 maize (EC-163) is also applied in view of concerns about labelling.
However, this concern asserted by the European Communities was not articulated by Italy in the
documents discussed by us above. Furthermore, th e European Communities has neither substantiated
nor explained its assertion. In the light of this , we are not persuaded that Italy is applying its
safeguard measure to address the additional concern identified by the European Communities.
7.2868 Having determined the purposes for which Italy a pplied its safeguard measure at the time of
review by the Panel, we now go on to assess whether these purposes fall within one of the categories
of purposes which according to Annex A(1) characterize an SPS measure.
Consumer health
7.2869 We consider first Italy's concerns regarding risks to human health arising from the
consumption of food or food ingredients from the re levant GM plants, due to the possibility that the
herbicide glyphosate could revert from its non-toxi c metabolite back to its original chemical
composition in the human gut.
7.2870 With respect to this concern, we recall our an alysis in Section VII.C regarding contaminants,
specifically our conclusion that the term "contamin ants" in Annex A(1)(b) could encompass herbicide
residues present in foods, and that these residues ma y have adverse effects on human life or health,
such as allergenic effects. We determined on that basis that measures applied to protect human life or

1792 Ibid.
1793 Ibid.
1794 This concern was raised generally in Exhibit EC-157/At. 1, and more specifically in Exhibit
EC-157/At. 2.

health from risks arising from pesticide residues, and hence contaminants, in GM plants used as or in
foods can be considered to fall within the scope of Annex A(1)(b).
7.2871 Consistent with our reasoning above, we c onsider that Italy's safeguard measure on
T25 maize, MON810 maize, MON809 maize and Bt-11 ma ize (EC-163), to the extent it is applied to
avoid potential risks to human health arising from residues in food of the herbicide glyphosate, which
is associated with the cultivation of the aforem entioned biotech products and thus linked to these
products, falls within the scope of Annex A(1)(b) of the SPS Agreement.
Environmental release
7.2872 We now consider the second concern identified by Italy, that the information available from
the simplified procedure under which the relevant GM Os were approved was in adequate with regard
to risks arising from "environmental release" of the GMOs in question or their products. Although no
further explanation of this concern is provided in Italy's Decree, and although the Italian Superior
Institute of Health indicated that any observations regarding the risk to the environment of possible
"environmental release" were unnecessary, it appear s to us that Italy was concerned about potential
adverse effects on the environment which might arise from "environmental release" of the GMOs in
question or their products.
7.2873 In Section VII.C we found that measures applied to protect animal or plant life or health from
risks arising directly or indirectly from the en try, establishment or spread of (i) GM plants qua
"pests", (ii) cross-breeds with undesired traits resu lting from transfer of genetic material from a GM
plant or (iii) other animals or plants which become pests as a result of the release of GMOs into the
environment, are measures within the scope of A nnex A(1)(a). We have also determined in
Section VII.C that measures applied to avoid adver se effects of GMOs on the environment other than
adverse effects on animal or plant life or h ealth, including on geochemical processes, can be
considered as measures applied to prevent "other damage" to the environment resulting from the
entry, establishment or spread of a pest and, as such, are covered by Annex A(1)(d).
7.2874 Consistent with our reasoning above, we c onsider that Italy's safeguard measure on
T25 maize, MON810 maize, MON809 maize and Bt-11 ma ize (EC-163), to the extent it is applied to
address potential risks to the environment arising from the "environmental release" of these GMOs,
falls within the scope of Annex A(1)(a) and (d) of the SPS Agreement.
Conclusion with regard to the purpose of the safeguard measure
7.2875 In the light of the above considerations, we c onclude that the safeguard measure applied by
Italy with respect to T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163) qualifies
as an SPS measure within the meaning of Annex A(1) as far as its purpose is concerned.
Form and nature of the measure
7.2876 We now turn to the issue of the form and natu re of Italy's safeguard measure on T25 maize,
MON810 maize, MON809 maize and Bt-11 maize (EC- 163). We start by recalling the arguments of
the Parties on this matter.
7.2877 The United States argues that the Italian measure is in the form of a "decree", which is one of
the types of measures expressly enumerated in Annex A(1) of the SPS Agreement.

7.2878 Canada argues that the Italian measure is in the form of a "decree", one of the types of
measures expressly enumerated in Annex A(1) of the SPS Agreement.
7.2879 Argentina notes that the measure was taken in the form of a decree, one of the forms
explicitly mentioned in Annex A(1).
7.2880 The Panel recalls that the second paragraph of Anne x A(1) addresses the form and nature of
measures which may qualify as SPS measures. In r espect of the form of SPS measures, we have
indicated earlier in this report that the referenc e in the second paragraph to "laws, decrees [and]
regulations" should not be taken to prescribe a part icular legal form and that SPS measures may in
principle take many different legal forms. Furthermore, in respect of the nature of SPS measures, we
have indicated earlier that the reference in the same paragraph to "requirements" is broad and
unqualified. Hence, both an authorization to mark et a particular product and a ban on the marketing
of a particular product may be considered "re quirements". The second example would constitute a
negative requirement.
7.2881 We note that Italian safeguard measure on T25 maize, MON810 maize, MON809 maize and
Bt-11 maize (EC-163) was implemented through a decree to prohibit commercialization of the
products concerned on the Italian territory. We note th at Annex A(1) specifically refers to "decrees".
We therefore consider that, for the purposes of A nnex A(1), the Italian decree is an SPS measure in
respect of the form of the measure.
7.2882 In respect of the nature of the Italian measure , we note that the decree prohibits the marketing
of T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163). As indicated above, we
are of the view that a prohibition on the market ing of a particular product (within a particular
territory) may be considered a "requirement" for the purposes of Annex A(1).
7.2883 We therefore conclude that the safeguard measure taken by Italy with respect to T25 maize,
MON810 maize, MON809 maize and Bt-11 maize (EC-163) qualifies as an SPS measure within the
meaning of Annex A(1) as far as its form and nature are concerned.
Conclusion
7.2884 We have now considered Italy's safeguard measure on T25 maize, MON810 maize, MON809
maize and Bt-11 maize (EC-163) in terms of its purpose, its form and its nature. In relation to each of
these issues, we have found that Italy's measure sa tisfies the definition of the term "SPS measure" set
out in Annex A(1). In the light of this, we come to the conclusion that the safeguard measure applied
by Italy with respect to T 25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163)
constitutes an "SPS measure" within the meaning of Annex A(1).
7.2885 At this juncture, we could go on and address the question of whether, in view of its multiple
purposes, the Italian safeguard measure could be c onsidered to embody more than one SPS measure.
However, neither the Complaining Parties nor th e European Communities have argued that to the
extent any of the safeguard measures at issue falls to be assessed under the SPS Agreement, it should
be deemed to constitute more than one SPS measure. In their submissions to the Panel, the Parties
treated the relevant safeguard measures as constituting one SPS measure each. In the light of this, like
the Parties, we will treat the Italian safeguard measure as constituting one single SPS measure. We
will revisit this issue, however, if our di sposition of the relevant claims under the
SPS Agreement
(and, where appropriate, any implementing action to be taken in view of our disposition of particular
claims) were to depend on, and be affected by, wh ether we treat the Italian safeguard measure as
constituting a single SPS measure or as embodying more than one SPS measure.

Effect on international trade

7.2886 We now turn to the issue of whether Italy's safeguard measure with respect to T25 maize,
MON810 maize, MON809 maize and Bt-11 maize (EC- 163) is a measure that affects international
trade, and that is therefore subject to the provisions of the SPS Agreement. We recall that according
to Article 1.1 of the SPS Agreement, the SPS Agreement applies to all SPS measures which "may,
directly or indirectly, affect international trad e." Accordingly, for Italy's safeguard measure on
T25 maize, MON810 maize, MON809 maize and Bt -11 maize (EC-163) to be subject to the
SPS Agreement, it must be a measure which may, directly or indirectly, affect international trade. We
recall the Parties' arguments on this matter.
7.2887 The United States argues that the measure adopted by Italy bans the "commercialization and
use" of T25 maize, MON810 maize, MON809 maize and Bt-11 maize, thereby effectively blocking
the importation of these products on the Italian terr itory. The measure as such therefore affects
international trade, and meets the second requirement under Article 1.1 of the SPS Agreement.
7.2888 Canada notes that the measure suspends the commercialization of the maize biotech varieties
T25 maize, MON810 maize, MON809 maize and Bt-11. Since the measure effectively blocks market
access for the targeted biotech products, it clearly affects international trade.
7.2889 Argentina notes that since the safeguard measure prevents access of T25 maize, MON810
maize, MON809 maize and Bt-11 maize to Italy, resulting in the absence of imports of these products,
the measure can be said to affect international trade.
7.2890 The Panel notes that the arguments of the parties regarding the effects on trade of Italy's
safeguard measure on T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163) are the
same as their arguments with respect to Austria's safeguard measure on T25 maize. We recall our
reasoning and conclusions with respect to Au stria's measure on T25 maize in paragraphs
7.2603-7.2609above. Therefore, in view of the fact that Italy's safeguard measure prohibits imports of
T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163), we have no difficulty
concluding that the safeguard measure applied by Italy is an SPS measure which may affect
international trade within the meaning of Article 1.1 of the SPS Agreement and, as such, is subject to
the provisions of the SPS Agreement.
Overall conclusions

7.2891 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Co mmunities, the Panel concludes that the
Italian safeguard measure on T25 maize, MON810 maize, MON809 maize and Bt-11
maize (EC-163) is an SPS measure within the meaning of Annex A(1) and Article 1.1
of the SPS Agreement.

 (ii) 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 the Italian
safeguard measure on T25 maize, MON810 maize, MON809 maize and Bt-11 maize

(EC-163) is an SPS measure within the meani ng of Annex A(1) and Article 1.1 of the
SPS Agreement.

 (iii) 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 the Italian
safeguard measure on T25 maize, MON810 maize and Bt-11 maize (EC-163) is an
SPS measure within the meaning of A nnex A(1) and Article 1.1 of the
SPS Agreement.

(x) Luxembourg – Bt-176 maize
7.2892 We now turn to the safeguard measure applie d by Luxembourg on Bt-176 maize. We recall
that the application for placing on the market of this product was initially submitted to France.
1795
The product was authorized by the European Commission in 1996 1796, and Luxembourg adopted its
safeguard measure to prohibit the sale of Bt-176 maize on its territory pursuant to Article 16 of
Directive 90/220 by a Ministerial Order issued in February 1997.1797
Is the Luxembourg safeguard measure on Bt-176 maize an SPS measure?
7.2893 We start with the issue of whether Luxembour g's safeguard measure on Bt-176 maize is an
SPS measure. In order to make this determination, we need to consider two distinct elements,
namely: (1) the purpose of the measure; and (2) the form and nature of the measure.
Purpose of the safeguard measure
7.2894 We first consider the issue of the purpose of th e safeguard measure. Before turning to the
arguments of the Parties on this issue, we recall that we must determine whether the purpose of the
safeguard measure falls within one of the categories of purposes set out in Annex A(1) of the
SPS Agreement.
7.2895 The United States notes that in the preamble of its decision to adopt a safeguard measure
concerning Bt-176 maize, Luxembourg refers to pot ential risks for human health related to the
antibiotic resistant gene. The United States argues that the safeguard measure is an SPS measure, as it
is applied "to protect human life or health" from "toxins or disease-causing organisms in foods".
7.2896 Argentina argues that the purpose of the safeguard measures may be inferred from the
Community legislation under which the bans were adopted, and that the relevant provisions of EC
Directive 90/220 and Regulation 258/97 clearly indicate that the purpose of the EC legislation is the
"protection of human health and the environment" . Since the EC member States have taken their
measures explicitly on the basis of this legislation, it can be inferred that the measures were imposed
for the purpose of protecting human health or th e environment. The safeguard measures are,
therefore, SPS measures as defined in the SPS Agreement.

1795 C/F/94/11-03.
1796 Commission Decision 97/98 (Exhibits US-97, ARG-37).
1797 Luxembourg, Journal Officiel du Grand Duché de Luxembourg, A – No.10, 28 February 1997,
p. 618 (Exhibit US-63).

7.2897 The European Communities argues that the main reasons for which the measure was
adopted and maintained include, inter alia, horizontal gene transfer; antibiotic resistance; effects on
non-target organisms; toxicity or allergenicity; persistence and invasiveness in agricultural and natural
habitats; development of resistance; out-crossing; undesirable effects on management practices;
biodiversity; monitoring; labelling; co-existence; and human and animal health.
7.2898 The Panel notes that Luxembourg explained the reasons for its safeguard measure in a
document submitted to the Commission at the time of notification of its measure (hereafter the
"Reasons document").
1798 The document identifies two main concerns for the adoption of the
safeguard measure, namely the transfer of the antibio tic (ampicillin)-resistance gene to the bacteria of
the intestinal tract of animals, and the development of insect resistance to Bt toxin. With respect to
the transfer of the ampicillin-resistance gene, Lu xembourg justifies its measure by arguing that
although the risk is low, some of the mechanisms ope rating in such a transfer are still being studied.
With respect to the development of insect resistance to Bt toxin, Luxembourg notes that given the
risks involved, the commercialization of Bt-176 ma ize should be made conditional upon the adoption
of relevant monitoring programmes.
7.2899 Based on the foregoing, we consider that at the time of review by the Panel, Luxembourg
applied its safeguard measure on Bt-176 maize to address concerns about:
 (1) the transfer of the bla-ampicillin resistance gene to bacteria of the intestine of
animals; and

 (2) the development of resistance to Bt toxin in insects.

7.2900 The European Communities asserts that Luxembourg's safeguard measure on Bt-176 maize is
also applied in view of concerns about labellin g, co-existence, out-crossing, and toxicity and
allergenicity. The asserted concerns were not ar ticulated by Luxembourg in the Reasons document
discussed above. Furthermore, the European Commun ities has neither substantiated nor explained its
assertion. In the light of this, we are not pers uaded that Luxembourg is applying its safeguard
measure to address these additional concerns identified by the European Communities.
7.2901 Having determined the purposes for which Luxe mbourg applied its safeguard measure at the
time of review by the Panel, we now go on to assess whether these purposes fall within one of the
categories of purposes which according to Annex A(1) characterize an SPS measure. To that end, we
will consider one by one each of the above-noted purposes of Luxembourg's safeguard measure.
Transfer of the bla-ampicillin resistance gene to bacteria of the intestine of
animals
7.2902 We consider first Luxembourg's stated con cern regarding the potential transfer of the bla-
ampicillin resistance gene to bacteria of the intestin e of animals due to consumption of Bt-176 maize.
The concern identified by Luxembourg with regard to Bt-176 maize is similar to that identified by
Austria with regard to its safeguard measures T 25 maize and Bt-176 maize. Thus, as in Austria's
case, we refer to our discussion in Section VII.C rega rding ARMG, and in particular our view that the
concern relates to the potential transfer to pat hogens of ARMG present in certain GMOs, and the

1798 The document is entitled "Interdiction provisoire d'importer le maïs génétiquement modifié ayant
meilleure résistance à l'herbicide glufosinate-ammonium – Motivation de la décision luxembourgeoise",
communicated to the Commission with the "Arrêté ministériel" on 17 March 1997 (Exhibit EC-158/At. 9).

possible resulting decrease in effectiveness of medi cal treatments involving specific antibiotics which
might pose a risk to the life or health of animals infected with the resistant pathogen.
7.2903 In Section VII.C we found that Annex A(1)(a) covers measures applied to protect animal life
or health from risks arising from the entry, estab lishment or spread of disease-causing organisms
which have or might become resistant to antibiotics due to the transfer of ARMG from a GM plant.
Similarly, we found that Annex A(1)(a) covers measu res applied to protect animal life or health from
risks arising from the entry, establishment or spr ead of diseases due to the reduced effectiveness of
antibiotics used to treat the pathogens which have become resistant to these antibiotics through gene
transfer. Furthermore, we found that Annex A(1)(b) covers measures applied to protect animal life or
health from risks arising indirectly, namely via the potential transfer to animals of marker genes
conferring resistance to antibiotics used in veteri nary medicine, from additives in feedstuffs. We
recall in this respect that, in our view, ARMGs can be considered to be additives for the purposes of
Annex A(1)(b).
7.2904 Consistent with our reasoning above, we cons ider that Luxembourg's safeguard measure on
Bt-176 maize, to the extent it is applied to a void risks associated with the transfer of the
bla-ampicillin resistance gene to bacteria of the in testine of animals, falls within the scope of
Annex A(1)(a) and (b) of the SPS Agreement.
Development of resistance to Bt toxin in insects
7.2905 Turning now to Luxembourg's stated concern regarding potential risk s associated with the
development of resistance to Bt toxin in insects, we understand the concern identified by Luxembourg
to be that resistance in insects to Bt toxin may de velop due to frequent exposure to this pesticide (the
Bt toxin) and that the development of high levels of resistance in insect populations might require the
application of a pesticide where none was used before , the increased application of a pesticide, or the
application of more harmful pesticides to control the resistant populations.
7.2906 We refer to our analysis in Section VII.C regard ing the development of pesticide-resistance in
insects. We found that resistant target organism s (insects) could be regarded as "pests" within the
meaning of Annex A(1), inasmuch as they present a ri sk to animal, plant or human life or health or
result in other damage. We further determine that risks to animal or plant life or health, or other
damage to the environment, resulting from a cha nge in pesticide use may be viewed as arising
indirectly from the entry, establishment or spread of resistant target organisms qua relevant pest. We
find that to the extent that a measure seeks to avoi d such risks and damage, it can be considered to be
covered by Annex A(1)(a) and (d) of the SPS Agreement.
7.2907 In view of the above findings, we consider that Luxembourg's safeguard measure on Bt-176
maize, to the extent it is applied to protect from potential risks associated with the development of
resistance to Bt toxin in insects due to the cultiv ation of Bt-176 maize, falls within the scope of
Annex A(1)(a) and (d) of the SPS Agreement.
Conclusion with regard to the purpose of the safeguard measure
7.2908 In the light of the above considerations, we c onclude that the safeguard measure applied by
Luxembourg with respect to Bt-176 maize qualif ies as an SPS measure within the meaning of
Annex A(1) as far as its purpose is concerned.

Form and nature of the measure
7.2909 We now turn to the issue of the form and nature of Luxembourg's safeguard measure on
Bt-176 maize. We start by recalling the arguments of the Parties on this matter.
7.2910 The United States argues that the measure was enacted by ministerial "decree", a form of
measure explicitly mentioned in Annex A(1) of the SPS Agreement.
7.2911 Argentina notes that the measure was adopted in the fo rm of an "arrêté ministériel", which is
defined as a "written decision by an administrative authority". The term "décret" is defined as
"a decision by the governmental authority by whic h the effects are similar to those of laws".
According to Argentina, an "arrêté ministériel" is similar in nature to a decree, which is one of the
measures listed in Annex A.
7.2912 The Panel recalls that the second paragraph of Anne x A(1) addresses the form and nature of
measures which may qualify as SPS measures. In r espect of the form of SPS measures, we have
indicated earlier in this report that the referenc e in the second paragraph to "laws, decrees [and]
regulations" should not be taken to prescribe a part icular legal form and that SPS measures may in
principle take many different legal forms. Furthermore, in respect of the nature of SPS measures, we
have indicated earlier that the reference in the same paragraph to "requirements" is broad and
unqualified. Hence, both an authorization to mark et a particular product and a ban on the marketing
of a particular product may be considered "re quirements". The second example would constitute a
negative requirement.
7.2913 We note that Luxembourg's safeguard measure on Bt-176 maize was implemented through an
"arrêté ministériel", or a Ministerial Order, to prohibit the commercialization of Bt-176 maize on
Luxembourg's territory. Annex A(1) does not specifica lly refer to "Ministerial Orders". As we have
pointed out, this fact alone does not necessarily mean that Luxembourg's safeguard measure is not an
SPS measure, since no specific legal form is prescrib ed. Luxembourg's decision clearly is a measure
attributable to Luxembourg's Government. It is also not in dispute that the decision is legally binding.
We therefore consider that, for the purposes of Annex A(1), Luxembourg's decision may be
assimilated to measures adopted in the form of "laws", "decrees" or "regulations".
7.2914 In respect of the nature of Luxembourg's me asure, we note that the decision prohibits the
marketing of Bt-176 maize. As indicated above, we are of the view that a prohibition of the
marketing of a particular product (within a particular territory) may be considered a "requirement" for
the purposes of Annex A(1).
7.2915 We therefore conclude that the safeguard me asure taken by Luxembourg with respect to
Bt-176 maize qualifies as an SPS measure within the meaning of Annex A(1) as far as its form and
nature are concerned.
Conclusion
7.2916 We have now considered Luxembourg's safeguard measure in terms of its purpose, its form
and its nature. In relation to each of these issues, we have found that Luxe mbourg's measure satisfies
the definition of the term "SPS measure" set out in A nnex A(1). In the light of this, we come to the
overall conclusion that the safeguard measure take n by Luxembourg with respect to Bt-176 maize
constitutes an "SPS measure" within the meaning of Annex A(1).

7.2917 At this juncture, we could go on and address the question of whether, in view of its multiple
purposes, Luxembourg's safeguard measure could be considered to embody more than one SPS
measure. However, neither the United States nor Argentina or the Eu ropean Communities have
argued that to the extent any of the safeguard measures at issue falls to be assessed under the
SPS Agreement, it should be deemed to constitute more th an one SPS measure. In their submissions
to the Panel, the Parties treated the relevant safeguard measures as constituting one SPS measure each.
In the light of this, like the Parties, we will tr eat Luxembourg's safeguard measure as constituting one
single SPS measure. We will revisit this issue, howe ver, if our disposition of the relevant claims
under the SPS Agreement (and, where appropriate, any implementing action to be taken in view of our
disposition of particular claims) were to depe nd on, and be affected by, whether we treat
Luxembourg's safeguard measure as constituting a single SPS measure or as embodying more than
one SPS measure.
Effect on international trade

7.2918 We now turn to the issue of whether Luxembourg's safeguard measure on Bt-176 maize is a
measure that affects international trade, and that is therefore subject to the provisions of the
SPS Agreement. We recall that according to Article 1.1 of the SPS Agreement, the SPS Agreement
applies to all SPS measures which "may, directly or indirectly, affect international trade."
Accordingly, for Luxembourg's safeguard measure on Bt-176 maize to be subject to the
SPS Agreement, it must be a measure which may, directly or indirectly, affect international trade. We
recall the Parties' arguments on this matter.
7.2919 The United States argues that the measure adopted by Luxembourg prohibits the "use and
sale" of Bt-176 maize, thereby effectively blocking the importation of the product. The measure as
such therefore affects international trade.
7.2920 Argentina notes that since the safeguard measure prevents access of Bt-176 maize to
Luxembourg's territory, resulting in the absence of impor ts of this product, the measure can be said to
affect international trade.
7.2921 The Panel notes that the arguments of the parties regarding the effects on trade of
Luxembourg's safeguard measure on Bt-176 maize are the same as their arguments with respect to
Austria's safeguard measure on T25 maize. We reca ll our reasoning and conclusions with respect to
Austria's measure on T25 maize in paragraphs 7.2603- 7.2609 above. Therefore, in view of the fact
that Luxembourg's safeguard measure prohibits im ports of Bt-176 maize, we have no difficulty
concluding that the safeguard measure applied by Luxembourg is an SPS measure which may affect
international trade within the meaning of Article 1.1 of the SPS Agreement and, as such, is subject to
the provisions of the SPS Agreement.
Overall conclusions

7.2922 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Communities, the Panel concludes that
Luxembourg's safeguard measure on Bt-176 maize is an SPS measure within the
meaning of Annex A(1) and Article 1.1 of the SPS Agreement.

 (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 Luxembourg's
safeguard measure on Bt-176 maize is an SPS measure within the meaning of
Annex A(1) and Article 1.1 of the SPS Agreement.

(b) Preliminary issue: The relationship between Article 5.1 and Article 5.7 of the SPS Agreement
7.2923 We have determined above that the SPS Agreement is applicable to all safeguard measures
which are being challenged. If we were to follow the Complaining Parties' approach, we would now
proceed to examine the consistency of the releva nt safeguard measures with Article 5.1 of the
SPS Agreement, which requires that these safeguard measu res be based on a risk assessment, as
appropriate to the circumstances. The European Communities objects to this manner of proceeding,
arguing that the safeguard measures at issue, to the extent they fall within the scope of the
SPS Agreement, fall to be assessed under Article 5.7 of the SPS Agreement, to the exclusion of
Article 5.1. Article 5.7 stipulates that in cases wh ere relevant scientific evidence is insufficient, SPS
measures may be provisionally adopted on the basis of available pertinent information.
7.2924 The European Communities presents two arguments in support of its contention that the
safeguard measures must not be assessed under Article 5.1. First, the European Communities argues
that the safeguard measures are provisional measur es, and that, for this reason, the applicable
provision is Article 5.7, and not Article 5.1. Secondly, the European Communities argues, more
broadly, that the relationship between Article 5.1 and Article 5.7 is one of exclusion, and that
Article 5.7 is not an exception to Article 5.1. We will address these arguments below and will then
determine whether to assess the safeguard me asures under Article 5.1, as requested by the
Complaining Parties.
(i) "Provisionally adopted" SPS measures
7.2925 It is useful to begin our consideration of the EC argument concerning "provisionally adopted"
SPS measures by setting out the text of relevant provisions.
7.2926 Article 2.2 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."
7.2927 Article 5.1 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."
7.2928 Article 5.7 provides:
"In cases where relevant scientific evid ence is insufficient, a Member may
provisionally adopt sanitary or phytosanitary measures on the basis of available

pertinent information, including that from the relevant international organizations as
well as from sanitary or phytosanitary measures applied by other Members. In such
circumstances, Members shall seek to obta in the additional information necessary for
a more objective assessment of risk and revi ew the sanitary or phytosanitary measure
accordingly within a reasonable period of time."
7.2929 In relation to Article 5.7, the Appellate Body has found that there are four requirements which
a Member must meet in order to adopt and mainta in a provisional SPS measure as contemplated in
Article 5.7. These requirements are:
1799
(a) the measure is imposed in respect of a situ ation where "relevant scientific evidence is
insufficient";
(b) the measure is adopted "on the basis of available pertinent information";
(c) the Member which adopted the measure "seek [s] to obtain the additional information
necessary for a more objective assessment of risk"; and
(d) the Member which adopted the measure "r eview[s] the … measure accordingly
within a reasonable period of time".
7.2930 The European Communities argues that Article 5.7 contains specific rules regarding
provisional measures, and that it is therefore by refe rence to these rules, not the rules in Article 5.1,
that the safeguard measures must be assessed. Re garding Article 5.7, the European Communities
submits that it applies only to provisional measur es. In the European Communities' view, if,
objectively, an SPS measure is "provisionally adopted" , it falls within the scope of Article 5.7. The
European Communities considers that the Appellate Body in Japan – Apples confirmed this when it
stated that "[w]hen a panel reviews a measure claimed by a Member to be provisional, that panel must
assess whether 'relevant scientif ic evidence is insufficient'".
1800 In the European Communities' view,
this statement indicates that the provisionality is the "demarcation line" between Article 5.1 and
Article 5.7.
7.2931 The European Communities considers that Article 5.1 also supports its view. According to
the European Communities, Article 5.1 concerns ri sk assessments to be carried out for SPS measures
other than provisional SPS measures. The Europe an Communities contends that for provisional SPS
measures the first sentence of Article 5.7 requires an "assessment", but not a "risk assessment" as that
term is defined in the SPS Agreement. The European Communities point s out in this connection that
the second sentence of Article 5.7 refers to a "m ore objective assessment", which in the European
Communities' view means an assessment that is more objective than that to be carried out on the basis
of the first sentence of Article 5.7. Thus, the Eu ropean Communities maintains that the first sentence
of Article 5.7 implies the need for an "assessme nt", but one which is different from the risk
assessment envisaged in Article 5.1.
7.2932 The European Communities further submits that its view that provisional measures are not
subject to Article 5.1 does not imply that provisional measures are not subject to a full set of controls
under the SPS Agreement. Rather, in the European Commun ities' view, there are two "parallel
universes" in the SPS Agreement, one for definitive measures and a nother for provisional measures.
According to the European Communities, provisional measures must comply with the requirements of

1799 Appellate Body Reports, Japan – Agricultural Products II, para. 89; Japan – Apples, para. 176.
1800 Appellate Body Report, Japan – Apples, para. 179.

Article 5.7, as well as with those of Articles 2.1
1801, 2.31802 and 2.4 1803 of the SPS Agreement. The
European Communities considers th at these provisions contain rules and obligations that are
analogous to those set out in Articles 2.2 and 5.1 to 5.6 for definitive measures.
7.2933 Having regard to the present dispute, the Eu ropean Communities asserts that all of the
safeguard measures at issue are provisional measur es within the meaning of Article 5.7. The
European Communities notes in this re gard that the text of the applicable EC legislation provides that
member States may "provisionally restrict" (Article 16 of Directive 90/220) or "temporarily restrict"
(Article 12 of Regulation 258/97) the use of a bi otech product which has received EC-wide marketing
approval. The European Communities further ar gues that the European Court of Justice has
confirmed that measures adopted based on the af orementioned legislation are temporary measures.
1804
Finally, the European Communities submits that th e provisional nature of the safeguard measures is
also reflected in the text of these measures as well as the national laws on which these measures are
based.
7.2934 The United States argues that in order to be covered by Article 5.7, a measure must meet
each of the criteria set out in that paragraph. The mere label of a measure as "provisional" is not
sufficient to bring it within the scope of Article 5. 7. Regarding the safeguard measures at issue, the
United States also notes that none of these measures satis fies the four criteria set out in Article 5.7.
Specifically, the evidence is suffi cient to perform a risk assessmen t, because the EC itself has
conducted positive risk assessments for each product subj ect to a member State measure. Secondly,
the EC's own scientific committees have confirmed th at the member State measures are not based on
"available pertinent information." Third, there is no information in the record that the Member States
have sought to perform risk assessments that would support their bans. Fourth, the EC argument that
"measures are constantly subject to review"
1805 does not meet the requirement that the measures are in
fact reviewed within a reasonable period of time of their adoption.
7.2935 Canada argues that neither in the text of the SPS Agreement nor in relevant jurisprudence is
there a basis for the European Co mmunities' bifurcation of the SPS regime on the basis of whether
measures are "definitive" or "provisional". Neither in Japan – Agricultural Products II nor in Japan –
Apples did the panels or the Appellate Body characterize provisionality as an a priori condition to be
met for Article 5.7 to apply. In Canada's view, th is strongly suggests that, for Article 5.7 to apply, it
is not relevant whether the measure in question is expressed in provisional terms. What matters,

1801 Article 2.1 provides:
Members have the right to take sanitary an d phytosanitary measures necessary for the
protection of human, animal or plant life or health, provided that such measures are not
inconsistent with the provisions of this Agreement.
1802 Article 2.3 provides:
Members shall ensure that their sanitary and phytosanitary measures do not arbitrarily or
unjustifiably discriminate between Members wh ere identical or similar conditions prevail,
including between their own territory and that of other Members. Sanitary and phytosanitary
measures shall not be applied in a manner whic h would constitute a disguised restriction on
international trade.
1803 Article 2.4 provides:
Sanitary or phytosanitary measures which co nform to the relevant provisions of this
Agreement shall be presumed to be in accordance with the obligations of the Members under
the provisions of GATT 1994 which relate to the use of sanitary or phytosanitary measures, in
particular the provisions of Article XX(b).
1804 The European Communities refers to Case C-236/01, Monsanto Agricoltura Italia SpA and Others
v. Presidenza del Consiglio dei Ministri and Others, judgement of 9 September 2003, para. 109.
1805 EC replies to Panel questions, para. 324.

according to Canada, is whether there is evidence to demonstrate that each of the conditions set out in
Article 5.7 has been fulfilled. Canada submits in th is regard that the first condition, which concerns
the sufficiency of relevant scientific evidence, is qualitatively different from the other conditions.
Canada considers that the first condition represents a logical threshold – a textual bridge – between
Article 2.2 and Article 5.7.
7.2936 Regarding the present dispute, Canada notes that it is true that the EC legislation indicates
that safeguard measures are meant to be tempor ary. Canada submits, however, that when one
considers the five safeguard me asures challenged by Canada, th e provisional quality of safeguard
measures is not obvious, as none of the five m easures in question has been in place less than 45
months, and some have been in place for more than five years.
7.2937 Argentina argues that Article 5.7 is not applicable to any measure which is labelled or
deemed "provisional". Rather, Article 5.7 establishes a specific requirement that a Member must
meet if it wishes provisionally to adopt an SPS measure: relevant scientific evidence must be
insufficient. Argentina considers, therefore, that for a measure to be covered by Article 5.7, what
matters is not whether that measure is designed to be provisional or definitive, but whether there is
sufficient relevant scientific evidence. Only in such cases may a Member provisionally adopt an SPS
measure on the basis of available pertinent information.
7.2938 The European Communities responds that the sufficiency or insufficiency of scientific
evidence cannot be the "demarcation line" between Article 5.1 and Article 5.7 in view of the
statement by the Appellate Body in Japan – Agricultural Products II that insufficiency of relevant
scientific evidence is one of four requirements set out in Article 5.7 and that "[t]hese four
requirements are clearly cumulative in nature and are equally important for the purposes of
determining consistency with this provision".
1806 According to the European Communities, this
statement confirms that none of the four requirement s has a special role to play in the demarcation of
the respective scopes of Articles 5.1 and 5.7, and th at these requirements are relevant to the question
of consistency with Article 5.7, not to the ques tion of the "demarcation line" to be drawn between
Articles 5.1 and 5.7.
7.2939 The Panel recalls the European Communities' argume nt that, for the purposes of the Panel's
analysis of the safeguard measures, the relevant provi sion is Article 5.7 rather than Article 5.1. We
first turn to examine this argument in the light of Article 5.7 itself. The first sentence of Article 5.7
provides in relevant part that " [i]n cases where relevant scientific ev idence is insufficient, a Member
may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent
information". The first sentence follows a classic "i f – then" logic: if a certain condition is met ( in
casu, insufficiency of relevant scientific evidence), a particular right is conferred ( in casu, the right
provisionally to adopt an SPS measure based on available pertinent information). Thus, it is clear that
Article 5.7 is applicable whenever the relevant c ondition is met, that is to say, in every case where
relevant scientific evidence is insufficient. 1807 The provisional adoption of an SPS measure is not a
condition for the applicability of Article 5.7. Rath er, the provisional adoption of an SPS measure is
permitted by the first sentence of Article 5.7.

1806 Appellate Body Report, Japan – Agricultural Products II, para. 89
1807 When we refer to the "applicability of Article 5.7", we address the issue of whether or not the right
conferred by the first sentence of Article 5.7 is, in pr inciple, available to a Member. In a specific case, a
Member must, of course, satisfy the various requirements se t forth in Article 5.7 if it wishes to benefit from the
right conferred by Article 5.7.

7.2940 If the provisional adoption of an SPS measure had been intended as a condition for the
applicability of Article 5.7, the first sentence of Ar ticle 5.7 would, in our view, have opened with a
different phrase, such as "In cases where a Member provisionally adopts an SPS measure [… ]". Also,
we note that in Japan – Apples the Appellate Body stated that "the application of Article 5.7 is
triggered not by the existence of scientific un certainty, but by the insufficiency of scientific
evidence".
1808 The Appellate Body made no mention of any additional "triggering factors".
7.2941 The European Communities draws our attention to the statement by the Appellate Body in
Japan – Apples that "[w]hen a panel reviews a measure claimed by a Member to be provisional, that
panel must assess whether 'relevant sci entific evidence is insufficient'". 1809 According to the
European Communities, this statement indicates that the provisional nature of a measure is what
determines whether a measure falls within the scope of Article 5.7. We do not agree. The European
Communities' interpretation is at odds with the af orementioned statement by the Appellate Body in
Japan – Apples that "the application of Article 5.7 is tri ggered [...] by the insufficiency of scientific
evidence". Reading the two statements by the Appellate Body harmoniously, we think that the
statement identified by the European Communitie s must be understood as referring to a situation
where a measure is claimed to be a provisional measure within the meaning of Article 5.7. In fact, the
Appellate Body in Japan – Apples pointed out that "Japan claimed, in the alternative, that its measure
is a provisional measure consistent with Article 5.7". 1810 In any event, we note that the Appellate
Body in Japan – Apples did not begin its Article 5.7 analysis by examining whether the measure at
issue was provisional, as claimed by Japan.
7.2942 The European Communities identifies another st atement by the Appellate Body which it
considers supports its position. In Japan – Agricultural Products II , the Appellate Body stated that
"[the] four requirements [contained in Article 5.7] are clearly cumulative in nature and are equally
important for the purposes of determini ng consistency with this provision". 1811 The European
Communities submits that this statement confirms that the requirement that relevant scientific
evidence be insufficient cannot be accorded a special role in the de marcation of the respective scopes
of Articles 5.1 and 5.7. Here again, we consider that the European Communities' argument is at odds
with the subsequent statement by the Appellate Body in Japan – Apples that "the application of
Article 5.7 is triggered [...] by the insufficiency of scientific evidence". Moreover, we note that in
Japan – Agricultural Products II the Appellate Body was addressing the issue of consistency with
Article 5.7, not applicability of Article 5.7. It is correct to say that for the specific purposes of
determining consistency with Article 5.7, all four requirement s are "equally important", for if any one
of these requirements is not met, a Member is not acting consistently w ith the provisions of
Article 5.7.1812
7.2943 The European Communities considers that its view regarding Article 5.7 is consistent with the
provisions of Article 5.1. In the European Comm unities' view, Article 5.1 prescribes risk assessment
only for SPS measures other than provisionally adopt ed SPS measures. Article 5.1 requires Members
to "ensure that their [SPS] measures are based on an assessment, as appropriate to the circumstances,
of the risks to human, animal or plant life or hea lth". We note, however, that Article 5.1 does not
qualify the term "SPS measures". Thus, the text of Article 5.1 provides no basis for the EC argument
that Article 5.1 prescribes risk assessment only for SPS measures other than provisionally adopted
SPS measures.

1808 Appellate Body Report, Japan – Apples, para. 184.
1809 Appellate Body Report, Japan – Apples, para. 179.
1810 Ibid., para. 170.
1811 Appellate Body Report, Japan – Agricultural Products II, para. 89
1812 We also address this issue below at paras. 7.3216-7.3220.

7.2944 Notwithstanding the lack of textual basis in Article 5.1, the European Communities argues
that provisionally adopted SPS measures should not be considered to be subject to Article 5.1 because
the first sentence of Article 5.7 also requires Member s to carry out an "assessment". According to the
European Communities, the "assessment" required by the first sentence of Article 5.7 is different from
a "risk assessment" as that term is defined in the SPS Agreement.
1813 Even assuming the European
Communities' argument regarding the required "assessment" were correct 1814, it is apparent from the
text of Article 5.7 that such an "assessment" would only be necessary for SPS measures which were
provisionally adopted in respect of situations where "relevant scientific eviden ce [was] insufficient".
Article 5.7 is not applicable to SPS measures wh ich were provisionally adopted in respect of
situations where relevant scientific evidence was not insufficient. Therefore, even accepting the EC
argument, Article 5.7 would not assist the European Communities in establishing that Article 5.1 does
not apply to any provisionally a dopted SPS measures, as first it woul d need to be established that
these measures were adopted in respect of situ ations where relevant scientific evidence was
insufficient.
7.2945 In response to a question from the Panel, the European Communities stated that the provisions
of Article 2.2 confirm that provisionality is the "d emarcation line" between Articles 5.1 and 5.7. The
European Communities points out that Article 2.2 refers to SPS measures which are "maintained"
while Article 5.7 refers to SPS measures which have been "provisionally adopted". The European
Communities concludes from this th at definitive measures fall to be assessed under Articles 2.2 and
5.1 while provisional measures fall to be assessed under Article 5.7. In our view, the verb "maintain"
in Article 2.2 does not support the conclusion that onl y definitive measures are subject to Article 2.2.
It is not apparent to us why a provisional measu re could not likewise be "maintained" within the
meaning of Article 2.2. The fact that Article 5.7, wh ich is part of the context of Article 2.2, refers to
SPS measures which have been "provisionally adopted ", and that Article 2.2 does not explicitly refer
to such measures, does not imply that any measure which has been "provisionally adopted" is
excluded, a priori, from the scope of application of Article 2. 2. Indeed, by its terms, Article 2.2 is
applicable to "any" SPS measures.
7.2946 The European Communities advances another argum ent based on Article 2.2. The European
Communities argues that the sufficiency or insuffi ciency of scientific evidence cannot have been
intended as a "demarcation line" between Articles 2.2 and 5.1, on the one hand, and Article 5.7, on the
other hand, because the word "sufficient" has differe nt meanings in the context of Article 2.2 and
Article 5.7. We see no force in this argument. Our view that Article 5.7 is applicable in every case
where relevant scientific evidence is insufficien t is based on the clause "[i]n cases where relevant
scientific evidence is insufficient" in Article 5.7. The Appellate Body in Japan – Apples has clarified
the meaning of the word "insufficient" as it appears in Article 5.7.
1815
7.2947 The European Communities also puts forward the argument that Articles 2.1, 2.3 and 2.4 of
the SPS Agreement serve to demonstrate that there are two "parallel universes" in the SPS Agreement,
one for definitive measures and another for provi sional measures. While we have no difficulty
accepting that the "basic rights and obligations" set ou t in these provisions are in principle applicable
to provisional SPS measures, we see nothing in the text of these provisions which would suggest that
they are applicable exclusively to provisional SPS measures. In our view, the provisions in question
are applicable also to definitive SPS measures. We note in this rega rd that Article 2 is captioned
"Basic Rights and Obligations". In the light of this, we do not think that these provisions serve to

1813 To recall, the second sentence of Article 5.7 refers to "a more objective assessment of risk"
(emphasis added).
1814 We further address this issue below at para. 7.2992.
1815 Appellate Body Report, Japan – Apples, para. 179.

demonstrate that the SPS Agreement sets out separate and special regimes – "parallel universes", in
the European Communities' parlance – for provisional SPS measures and for definitive SPS measures.
7.2948 For all these reasons, we are unable to accept the European Communities' argument that since
the safeguard measures at issue are provisionally adopted SPS measures, they fall to be assessed
under Article 5.7, to the exclusion of Article 5.1. The safeguard measures may or may not have been
provisionally adopted. If they were provisionally adopted, this fact alone would not exclude the
applicability of Article 5.1.
(ii) Article 5.7 of the SPS Agreement – right or exception from the "general obligation" under
Article 5.1?
7.2949 We now examine the second argument put forwar d by the European Communities in support
of its view that the safeguard measures must not be assessed under Article 5.1. To recall, the second
argument is that the relationship between Article 5.1 and Article 5.7 is one of exclusion, not
exception. In developing its argument, the Europ ean Communities made reference to Articles 3.1 and
3.3 of the SPS Agreement. The text of these provisions is set out below.
7.2950 Article 3.1 provides:
"To harmonize sanitary and phytosanitary measures on as wide a basis as possible,
Members shall base their sanitary or phytosanitary measures on international
standards, guidelines or recommendations, where they exist, except as otherwise
provided for in this Agreement, and in particular in paragraph 3."
7.2951 Article 3.3 provides:
"Members may introduce or maintain sanitary or phytosanitary measures which result
in a higher level of sanitary or phytosan itary protection than would be achieved by
measures based on the relevant international standards, guidelines or
recommendations, if there is a scientific justification, or as a consequence of the level
of sanitary or phytosanitary protection a Me mber determines to be appropriate in
accordance with the relevant provisions of paragraphs 1 through 8 of Article 5."
1816
7.2952 The European Communities argues that the relationship betw een Articles 3.1 and 3.3 of the
SPS Agreement is one of exclusion, not exception. 1817 The European Communities notes that
Article 2.2 contains wording substantially identical to that of Article 3.1. According to the European
Communities, it necessarily follows that the relations hip between Article 2.2 and Article 5.7 is also
one of exclusion. In other words, Article 2.2 excludes from its scope of application the kinds of
situations covered by Article 5.7. The European Communities further notes that in EC – Hormones
the Appellate Body stressed that Article 2.2 and Article 5.1 must be constantly read together. 1818 The
European Communities deduces from th is that the relationship between Article 5.1 and Article 5.7
must, equally, be one of exclusion. Thus, in th e European Communities' view, Article 5.7 is an
autonomous right, and not an exception to Articles 2.2 and 5.1.

1816 (original footnote) For the purposes of paragraph 3 of Article 3, there is a scientific justification if,
on the basis of an examination and evaluation of available scientific information in conformity with the relevant
provisions of this Agreement, a Member determines that the relevant international standards, guidelines or
recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary protection.
1817 The European Communities refers to Appellate Body Report, EC – Hormones, para. 104.
1818 The European Communities refers to Appellate Body Report, EC – Hormones, para. 180.

7.2953 In support of its view that Article 5.7 is not an exception to Article 2.2, the European
Communities further argues that the text of Article 5. 7 is incorporated by reference into the text of
Article 2.2. The European Communities considers that Article 5.7 is therefore part of Article 2, which
is entitled "Basic Rights and Obligations". In the European Communities' view, Article 5.7 thus sets
out basic rights and obligations of equivalent stat us to the basic rights and obligations set out in
Article 2.
7.2954 The European Communities notes that none of th e Complaining Parties has presented a claim
of violation under Article 5.7. The European Comm unities submits that in view of this circumstance,
and given the fact that, in its view, the safeguard measures are provisional measures falling within the
scope of application of Article 5.7, it is irrele vant whether the safeguard measures meet the four
requirements of Article 5.7. By bringing a claim of inconsistency with Article 5.1, the European
Communities maintains, the Complaining Parties have simply invoked the wrong provision. The
European Communities considers that there is therefore no basis for the Panel to conclude that the
safeguard measures are inconsistent with Article 5.1.
7.2955 Moreover, the European Communities consider s that if the Panel nonetheless were to
determine that the safeguard measures did not me et one of the requirements of Article 5.7, e.g.,
because there was sufficient scientific evidence, the Panel would need to conclude that the provisional
measure in question is inconsistent with Article 5.7, and not that Article 2.2 or Article 5.1 becomes
the relevant applicable provision. The European Communities contends that this has been confirmed
by the Appellate Body in Japan – Agricultural Products II when it stated that "[w]henever one of
[the] requirements [of Article 5.7] is not met, the measure at issue is inconsistent with Article 5.7".
1819
7.2956 The United States argues that Article 5.7 does not provide a basis for a claim of an alleged
breach of a WTO obligation, but acts as a defence to shield measures that would otherwise violate
Articles 2.2 and 5.1. The United States submits that Article 5.7 provides an exception to Article 2.2
as well as Article 5.1, as these two articles "should constantly be read together".
1820 The United States
points out that in Japan – Agricultural Products II and Japan – Apples the responding party invoked
Article 5.7 to defend the challenged measure. The complaining party did not assert Article 5.7 as an
independent claim of violation in either dispute, nor did the panels in these disputes suggest that the
complaining party should have invoked Article 5.7.
7.2957 With regard to the issue of burden of proof, the United States is not arguing in this dispute
that the responding party has the burden of proof to show that Article 5.7 applies to a particular SPS
measure. The United States considers that in the present dispute it has established that the member
State safeguard measures are inconsistent with Articl es 2.2 and 5.1. In the United States' view, this
necessarily means that Article 5.7 does not apply. Moreover, by showing that each of the products
subject to a member State safeguard measure was subject to positive risk assessments by the European
Communities' own scientists, the United States has met any burden of proof to show that scientific
evidence was not "insufficient" and that Article 5.7 does not apply.
7.2958 Canada argues that equating the relationship between Articles 2.2 and 5.1, and Article 5.7,
with the relationship between Articles 3.1 and 3.3 is inappropriate because the purposes, and therefore
the relationships between these articles, respectiv ely, are quite different. Articles 3.1 and 3.3
represent "separate but equal" tracks to follow in adopting an SPS measure. A Member can adopt a
measure that is based on a relevant internatio nal standard, where such a standard exists.
Alternatively, a Member can adopt a measure in a ccordance with the provisions of Article 3.3, where

1819 Appellate Body Report, Japan – Agricultural Products II, para. 89 (emphasis omitted).
1820 The United States refers to Appellate Body Report, EC – Hormones, para. 180.

it seeks a level of protection that is higher than th e level of protection implied by the international
standard. Article 3.3 is not merely a qualified exemption from the basic obligation in Article 3.1. It is
the expression of the autonomous right of Members to establish their own appropriate levels of
protection.
7.2959 Canada argues that in contrast, Articles 2.2 and 5.7 are not "separate but equal" tracks for
Members to follow. Canada submits that Article 5.7 does not exist as an option that can be freely
chosen by the Member concerned in place of Articl es 2.2 and 5.1. Canada points out that unlike
Article 3.3, Article 5.7 is a temporary solution. Ultimately, Article 5.7 must give way to the basic
obligation in Article 2.2. Canada further argues that the application of Article 5.7 logically only arises
where it has been determined that a measure is maintained without suffici ent scientific evidence,
which, unless justified under Article 5.7, would am ount to a violation of Article 2.2. For these
reasons, Canada considers that Article 5.7 operates as an exception to Articles 2.2 and 5.1. Therefore,
Canada maintains, it is only if a challenged measure is found by a panel to be inconsistent with
Article 2.2 and/or Article 5.1 that Article 5. 7 comes into play, provided the importing Member
invokes the provision as a source of justification fo r maintaining the challenged measure. Canada
considers that it would be the Member invoking Ar ticle 5.7 that would have the initial burden of
demonstrating a prima facie case.
7.2960 Argentina argues that Article 5.7 operates as a defence for measures which would otherwise
be inconsistent with Articles 2.2 and 5.1. Ar gentina considers that when a Member meets the
conditions set out in Article 5.7, it is entitled to adopt and maintain a measure under Article 5.7, and
to depart from the general conditions set out in Article 2.2. In Argentina's view, a failure to meet the
first condition of Article 5.7 – namely, that relevant scientific evidence must be insufficient – does not
lead to an infringement of Article 5.7. Rather, it would prevent the relevant Member from departing
from the general conditions set out in Article 2.2. According to Argentina, it is up to the responding
party to invoke a defence under Article 5.7 and to meet the burden of establishing that defence.
7.2961 The Panel finds it appropriate to begin its examination of the relationship between Article 5.1
and Article 5.7 by examining the relationship between Article 2.2 and Article 5.7. It should be noted
in this regard that Article 5.1 and Article 2.2 should "constantly be read together"
1821, and that
Article 2.2 is an important part of the context of Article 5.1.
Relationship between Article 2.2 and Article 5.7
7.2962 The European Communities argues that Article 5.7 is not an exception to Article 2.2 in the
sense that it could be invoked as an affirmative defe nce to a claim of violation under Article 2.2.
Rather, the European Communities maintains, Artic le 5.7 establishes an autonomous right of the
importing Member. The European Communities furthe r submits that in cases where Article 5.7 is
applicable, it is for the complaining party to establish that the importing Member has acted
inconsistently with Article 5.7.
7.2963 In EC – Tariff Preferences , the Appellate Body was called on to determine whether the
Enabling Clause constituted a right or an exception to Article I:1 of the GATT 1994. In that context,
the Appellate Body made the following statement:
"We recall that the Appellate Body has a ddressed the allocation of the burden of
proof in similar situations. In cases where one provision permits, in certain
circumstances, behaviour that would otherwis e be inconsistent with an obligation in

1821 Appellate Body Report, EC – Hormones, para. 180.

another provision, and one of the two provi sions refers to the other provision, the
Appellate Body has found that the complaining party bears the burden of establishing
that a challenged measure is inconsistent with the provision permitting particular
behaviour only where one of the provisions suggests that the obligation is not
applicable to the said measure. Otherwise, the permissive provision has been
characterized as an exception, or defence, and the onus of invoking it and proving the
consistency of the measure with its requi rements has been placed on the responding
party. However, this distinction may not always be evident or readily applicable."
1822
7.2964 As an illustration of a case of two WTO provi sions where the "permissive provision" was
characterized by the Appellate Body as a right rath er than an exception, the Appellate Body cited a
paragraph in its report in EC – Hormones .1823 The paragraph in questi on addresses the relationship
between Article 3.1 and Article 3.3 of the SPS Agreement. The paragraph states in relevant part that:
"Article 3.1 of the SPS Agreement simply excludes from its scope of application the
kinds of situations covered by Article 3.3 of that Agreement, that is, where a Member
has projected for itself a higher level of sanitary protection than would be achieved by
a measure based on an international standa rd. Article 3.3 recognizes the autonomous
right of a Member to establish such higher level of protection, provided that that
Member complies with certain requirements in promulgating SPS measures to
achieve that level. The general rule in a dispute settlement proceeding requiring a
complaining party to establish a prima facie case of inconsistency with a provision of
the SPS Agreement before the burden of showing c onsistency with that provision is
taken on by the defending party, is not avoided by simply describing that same
provision as an 'exception'."
1824
7.2965 Later in the same report, the Appellate Body found that:
"[T]his right of a Member to establish its own level of sanitary protection under
Article 3.3 of the SPS Agreement is an autonomous right and not an 'exception' from a
'general obligation' under Article 3.1."1825
7.2966 Returning to the general test enunciated by the Appellate Body in EC – Tariff Preferences, we
note that, indeed, the relationship between Article 3. 1 and Article 3.3 may be described as one where
"one provision [namely, Article 3.3 ] permits, in certain circumstances, behaviour that would
otherwise be inconsistent with an obligation in another provision [namely, the obligation in
Article 3.1 to base SPS measures on international standards ], [where] one of the two provisions
[namely, Article 3.1 ] refers to the other provision, [and] where one of the provisions [namely,
Article 3.1] suggests that the obligation [in Article 3.1 to base SPS measures on international
standards] is not applicable" to measures falling within the scope of Article 3.3. With regard to this
last element, we note that Article 3.1 contains the clause "except as otherwise provided for in this
Agreement, and in particular in paragraph 3".
7.2967 The European Communities submits that we s hould conceive of the relationship between
Article 2.2 and Article 5.7 in the same way that the Appellate Body conceived of the relationship
between Article 3.1 and Article 3.3. The European Communities notes in this regard that there are

1822 Appellate Body Report, EC – Tariff Preferences, para. 88 (footnotes omitted).
1823 Ibid., footnote 189.
1824 Appellate Body Report, EC – Hormones, para. 104.
1825 Ibid., para. 172.

significant textual similarities between Article 3. 1 and Article 2.2. Indeed, whereas Article 3.1
contains the clause "except as otherwise provided fo r in this Agreement, and in particular in
paragraph 3", Article 2.2 contains the closely simi lar clause "except as provided for in paragraph 7 of
Article 5". It is clear from the Appellate Body's statement in EC – Tariff Preferences that in the
context of Article 3.1, the relevant clause play ed an important part in the Appellate Body's
determination of whether Article 3. 3 constituted a right or an exception. As a result, we agree with
the European Communities that we may in principle attach simila r weight to the corresponding clause
in Article 2.2, provided there is also a corres pondence of the other elements highlighted by the
Appellate Body in its statement in EC – Tariff Preferences.
7.2968 Evaluating the relationship between Article 2.2 and Article 5.7 in the light of the general test
provided by the Appellate Body in EC – Tariff Preferences , we consider that the relationship in
question is one where "one provision [namely, Article 5.7 ] permits, in certain circumstances,
behaviour [namely, the provisional adoption of SPS measu res in cases where scientific evidence is
insufficient on the basis of av ailable pertinent information] that would otherwise be inconsistent with
an obligation in another provision [namely, the obligation in Article 2.2 not to maintain SPS measure
without sufficient scientific evidence ], [where] one of the two provisions [namely, Article 2.2] refers
to the other provision, [and] where one of the provisions [namely, Article 2.2, and in particular the
clause "except as provided for in paragraph 7 of Article 5"] suggests that the obligation [in Article 2.2
not to maintain SPS measure wit hout sufficient scientific evidence ] is not applicable" to measures
falling within the scope of Article 5.7.
7.2969 Thus, we find the general test provided by the Appellate Body in EC – Tariff Preferences to
be applicable, and application of that test lead s us to the conclusion that Article 5.7 should be
characterized as a right and not an exception from a general obligation under Article 2.2.
1826 In other
words, we consider that in the same way that "Article 3.1 of the SPS Agreement [...] excludes from its
scope of application the kinds of situations covered by Article 3.3 of that Agreement" 1827, Article 2.2
excludes from its scope of application the kinds of situations covered by Article 5.7. As we will
explain further below, characterizing Article 5.7 as a right rather than as an exception has implications
for the allocation of the burden of proof.
7.2970 We have said that Article 2.2 excludes from its scope of application the kinds of situations
covered by Article 5.7. We recall in this conn ection that Article 2.2 contains three distinct
obligations. It is therefore important to note that the Appellate Body did not say that Article 5.7
operates as a qualified exemption from the fi rst and second obligations in Article 2.2, i.e., the
obligation to ensure that SPS measures are applie d only to the extent necessary to protect human,
animal or plant life or health, and the obligation to ensure that they are based on scientific principles.
In the present case, it is not necessary, however, to examine the legal issue of whether the phrase
"except as provided for in paragraph 7 of Article 5" relates only to the third obligation contained in
Article 2.2 – the obligation not to maintain SPS m easures without sufficient scientific evidence – or
whether it relates to all three obligations laid down in Article 2.2.

1826 Regarding our use of the term "right", we note that the Appellate Body's test in EC – Tariff
Preferences does not provide a term to characterize the permissive provision in the kind of relationship we
found to exist between Article 2.2 and Article 5.7. However, as we have noted, the Appellate Body referred to
the relationship between Articles 3.1 and 3.3 as an illustration of the relevant kind of relationship. We have also
pointed out that in EC – Hormones, the Appellate Body referred to the permissive provision, Article 3.3, as an

"autonomous right", noting also that Article 3.3 does not constitute an exception from a general obligation under
Article 3.1.
1827 Appellate Body Report, EC – Hormones, para. 104.

7.2971 We note that Article 5.7 makes clear that SPS measures adopted and maintained pursuant to
Article 5.7 are meant to be temporary in nature.
1828 In our view, the fact that Article 2.2 only
temporarily excludes from its scope of application th e kinds of situations c overed by Article 5.7 does
not detract from our characterization of Article 5.7 as a right. Where a right is conferred, it does not
cease to be a right merely because it has been conf erred on a temporary basis. Moreover, there is
nothing unusual about the temporary inapplicability of a WTO provision. One need look no further
than Article 14 of the SPS Agreement, which provides for specific tr ansitional periods for least
developed country Members and other developing country Members. During the applicable
transitional periods, these Members are entitled to the no n-application of some or all other provisions
of the SPS Agreement.
7.2972 The view that Article 5.7 is not an exception in the nature of an affirmative defence is also
consistent with the statement by the Appellate Body in Japan – Agricultural Products II that
"Article 5.7 operates as a qualified exemption from the obligation under Article 2.2 not to maintain
SPS measures without sufficient scientific evidence".
1829 Had the Appellate Body been of the view
that Article 5.7 operates as an exception unde r which an importing Member could justify an
inconsistency with an applicable obligation, it wo uld, in our view, have been more natural and
appropriate to use the term "exception" rather th an the term "exemption", as the term "exemption"
connotes freedom from, and hence inapplicability of, an obligation.1830
7.2973 We stress that Article 5.7 does not establish an absolute or unqualified right. In Japan –
Agricultural Products II, the Appellate Body made clear that there are four cumulative requirements
in Article 5.7 which must be met in order for a Member to adopt and maintain a provisional SPS
measure consistently with Article 5.7. 1831 We think that these requirements are the reason why the
Appellate Body emphasised that "Article 5.7 operates as a qualified exemption from the obligation
under Article 2.2 not to maintain SPS measures without sufficient scientific evidence".1832
7.2974 In concrete terms, characteri zing Article 5.7 as a qualified right rather than an exception
means that if a challenged SPS measure was adopted and is maintained consistently with the four
cumulative requirements of Article 5.7, the situation is "as provided for in paragraph 7 of Article 5"
(Article 2.2), and the obligation in Article 2. 2 not to maintain SPS measures without sufficient
scientific evidence is not applicab le to the challenged measure. Conversely, if a challenged SPS
measure is not consistent with one of the four re quirements of Article 5.7, the situation is not "as
provided for in paragraph 7 of Artic le 5" (Article 2.2), and the rele vant obligation in Article 2.2 is
applicable to the challenged measure, provided th ere are no other elements which render Article 2.2
inapplicable.
7.2975 The European Communities draws our attention to the statement by the Appellate Body in
Japan – Agricultural Products II that "[w]henever one of [the] re quirements [of Article 5.7] is not

1828 The first sentence of Article 5.7 refers to SPS measures being "provisionally adopted" on the basis
of available pertinent information, and the Appellate Body has noted that the requirements set out in the second
sentence of Article 5.7 highlight the provisional nature of measures adopted pursuant to Article 5.7. Appellate
Body Report, Japan – Apples, footnote 318.
1829 Appellate Body Report, Japan – Agricultural Products II, para. 80 (emphasis in original).
1830 The adjective "exempt" means "free from an obligation or liability imposed on others". The
Concise Oxford Dictionary, 10th ed, J. Pearsall (ed.) (Clarendon Press, 1999), p. 498.
1831 Appellate Body Report, Japan – Agricultural Products II , para. 89. See also Appellate Body
Report, Japan – Apples, para. 176. We identify the four cumulative requirements contained in Article 5.7 above
at para. 2.
1832 Appellate Body Report, Japan – Agricultural Products II, para. 80 (emphasis in original).

met, the measure at issue is inconsistent with Article 5.7".
1833 The European Communities argues that
in view of this statement, if a challenged SPS measure is not consistent with one of the four
requirements of Article 5.7, the Panel should find that the challenged measure violates Article 5.7, and
not that the relevant obligation in Article 2.2 is applicable to the measure in question. We do not
consider that the aforementioned statement by the Appellate Body supports the European
Communities' argument. To say, as the Appellate Bo dy did, that a measure is "inconsistent" with
Article 5.7 when the relevant requirements are not satisfied is not tantamount to saying that
Article 2.2 is inapplicable to that measure. In deed, as we have pointed out, the Appellate Body in
Japan – Agricultural Products II also stated that Article 5.7 operates as a qualified exemption from
the obligation under Article 2.2 not to maintain SPS measures without sufficient scientific evidence.
Moreover, the ordinary meaning of the clause "excep t as provided for in paragraph 7 of Article 5" in
Article 2.2 indicates that Article 2.2 would be appl icable in a situation where a measure meets some,
but not all, of the requirements of Article 5.7.
7.2976 Characterizing Article 5.7 as a qualified right and not an exception also has implications for
the allocation of the burden of proof concerning the issue of the consistency of an SPS measure with
Article 5.7. According to the Appellate Body's statement in EC – Tariff Preferences , in cases where
the permissive provision constitutes a right rather th an an exception, "the complaining party bears the
burden of establishing that a challenged measure is inconsistent with the provision permitting
particular behaviour". 1834 And in EC – Sardines , the Appellate Body observed that "[i]n EC –
 Hormones, we found that a 'general rule-exception' re lationship between Articles 3.1 and 3.3 of the
SPS Agreement does not exist, with the consequence that the complainant had to establish a case of
inconsistency with both Articles 3.1 and 3.3".1835 We deduce from these two statements that in cases
where a complaining party alleges that an SPS me asure is inconsistent with the obligation in
Article 2.2 not to maintain SPS measures without suffi cient scientific evidence, it is incumbent on the
complaining party, and not the responding party, to demonstrate that the challenged SPS measure is
inconsistent with at least one of the four requireme nts set forth in Article 5.7. If such non-compliance
is demonstrated, then, and only then, does the re levant obligation in Article 2.2 apply to the
challenged SPS measure.
7.2977 Our view of the nature of the relationship be tween Article 2.2 and Article 5.7 and of the
proper allocation of the burden of proof under these provi sions is consistent with that of the panel in
Japan – Agricultural Products II . In that case, the United States as the complaining party claimed
that the challenged measure was inconsistent, inter alia , with the obligation in Article 2.2 not to
maintain SPS measures without su fficient scientific ev idence. After reaching the provisional
conclusion that the challenged measure was inconsistent with Article 2.2, the panel noted that Japan,
the responding party, was invoking Article 5.7 in support of its measure. Recalling the text of
Article 2.2, and notably the clause "except as provided for in paragraph 7 of Article 5", the panel then
stated that in view of Japan's invocation of Artic le 5.7 it needed to examine whether the challenged
measure was a measure meeting the requirements in Article 5.7. The panel noted that "[i]f the
[challenged measure] meets these requirements, we cannot find that it violates Article 2.2". 1836 The
panel then went on to analyse the measure in the light of the requirements of Article 5.7, finding that
"the United States [as the complaining party] has established a presumption that Japan did not comply
with the requirements in the second sen tence of Article 5.7. We also consider that Japan has not been

1833 Appellate Body Report, Japan – Agricultural Products II, para. 89 (emphasis omitted).
1834 Appellate Body Report, EC – Tariff Preferences, para. 88.
1835 Appellate Body Report, EC – Sardines, para. 275 (emphasis in original).
1836 Panel Report, Japan – Agricultural Products II, para. 8.48.

able to rebut this presumption".
1837 In the light of this finding, th e panel then reached the overall and
final conclusion that the challenged measure was inconsistent with Article 2.2.1838
7.2978 We note that in a later case, Japan – Apples, the panel confronted a very similar situation. In
that case, the United States as the complaining part y also claimed that the challenged measure was
inconsistent with the obligation in Article 2. 2 not to maintain SPS measures without sufficient
scientific evidence. Japan as the responding party cont ested this claim, but argued, in the alternative,
that its measure was consistent with the requirement s of Article 5.7. The panel recalled the approach
followed by the panel in Japan – Agricultural Products II , stating that it agreed with that approach
and that it would therefore make no final findings w ith respect to the consistency of the measure at
issue with Article 2.2 until it had co mpleted its analysis under Article 5.7. 1839 However, contrary to
the approach of the panel in Japan – Agricultural Products II, the panel in Japan – Apples determined
that "the burden [was] on Japan, as the party invok ing Article 5.7, to make a prima facie case in
support of its position". 1840 The panel did not elaborate further on why it had decided to place this
burden of proof on Japan. Following the approach it had outlined, the panel then determined, on a
provisional basis, that the challenged measure was in consistent with Article 2.2. The panel next
examined Japan's alternative argument under Article 5.7, finding that Japan had failed to establish that
its measure was justified under Article 5.7. In view of this finding, the panel confirmed its
provisional conclusion under Article 2.2, finding that the challenged measure was inconsistent with
Article 2.2.1841
7.2979 In relation to the approach followed by the panel in Japan – Apples , it is important to point
out that the Appellate Body in that same case noted that "[t]he Panel's assignment of the burden of
proof to Japan to make a prima facie case of consistency with Ar ticle 5.7 is not challenged on
appeal".1842 We take this statement as a reservation expressed by the Appellate Body in respect of the
panel's assignment of the burden of proof to Japan. In any event, as we have stated above, and for the
reasons stated above, we consider that it is incu mbent on the complaining party to establish a prima
facie case of inconsistency with both Articles 2.2 and 5.7.
7.2980 Before proceeding to analyse the relationship betw een Article 5.1 and Article 5.7, we wish to
address two arguments presented by Ca nada. First of all, Canada invok es basic logic in support of its
position that Article 5.7 should be considered as an exception. In Canada's view, it is logically
necessary to determine first whether a measure is maintained without sufficient evidence within the
meaning of Article 2.2. Canada submits that onl y if a measure is maintained without sufficient
evidence, the question arises whether maintaini ng that measure is nonetheless justifiable under
Article 5.7. Canada's argument is based on the prem ise that Article 2.2 is applicable in the kinds of
situations covered by Article 5.7. However, such a premise does not comport well with the text of
Article 2.2. Indeed, the clause "except as provided for in paragraph 7 of Article 5" in Article 2.2
suggests the opposite of what Canada is assuming, na mely, that the relevant obligation in Article 2.2
is not applicable in situations covered by Article 5.7. If, as we believe, Article 2.2 was not intended to
apply in the situations covered by Article 5.7, it made entire sense for the drafters to include the
aforementioned exclusionary clause in the text of Article 2.2. Conversely, if, as Canada argues,
Article 5.7 was intended to constitute an affirmative defence to a claim of violation under Article 2.2,
it was unnecessary to include the aforementioned exclusi onary clause in the text of Article 2.2. The

1837 Ibid., para. 8.58.
1838 Ibid., para. 8.61.
1840 Ibid., para. 8.212.
1841 Ibid., paras. 8.199, 8.222 and 8.224.
1842 Appellate Body Report, Japan – Apples, footnote 316.

"logical" way of giving expression to such an intentio n would have been for Article 2.2 not to include
the aforementioned exclusionary clause, and for Article 5.7 to state that "notwithstanding the
provisions of Article 2.2, in cases where relevant scientific evidence is in sufficient, Members may
provisionally adopt SPS measures on the basis of available pertinent information".
1843 Thus, while
our view accounts for, and gives meaning and effect to , all of the terms used in Article 2.2, Canada's
view renders the exclusionary cl ause effectively redundant. We recall in this regard that in
interpreting Article 2.2, we must give me aning and effect to all of its terms – " ut res magis valeat
quam pereat " – and must not adopt an interpretation wh ich would result in rendering some of its
terms effectively redundant.1844
7.2981 In any event, the logic argued for by Canada could also be said to apply to the relationship
between Article 3.1 and Article 3.3. Thus, by th e same token, it could be said that it is only once it
has been determined that an SPS measure is not b ased on an existing international standard that it
becomes relevant to ask whether a Member may neve rtheless depart from that standard to achieve a
higher level of protection. Yet th e Appellate Body found that Article 3.3 is not an exception to a
"general obligation" in Article 3.1.
7.2982 The second argument put forward by Canada whic h we wish to comment on is Canada's
argument that, for the purposes of interpreting the relationship between Articles 2.2 and 5.7, any
reliance on the Appellate Body's interpretation in EC – Hormones of the relationship between
Article 3.1 and Article 3.3 would be misplaced and inappropriate. According to Canada, Article 3.1
and Article 3.3 give Members the free choice of b asing their SPS measures either on an international
standard or on a stricter national standard. In c ontrast, Canada maintains, Members do not have the
option of either maintaining SPS measures with su fficient scientific evidence, as contemplated in
Article 2.2, or of maintaining SPS measures on th e basis of available pertinent information, as
contemplated in Article 5.7. As an initial matter, we note that Articles 3.1 and 3.3 are part of the
context of Articles 2.2 and 5.7. Moreover, we consider that there is an undeniable structural and
textual similarity between Articles 3.1 and 3.3 and Articles 2.2 and 5.7. Both pairs of articles are
linked to each other through a textual cross-reference, and Article 3.1 contains an "except as provided
for" clause which is textually almost identical to the corresponding clause in Article 2.2. It is
primarily this structural and textual similarity of Articles 3.1 and 3.3, coupled with the fact that these
provisions, and their mutual relationship, have alre ady been interpreted by the Appellate Body, which
renders them relevant to, and hence has factored in, our examination of the relationship between
Article 2.2 and Article 5.7.
7.2983 Thus, our view of the relationship between Artic les 2.2 and 5.7 is not reliant on the premise
that the relationship between Articles 3.1 and 3.3, on the one hand, and Articles 2.2 and 5.7, on the
other hand, is the same in all respects. Indeed, we agree with Canada that there are important
substantive differences. A Member can, subject to compliance with applicable requirements, choose
whether to base an SPS measure on a relevant intern ational standard in line with Article 3.1 or,
alternatively, to avail itself of the qualified right not to do so provided in Article 3.3. In contrast, in
cases where the relevant scientif ic evidence is insufficient, e.g., because none is available, a Member
who wishes nonetheless to take a precautionary SPS measure could not meet the requirement in
Article 2.2 to ensure that this measure "is not main tained without sufficient scientific evidence". This
further strengthens our conviction that Article 5.7 should be viewed as a qualified exemption from the
relevant obligation in Article 2.2, confirming th e right of Members to take measures which are
"necessary for the protection of human, animal or plant life or health" in situations where the available
scientific evidence is "insufficient". Therefore, while recognizing the existence of substantive

1843 See, for a similar argument, Appellate Body Report, US – Upland Cotton, para. 609.
1844 See also Appellate Body Report, US – Gasoline, p. 23.

differences between Articles 3.1 and 3.3, on the one hand, and Articles 2.2 and 5.7, on the other hand,
we do not consider that these differences support Ca nada's view that Article 5.7 constitutes an
exception to Article 2.2 in the nature of an affirmative defence.
Relationship between Article 5.1 and Article 5.7

7.2984 We now turn to examine the relationship between Article 5.1 and Article 5.7. We recall at the
outset that Article 5.1 requires Members to b ase their SPS measures on a risk assessment, whereas
pursuant to Article 5.7, in cases where relevant sc ientific evidence is insufficient, Members may
provisionally adopt SPS measures on the basis of av ailable pertinent information. The European
Communities submits that we should view the relati onship between Article 5.1 and Article 5.7 in the
same way that we view the relationship between Ar ticle 2.2 and Article 5.7. Or as the European
Communities also put it, Article 5.7 is not an ex ception from a general obligation under Article 5.1,
but an autonomous right.
7.2985 We recall that in accordance with the guidance provided by the Appellate Body in EC – Tariff
Preferences, we could characterize Article 5.7 as a right in relation to Article 5.1 if the relationship
between Article 5.1 and Article 5.7 is one "where one provision perm its, in certain circumstances,
behaviour that would otherwise be inconsiste nt with an obligation in another provision, [where] one
of the two provisions refers to the other provision, [and] where one of the provisions suggests that the
obligation is not applicable to the said measure". 1845 We will therefore examine below whether the
relationship between Article 5.1 and Article 5.7 m eets these various elements of the general test
articulated by the Appellate Body.
7.2986 We consider first whether Article 5.7 permits, in certain circumstances, what would otherwise
be inconsistent with Article 5.1. We note in this regard the statement by the panel in Australia –
Salmon that "Article 5.7 allows for an exception to the obligation to base sanitary measures on a risk
assessment, namely 'in cases where relevant scientific evidence is insufficient'". 1846 This statement
clearly suggests that Article 5.7 permits what Article 5.1 prohibits. This statement also suggests that
Article 5.7 constitutes an exception, although it is less than clear that the panel conceived of
Article 5.7 as an exception in the na ture of an affirmative defence. As the panel did not explain why
it described Article 5.7 as an exception, we ar e bound to recall the above-quoted statement by the
Appellate Body in EC – Hormones that characterizing a treaty provision as an "exception" does not,
by itself, place the burden of proof on the responding party.1847
7.2987 Looking at the first sentence of Article 5.7, we note that, by its terms, it does not require that
Members provisionally adopting SPS measures perform a risk assessment as defined in Annex A(4) to
the SPS Agreement, and that they base their measure on the completed risk assessment as
contemplated in Article 5.1. The first sentence of Article 5.7 requires that in cases where relevant
scientific evidence is insufficient, SPS measures be adopted "on th e basis of available pertinent
information".
7.2988 We note that the second sentence of Article 5.7 obligates Members maintaining SPS measures
under Article 5.7 to seek to obtain the additiona l information necessary for "a more objective
assessment of risk", and to revi ew their measures "accordingly". We understand the phrase "a more
objective assessment of risk", taken as a whole, to refer to a risk assessment which satisfies the
definition provided in Annex A(4) – or at least which is closer to satis fying the definition in

1845 Appellate Body Report, EC – Tariff Preferences, para. 88.

Annex A(4) than consideration of "available pertinent information". This also appears to be the
Appellate Body's view, for it stated in Japan – Agricultural Products II that:
"Article 5.7 states that the additional informa tion is to be sought in order to allow the
Member to conduct 'a more objective assessment of risk'. Therefore, the information
sought must be germane to conducting such a risk assessment , i.e., the evaluation of
the likelihood of entry, establishment or spread of, in casu, a pest, according to the
SPS measures which might be applied."
1848
7.2989 It is clear from this statement that by "suc h a risk assessment" the Appellate Body meant "a
more objective assessment of risk". We consid er that the use of "more" objective invokes a
movement in a certain direction, that is, towards the eventual "objective" assessment of risk as defined
in Annex A(4), i.e., an evaluation of the likelihood of entry, establishment or spread of a pest,
according to the SPS measures which might be applied.
7.2990 According to the Appellate Body, "'relevant scien tific evidence' will be 'insufficient' within
the meaning of Article 5.7 if the body of availabl e scientific evidence does not allow, in quantitative
or qualitative terms, the performance of an adequa te assessment of risks as required under Article 5.1
and as defined in Annex A to the SPS Agreement".1849 Thus, if a Member may provisionally adopt an
SPS measure on the basis of available pertinent information in situations where the scientific evidence
is insufficient for an adequate risk assessment , as required by Article 5.1 and as defined in
Annex A(4), it makes sense to require, as the second sentence of Article 5.7 does, that that Member
seek to obtain "the additional information necessary" for such a risk assessment. Once a Member has
obtained the additional information necessary for a risk assessment which meets the definition of
Annex A(4), it will be in a position to comply w ith its obligation in Article 5.1 to base its SPS
measure on a risk assessment which satisfies the definition of Annex A(4).
7.2991 Based on the foregoing considerations, we th ink the second sentence of Article 5.7 does not
support the view that SPS measures which have been provisionally adopted pursuant to Article 5.7
can be maintained only if they are based on a ri sk assessment as required under Article 5.1 and as
defined in Annex A(4). However, there is one element of the second sentence of Article 5.7 which we
need to examine further.
7.2992 The second sentence of Article 5.7 refers to "a more objective assessment of risk" (emphasis
added). The element "more objective" suggests th at SPS measures provisionally adopted pursuant to
the first sentence of Article 5.7 must also be based on a risk assessment, namely, a risk assessment
which takes into account available pertinent informa tion. It follows that if the first sentence of
Article 5.7 required a risk assessment, it would necessarily be different in nature from the kind of risk
assessment envisaged in Annex A(4). In other wo rds, any risk assessment which might be required
by the first sentence of Article 5.7 would not n eed to meet the definition of a risk assessment
contained in Annex A(4). The a bove-mentioned interpretation by th e Appellate Body of the phrase
"[i]n cases where relevant scientific evidence is insuffi cient" also supports this view. For if the right
conferred by the first sentence of Article 5.7 only arises in cases where th e scientific evidence is
insufficient for an adequate risk assessment as required by Article 5.1 and as defined in Annex A(4),
then the kind of risk assessment which the first sen tence might require by definition could not meet
the standard set out in Annex A(4).

1848 Appellate Body Report, Japan – Agricultural Products II, para. 92 (emphasis added).
1849 Appellate Body Report, Japan – Apples, para. 179.

7.2993 In the light of the above, we consider that s ubject to compliance with the requirements set out
in Article 5.7, SPS measures may be provisionally a dopted and maintained under Article 5.7 even if
these measures are not based on a risk assessment as defined in Annex A(4) . Accordingly, we
conclude that Article 5.7 permits Members to do, in certain circumstances, what they would not be
permitted to do under Article 5.1.
7.2994 The next issue for consideration is whether either Article 5.1 or Article 5.7 refers to the other
provision. The first thing to be noted with regard to this issue is that neither Article 5.1 nor
Article 5.7 contains an explicit cross-reference to the other provision. Our previous discussion of the
relationship between Article 5.1 a nd Article 5.7 shows, however, that Article 5.7 contains implicit
references to Article 5.1. First, the second sentence of Article 5.7 refers to "a more objective risk
assessment", a phrase which we have construed to refe r to a risk assessment within the meaning given
to that term in Annex A(4). We have also noted that only Article 5.1 requires a risk assessment as
defined in Annex A(4). Secondly, we have noted earlier that according to the Appellate Body,
relevant scientific evidence is "insufficient" within the meaning of the first sentence of Article 5.7 if it
does not allow the performance of an adequate as sessment of risks as required under Article 5.1 and
as defined in Annex A(4). Thus, through its inte rpretation of the phrase "[i]n cases where relevant
scientific evidence is insufficient", the Appellate Bo dy has made explicit a re ference to Article 5.1
which in its view is implicit in Article 5.7. Ind eed, the Appellate Body justified its interpretation on
the basis that there is "a link or relationship betw een the first requirement under Article 5.7 and the
obligation to perform a risk assessment under Article 5.1".
1850 In view of these elements, we conclude
that Article 5.7 should be considered to refer to Article 5.1.
7.2995 The last element we need to address in accordance with the general test set out in EC – Tariff
Preferences is whether either Article 5.1 or Article 5.7 suggests that the obligation in Article 5.1 to
base SPS measures on a risk assessment is not appli cable to measures falling within the scope of
Article 5.7. We begin by noting that unlike Article 2.2, Article 5.1 does not explicitly say that its
provisions apply "except as provided for in paragrap h 7 of Article 5". However, Article 5.7 opens
with the phrase "[i]n cases where relevant scientific evidence is insufficient". As mentioned by us
before, the Appellate Body opined that "'relevant scientific evidence' will be 'insufficient' within the
meaning of Article 5.7 if the body of available scien tific evidence does not allow, in quantitative or
qualitative terms, the performance of an adequate assessment of risks as required under Article 5.1
and as defined in Annex A to the SPS Agreement".1851 Accordingly, if the right conferred by the first
sentence of Article 5.7 only arises in cases where the scientific evidence is insufficient for an adequate
risk assessment as defined in Annex A(4), and if, as the Appellate Body suggests, Article 5.1 requires
such a risk assessment, then the logical conclusion to be drawn is that the obligation in Article 5.1 to
base SPS measures on a risk assessment was not intende d to be applicable to measures falling within
the scope of Article 5.7. Indeed, "[i]n cases where relevant scientific evidence is insufficient", it is
impossible, under the Appellate Body's interpretation of that phrase, for Members to meet the
obligation to base their SPS measures on a risk as sessment as defined in Annex A(4). We find it
unreasonable to assume that Members would accept, even in principle, an obligation with which they
cannot comply. In our view, the phrase "[i]n cases wh ere relevant scientific ev idence is insufficient"
should, therefore, be taken to suggest that the oblig ation in Article 5.1 is not applicable to measures
falling within the scope of Article 5.7.
7.2996 In addition, we think the clause "except as pr ovided for in paragraph 7 of Article 5" in
Article 2.2 also suggests that the obligation in Artic le 5.1 is not applicable to measures falling within
the scope of Article 5.7. We recall in this regard that in EC – Hormones the Appellate Body agreed

1850 Ibid.
1851 Ibid.

with a statement by the panel in that case that Artic le 5.1 may be viewed as a specific application of
the basic obligations contained in Article 2.2.
1852 If Article 5.1 is properly viewed as a specific
application of the obligations provided for in Ar ticle 2.2, it follows that Article 5.1 cannot be
applicable in situations where Article 2.2 is not a pplicable. We have explained above that the clause
"except as provided for in paragraph 7 of Article 5" exempts the kinds of situations covered by
Article 5.7 from the obligation in Article 2.2 to en sure that SPS measures are not maintained without
sufficient scientific evidence. Since Article 5.1 is not applicable in situations where Article 2.2 is not
applicable, the clause "except as provided for in pa ragraph 7 of Article 5" in Article 2.2 necessarily
implies that Article 5.1 cannot be applicable in situations covered by Article 5.7.
7.2997 From our analysis above, it is clear that the general test stated by the Appellate Body in EC –
Tariff Preferences can be applied also to the relationship between Article 5.1 and Article 5.7. Our
application of that test has shown that this rela tionship meets all the elements which according to the
Appellate Body support characterizing Article 5.7 as a right vis-à-vis Article 5.1. Furthermore, we
think it would be incongruous to reach the conclusion that Article 5.7 is a right vis-à-vis Article 2.2,
but an exception vis-à-vis Article 5.1. For these reasons, we conclude that Article 5.7 should be
characterized as a right also in relation to Article 5.1, rather than as an exception from a "general
obligation" under Article 5.1. In our view, Ar ticle 5.7 operates as a qualified exemption from the
obligation under Article 5.1 to base SPS measures on a risk assessment.
7.2998 We have already stated the main implications of characterizing Article 5.7 as a qualified right
rather than as an exception in our discussion of the relationship between Article 2.2 and Article 5.7.
Nonetheless, for clarity, it is useful to do so again given that we are concerned here with the
relationship between Article 5.1 and Article 5.7. Thus, in terms of applicability of Article 5.1,
characterizing Article 5.7 as a right means that if a challenged SPS measure was adopted and is
maintained consistently with the four cumulativ e requirements of Article 5.7, the obligation in
Article 5.1 to base SPS measures on a risk assessment is not applicable to the challenged measure.
Conversely, if a challenged SPS measure is not cons istent with one of the four requirements of
Article 5.7, the aforementioned obligation in Article 5.1 is applicable to that measure, provided there
are no other elements which render Article 5.1 inapplicable.
7.2999 We note in this context that in relation to the safeguard measures at issue in this dispute, the
European Communities has advanced the argument th at in the event the Panel deemed Article 5.1
applicable, the phrase "as appropriate to the circum stances" in Article 5.1 would send the Panel right
back to Article 5.7, because, in the European Communities' view, the safeguard measures in question
are provisional measures, and the circumstances are th at the scientific evidence is insufficient. The
European Communities has not explained how the phrase "as appropriate to the circumstances" would
"send the Panel back" to Article 5.7. We note th at the European Communities' argument is premised
on the applicability of Article 5.1. In view of the assumptions posited by the European Communities
– provisional adoption of the safeguard measures in a situation where relevant scientific evidence is
insufficient – Article 5.1 would be applicable onl y if the safeguard measures are not maintained
consistently with the second sentence of Article 5.7. We fail to see how in such a case, that is, in a

1852 Appellate Body Report, EC – Hormones , para. 180. See also Appellate Body Report, Japan –
Agricultural Products II, para. 82. It appears that the Appellate Body views Article 5.1 as a specific application
of the second and third obligation in Article 2.2, i.e., the obligation to base SPS measures on scientific principles
and the obligation not to maintain SPS measures without sufficient scientific evidence. In Australia – Salmon,
the Appellate Body agreed with the panel in that case that in the event an SPS measure is not based on a risk
assessment as required in Article 5.1, this measure can be presumed, more generally, not to be based on
scientific principles or to be maintained without suffici ent scientific evidence within the meaning of Article 2.2.
Appellate Body Report, Australia – Salmon, para. 138.

case where the right conferred by Article 5.7 could not be validly asserted, the phrase "as appropriate
to the circumstances" in Article 5.1 could "send the Panel back" to Article 5.7.
7.3000 We now turn to the implications of characteriz ing Article 5.7 as a qualified right rather than
as an exception for the allocation of the burden of proof concerning the issue of the consistency of an
SPS measure with Article 5.7. In our view, the im plication is that in cases where a complaining party
alleges that an SPS measure is inconsistent with Ar ticle 5.1, it is incumbent on the complaining party,
and not the responding party, to demonstrate that the challenged measure is inc onsistent with at least
one of the four requirements set forth in Article 5. 7. If such non-compliance is demonstrated, then,
and only then, is Article 5.1 applicable to the ch allenged SPS measure. Accord ingly, we think that
when a complaining party presents a claim of vi olation under Article 5.1, the burden is on the
complaining party to establish a prima facie case of inconsistency with both Articles 5.1 and 5.7.
7.3001 We recognize that previous panels have found inconsistencies with Article 5.1 without
specifically examining whether the complaining party had established a prima facie case of
inconsistency with both Articles 5.1 and 5.7.
1853 In our view, this reflects the fact that in these cases
the responding party did not invoke the provisions of Article 5.7 in response to a claim of violation
under Article 5.1. In other words, in previous cases, the responding parties did not contest that the
relevant measure fell to be assessed under Article 5.1 as opposed to Article 5.7. Since we are
confronted in this case with a different situation, it would be improper for us to place the burden of
establishing a prima facie case of inconsistency w ith Article 5.7 on the responding party on the
grounds that panels in the past did not explicitly require of the complaining party that it establish a
prima facie case of inconsistency with both Articles 5.1 and 5.7. The fact that responding parties in
the past did not contest the applicability of Article 5.1 does not, and should not, preclude the
responding party in the present case from doing so and thus asserting the right conferred on it by
Article 5.7.
7.3002 Additionally, we note that if we had determin ed that Article 5.7 is an exception from a
"general obligation" under Article 5.1, the burden would be on the responding party to demonstrate
that the challenged measure is consistent with all of the requirements set forth in Article 5.7. In
contrast, in the context of a claim under Article 2.2, it is, according to our view, incumbent on the
complaining party to establish a prima facie case of inconsistency with Article 5.7. If we were to
accept such a situation, a complaining party coul d unilaterally determine whether to assume the
burden of establishing a prima facie case of inconsistency with Article 5.7. If it wished to avoid that
burden, all it would need to do is to present a cl aim of violation under Article 5.1 rather than under
Article 2.2. This, we think, is a further reason fo r conceiving of the relationship between Article 5.1
and Article 5.7 in the same way as of the relationship between Article 2.2 and Article 5.7.
(iii) Conclusion
7.3003 We have now completed our analysis of the two arguments presented by the European
Communities in support of its contention that the safeguard measures must not be assessed under
Article 5.1. Regarding the first argument, we have found that even if the European Communities
were correct in asserting that the safeguard measures at issue in this dispute are provisional measures,
this fact alone would not render Article 5.1 inapplicable.
7.3004 Regarding the second argument, we have determin ed that Article 5.7 does not provide for an
exception from Article 5.1, but establishes a qualified right. We have said that, on this view of the

1853 But see, Panel Report, Australia – Salmon, para. 8.57, where the panel intimated, in the context of
an inquiry under Article 5.1, that the challenged measure was not consistent with Article 5.7.

relationship between Article 5.1 a nd Article 5.7, if an SPS measur e challenged under Article 5.1 was
adopted and is maintained consistently with the cu mulative requirements of Article 5.7, the obligation
in Article 5.1 to base SPS measures on a risk assessmen t is not applicable to the challenged measure.
In such a case, the complaining party would not have invoked the "wrong" provision, in the sense that
it should have brought a challenge under Article 5.7 instead of Article 5.1. The complaining party
would have invoked the "correct" provision, but the complaining party's claim under Article 5.1 could
not succeed as long as the responding party complies with the requirements of Article 5.7.
7.3005 In the present case, the Complaining Parties are challenging the safeguard measures under
Article 5.1. It is clear from the previous paragr aph that, in such circumstances, it is both necessary
and appropriate to examine the c onsistency of the safeguard measur es with Article 5.7 within the
context, and as part, of an examination of the cons istency of the same measures with Article 5.1.
Therefore, unlike the European Co mmunities, we consider that we may, and indeed must, assess the
safeguard measures under Article 5.1.
1854 Accordingly, in the next section, we will address the issue
of the consistency of the individual safeguard measures with Article 5.1.
7.3006 Concerning the structure of our Article 5.1 anal ysis, one possibility would be to examine first
whether the Complaining Parties have met their burden of establishing a prima facie case of
inconsistency with Article 5.7 in respect of the rele vant safeguard measures. However, in the specific
circumstances of this case, the critical legal issue in our view is whether the relevant safeguard
measures meet the requirements set out in the text of Article 5.1, not whether they are consistent with
Article 5.7. Therefore, consistent with the order of analysis followed by the panels in Japan –
Agricultural Products II and Japan – Apples when examining the consistency of measures with
Articles 2.2 and 5.7, we prefer to begin our Article 5.1 analysis by examining whether the relevant
safeguard measures meet the requirements set out in th e text of Article 5.1, notably the requirement to
base SPS measures on a risk assessment.
7.3007 Under this approach, should we find that a relevant safeguard measure meets the requirements
set out in the text of Article 5.1, there would be no need to examine the Complaining Parties' claims
under Article 5.1 further, as their claims would then fail even if we were satisfied that the safeguard
measure is not consistent with Article 5.7 and th at Article 5.1 therefore applies to the safeguard
measure. Should we find, however, that the safeguard measure does not meet the requirements set out
in the text of Article 5.1, we would need to go on to examine whether this measure is consistent with
the requirements of Article 5.7. If the safeguard measure were consistent with the requirements of
Article 5.7, Article 5.1 would not be applicable and we would consequently need to conclude that the
European Communities has not acted inconsisten tly with its obligations under Article 5.1.
Conversely, if the safeguard measure were incons istent with the requirements of Article 5.7,
Article 5.1 would be applicable and, in view of the assumed fact that the safeguard measure does not
meet the requirements set out in the text of Article 5.1, we would need to conclude that the European
Communities has acted inconsistently with its obligations under Article 5.1.
(c) Consistency with Article 5.1 of the SPS Agreement (initial assessment)
7.3008 As indicated, in this section, we will make an initial assessment of the consistency of the
relevant safeguard measures with Article 5.1 of the SPS Agreement. Specifically, we will examine
whether the safeguard measures meet the requirements set out in the text of Article 5.1. We begin this
task by addressing a number of general arguments put forward by the Parties.

1854 For clarity, we should mention that our assessment of the safeguard measures under Article 5.1
might lead us to conclude that Article 5.1 is not applicable.

(i) General
7.3009 To recall, 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."
7.3010 Annex A(4) of the SPS Agreement provides the following definition of the term "risk
assessment":
"Risk assessment – The evaluation of the likelihood of entry, establishment or spread
of a pest or disease within the territory of an importing Member according to the
sanitary or phytosanitary measures which mi ght be applied, and of the associated
potential biological and economic consequences; or the evaluation of the potential for
adverse effects on human or animal health arising from the presence of additives,
contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs."
7.3011 We have already determined that the releva nt safeguard measures are "SPS measures". As
such, they are subject to the provisions of Article 5.1. Thus, the safeguard measures must be based on
an appropriate risk assessment.
7.3012 The United States claims that the safeguard measures are not based on a risk assessment and
are, therefore, inconsistent with Article 5.1. Although the member States have offered reasons for
their measures, they did not put forth a risk assessment as defined in Annex A(4) of the
SPS Agreement. The member States have expressed concer ns about the potential adverse effects of
the relevant products, or biotech products in genera l, but there is no evidence that these objections
were based on any risk assessments. The only ri sk assessments put forth for the banned products are
those conducted by the member States to which th e product applications were originally submitted,
and by the European Communities' own scientif ic committees. These risk assessments were
favourable to the products, and did not raise any concerns with respect to human health or the
environment. Given that the information provided by the member States in support of their measures
was rejected by the EC scientific committees, which reaffirmed their initial favourable risk
assessment, it cannot be argued that the safeguard me asures bear a "rational relationship" to these risk
assessments. The United States contends that by fai ling to put forth their own risk assessments, or to
provide sufficient information to overturn the European Communities' ear lier positive assessments,
the member States have violated Article 5.1.
7.3013 Canada similarly argues that the safeguard measures are not based on a risk assessment, and
therefore violate Article 5.1. Although the me mber States have presented reasons when notifying
their safeguard measures to the Commission, they did not file any supporting scientific evidence or
analysis that meets the definition of a risk assessment set out in the SPS Agreement. Canada notes
that while the notifications to the Commission point ed to the shortcomings in the risk assessments
done as part of the approval process, or put forward general concerns with respect to risks to human
health or the environment arising from the banned varieties of biotech products, they did not present a
comprehensive analysis of the available scientific evidence. Furthermore, the risk assessments
undertaken by the member States where the products were originally filed and by the EC scientific
committees both supported the approval of the produc t applications. The EC scientific committees
also rejected in each case the reasons presente d by the member States to justify the safeguard
measures. Therefore, it cannot be argued that th e risk assessments available sufficiently support or

reasonably warrant the safeguard measures, nor that there is a rational relationship between these risk
assessments and the member States measures.
7.3014 Argentina also argues that the member States measur es are inconsistent with Article 5.1 and
Annex A(4) of the SPS Agreement. It notes that the member States have failed to perform a risk
assessment within the meaning of the SPS Agreement. The safeguard measures, it argues, have been
adopted and maintained without reference to any t ype of scientific evidence, and in spite of the
scientific committee opinions which "disqualified" the member State measures as lacking any
scientific basis.
7.3015 The European Communities argues that Article 5.1 does not expressly require a "risk
assessment". It requires only that Members take into account risk assessment techniques developed
by the relevant international organizations.
1855 According to the Europ ean Communities, these risk
assessment techniques generally recognize that in certain circumstances, namely in the case of the
adoption of provisional measures, only an assessment, and not a "risk assessment" within the meaning
of the SPS Agreement, is necessary. The European Communities argues, in the alternative, that the
member States' safeguard measures are based on risk assessments within the meaning of the
SPS Agreement, as can be inferred from the history of each safeguard measure as well as the sequence
of events which led the member States to adopt and maintain those measures. 1856 In its response to a
question from the Panel, the European Communities not es that "[a] risk assessment was carried out at
the time when the original […] con sent was given" for the product, and that such risk assessment "can
serve, at least temporarily, as a basis both for the original Community consent, and for the Member
States provisional [safeguard] measures".1857
7.3016 The European Communities further contends that the requirement that an SPS measure be
"based on" a risk assessment does not necessarily mean that this measure must "conform to" the risk
assessment. The same risk assessment may "sufficiently warrant", or "reasonably support", more than
one possible SPS measure, depending, inter alia , on the specific circumstances of the legislator.
There may be both a mainstream scientific opinion on which responsib le and representative
governments may base themselves, and divergent sci entific views on the basis of which equally
responsible and representative governments may act. In other words, the same risk assessment can
reasonably support divergent responses by equally responsible and representative governments. The
European Communities also notes that in any event, the member States have made their own risk
assessments, and that further risk assessments may be forthcoming.1858
7.3017 Canada disagrees with the EC argument that Article 5.1 does not expressly require a "risk
assessment", but only that Members take into account risk assessment techniques developed by
relevant international organizations. That Article 5.1 creates a clear obligation on Members to base
their measures on a risk assessment is supported by the definition of the term "risk assessment" in
Annex A(4), as well as relevant jurisprudence.1859 Canada further notes that it fails to see how the risk
assessments that formed the basis for the European Communities' approval of the products can serve
as the basis for both the original Community consent and for the memb er States' safeguard measures.

1855 EC reply to Panel question No. 107.
1857 EC reply to Panel question No. 107.
1858 Ibid.
1859 Canada argues that relevant jurisprudence supports the interpretation that Article 5.1 creates a clear
obligation on the Members to base their measures on a risk assessment, and that it, together with Article 2.2, is
"essential for the maintenance of the delicate and carefully negotiated balance in the SPS Agreement between
the shared, but sometimes competing, interests of promoting international trade and of protecting the life and
health of human beings" (Appellate Body Report, EC – Hormones, para. 177).

The publicly available scientific opinions do not equi vocate in their conclusions, nor do they present
diverging views on the potential risks associated with these products.
7.3018 Canada notes that while the A ppellate Body has recognized in EC – Hormones that a risk
assessment can reflect diverging views, and that responsible and representative governments may act
in good faith on the basis of divergent opinions, it did not say that "the same risk assessment can
reasonably support divergent responses by equally responsible and representative governments" in
cases where the risk assessments do not contain divergent views. This must be all the more true when
the contrast between the two risk management opti ons, i.e. full approval or complete ban of the
product, is as stark as in this case. Finally, with regard to the European Communities' suggestion that
the member States have conducted their own risk assessment and that such assessments may be
forthcoming, Canada notes that the European Comm unities has failed to present any evidence of such
assessments having been undertaken.
7.3019 The Panel recalls that pursuant to Article 5.1, Members must "base" their SPS measures on a
"risk assessment". To determine whether an SPS meas ure is consistent with Article 5.1, we must
therefore address two distinct issues: (i) whether th ere is a "risk assessment" within the meaning of
the SPS Agreement; and (ii) whether the measure is "based on" this risk assessment.
7.3020 In relation to the first issue, i.e., the issue of whether a risk assessment was carried out, we
note the European Communities' argument that Article 5.1 does not expressly require a "risk
assessment" within the meaning of the SPS Agreement, but only requires that Members take into
account risk assessment techniques developed by relevant international organizations.
7.3021 To the extent the European Communities is ar guing that there is no requirement to assess
"risks", we disagree. By its own terms, Article 5.1 requires Members to base their SPS measures on
an appropriate assessment "of the risks to human, animal or plant life or health".
1860 The immediate
context of Article 5.1 confirms this view. Article 5 is captioned " Assessment of Risk and
Determination of the Appropriate Le vel of Sanitary and Phytosanitary Protection" (emphasis added).
Moreover, Articles 5.2 and 5.3 of the SPS Agreement specify relevant factors to be taken into account
by Members "in the assessment of risks" and "in assessing the risk to animal or plant life or health".
Finally, Article 5.7 of the SPS Agreement provides that in circumstances where relevant scientific
evidence is insufficient and a Member has adopt ed a provisional SPS measure based on available
pertinent information, it must seek to obtain the additional information necessary for a more objective
assessment of "risk".
7.3022 As the European Communities points out, Article 5.1 provides that Members must base their
SPS measures on an appropriate assessment of risks, "taking into account risk assessment techniques
developed by relevant internationa l organizations". In our view, the phrase "taking into account risk
assessment techniques developed by relevant inte rnational organizations" does not address the issue
of whether risks are to be assessed, but rather how risks are to be assessed. This is clear from the
reference to "techniques" of risk assessment. Contrary to the European Communities, we therefore do
not consider that the phrase in question supports the vi ew that no assessment of risks is required. To
the contrary, the phrase in question would, in our view, be unnecessary if there were no requirement
to assess risks.
7.3023 The European Communities asserts that risk asse ssment techniques developed by the relevant
international organizations generally recognize that in circumstances where provisional SPS measures

1860 In Japan – Apples , the Appellate Body referred to an "obligation to conduct an assessment of
'risk'". Appellate Body Report, Japan – Apples, para. 202.

are adopted, an assessment is required, but not a "risk assessment" as that term is defined in the
SPS Agreement. It is not clear to us what the Europe an Communities means by "an assessment". If it
means to say that some type of assessment of ri sks would be required, but not an assessment which
meets the definition of the term "risk assessment" provided in Annex A(4), we see no basis for such
an argument. It is well established in WTO jurispru dence that the Annex A(4) definition is applicable
to Article 5.1.
1861 Moreover, since the definition of the term "risk assessment" in Annex A(4) does not
itself provide for a particular risk assessment "technique", we have difficulty seeing how a particular
risk assessment "technique" developed by an intern ational organization could render inapplicable the
general definition of the term "risk assessment" in Annex A(4). In any event, the European
Communities has not identified th e risk assessment techniques which it says support its assertion that
a "risk assessment" within the meaning of Annex A( 4) is not required in the case of provisional SPS
measures. We therefore do not examine this argument further.
7.3024 We have said that, in our view, an assessment of risks is required. We recall in this respect
that Article 5.1 of the SPS Agreement does not require a Member to conduct its own risk assessment.
As noted by the Appellate Body in EC - Hormones , "Article 5.1 does not insist that a Member that
adopts a sanitary measure shall have carried out its own risk assessment. It only requires that the SPS
measure be 'based on an assessment, as appropriate to the circumstances [...]'. The SPS measure
might well find its objective justification in a risk assessment carried out by another Member, or an
international organization".
1862 Thus, an SPS measure may be based on a risk assessment conducted
by another Member, or an international organization.
7.3025 In the present case, the relevant member St ate safeguard measures might therefore be
supported by a risk assessment carried out by these memb er States in respect of the product subject to
their safeguard measures, or by a risk assessment performed by another entity.
7.3026 Regarding the possibility of there being a risk assessment performed by an entity other than
the member State adopting a particular safeguard m easure, we note that assessments were carried out
in respect of the relevant products before their approval. Before their approval, assessments were
performed by the CA of the member State to which the product application was originally submitted –
the "lead CA"1863- and by the relevant EC scientific committee. Furthermore, after the approval of the
product, these assessments were reviewed by the re levant EC scientific committee on the basis of the
information provided by the member State adopting the safeguard measure.
7.3027 It is common ground among the Parties that the assessments carried out by the lead CA and
by the EC scientific committees constitute "risk asse ssments" within the meaning of Annex A(4) and
Article 5.1 of the SPS Agreement. It is apparent from the assessments provided to us that they
evaluated the likelihood of potential adverse effects on human health and/or the environment, as well
as the associated potential consequences, according to the proposed use of the specific biotech product
under consideration.1864 These assessments were of a qualitativ e and not quantitative nature, however
the WTO jurisprudence has cl early established that the SPS Agreement does not require that risk
assessments be of a quantitative nature in order to satisfy the definition in Annex A(4). We therefore

1861 See, e.g., Appellate Body Reports, Japan – Apples, para. 196; Australia – Salmon, para. 121.
1862 Appellate Body Report, EC - Hormones, para. 190.
1863 We note that for none of the nine safeguard measures at issue the me mber State adopting the
safeguard measure acted as the lead member State during the relevant approval procedure.
1864 We note that the assessments by the relevant EC scientific committees which reviewed these
committees' earlier assessments in the light of information provided by the member States taking safeguard
measures are generally in the nature of supplemental assessments. Thus, the review assessments need to be read
in conjunction with the earlier (original) assessments.

agree with the Parties that risk assessments within the meaning of Annex A( 4) and Article 5.1 have
been conducted in respect of the products subject to the safeguard measures by the lead CA and by the
relevant EC scientific committee. Below, we w ill examine for each safeguard measure whether, in
addition, other risk assessments have been cond ucted in respect of these same products, and in
particular whether the EC member States applying safeguard measures have carried out their own risk
assessment.
7.3028 Once we have determined that one or more risk assessments exist in respect of a product
subject to one of the relevant safeguard measures – and we have already found in the previous
paragraph that such risk assessments exist – we must go on to analyse any claims that the relevant
safeguard measure is "based on" one or more of these risk assessments. With respect to the issue of
whether an SPS measure is "based on" a risk assessm ent, we note that this requirement has been
interpreted as meaning that there must be a rati onal relationship between a risk assessment and the
SPS measure taken, or in other words, that the results of the risk assessment must "sufficiently
warrant" or "reasonably support" the SPS measure at issue.
1865
7.3029 Consistent with the foregoing considerations, we will determ ine below, for each safeguard
measure, whether there exists a "risk assessment " upon which the safeguard measure is "based".
Before undertaking this task, however, we must addr ess one further issue. The issue to be addressed
is whether the maintenance of the relevant safegua rd measures may be justified both by reference to
risk assessments which were carried out before thes e measures were adopted and by reference to risk
assessments which were carried out after these measures were adopted.
7.3030 Article 5.1 does not explicitly speak to this speci fic issue. We recall that Article 5.1 requires
Members to ensure that their SPS measures "are based on" an assessment, "as appropriate to the
circumstances", of risks to animal, plant or human life or health. Regarding the requirement that SPS
measures be "based on" a risk assessment, it is clea r to us that SPS measures must be "based on", or
"sufficiently warranted" or "reasonably supported" by, a risk assessment throughout the period of time
for which these measures are maintained. 1866 In our view, both a risk assessment carried out before
the adoption of a particular safeguard measure a nd a risk assessment carried out after its adoption
could "sufficiently warrant", or "reasonably support", the maintenance of that measure.
7.3031 Also relevant to our inquiry is the requirement that a risk assessment be "appropriate to the
circumstances". The phrase "as appropriate to the ci rcumstances" is unqualified as far as its temporal
scope is concerned. Notably, Article 5.1 does not say "as appropriate to the circumstances existing at
the time of adoption of such measures", or "as appropr iate to the circumstances existing at the time of
the assessment". We think it may be inferred from th e absence of any temporal limitation that at any
given time, SPS measures must be based on an asse ssment of risks which is appropriate to the
circumstances existing at that time. Indeed, this is consistent with the fact that relevant circumstances
may change over time. 1867 A change in relevant circumstances may have an impact on a completed

1865 Appellate Body Report, EC - Hormones, paras. 193-194.
1866 This view is consistent with the following finding by the panel in Australia – Salmon:
We note Australia's statement that its policy of allowing imports of salmon products heat-
treated in accordance with the 1988 Conditions will be reviewed and that for these purposes
an import risk analysis is scheduled. It is possible that this risk analysis provides a rational
basis for the measure at issue. However, as of today and on the basis of the risk assessment
before us, we do not detect such a basis. (Panel Report, Australia – Salmon , para. 8.100
(emphasis added).)
1867 Article 2.2 also contains separate requirements supporting this view, stating that Members shall
ensure that their measures are 1) "b ased on scientific principles" and 2) "not maintained without sufficient
scientific evidence".

risk assessment, and in some cases the impact may be such as to affect the continued relevance of a
completed risk assessment and th e validity of its conclusions.
1868 If and when a change in relevant
circumstances affects the continued relevance an d validity of a completed risk assessment, that
assessment would, in our view, no longer c onstitute an assessment "appropriate to the
circumstances".1869
7.3032 We note that the Appellate Body observed that the phrase "as appropriate to the
circumstances" provides Members with "a certain de gree of flexibility in meeting the requirements of
Article 5.1".1870 However, this statement did not relate to a situation such as the one we are
considering here where relevant circumstances ch ange over time. We see nothing in the ordinary
meaning of the phrase "as appropriate to the circum stances", or in the aforementioned observation by
the Appellate Body, to contradict our view that a change in relevant circumstances could in some
cases render a completed risk assessment no longer "appropriate to the circumstances".
7.3033 This approach is also supported by the context of Article 5.1. Article 5.6 provides that "when
establishing or maintaining [SPS] measures to achieve the appropriate level of sanitary or
phytosanitary protection, Members shall ensure that such measures are not more trade-restrictive than
required to achieve their appropriate level of sanitary or phytosanitary protection" (emphasis added).
We have previously observed that one of the purpos es of a risk assessment is to allow the importing
Member to determine the measure to be applied, if any, for achieving its appropriate level of
protection. Thus, if a Member could maintain und er Article 5.1 a significantly trade-restrictive SPS
measure on the basis of a risk assessment which is no longer appropriate to the circumstances ( e.g.,
due to new scientific evidence which affects the continued relevance and validity of the risk
assessment in question), and a risk assessment appr opriate to the circumstances would establish that
essentially no risk in fact exists, then that Memb er would be "maintaining" an SPS measure which ex
hypothesi is more trade-restrictive than required to achieve its appropriate level of protection, contrary
to the requirements of Article 5.6. Irrespective of whether the trade-restrictive measure could be
challenged under Article 5.6, we cons ider that it would be improper to interpret Article 5.1 so as to
allow the Member to maintain its trade-restrictiv e measure, as such an interpretation would frustrate
an important purpose of a risk assessment, which is "to serve as a basis for regulatory actions" 1871.
The determination of a measure which is not more trade-restrictive than required to achieve a
Member's appropriate level of protection is a relevant "regulatory action".
7.3034 In the present case, the Complaining Parties ar e challenging the maintenance by the European
Communities of the relevant safeguard measures. Thus, in accordance with our interpretation of
Article 5.1 we must examine whether, on the date of establishment of this Panel, each safeguard
measure was based on an assessment of risks which was appropriate to the circumstances existing at
that time. Since what is being challenged is the maintenance of each safeguard measure, it is of no

1868 In our view, the state of scientific knowledge is one example of a circumstance which is relevant to
the assessment of risks and which is subject to change over time. Indeed, evolution of science may result in new
and/or better scientific evidence becoming available, and such evidence may have an effect on the continued
relevance and validity of the conclusions of an existing risk assessment.
1869 It should be noted in this context that, in our view, a completed risk assessment which meets the
definition of Annex A(4) and is consistent with the requirements of Articles 5.2 and 5.3 of the SPS Agreement
would not cease to satisfy that defin ition or these requirements merely becau se there was a change in relevant
circumstances and that change affected the continued relevance of that risk assessment. To provide a simple
example: A risk assessment within the meaning of Annex A(4) which has not been updated over time continues
to be a risk assessment within the meaning of Annex A(4) . However, as we have said, such a risk assessment
may no longer be "appropriate to the circumstances" in the sense of Article 5.1.
1870 Appellate Body Report, EC – Hormones, para. 129.

particular importance whether a specific risk assess ment which is claimed to serve as a basis for a
safeguard measure was performed before or after the adoption of that safeguard measure. What
matters is that the relevant risk assessment was a ppropriate to the circumstances existing at the time
this Panel was established. In the light of this, in our analysis of whether there are risk assessments on
which individual safeguard measures were based at the relevant time, we will consider assessments
which were carried out before these measures were adopted as well as assessments which were carried
out after these measures were adopted.
(ii) Austria – T25 maize
7.3035 The Panel commences its analysis of individual safeguard measures with Austria's measure
on T25 maize. The first issue we will address is wh ether the documents Austria relies on to justify its
safeguard measure meet the definition of a risk assessment.
"Risk assessment"

7.3036 We first recall that in the Reasons document, Austria presented various concerns in support of
its safeguard measure on T25 maize, including, inter alia , the fact that the product had not been
examined under realistic conditions as far as the use of herbicide is concerned, and that no monitoring
programme was foreseen to assess the long-term effects of T25 maize.1872 With respect to its concern
regarding the assessment of long-term effects, Au stria invoked the need to protect sensitive areas,
referring to a study by Hoppichler entitled "Con cepts of GMO-Free Environmentally Sensitive
Areas", which was commissioned by the Austrian Federal Ministry of Women's Affairs and
Consumer Protection (hereafter the "Hoppichler study "). 1873 This study appears to be the only
scientific evidence which Austria relied on at the time of adoption of its safeguard measure.
7.3037 As also noted earlier, Austria invoked furthe r concerns in the January 2004 document,
namely, with respect to risks related to allergenic ity and toxicity, the potential environmental impact
of Bt toxin as well as antibiotic resistance marker genes.1874 In relation to the January 2004 document,
we recall that our task is to assess whether the Austrian safeguard measure was based on a risk
assessment as of 29 August 2003, when this Panel was established. A risk assessment completed after
August 2003 in our view would not assist the Eu ropean Communities in rebutting the Complaining
Parties' claim that Austria's safeguard measure was not based on a risk assessment in August 2003.
However, we note that one of the studies menti oned by Austria in the January 2004 document was
published in March 2003, and we ther efore take it into account. The study in question is a joint study
by the Federal Ministry of the Environmen t ("Umweltbundesamt GmbH") and IFF/IFZ –
Inter-University Research Centre for T echnology, Work and Culture, entitled " Toxicology and
Allergology of GM Products: Investigations into practice and recommendations on the
standardization of risk assessment of genetically modified food " (hereinafter the "March 2003
document").1875
7.3038 Having identified the documents which Austria re lies on to justify its safeguard measure, we
can now go on to determine whether any of these documents constitutes a "risk assessment" within
the meaning of the SPS Agreement.

1872 Exhibit EC-160/At. 3.
1873 Exhibit EC-160/At. 5.
1874 Exhibit EC-158/At. 30.
1875 Exhibit EC-158/At. 41_trans.

7.3039 We recall that Austria justified its safeguard meas ures by reference to concerns relating to the
spread of pollen to cultivated surrounding fiel ds, long-term ecological effects, the potential
development of antibiotic resistance and allergenicit y and toxicity. We have determined that to the
extent Austria's measure is applied to address concerns over the spread of pollen to cultivated
surrounding fields, long-term ecological effects and th e development of antibiotic resistance, it falls
within the scope of Annex A(1)(a) and/or (d) of the SPS Agreement. The first clause of Annex A(4)
to the SPS Agreement provides the following definition for the "risk assessment" to be carried out for
measures which have purposes falling within the scope of Annex A(1)(a) or (d):
"Risk assessment – The evaluation of the likelihood of entry, establishment or spread
of a pest or disease within the territory of an importing Member according to the
sanitary or phytosanitary measures which mi ght be applied, and of the associated
potential biological and economic consequences."
7.3040 Based on this definition, the Appellate Body in Australia – Salmon found that a risk
assessment must:
1876
"1) identify the diseases [or pests] whose entry, establishment or spread a Member
wants to prevent on its territory, as well as the potential biological and economic
consequences associated with the entry, establishment or spread of these diseases;
2) evaluate the likelihood of entry, establishment or spread of these diseases
[or pests], as well as the associated potentia l biological and economic consequences;
and
3) evaluate the likelihood of entry, establishment or spread of these diseases [or pests]
according to the SPS measures which might be applied."
7.3041 We begin our analysis of Austria's Reasons docum ent. In this document, Austria alleges that
T25 maize was not examined under realistic cond itions of the use of the herbicide and of
correspondent agricultural practices; that there was no monitoring programme to assess the long-term
effects of biotech plants and herbicides, and in particular with respect to the protection of
environmentally sensitive areas; that there were no special measures to monitor the possible spread of
pollen to fields in the surroundings cultivated with conventional maize (co-existence); and that
regional ecological aspects were not differentiated as far as resistance development is concerned. We
note that the Reasons document highlights concerns related to the lack of a monitoring programme for
possible long term environmental impacts associated with herbicide use on GM plants and the spread
of pollen from GM cultivated fields to fields in surrounding areas. Regarding the concern over the
spread of pollen, the Reasons document includes refe rences to possibilities of associated risks, but it
does not provide an evaluation of the likelihood of such risks occurring. For example, the document
states that the spread of pollen is "mostly regarded as safe."
1877 On the other hand, the Reasons
document does not make explicit claims regarding the risks associated with the long-term
environmental impacts of herbicide use in conjunc tion with GM crops in eco logically sensitive areas,
but rather refers to the Hoppichler study for discussion of these risks.

1876 Appellate Body Report, Australia-Salmon, para. 121 (bracketed text added).
1877 Exhibit EC-160/At. 3.

7.3042 The Hoppichler study focuses on the protection of environmentally-sensitive areas. Based on
the evidence submitted to us
1878, we understand that Austria is seek ing to prevent the cultivation and
other uses of GMOs on its territory due to possible long-term ecological risks associated with GMOs,
particularly in fragile areas. In addition, the study argues that "multiple releases and the marketing of
GMOs are irreversible processes, and [...] products of organic agriculture will also contain GMOs
even if they are produced strictly on the basis of organic guidelines."1879
7.3043 In considering the Hoppichler study, we recall that the Commission requested the SCP to
analyse the information provided by Austria, including the aforementioned study, in order to
determine whether this information may "constitute relevant scientific evidence, which would cause
the SCP to consider that this product constitutes a risk to human health and the environment." 1880 In
response, the SCP prepared an opinion which notes that the Hoppichler study "does not contain any
new scientific information which is relevant to the or iginal scientific risk assessment that [the SCP]
published in 1998. Rather the document contains arguments for the establishment of GMO-free
environmentally-sensitive areas and summarises surveyed opinions of people who may be confronted
professionally with any environmental effects of the release of GMOs." We understand this statement
to indicate that the SCP did not view this study as a risk assessment.
7.3044 We also note that the Hoppichler study does not indicate relative probability of the potential
risks it identifies, but rather makes reference to possibilities of risks or simply to the inability to
determine probabilities. For example, the document st ates that "there are possibilities of direct risks
which can be assessed with in some limits according to the status of science and technology".
1881
In addition, the study cites two analyses regarding environmental risk assessment of releasing GMOs.
A quote from the first analysis indicates that "t he ecological impact of transgenic grasses may be
pervasive" (emphasis added). 1882 The second analysis is said to demonstrate that "the contamination
of natural gene pools through sy nthetic genes is incalculable in principle in predictive risk
assessment".1883 This statement highlights the lack of estim ated risk associated with gene flow from
GMOs.
7.3045 Regarding these references to possibilities of ri sks, we recall that the Appellate Body in
Australia – Salmon stated that:
"[I]t is not sufficient that a risk assessment conclude that there is a possibility of
entry, establishment or spread of diseases and associated biological and economic
consequences. A proper risk assessment of this type must evaluate the 'likelihood'
i.e., the 'probability', of entry, establishment or spread of diseases and associated
biological and economic consequences."
1884
7.3046 Given the lack of evaluation of likelihood in th e Hoppichler study, we consider that the study
does not meet the definition of a risk assessment as provided in Annex A(4), and therefore does not
constitute a risk assessment within the meaning of Annex A(4) and Article 5.1.

1878 We note that the European Communities provided a summary of the Hoppichler study in English
(Exhibit EC-160/At. 5).
1879 Exhibit EC-160/At. 5, p. 8.
1880 Exhibits US-56; CDA-77; ARG-45 and -46.
1881 Exhibit EC-160/At. 5, p. 4.
1882 Exhibit EC-160/At. 5, p. 4.
1883 Exhibit EC-160/At. 5, p. 4.
1884 Appellate Body Report, Australia – Salmon, paras. 123-124.

7.3047 We now turn to determine whether any of th e relevant documents relied on by Austria
contains a risk assessment with regard to Austri a's concerns over the development of antibiotic
resistance and allergencity and toxicity. We recall in this respect our earlier finding that to the extent
Austria's measure is applied to address such concer ns, it falls within the scope of Annex A(1)(b) the
SPS Agreement. The second clause of Annex A(4) to the SPS Agreement provides the following
definition for the "risk assessment" to be carried out for measures which have purposes falling within
the scope of Annex A(1)(b):
"Risk assessment: [...] the evaluation of the potential for adverse effects on human or
animal health arising from the presence of additives, contaminants, toxins or disease-
causing organisms in food, beverages or feedstuffs."
7.3048 We note that, unlike for the definition of risk assessment contained in the first clause of
Annex A(4), WTO jurisprudence provides little guidance on the meaning of key concepts contained in
the definition provided in the second clause. The Appe llate Body merely observed in this respect that
the first clause is substantially different from the second clause, and that the second clause requires
"only" the evaluation of the "potential" for adverse effects on human or animal health arising from the
presence of certain substances in foods, whereas the first clause requires an evaluation of the
"likelihood" of entry, establishment or spread of a pest or disease and of the associated biological and
economic consequences.
1885 We note that the dictionary defines the term "potential" as "the
possibility of something happening [...] in the future".1886
7.3049 In this context, one relevant document to be examined is the Austrian study on toxicology and
allergology of biotech products of March 2003. This st udy reviews the assessment under
Regulation 258/97 of toxic and allergenic risks of food containing or c onsisting of GMOs. The
objective of the study was to investigate risk assessment practices for food derived from biotech
plants, and to make proposals to "concretise and stan dardise the toxicological and allergological risk
assessment."1887 We consider that this study evaluates risk assessment procedures, and not the
potential for adverse effects on human or animal health arising from the consumption of specific
foods containing or consisting of GMOs. We therefore think that the March 2003 study does not meet
the definition of a risk assessment as provided in Annex A(4).
7.3050 Regarding Austria's concern about the development of antibiotic resistance, we recall that this
concern was raised in the January 2004 document. 1888 However, none of the supporting documents
which were provided to the Panel contains a discussi on of risks associated with this specific concern
in the context of the product at issue. The Austri an study on toxicology and allergology of biotech
products of March 2003 reviews procedures for th e assessment of risks of food containing or
consisting of GMOs; the issue of antibiotic resistance is not included in the analysis. Thus, we are not
aware of any pre-August 2003 document which addresses the issue of antibiotic resistance and which
meets the definition of a risk assessment provided in Annex A(4).
7.3051 In the light of the foregoing, we conclude that the above-mentioned documents relied on by
Austria to justify its safeguard measure are not in themselves risk assessments within the meaning of
Annex A(4) and Article 5.1.

1885 Appellate Body Report, Australia – Salmon, footnote 69.
1886 The Concise Oxford Dictionary , 10th edn, J. Pearsall (ed.) (Oxford University Press, 1999),
p. 1120.
1887 Exhibit EC-158/At. 41, p. 19.
1888 Exhibit EC-158/At. 30.

7.3052 In connection with the documents relied on by Austria, we should also note the European
Communities' argument that Austria's safeguard me asure was based on an assessment "appropriate to
the circumstances" within the meaning of Article 5. 1. According to the European Communities, the
phrase "as appropriate to the circumstances" makes it clear that Members have a certain degree of
flexibility in meeting the requirements of Article 5.1.
1889 The European Communities submits that the
circumstances in the case of the Austrian safegua rd measure include the fact that, from Austria's
perspective, relevant scientific evidence was or is insufficient.
7.3053 We need not determine whether relevant scientific evidence was or is insufficient for Austria,
and if so, whether this would be a relevant circumst ance. Even if this were the case, the flexibility
which the phrase "as appropriate to the circumstan ces" may in some situations provide does not
relieve Austria from the requirement in Article 5.1 to base its safeguard measure on a risk assessment
which meets the definition of Annex A(4). 1890 All of the Annex A(4) definition of the term "risk
assessment" which are applicable to Austria's safegua rd measure, must, in our view, be met. It is
useful to recall in this respect that the Appellate Body in Australia – Salmon observed that an
evaluation of the likelihood of entry, establishment or spread of a pest could be done both
quantitatively and qualitatively.
1891 Moreover, in circumstances where there is little available
scientific evidence, the phrase "as appropriate to the circumstances" may provide a measure of
flexibility in terms of how (but not whether) the ap plicable elements of the Annex A(4) definition,
including the likelihood evaluation, are satisfied. In the case at hand, we have answered in the
negative the question of whether the documents which Austria relied on satisfy the applicable
elements of the Annex A(4) defin ition of the term "risk assessment". Therefore, we see no need to
examine further the European Communities' argument in relation to the phrase "as appropriate to the
circumstances".
7.3054 We have found above that none of the docum ents relied on by Austria constitute risk
assessments. However, the European Communities cont ends that there is a document other than the
documents relied on by Austria which constitutes a risk assessment for T25 maize. The document in
question is the "[r]isk assessment [which] was carri ed out at the time when the original Community
consent was given" (hereafter the "original risk assessment"). 1892 It is not clear from this assertion
whether the European Communities is referring to th e risk assessment conducted by the lead CA or to
that conducted by the SCP. 1893 In any event, we have noted above that it is not in dispute that both of
these documents constitute risk assessments within the meaning of Annex A(4) and Article 5.1.
7.3055 In addition, we note that none of the Parties has argued that, on the date of establishment of
this Panel, the risk assessments conducted by the l ead CA and the SCP were no longer "appropriate to
the circumstances". We also recall in this regard that the SCP confirmed its original risk assessment
after reviewing the information relied on by Austria. In the light of this, and in view of our findings
below with regard to whether the Austrian safeguard measure is "based on" these risk assessments, we
do not need to examine this issue further.

1889 In support of its statement, the European Communities refers to the Appellate Body report on EC –
Hormones, para. 129.
1890 We note in this context the statement by the panel in Australia – Salmon to the effect that the
phrase "as appropriate to the circum stances" "cannot [...] annul or supers ede the substantive obligation resting
on Australia to base the sanitary measure in dispute [...] on a risk assessment". Panel Report, Australia –
Salmon, para. 8.57.
1891 Appellate Body Report, Australia – Salmon, para. 124.
1892 EC reply to Panel question No. 107.
1893 Exhibits EC-160/At. 2; CDA-75 and 87; US-56 (referencing original SCP assessment); ARG-45
and 46 (referencing original SCP assessment).

"Based on"

7.3056 As noted, it is not clear whether the orig inal risk assessment referred to by the
European Communities is the risk assessment conducted by the lead CA or that conducted by the
SCP. In our analysis below, we will examine whethe r, at the time of establishment of this Panel, the
Austrian safeguard measure was "based on" either of these risk assessments.
7.3057 The European Communities presents two main arguments to support its assertion that the
Austrian safeguard measure is based on a risk asse ssment pursuant to Article 5.1. The first argument
of the European Communities is that responsible and representative governments may act either on
the basis of mainstream scientific opinion or on th e basis of a divergent scientific view. Regarding
Austria's safeguard measure on T25 maize, the Eu ropean Communities submits that Austria acted on
the basis of new scientific information, which presented a view divergent from the mainstream
scientific opinion reflected in the original risk assessment.
7.3058 The Panel notes that in EC - Hormones , the Appellate Body observed that a "[r]isk
assessment could set out both the prevailing view representing the 'mainstream' of scientific opinion,
as well as the opinions of scientists taking a divergent view". 1894 It then went on to state that
"responsible and representative governments may act in good faith on the basis of what, at a given
time, may be a divergent opinion coming from qualifie d and respected sources. By itself, this does
not necessarily signal the absence of a reasonable relationship between the SPS measure and the risk
assessment, especially where the risk involved is li fe-threatening in character and is perceived to
constitute a clear and imminent threat to public health and safety."
1895
7.3059 It is important to recall that this statement related to a hypothetical situation where divergent
views were expressed as part of, and in, the same risk assessment. In the case at hand, we are not
aware, and have not been made aware, of any di vergent views that would be expressed in the risk
assessments of the lead CA and SCP concerning T25 maize. Therefore, we are presented here with a
situation that is different from that described by the Appellate Body in EC – Hormones. Furthermore,
we note that the contributions of the Panel's experts do not support the view that the potential risks
arising from the deliberate release of T25 maize and the other biotech products subject to this dispute
can be considered to be risks that are "life-thr eatening in character" or that "constitute a clear and
imminent threat to public health and safety".
1896
7.3060 Where a given risk assessment sets out a divergent opinion 1897 and this opinion comes from
qualified and respected sources, it can be reasona bly said that an SPS measure which reflects the
divergent opinion is "based on" the risk assessment in question inasmuch as th e divergent opinion is
expressed in that risk assessment. In contrast, where a given risk assessment sets out a single opinion,
it cannot be reasonably said that an SPS measure is "based on" that risk assessment if the relevant
SPS measure reflects a divergent opinion which is not expressed in the risk assessment in question.
Ex hypothesi , the opinion expressed in that risk assessm ent would not "sufficiently warrant", or
"reasonably support", the SPS measure taken.
7.3061 In the case of the Austrian safeguard measure, the European Communities asserts that new
scientific information became available and that th is new information justified Austria's differing

1894 Appellate Body Report, EC - Hormones, para. 194.
1895 Appellate Body Report, EC - Hormones, paras. 193-194.
1896 Ibid.
1897 We use the term "divergent opinion" or "divergent assessment" to refer to an opinion or assessment
which argues for, and supports, a significantly different overall conclusion.

assessment of the risks. Even assuming this were th e case, however, this would not alter the fact that
we are unaware of any divergent opinions expressed in the risk assessments which were conducted by
the lead CA and the SCP. Therefore, it would be clear that, on the date of establishment of this Panel,
Austria's safeguard measure would not have been based on these existing risk assessments, but on its
own modified version of these assessments, namely, its divergent assessment.
7.3062 Even if the alleged divergent assessment by Aust ria in a number of respects did not depart
from the existing risk assessments, Austria's safeguard measure could not, for that reason alone, be
considered to be based on these risk assessments if these assessments reached a different overall
conclusion. To be clear, we are not suggesting that Members cannot rely in part on an existing risk
assessment which sets out a single opinion. But to th e extent they disagree with some or all of the
conclusions contained in such an assessment, it would in our view be necessary for Members to
explain, by reference to the existing assessment, how and why they assess the risks differently, and to
provide their revised or supplemental assessment of the risks. The European Communities or Austria
did not do so in relation to the safeguard measure on T25 maize.
7.3063 Since we are unable to accept the European Co mmunities' first argument in support of its
view that the Austrian safeguard measure is base d on the risk assessments conducted by the lead CA
and the SCP, we must go on to examine the Eu ropean Communities' second argument. The second
argument of the European Communities is that the risk assessment carried out before
Community-wide marketing approval was given, can serve, at least temporarily, as a basis for both
the Community-wide marketing approval and Austri a's provisional safeguard measure. In other
words, the European Communities contends that the same risk assessment can "sufficiently warrant",
or "reasonably support", more than one type of SPS measure, or, as the European Communities puts
it, one and the same risk assessment may justify "divergent responses by equally responsible and
representative governments".
1898
7.3064 As a general matter, the Panel agrees with the European Communities that a particular risk
assessment might conceivably serve as a basis for different types of SPS measures. Indeed, there may
be a range of measures that may be rationally rela ted to a given risk assessment, at least in cases
where a risk is determined to exist. 1899 In the present case, the risk assessments conducted by the lead
CA and by the SCP with regard to T25 maize were favourable. 1900 These assessments concluded that
there was no evidence that T25 mai ze presents any greater risk to human health or the environment
than its conventional (non-biotech) counterpart. Ye t, the safeguard measure which Austria allegedly
adopted on the basis of these risk assessments provides for a complete prohibition of the product. 1901
In our view, the favourable findings of the risk asse ssments in question do not naturally lead to the
conclusion that what is arguably the strictest type of SPS measure, i.e., a complete prohibition, was
warranted in Austria's case to protect human heal th and the environment. To the contrary, these
findings strongly suggest that this type of measure was not sufficiently warranted.
7.3065 The European Communities asserts that each of the safeguard measures at issue in this
dispute is based on the precautionary principle. We would agree that the fact that a Member has

1898 See EC reply to Panel question No. 107.
1899 While there may be a variety of SPS measures th at would be rationally re lated to a given risk
assessment, some of these measures may be inconsistent with Article 5.6 of the SPS Agreement. In other words,
there may be SPS measures which are rationally related to a risk assessment, but more trade-restrictive than
required to achieve a Member's appropriate level or protection.
1900 Exhibits EC-160/At. 2; CDA-75 and 87; US-56 (referencing original SCP risk assessment);
ARG-45 and 46 (referencing original SCP risk assessment).
1901 As we have noted, the prohibition is subject to an exception which applies in cases where the
products are meant to be immediately re-exported after handling and repackaging (Exhibit EC-160/At. 3_trans).

decided to follow a precautionary approach could have a bearing on a panel's assessment of whether
an SPS measure is "based on" a risk assessment as require d by Article 5.1. We consider that if there
are factors which affect scientists' level of conf idence in a risk assessment they have carried out
1902, a
Member may in principle take this into account in determining the measure to be applied for
achieving its appropriate level of protection from risks. 1903 Thus, there may conceivably be cases
where a Member which follows a precautionary appr oach, and which confronts a risk assessment that
identifies uncertainties 1904 or constraints, would be justified in applying (i) an SPS measure even
though another Member might not decide to apply any SPS measure on the basis of the same risk
assessment, or (ii) an SPS measure which is stricter than the SPS measure applied by another Member
to address the same risk. However, even if a Member follows a precautionary approach, its SPS
measures need to be "based on" ( i.e., "sufficiently warranted" or "reasonably supported" by) a risk
assessment. Or, to put it another way, such an appr oach needs to be applied in a manner consistent
with the requirements of Article 5.1.1905
7.3066 In the case of Austria's safeguard measure on T25 maize, the European Communities has not
identified possible uncertainties or constraints in the risk assessments in question, much less explained
why, in view of any such uncertainties or constr aints, Austria's prohibition is warranted by the
relevant risk assessments. Therefore, the Eur opean Communities' argument about the precautionary
approach does not persuade us that Austria's safeg uard measure is "sufficiently warranted" by the
favourable risk assessments which were performed with regard to T25 maize. In other words, if
Austria's safeguard measure reflects a precautionary approach, we consider, based on the evidence
before us, that Austria did not implement that appr oach in a manner consistent with the requirements
of Article 5.1.
7.3067 We note the European Communities' argument th at "based on" does not mean "conform to".
To the extent the European Comm unities means to argue that Members are free to adopt any kind of
SPS measure provided there exists a risk assessment for the product subject to the SPS measure, we

1902 E.g., a limited body of relevant scientific evidence may be such a factor.
1903 This view is consistent with risk assessment techniques established by relevant international
organizations. For instance, the Working Principles for Risk Analysis for Application in the Framework of the
Codex Alimentarius state that "[t]he report of the risk assessment should indicate any constraints, uncertainties,
assumptions and their impact on the risk assessment. Minority opinions should also be recorded. The
responsibility for resolving the impact of uncertainty on the risk management decision lies with the risk
manager, not the risk assessors". Codex Alimentarius Commission, Working Principles for Risk Analysis for
Application in the Framework of the Codex Alimentarius (adopted in June/July 2003), Section III, Codex
Procedural Manual, 14th edition, 2004, para. 25. Along similar lines, the Codex Principles for the Risk Analysis
of Foods Derived from Modern Biotechnology state that "[r]isk managers should take into account the
uncertainties identified in the risk assessment and implement appropriate measures to manage these
uncertainties". Codex Alimentarius Commission, Principles for the Risk Analysis of Foods Derived from
Modern Biotechnology (adopted in June/July 2003), CAC/GL 44-2003, para. 18. Similarly, the IPPC's ISPM
#11 (2001) states in relevant part that "[t]he uncertainty noted in the assessments of economic consequences and
probability of introduction should also be considered and included in the selection of a pest management
option". IPPC, ISPM #11: Pest Risk Analysis for Quarantine Pests , April 2001, para. 3. The quoted passage
stayed the same in the 2004 version of ISPM #11, which applies specifically to living modified organisms.
1904 We are not referring here to the theoretical un certainty which inevitably remains because science
can never provide absolute certainty that a product will never have adverse effects on human health or the
environment. The Appellate Body has made it clear that this theoretical uncertainty is not the kind of risk which
is to be assessed under Article 5.1. Appellate Body Report, EC – Hormones, para. 186.
1905 We recall that according to the Appellate Body, the precautionary principle "has not been written
into the SPS Agreement as a ground for justifying SPS measures that are otherwise inconsistent with the
obligations of Members set out in particular provis ions of that Agreement". Appellate Body Report, EC –
Hormones, para. 124.

disagree. It is correct that the Appellate Body in EC – Hormones has said that the expression
"based on" as it appears in Article 3.1 of the SPS Agreement
1906 does not mean "conform to". 1907
However, the Appellate Body also said in EC – Hormones that in the specific context of Article 5.1,
the expression "based on" should be interpreted to mean "sufficiently warranted by", "reasonably
supported by" or "rationally related to". 1908 As we have said, in the case of Austria's safeguard
measure on T25 maize, there exists no apparent rational relationship between that measure, which
imposes a complete prohibition, and risk assessments which found no evidence that T25 maize
presents any greater risk to human health or th e environment than its conventional (non-biotech)
counterpart.
1909 At any rate, if we were to allow Aust ria effectively to ignore favourable risk
assessments, we would turn these assessments into documents wit hout any substantive importance
and the conduct of these assessments into a mere form ality. Yet, the requirement in Article 5.1 to
"base" an SPS measure on a risk assessment is plainl y a substantive requirement, and not simply a
formal requirement to accompany an SPS measure by a risk assessment.1910
7.3068 In view of the foregoing considerations, wh ile not rejecting the European Communities'
second argument generally, we do not agr ee with the European Communities that Austria's safeguard
measure can be considered to be "based on" the ri sk assessments performed by the lead CA and the
SCP in relation to T25 maize.
7.3069 Accordingly, since we are of the view that Au stria's safeguard measure cannot be considered
to be "based on" the existing (original) risk asse ssments, and recalling also that no other risk
assessment which might reasonably support Austria's safeguard measure has been provided to us, we
find that the Austrian measure prohibiting the placing on the market of T25 maize is not based on a
risk assessment pursuant to Article 5.1.
1911
Overall conclusions
7.3070 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that, contrary to
the provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure
on T25 maize is not based on a risk assessment.

1906 Article 3.1 states in relevant part that "Members shall base their [SPS] measures on international
standards, guidelines or recommendations, where they exist [...]".
1907 Appellate Body Report, EC - Hormones, para. 166.
1908 Ibid., para. 193.
1909 We note that the Appellate Body in EC – Hormones confronted a comparable situation.
Specifically, the Appellate Body found that scientific reports which concluded that the use of certain hormones
for growth promotion purposes was safe did not rationally support an import prohibition maintained by the
European Communities. Appellate Body Report, EC - Hormones, paras. 196-197.
1910 We note that the Appellate Body in EC – Hormones also characterized the requirement that an SPS
measure be "based on" a risk assessment as a "s ubstantive requirement". Appellate Body Report,
EC - Hormones, para. 193.
1911 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the Austrian safeguard measure should be tr eated as constituting one or more SPS measures. Thus,
like the Parties, we will continue to treat this measure as constituting one single SPS measure.

 (ii) DS292 (Canada)

 With reference to DS292, and having re gard to the arguments and evidence presented
by Canada and the European Communities, the Panel finds that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure on
T25 maize is not based on a risk assessment.

 (iii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communities, the Panel finds that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure on
T25 maize is not based on a risk assessment.

7.3071 In view of our findings in the previous para graph with regard to DS291 (United States),
DS292 (Canada) and DS293 (Argentina), it is necessary to examine, in addition, whether the Austrian
safeguard measure on T25 maize is consistent with the requirements of Article 5.7 of the
SPS Agreement. It is only once we have completed this additional examination that we can come to a
final conclusion regarding the c onsistency of the Austrian safeguard measure on T25 maize with
Article 5.1 of the SPS Agreement. We undertake the necessary examination under Article 5.7 in the
next section.
(iii) Austria – Bt-176 maize
7.3072 The Panel turns to its analysis of Austria's m easure on Bt-176 maize. The first issue we will
address is whether the documents Austria relies on to justify its safeguard measure meet the definition
of a risk assessment.
"Risk assessment"

7.3073 We recall from the Reasons document that Austri a's concerns with respect to Bt-176 maize
were related in particular to the issues of gene tr ansfer (development of antibiotic resistance) and the
development of resistance to Bt toxin.1912 With respect to each of these concerns, Austria presented
the scientific reasons for its decision to prohibit Bt-176 maize.1913
7.3074 We note that Austria provided additional scientif ic evidence to the Commission in May 1997
in support of its safeguard measure on Bt-176 maize. 1914 In particular, Austria provided two studies
concerning the development of resistance to Bt toxin arising from the circumstance that transgenic
crops producing insecticidal proteins from Bt are being grown commercially (hereafter the "March
and April 1997 studies").1915

1912 Exhibit EC-158/At. 7.
1913 We note that Austria's Reasons document makes reference to a number of scientific studies in
support of its safeguard measure. However, since these studies were not submitted to the Panel as evidence, we
cannot determine whether any of these studies constitute s in itself a risk assessment on which the safeguard
measure might be based. We do note, however, that many of these studies predate the original EC risk
assessment and would presumably have been known to and taken into account in the context of that risk
assessment.
1914 Exhibit EC-158/At. 10.
1915 Exhibit EC-158/Ats. 11-12.

7.3075 Furthermore, in the January 2004 document, Austria invoked recent scientific findings
concerning risks related to allergenicity and t oxicity, the potential environmental impact of Bt toxin,
including effects on non-target organisms, as well as antibiotic resistance marker genes.
1916 In
relation to the January 2004 document, we recall th at our task is to assess whether the Austrian
safeguard measure was based on a risk assessment as of 29 August 2003, when this Panel was
established. A risk assessment completed afte r August 2003 in our view would not assist the
European Communities in rebutting the Complaining Pa rties' claim that Austria's safeguard measure
was not based on a risk assessment in August 2003. However, we note that one of the studies
mentioned by Austria in the January 2004 document was published in March 2003, and we therefore
take it into account. The study in question is a joint study by the Federal Ministry of the Environment
("Umweltbundesamt GmbH") and IFF/IFZ – Inter-U niversity Research Centre for Technology, Work
and Culture, entitled " Toxicology and Allergology of GM Pr oducts: Investigations into practice and
recommendations on the standardization of ri sk assessment of genetically modified food " (hereinafter
the "March 2003 document").
1917
7.3076 Having identified the documents which Austria re lies on to justify its safeguard measure, we
can now go on to determine whether any of these documents constitutes a "risk assessment" within
the meaning of the SPS Agreement. As with Austria's safeguard measure for T25 maize, given the
concerns raised by Austria in the context of Bt- 176 maize, we consider that both the first and the
second clause of Annex A(4) to the SPS Agreement define the "risk assessment" to be carried out for
Austria's measure on Bt-176 maize.
7.3077 We begin our analysis with Austria's Reasons document. We note that the Reasons document
highlights concerns related to the development of antibiotic resistance and the impacts of the
development of insect resistance to Bt toxin. Furt hermore, we note that Austria makes reference in
the Reasons document to the original risk assess ments undertaken by the Scientific Committee for
Food (SCF), the Scientific Committee for Animal Nutrition (SCAN) and the Scientific Committee on
Pesticides (SCPE). While noting that all the sci entific comments and arguments presented in the
opinions of these scientific comm ittees are "valid and well taken" 1918, Austria asserts that new
scientific results raise questions about the possibilit y of a conclusive evaluation of the mechanism of
gene transfer, as well as the development of resistance to Bt toxin. With regard to these new scientific
results, Austria notes that " possible risks are very hard to assess and should be avoided at the present
state of the scientific discussion." 1919 In a similar vein, the Reasons document states that "[t]here are
adequate maize-products already available which do not comprise these restrictions and by this there
is no reason to accept risks which are difficult to assess". 1920 Elsewhere, the Reasons document states
that "[t]he impact of a transfer of the bla gene to bacteria of humans or animals can not be fully
evaluated".1921 These statements serve to demonstrate th at Austria did not "assess" the alleged risks
identified in the Reasons document. Therefore, we do not consider that the Reasons document
constitutes an "assessment" of ri sks within the meaning of Annex A(4) and Article 5.1 of the
SPS Agreement.
7.3078 We now turn to the two scientific studies that Austria provided to the Commission in
May 1997 in support of its safe guard measure on Bt-176 maize. 1922 These studies focused on the

1916 Exhibit EC-158/At. 30.
1917 Exhibit EC-158/At. 41_trans.
1918 Exhibit 158/At. 7, p. 5.
1919 Ibid.
1920 Ibid.
1921 Exhibit 158/At. 7, p. 6.
1922 Exhibit EC-158/At. 10.

development of resistance to Bt toxin due to th e commercial production of transgenic Bt crops
(studies published in the National Academy of Science from March and April 1997).
1923 Both of these
studies examine the mechanism through which insects de velop resistance to Bt toxin. The first study
describes a technique for estimating the likelihood that a particular population of insects would
develop resistance to Bt toxin, while the second uses genetic analysis to show that a single insect gene
can confer resistance to several different strains of the Bt toxin. The first study focuses on insects
feeding on Bt cotton; the second examines the genetics underlying the evolution of resistance through
feeding studies of insects on Bt toxins in dust form. While the results of these studies may be of
relevance to the assessment of the risks of the poten tial development of resistance to Bt-176 maize,
neither study assesses the likelihood of this risk. For this reason, we do not consider that the
March 1997 and April 1997 studies meet the definition of a risk assessment as provided in
Annex A(4). We therefore consider that these st udies cannot be considered risk assessments within
the meaning of Annex A(4) and Article 5.1.
7.3079 We recall that the European Communities provided as evidence a study by Austria on
toxicological and allergological risks related to biotech products (the March 2003 document).
1924 As
we noted above with respect to T25 maize, we c onsider that this study evaluates risk assessment
procedures, and not the potential for adverse effects on human or animal health arising from the
consumption of specific foods containing or consisting of GMOs. 1925 We therefore think that this
March 2003 study does not constitute a risk assessm ent within the meaning of Annex A(4) and
Article 5.1.
7.3080 In the light of the foregoing, we conclude that the above-mentioned documents relied on by
Austria to justify its safeguard measure are not ri sk assessments within the meaning of Annex A(4)
and Article 5.1.
7.3081 Furthermore, in connection with the documents relied on by Austria, we should also note the
European Communities' argument that Austria' s safeguard measure was based on an assessment
"appropriate to the circumstances" within the me aning of Article 5.1. The European Communities
submits that the circumstances in the case of the Austrian safeguard measure include the fact that,
from Austria's perspective, relevant scientific eviden ce was or is insufficient. We recall our previous
consideration of the European Communities' argument based on the phrase "appropriate to the
circumstances" within the meaning of Article 5. 1 in paragraphs 7.3052-7. 3053 above, and consider
that our conclusions there apply mutatis mutandis to this measure.
7.3082 We have found above that none of the documents relied on by Austria with regard to its
safeguard measure on Bt-176 maize constitute ri sk assessments. Howe ver, the European
Communities contends that there is a document othe r than the documents relied on by Austria which
constitutes a risk assessment for Bt-176. The docum ent in question is the "risk assessment [which]
was carried out at the time when the original Community consent w as given" (hereafter the "original
risk assessment"). 1926 It is not clear from this asserti on whether the European Communities is
referring to the risk assessment conducted by the lead CA or any of the risk assessments which were
conducted by the Scientific Committee for Pesticid es (SCPE), the Scientific Committee for Animal

1923 Exhibit EC-158/Ats. 11-12.
1924 See supra, para. 7.3037.
1925 See supra, para. 7.3049.
1926 EC reply to Panel question No. 107.

Nutrition (SCAN) or the SCF.
1927 In any event, we have noted above that it is not in dispute that all of
these documents constitute risk assessments within the meaning of Annex A(4) and Article 5.1.
7.3083 In addition, we recall that none of the Parties has argued that, on the date of establishment of
this Panel, the risk assessments conducted by th e lead CA and the risk assessments which were
conducted by the SCPE, the SCAN or the SCF were no longer "appropriate to the circumstances". In
the light of this, and in view of our findings belo w with regard to whether the Austrian safeguard
measure on Bt-176 maize is "based on" these risk asse ssments, we do not need to examine this issue
further.
"Based on"
7.3084 We now turn to the question of whether, at th e time of establishment of this Panel, the
Austrian safeguard measure on Bt-176 maize was "based on" either the risk assessment of the lead CA
or any of those conducted by the SCPE, the SCAN or the SCF.1928
7.3085 We note that the European Communities' arguments in respect of this issue were the same as
those it presented in the context of Austria's safe guard measure on T25 maize. We have addressed
these arguments above and have reached the conclusion that Austria's safeguard measure on T25
maize cannot be considered to be "based on" the risk assessments performed by the lead CA and the
SCP in relation to T25 maize. This conclusi on, and the reasoning supporting it, also apply, mutatis
mutandis, to Austria's safeguard measure on Bt-176 maiz e and the risk assessment performed by the
lead CA and the risk assessments which were c onducted by the SCPE, the SCAN or the SCF in
relation to Bt-176. This is because, as in the case of Austria's safeguard measure on T25 maize:
(a) we are not aware of any divergent opinions expressed in the risk assessments which
were conducted by the lead CA and the risk assessments which were conducted by
the SCPE, the SCAN or the SCF with regard to Bt-176 maize;
(b) the European Communities or Austria did not explain, by reference to these risk
assessments, how and why Austria assessed the risks differently, and did not provide
a revised or supplemental assessment of the risks;
(c) the European Communities has not identified possible uncertainties or constraints in
the risk assessments in question, and has not explained why, in view of any such
uncertainties or constraints, Austria's prohibition is warranted by the relevant risk
assessments; and
(d) there is no apparent rational relationship between Austria's safeguard measure, which
imposes a prohibition, and risk assessments which found no evidence that
Bt-176 maize will give rise to any adverse effects on human or animal health and the
environment.
7.3086 Thus, in view of our conclusion that Austri a's safeguard measure on Bt-176 maize cannot be
considered to be "based on" the risk assessment pe rformed by the lead CA or the risk assessments

1927 Exhibits EC-158/Ats. 1-3; EC-158/At. 4; EC-158/At. 5; EC-158/At. 6.
1928 As noted, we must examine as part of our anal ysis whether the safeguard measure is based on any
of those risk assessments, as it is not clear whethe r the original risk assessment referred to by the
European Communities is the risk assessment conducted by the lead CA or those conducted by the SCPE, the
SCAN or the SCF.

which were conducted by the SCPE, the SCAN or th e SCF in relation to Bt-176 maize, and recalling
the fact that no other risk assessment which might reasonably support Austria's safeguard measure has
been provided to us, we find that the Austrian safeguard measure is not based on a risk assessment
pursuant to Article 5.1.
1929
Overall conclusions
7.3087 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that, contrary to
the provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure
on Bt-176 maize is not based on a risk assessment.

 (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 finds that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure on
Bt-176 maize is not based on a risk assessment.

7.3088 In view of our findings in the previous para graph with regard to DS291 (United States) and
DS293 (Argentina), it is necessary to examine, in a ddition, whether the Austrian safeguard measure
on Bt-176 maize is consistent with the requirements of Article 5.7 of the SPS Agreement. It is only
once we have completed this additional examination that we can come to a final conclusion regarding
the consistency of the Austrian safeguard me asure on Bt-176 maize with Article 5.1 of the
SPS Agreement. We undertake the necessary examination under Article 5.7 in the next section.
(iv) Austria – MON810 maize
7.3089 We now turn to the analysis of Austria's meas ure on MON810 maize. The first issue we will
address is whether the documents Austria relies on to justify its safeguard measure meet the definition
of a risk assessment.
"Risk assessment"

7.3090 We recall from the Reasons document that Austri a's concerns with respect to MON810 maize
were related in particular to undesired effect s on non-target organisms and the development of
resistance to Bt toxin in insects. 1930 In relation to each of these concerns, Austria refers to the results
of recent scientific studies. We note that only the following scientific studies invoked by Austria in
the Reasons document in support of its safeguard measure on MON810 maize were submitted to the
Panel:

1929 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the Austrian safeguard measure should be tr eated as constituting one or more SPS measures. Thus,
like the Parties, we will continue to treat this measure as constituting one single SPS measure.
1930 Exhibit EC-159/At. 3.

 (i) Study by Losey (1999), "Transgenic pollen harms monarch larvae"
1931;

 (ii) Study by Hilbeck et al. (1998), "Toxicity of Bacillus thuringiensis Cry1Ab Toxin to
the Predator Chrysoperla carnea (Neuroptera: Chrysopidae)"
1932;

 (iii) Study by Hilbeck et al. (1998), "Effects of transgenic Bacillus thuringiensis corn-fed
prey on mortality and development time of immature Chrysoperla carnea
(Neuroptera: Chrysopidae)"
1933.

7.3091 Furthermore, we recall that in the January 2004 document, Austria invoked scientific findings
concerning risks related to allergenicity and t oxicity, the potential environmental impact of Bt toxin,
as well as antibiotic resistance marker genes. 1934 In relation to the document of January 2004, we
recall that our task is to assess whether the Au strian safeguard measure was based on a risk
assessment as of 29 August 2003, when this Panel was established. A risk assessment completed after
August 2003 in our view would not assist the Eu ropean Communities in rebutting the Complaining
Parties' claim that Austria's safeguard measure was not based on a risk assessment in August 2003.
However, we note that one of the studies menti oned by Austria in the January 2004 document was
published in March 2003, and we ther efore take it into account. The study in question is a joint study
by the Federal Ministry of the Environmen t ("Umweltbundesamt GmbH") and IFF/IFZ –
Inter-University Research Centre for T echnology, Work and Culture, entitled " Toxicology and
Allergology of GM Products: Investigations into practice and recommendations on the
standardization of risk assessment of genetically modified food " (hereinafter the "March 2003
document").1935
7.3092 As with Austria's safeguard measures on T25 maize and Bt-176 maize, given the concerns
raised by Austria in the context of MON810 maize, we consider that both the first and the second
clause of Annex A(4) to the SPS Agreement provide definitions for the "risk assessment" to be carried
out for Austria's measure on MON810 maize.
7.3093 We begin our analysis with Austria's Reasons doc ument. In this document, Austria points to
new scientific evidence which, accord ing to Austria, raises uncertainty with respect to the potential
risks related to MON810 maize, in particular re garding the effects on non-target organisms and the
development of resistance in insects. According to Austria, this new scientific evidence raises doubts
with regard to the safety of MON810 maize for human health or the environment.
7.3094 However, nothing in the Reasons document indicates that Austria carried out a new
assessment of the alleged risks in the light of the scientific evidence mentioned by Austria. We recall
in this connection that a risk assessment must evaluate the likelihood or probability of particular risks,
or evaluate the potential for adverse effects on animal health arising from the presence of certain
substances in food, beverages or feedstuffs. 1936 The Reasons document refers to possibilities of risks
arising in respect of MON810 maize, but it does not itself evaluate the potential for adverse health
effects or the likelihood of the risk of establishment, entry or spread of a pest. For example, Austria
notes that reservations concern the "[p]ossible undesired effects of the Bt toxin on non-target

1931 Exhibit EC-158/At. 24.
1932 Exhibit EC-158/At. 26.
1933 Exhibit EC-158/At. 27.
1934 Exhibit EC-158/At. 30.
1935 Exhibit EC-158/At. 41_trans.
1936 We note that "evaluate" is defined as "form an idea of the amount, number or value of; assess",
Concise Oxford English Dictionary, Eleventh Ed. 2004, p. 493.

organisms and the possible development of resistance in insects".
1937 The document highlights studies
of undesired effects on non-target organisms relate d to the consumption of Bt maize but does not
itself make an evaluation of the potential for adve rse health effects or the likelihood of these
undesired effects occurring in the event th at MON810 maize were to be introduced. 1938 The Reasons
document also identified one study which noted that "further effects on the food chain [of
consumption of Bt pollen by monarch butterflies] are possible." 1939 Yet, there is no evaluation of the
potential for adverse health effects or the likelihood of such effects occurring.
7.3095 Furthermore, we note that with respect to one of the risks identified in the Reasons document,
namely the development of resistance to Bt toxin in insects, the Reasons document states that "[t]he
risk for related groups of insects [...] cannot be assessed conclusively based on the available data." 1940
This statement further confirms that Austria did not "evaluate" or "assess" the alleged risk.
7.3096 Accordingly, we are of the view that the R easons document does not meet the definition of a
risk assessment as provided in Annex A(4). We th erefore consider that the Reasons document cannot
be considered a risk assessment within the meaning of Annex A(4) and Article 5.1.
7.3097 We now turn to the scientific studies referred to by Austria in its Reasons document. Each of
these studies describes aspects of Bt toxin im pacts on insects. The study by Losey, entitled
"Transgenic pollen harms monarch larvae" 1941, describes results from a laboratory experiment in
which monarch butterfly caterpillars were fed Bt maize pollen. The study focuses on a variety of Bt
maize other than MON810 maize. Furthermore, while the Losey study notes that results on larvae
consumption and growth rates have "potentially profound implications for the conservation of
monarch butterflies" there is no attempt to evalua te these potential implications, rather the study
notes that the experimental results point to possible environmental outcomes. For example, in arguing
that monarch butterfly caterpillars are at risk from the production of Bt maize, the study states that
"[t]he large land area covered by corn in this region suggests that a substantial portion of available
milkweeds may be within range of corn pollen deposition". 1942 Hence, we do not consider that the
Losey study in itself constitutes a risk assessment with in the meaning of either the first or the second
clause of Annex A(4) and Article 5.1.
7.3098 The second study, by Hilbeck et al., on "[t]oxicity of Bacillus thuringiensis Cry1Ab Toxin to
the Predator Chrysoperla carnea (Neuroptera: Chrysopidae)" 1943 described a feeding study in which
insects were fed a liquid diet containing Bt toxins, rath er than being fed Bt plants directly. Thus, we
do not consider that this study evaluated the potentia l for adverse effects associated with the insects
eating MON810 maize plants. In addition, in its conclusion it notes that "trials investigating predation
efficiency and predator performance under fiel d conditions are necessary before conclusions
regarding the potential ecological relevance of the results presented [...] can be drawn." 1944 Hence,
like the Losey study, the study by Hilbeck et al. does not evaluate the likelihood of an outcome in the
field. Accordingly, as with the Losey st udy, we do not consider that the Hilbeck et al. study in itself
constitutes a risk assessment within the meaning of ei ther the first or the second clause of Annex A(4)
and Article 5.1, although we accept that it may be of relevance for a risk assessment.

1937 Exhibit EC-159/At. 3_trans p. 5.
1938 Exhibit EC-159/At. 3_trans pp. 5-6.
1939 Exhibit EC-159/At. 3_trans p. 6.
1940 Exhibit EC-159/At. 3_trans p. 8.
1941 Exhibit EC-158/At. 24.
1942 Exhibit EC- 158/At. 24 (emphasis added).
1943 Exhibit EC-158/At. 26.
1944 Exhibit EC-158/26 p. 7.

7.3099 The third study, also by Hilbeck et al., concerns "[e]ffects of transgenic Bacillus thuringiensis
corn-fed prey on mortality and development time of immature Chrysoperla carnea (Neuroptera:
Chrysopidae)".
1945 This study used a maize hybrid containing a gene from Bacillus thuringiensis .
The study provides information regarding the impact on non-maize eating insects of eating
herbivorous insects raised on Bt maize and thus is aimed at evaluating non-target impacts of Bt crop
cultivation. While this study concludes that, in this experiment, differences in mortality exist for
insect predators fed prey raised on Bt versus non-Bt maize, the study notes that "[n]o conclusions can
be drawn at this point as to how results from [... ] laboratory trials might translate in the field".
1946
This statement, in our view, implies that this study per se cannot be said to evaluate the alleged risks
identified by Austria in its Reasons document. In addition, given the lack of conclusions concerning
how the laboratory trials might translate in the fiel d noted above, we do not consider that the second
Hilbeck study provides an evaluation of the poten tial for adverse effects on insect health from the
presence of Bt toxin in food or feedstuffs. Therefore, we do not consider that this study in itself
constitutes a risk assessment within the meaning of ei ther the first or the second clause of Annex A(4)
and Article 5.1, although we accept that it may be of relevance for a risk assessment.
7.3100 Finally, we recall that the European Comm unities provided as evidence a study by Austria on
toxicological and allergological risks related to biotech products (the March 2003 document). 1947 As
we noted above with respect to T25 maize, we c onsider that this study evaluates risk assessment
procedures, and not the potential for adverse effects on human or animal health arising from the
consumption of specific foods containing or consis ting of GMOs. We therefore think that this
March 2003 study does not constitute a risk assessm ent within the meaning of Annex A(4) and
Article 5.1.
7.3101 In the light of the foregoing, we conclude that the above-mentioned documents relied on by
Austria to justify its safeguard measure are not ri sk assessments within the meaning of Annex A(4)
and Article 5.1.
7.3102 Furthermore, in connection with the documents relied on by Austria, we should also note the
European Communities' argument that Austria' s safeguard measure was based on an assessment
"appropriate to the circumstances" within the me aning of Article 5.1. The European Communities
submits that the circumstances in the case of the Austrian safeguard measure include the fact that,
from Austria's perspective, relevant scientific eviden ce was or is insufficient. We recall our previous
consideration of the European Communities' argument based on the phrase "appropriate to the
circumstances" within the meaning of Article 5. 1 in paragraphs 7.3031-7. 3032 above, and consider
that our conclusions there apply mutatis mutandis to this measure.
7.3103 We have found above that none of the documents relied on by Austria with regard to its
safeguard measure on MON810 maize constitute ri sk assessments. However, the European
Communities contends that there is a document othe r than the documents relied on by Austria which
constitutes a risk assessment for MON810 maize. The document in question is the "risk assessment
[which] was carried out at the time when the orig inal Community consent was given" (hereafter the
"original risk assessment").1948 It is not clear from this assertion whether the European Communities
is referring to the risk assessment conducted by the lead CA or to that conducted by the SCP. 1949 In

1945 Exhibit EC-158/At. 27.
1946 Exhibit EC-158/At. 27 p. 485.
1947 See supra, para. 7.3069.
1948 EC reply to Panel question No. 107.
1949 Exhibits EC-159/Ats. 1-2; CDA-82; US-55 (refe rencing original SCP risk assessment); ARG–44
(referencing original SCP risk assessment).

any event, we have noted above that it is not in dispute that both of these documents constitute risk
assessments within the meaning of Annex A(4) and Article 5.1
7.3104 In addition, we note that none of the Parties has argued that, on the date of establishment of
this Panel, the risk assessments conducted by the l ead CA and the SCP were no longer "appropriate to
the circumstances". In the light of this, and in view of our findings below with regard to whether the
Austrian safeguard measure on MON810 maize is "based on" these risk assessments, we do not need
to examine this issue further.
"Based on"

7.3105 We now turn to the question of whether, at th e time of establishment of this Panel, the
Austrian safeguard measure on MON810 maize was "b ased on" either the risk assessment of the lead
CA or that conducted by the SCP.1950
7.3106 We note that the European Communities' arguments in respect of this issue were the same as
those it presented in the context of Austria's safe guard measure on T25 maize. We have addressed
these arguments above and have reached the conclusion that Austria's safeguard measure on T25
maize cannot be considered to be "based on" the risk assessments performed by the lead CA and the
SCP in relation to T25 maize. This conclusi on, and the reasoning supporting it, also apply, mutatis
mutandis, to Austria's safeguard measure on MON810 maize and the risk assessments performed by
the lead CA and the SCP in relation to MON810 mai ze. This is because, as in the case of Austria's
safeguard measure on T25 maize:
(a) we are not aware of any divergent opinions expressed in the risk assessments which
were conducted by the lead CA and the SCP with regard to MON810 maize;
(b) the European Communities or Austria did not explain, by reference to these risk
assessments, how and why Austria assessed the risks differently, and did not provide
a revised or supplemental assessment of the risks;
(c) the European Communities has not identified possible uncertainties or constraints in
the risk assessments in question, and has not explained why, in view of any such
uncertainties or constraints, Austria's prohibition is warranted by the relevant risk
assessments; and
(d) there is no apparent rational relationship between Austria's safeguard measure, which
imposes a prohibition, and risk assessmen ts which found no evidence that MON810
maize is likely to cause adverse effect s on human or animal health and the
environment.
7.3107 Thus, in view of our conclusion that Austri a's safeguard measure on MON810 maize cannot
be considered to be "based on" th e risk assessments performed by the lead CA or the SCP in relation
to MON810 maize, and recalling the fact that no other risk assessment which might reasonably

1950 We recall that we must examine as part of our analysis whether the safeguard measure is based on
either risk assessment, as it is not clear whether the original risk assessment referred to by the
European Communities is the risk assessment conducted by the lead CA or that conducted by the SCP.

support Austria's safeguard measure has been provid ed to us, we find that the Austrian safeguard
measure is not based on a risk assessment pursuant to Article 5.1.
1951
Overall conclusions
7.3108 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that, contrary to
the provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure
on MON810 maize is not based on a risk assessment.

 (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 finds that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure on
MON810 maize is not based on a risk assessment.

7.3109 In view of our findings in the previous para graph with regard to DS291 (United States) and
DS293 (Argentina), it is necessary to examine, in a ddition, whether the Austrian safeguard measure
on MON810 maize is consistent with the requirements of Article 5.7 of the SPS Agreement. It is only
once we have completed this additional examination that we can come to a final conclusion regarding
the consistency of the Austrian safeguard me asure on MON810 maize with Article 5.1 of the
SPS Agreement. We undertake the necessary examination under Article 5.7 in the next section.
(v) France – MS1/RF1 oilseed rape (EC-161)
7.3110 We now turn to the analysis of France's measure on MS1/RF1 oilseed rape (EC-161). The
first issue we will address is whether the documents France relies on to justify its safeguard measure
meet the definition of a risk assessment.
"Risk assessment"

7.3111 We recall from the Reasons document that the main concerns of France were related to the
risk of contamination of traditional oilseed rape by genetically modified oilseed rape; the likelihood
of transfer of the herbicide-tolerance gene to adventitious flora; and the overall impact on the
environment or long-term ecological effects of MS1/RF1 oilseed rape (EC-161). 1952 With respect to
France's concerns related to gene flow and pollen dispersal, we note that France makes reference to a
number of scientific studies. However, these studies were not submitted as evidence to the Panel. We
therefore cannot determine whether any of these studies constitutes a risk assessment on which the
safeguard measure on MS1/RF1 oilseed rape (EC-161) is based.

1951 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the Austrian safeguard measure should be tr eated as constituting one or more SPS measures. Thus,
like the Parties, we will continue to treat this measure as constituting one single SPS measure.
1952 Exhibits EC-161/At. 2 and EC-162/At. 5.

7.3112 We further recall that the decision by France to extend the suspension of the authorization for
placing on the market of MS1/RF1 oilseed rape (EC- 161) in July 2001 and Ju ly 2003 were allegedly
based on the conclusions of opinions delivered by the BEC in 2001 and 2003, respectively. We note
that the BEC delivered a further opinion on MS1/RF 1 oilseed rape (EC-161) on 13 February 2004.
1953
We recall that we must assess whether the Fren ch safeguard measure on MS1/RF1 oilseed rape
(EC-161) was based on a risk assessment as of August 2003, when this Panel was established. Since
the 2004 opinion of the BEC was delivered after the time of establishment of the Panel, we do not
take it into account as part of our analysis.
7.3113 Having identified the documents which France re lies on to justify its safeguard measure, we
can now go on to determine whether any of these documents constitutes a "risk assessment" within
the meaning of the SPS Agreement. We recall our previous conclusion that France's concerns fall
within the scope of Annex A(1)(a) and/or (d). We consider, therefore, that the first clause of
Annex A(4) to the SPS Agreement provides the relevant definition for the "risk assessment" to be
carried out for France's measure on MS1/RF1 oilseed rape (EC-161) and consider that the
requirements for such a risk assessment, as clarified by the Appellate Body in Australia–Salmon,
apply.
7.3114 The Panel begins its analysis with France's Reasons document. In this document, France
points to new scientific evidence which, according to France, raises uncertainty with respect to the
potential risks related to MS1/RF1 oilseed rape (E C-161), in particular regarding the environmental
effects associated with out-crossing between MS1/RF1 oilseed rape (EC-161) and other plants.
According to France, this new scientific evidence raises doubts with regard to the environmental
safety of MS1/RF1 oilseed rape (EC-161).
7.3115 We note that nothing in the Reasons document indicates that France has made a new
assessment of the alleged risks in the light of th e scientific evidence invoked by France. Indeed, we
are of the view that the statement in the Reasons document that "these possible developments in
agronomic practices must be assessed in term s of their overall impact on the environment"
1954 implies
that France is calling for further study rather th an presenting a new assessment. Furthermore, the
Reasons document notes that a prohibition of MS1/RF 1 oilseed rape (EC-161) is justified "pending a
clear and full scientific report on these issues". 1955 Consequently, we are of the view that the Reasons
document does not itself constitute an "assessment" of risks within the meaning of Annex A(4) and
Article 5.1.1956
7.3116 We also note that while the Reasons document re fers to the likelihood of risks arising in
respect of MS1/RF1 oilseed rape (EC-161), the document does not "evaluate" the likelihood of the
risk of establishment, entry or spread of a pest ( in casu , hybrid plants) "according to the [SPS]
measures which might be applied". It is merely co ncluded that "dispersal into the environment [of
herbicide tolerance tr ansgenes] is likely".
1957 The discussion in the Reasons document cannot
therefore be said to meet the definition of a risk assessment as defined in Annex A(4).

1953 Exhibit EC-161/At. 10.
1954 Exhibit EC-161/At. 2 p. 3.
1955 Ibid., p. 4.
1956 We note that in its Reasons document, France refers to numerous scientific studies. However,
these studies were not submitted to the Panel as evidence. Therefore, we can not ev aluate in detail whether any
of these documents would constitute a risk assessment within the meaning of Annex A(4) and Article 5.1.
1957 Exhibit EC-161/At. 2, p. 2.

7.3117 Turning to the BEC opinions, we recall that th e BEC apparently issued an opinion in 2001
which allegedly supported France's decision to prolo ng the safeguard measure for a further two years.
As we noted earlier, it is not clear to the Panel whether this opinion of the BEC was submitted to us as
evidence. An undated report by the BEC has been provided.
1958 This document makes reference to
the French decision to take a safeguard measure in November 1998, and to production data in 2000.
The document addresses concerns with regard to both genetically modified sugar beet and oilseed
rape. For the sake of our analysis, we will assume that this document is th e 2001 opinion of the BEC
(hereafter "the 2001 BEC report"). According to th is report, the BEC "proceeded to make an expert
appraisal of the scientific information whic h was available for assessing the impacts on the
environment of genetically modified oilseed rape and beet plants which were tolerant to a
herbicide".1959 In this context, reference is made to documents appended to the opinion, however
these documents were not provided to the Panel. The 2001 BEC report identifies some possible
ecological and agronomic impacts of herbicide tole rant oilseed rape. These include the "possible
proliferation of the tolerant plants in the ecosystem "; the "possible development of adventitious flora
[...]"; and possible changes in the ability of farmers to carry out weed control.
1960
7.3118 We note that the 2001 BEC report purports to provide some evaluation of likelihood with
respect to the "ability of oilseed rape to hybridize". 1961 Specifically, the report indicates that "the
hybridizations which have been observed in Englan d and in certain countries in the north of Europe
are very unlikely in France". 1962 The report indicates that the st udies in France focussed on "the
analysis of the probability" of obtaining thr ee types of hybrids, involving wild radish ( Raphanus
raphanistrum), short-pod mustard ( Hirschfeldia incana ) and wild mustard ( Sinapis arvensis ). The
report indicates that "oilseed rape hybridizes rarely w ith wild radish, even more rarely with short-pod
mustard and not at all with wild mustard". 1963 With respect to consequences for the environment, the
report states: "In the case of genes for tolerance to a herbicide, and in natural environments, there is
no information which leads one to suppose that the ab ility of plants, which have received these genes,
to multiply and invade environments should be diff erent from that of any other oilseed rape plant
which has escaped from farmed land or from that of any other wild-type crucifer."1964
7.3119 The 2001 BEC report goes on to identify a number of areas for further study. 1965 Finally, the
report contains the following "general conclusion": "The Biomolecular Engineering Committee is of
the opinion that, even if cultivating genetically modified oilseed rapes which are tolerant to herbicides
does not present any direct risks for the environmen t, a transitional phase of two years would make it
possible, by carrying out experiments on areas of different scale, to validate the forms of management
which are proposed for weed control and for coexistence between two methods of agriculture."
1966
7.3120 With reference to the requirements for a risk assessment as clarified by the Appellate Body in
Australia–Salmon1967, the Panel notes that unlike the Reasons document, the 2001 BEC report does
appear to provide some evaluation of the likelihood of entry, establishment or spread of one of the
"pests" of concern, that is of hybrids between herb icide tolerant oilseed rape and some wild plants.

1958 Exhibit EC-161/At. 6, with translations of the summary and body of this document apparently
submitted as EC-161/Ats. 7 and 8, respectively. None of these submissions are dated.
1959 Exhibit EC-161/At. 8, p.5.
1960 Ibid., p.5.
1961 Ibid., p.9
1962 Ibid.
1963 Ibid.
1964 Ibid., p. 10.
1965 Ibid., p. 11.
1966 Exhibit EC-161/At. 8, p. 19.
1967 See supra, para. 7.3040.

However, this is addressed, in the context of the BEC report, with respect to all herbicide tolerant
oilseed rape varieties and not specifically those which are genetically modified. Furthermore, we note
that the 2001 BEC report does not provide any anal ysis of the associated potential biological and
economic consequences of these hybrids, nor does it purport to evaluate the likelihood of entry,
establishment or spread of these hybrids according to the SPS measures which might be applied.
Consequently, we do not consider that the 2001 BE C report fulfils all of the criteria of a risk
assessment in accordance with the definition in Annex A(4).
7.3121 The decision by France in July 2003 to further prolong its safeguard measure on MS1/RF1
oilseed rape (EC-161) was allegedly supported by another opinion of the BEC issued in July 2003
(hereafter "the 2003 BEC report").
1968 We note that the 2003 BEC re port refers to the concerns
identified by France at the time the safeguard measure was first taken. The 2003 BEC report points to
some new elements of information and to on-going research which it indicates may shed new light on
some of the conclusions of the 2001 BEC report.
1969 However, the 2003 BEC report does not contain
any evaluation of new information. Rather, th e report calls for further analysis and for the
organization of a scientific workshop to consider wh ether this information might affect the opinions
contained in the 2001 BEC report. 1970 We note that this workshop, which was held in November
2003, resulted in the issuance of another report by the BEC in February 2004. As we have previously
indicated, we will not take into account the BEC opinion of February 2004.1971
7.3122 In the light of the foregoing, we conclude that the above-mentioned documents relied on by
France to justify its safeguard measure are not ri sk assessments within the meaning of Annex A(4)
and Article 5.1.
7.3123 Furthermore, in connection with the documents relied on by France, we should also note the
European Communities' argument that France's safeguard measure was based on an assessment
"appropriate to the circumstances" within the mean ing of Article 5.1. The European Communities
submits that the circumstances in the case of the Fr ench safeguard measure include the fact that, from
France's perspective, relevant scientific evidence was or is insufficient. We recall our previous
consideration of the European Communities' argument based on the phrase "appropriate to the
circumstances" within the meaning of Article 5. 1 in 7.3031-7.3032 above, and consider that our
conclusions there apply mutatis mutandis to this measure.
7.3124 We have found above that none of the documen ts relied on by France with regard to its
safeguard measure on MS1/RF1 oilseed rape (EC-161) constitute risk assess ments. However, the
European Communities contends that there is a document other than the documents relied on by
France which constitutes a risk assessment for MS 1/RF1 oilseed rape (EC-161). The document in
question is the "risk assessment [which] was carri ed out at the time when the original Community
consent was given" (hereafter the "original risk assessment"). 1972 As we understand it, the European
Communities in this instance is referring to the risk assessment conducted by the lead CA. This is
because the Commission did not consult the SC P before approving MS1/RF1 oilseed rape
(EC-161).1973 As we have noted above, it is not in disput e that the lead CA's assessment constitutes a
risk assessment within the meaning of Annex A(4) and Article 5.1.

1968 Exhibit EC-161/At. 9.
1969 Exhibit EC-161/At. 9 p. 1.
1970 Exhibit EC-161/At. 9 p. 3.
1971 See supra, para. 7.3112.
1972 EC reply to Panel question No. 107.
1973 The SCP was only established in 1997. Exhibits US-61; CDA-69.

7.3125 In addition, we recall that none of the Parties has argued that, on the date of establishment of
this Panel, the risk assessment conducted by the lead CA was no longer "appropriate to the
circumstances". In the light of this, and in view of our findings below with regard to whether the
French safeguard measure on MS1/RF1 oilseed rape (EC-161) is "based on" this risk assessment, we
do not need to examine this issue further.
"Based on"

7.3126 We now turn to the question of whether, at the time of establishment of this Panel, the French
safeguard measure on MS1/RF1 oilseed rape (EC-161) was "based on" the risk assessment of the lead
CA.
7.3127 We note that the European Communities' arguments in respect of this issue were the same as
those it presented in the context of Austria's safe guard measure on T25 maize. We have addressed
these arguments above and have reached the conclusion that Austria's safeguard measure on T25
maize cannot be considered to be "based on" the risk assessments performed by the lead CA and the
SCP in relation to T25 maize. This conclusi on, and the reasoning supporting it, also apply, mutatis
mutandis, to France's safeguard measure on MS1/RF1 o ilseed rape (EC-161) and the risk assessment
performed by the lead CA in relation to T25 mai ze. This is because, as in the case of Austria's
safeguard measure on T25 maize:
(a) we are not aware of any divergent opinions expressed in the risk assessments which
were conducted by the lead CA and the SC P with regard to MS1/RF1 oilseed rape
(EC-161);
(b) the European Communities or France did no t explain, by reference to these risk
assessments, how and why France assessed the risks differently, and did not provide a
revised or supplemental assessment of the risks;
(c) the European Communities has not identified possible uncertainties or constraints in
the risk assessments in question, and has not explained why, in view of any such
uncertainties or constraints, France's prohi bition is warranted by the relevant risk
assessments; and
(d) there is no apparent rational relationship between France's safeguard measure, which
imposes a prohibition, and risk assessments which found no evidence that
MS1/RF1 oilseed rape (EC-161) is likely to cause any adverse effects on human
health and the environment.
7.3128 Thus, in view of our conclusion that France's safeguard measure on MS1/RF1 oilseed rape
(EC-161) cannot be considered to be "based on" the risk assessments performed by the lead CA or the
SCP in relation to MS1/RF1 oilseed rape (EC-161) , and recalling the fact that no other risk
assessment which might reasonably support France's safeguard measure has been provided to us, we
find that the French safeguard measure is not based on a risk assessment pursuant to Article 5.1.
1974

1974 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the French safeguard measure should be treated as constituting one or more SPS measures. Thus, like
the Parties, we will continue to treat this measure as constituting one single SPS measure.

Overall conclusions

7.3129 In the light of the above, the Panel reaches the following overall conclusions:
(i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that, contrary to
the provisions of Article 5.1 of the SPS Agreement, the French safeguard measure on
MS1/RF1 oilseed rape (EC-161) is not based on a risk assessment.

 (ii) DS292 (Canada)

 With reference to DS292, and having re gard to the arguments and evidence presented
by Canada and the European Communities, the Panel finds that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the French safeguard measure on
MS1/RF1 oilseed rape (EC-161) is not based on a risk assessment.

7.3130 In view of our findings in the previous para graph with regard to DS291 (United States) and
DS292 (Canada), it is necessary to examine, in add ition, whether the French safeguard measure on
MS1/RF1 oilseed rape (EC-161) is consistent with the requirements of Article 5.7 of the
SPS Agreement. It is only once we have completed this additional examination that we can come to a
final conclusion regarding the cons istency of the French safeguard measure on MS1/RF1 oilseed rape
(EC-161) with Article 5.1 of the SPS Agreement. We undertake the necessary examination under
Article 5.7 in the next section.
(vi) France – Topas oilseed rape
7.3131 We now turn to the analysis of France's measu re on Topas oilseed rape. The first issue we
will address is whether the documents France relies on to justify its safeguard measure meet the
definition of a risk assessment.
"Risk assessment"

7.3132 We note that France relied on the same documents with respect to its safeguard measure on
Topas oilseed rape as for its measure on MS1/RF1 oilseed rape (EC-161). We recall our analysis of
the relevant documents relied on by France in r espect of its safeguard measure on MS1/RF1 oilseed
rape (EC-161) above. Based on a review of these doc uments, we found that none constituted a risk
assessment within the meaning of Annex A(4) and Article 5.1 of the SPS Agreement. Consistent with
our analysis above, we also find in the case of th e French safeguard measure on Topas oilseed rape
that none of the documents relied on by France constitute a risk assessment.
7.3133 Furthermore, in connection with the documents relied on by France, we should also note the
European Communities' argument that France's safeguard measure was based on an assessment
"appropriate to the circumstances" within the mean ing of Article 5.1. The European Communities
submits that the circumstances in the case of the Fr ench safeguard measure include the fact that, from
France's perspective, relevant scientific evidence was or is insufficient. We recall our previous
consideration of the European Communities' argument based on the phrase "appropriate to the
circumstances" within the meaning of Article 5. 1 in paragraphs 7.3031-7. 3032 above, and consider
that our conclusions there apply mutatis mutandis to this measure.

7.3134 We have found above that none of the documen ts relied on by France with regard to its
safeguard measure on Topas oilseed rape constitute risk assessments. However, the European
Communities contends that there is a document ot her than the documents relied on by France which
constitutes a risk assessment for Topas oilseed rape. The document in question is the "risk assessment
[which] was carried out at the time when the orig inal Community consent was given" (hereafter the
"original risk assessment").
1975 It is not clear from this assertion whether the European Communities
is referring to the risk assessment conducted by the lead CA or to that conducted by the SCP. 1976 In
any event, we have noted above that it is not in dispute that both of these documents constitute risk
assessments within the meaning of Annex A(4) and Article 5.1.
7.3135 In addition, we recall that none of the Parties has argued that, on the date of establishment of
this Panel, the risk assessments conducted by the l ead CA and the SCP were no longer "appropriate to
the circumstances". In the light of this, and in view of our findings below with regard to whether the
French safeguard measure on Topas oilseed rape is "based on" these risk assessments, we do not need
to examine this issue further.
"Based on"
7.3136 We now turn to the question of whether, at the time of establishment of this Panel, the French
safeguard measure on Topas oilseed rape was "based on" either the risk assessment of the lead CA or
that conducted by the SCP.1977
7.3137 We note that the European Communities' arguments in respect of this issue were the same as
those it presented in the context of Austria's safe guard measure on T25 maize. We have addressed
these arguments above and have reached the conclusion that Austria's safeguard measure on T25
maize cannot be considered to be "based on" the risk assessments performed by the lead CA and the
SCP in relation to T25 maize. This conclusi on, and the reasoning supporting it, also apply mutatis
mutandis, to France's safeguard measure on Topas oilseed rape and the risk assessments performed by
the lead CA and the SCP in relation to Topas oilseed rape. This is because, as in the case of Austria's
safeguard measure on T25 maize:
(a) we are not aware of any divergent opinions expressed in the risk assessments which
were conducted by the lead CA and the SCP with regard to Topas oilseed rape;
(b) the European Communities or France did no t explain, by reference to these risk
assessments, how and why France assessed the risks differently, and did not provide a
revised or supplemental assessment of the risks;
(c) the European Communities has not identified possible uncertainties or constraints in
the risk assessments in question, and has not explained why, in view of any such
uncertainties or constraints, France's prohi bition is warranted by the relevant risk
assessments; and
(d) there is no apparent rational relationship between France's safeguard measure, which
imposes a prohibition, and risk assessments which found no evidence that Topas

1975 EC reply to Panel question No. 107.
1976 Exhibits EC-162/At. 1; CDA-63; US-62 (referencing original SCP risk assessment).
1977 We recall that we must examine as part of our analysis whether the safeguard measure is based on
either risk assessment, as it is not clear whether the original risk assessment referred to by the
European Communities is the risk assessment conducted by the lead CA or that conducted by the SCP.

oilseed rape is likely to cause adverse e ffects on human or animal health and the
environment.
7.3138 Thus, in view of our conclusion that France's safeguard measure on Topas oilseed rape cannot
be considered to be "based on" th e risk assessments performed by the lead CA or the SCP in relation
to Topas oilseed rape, and recalling the fact that no other risk assessment which might reasonably
support France's safeguard measure has been provi ded to us, we find that the French safeguard
measure is not based on a risk assessment pursuant to Article 5.1.
1978
Overall conclusions
7.3139 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that, contrary to
the provisions of Article 5.1 of the SPS Agreement, the French safeguard measure on
Topas oilseed rape is not based on a risk assessment.

 (ii) DS292 (Canada)

 With reference to DS292, and having re gard to the arguments and evidence presented
by Canada and the European Communities, the Panel finds that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the French safeguard measure on
Topas oilseed rape is not based on a risk assessment.

7.3140 In view of our findings in the previous para graph with regard to DS291 (United States) and
DS292 (Canada), it is necessary to examine, in add ition, whether the French safeguard measure on
Topas oilseed rape is consistent with the requirements of Article 5.7 of the SPS Agreement. It is only
once we have completed this additional examination that we can come to a final conclusion regarding
the consistency of the French safeguard measure on Topas oilseed rape with Article 5.1 of the
SPS Agreement. We undertake the necessary examination under Article 5.7 in the next section.
(vii) Germany – Bt-176 maize
7.3141 We now turn to Germany's safeguard measure on Bt-176 maize. We recall that we must
determine whether Germany's measure is "based on" a ri sk assessment pursuant to Article 5.1. In this
context, the first issue we will address is whet her the documents Germany relies on to justify its
safeguard measure meet the definition of a risk assessment.
"Risk assessment"

7.3142 We recall that Germany (Robert Koch Institute) notified its decision to prohibit Bt-176 maize
to the Commission in a letter dated 4 April 2000. 1979 In this letter, Germany explained the reasons for

1978 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the French safeguard measure should be treated as constituting one or more SPS measures. Thus, like
the Parties, we will continue to treat this measure as constituting one single SPS measure.
1979 Exhibit EC-158/At. 21. We note that the concerns of Germany were also set out in an earlier letter
addressed by the Robert Koch Institute to the Commissi on on 2 March 2000 (Exhibit EC-158/At. 19_trans), as

adopting its safeguard measure on Bt-176 maize. The letter refers to the following scientific studies
in support of Germany's safeguard measure:
 (i) Study by Losey (1999), "Transgenic pollen harms monarch larvae"
1980;
 (ii) Study by Hilbeck et al. (January 1999), "Prey-mediated effects of Cry1Ab toxin and
protoxin and Cry2A protoxin on the predator Chrysoperla carnea"1981;
 (iii) Study by Hilbeck et al. (1998), "Toxicity of Bacillus thuringiensis Cry1Ab Toxin to
the Predator Chrysoperla carnea (Neuroptera: Chrysopidae)"1982;
 (iv) Study by Hilbeck et al. (1998), "Effects of transgenic Bacillus thuringiensis corn-fed
prey on mortality and development time of immature Chrysoperla carnea
(Neuroptera: Chrysopidae)"1983;
 (v) Study by Saxena et al. (1999), "Insecticidal toxin in root exudates from Bt corn"1984;
 (vi) Öko-Institut e. V. (Dec. 1999) – Study on the "Therapeutical relevance of antibiotics
in connection with the use of antibiotic resistance genes in transgenic plants"1985.

7.3143 Having determined the documents relied on by Germany with respect to its safeguard
measure on Bt-176 maize, we must now determ ine whether one or more of these documents
constitutes a "risk assessment" within the meaning of the SPS Agreement.
7.3144 We recall our conclusions that the concerns identified by Germany, relating to possible
effects on non-target organisms, the development of resistance to Bt toxins in insects, the possible
adverse effects of Bt toxin in the soil and potential for development of antibiotic resistance, fall within
the scope of Annex A(1)(a), (b) and/or (d) of the SPS Agreement. Both clauses of Annex A(4) to the
SPS Agreement define the "risk assessment" to be ca rried out for SPS measures which have these
types of purposes. As discussed earlier, Germ any's concern relating to potential increased
development of antibiotic resistance could also fall within the scope of Annex A(1)(b) of the
SPS Agreement. The second clause of Annex A(4) to the SPS Agreement defines the "risk
assessment" to be carried out for SPS measures which fall within the scope of Annex A(1)(b).
7.3145 We begin our analysis with Germany's Re asons document. That document includes
references to possibilities of risks, but does not eval uate the potential or likelihood of such risks
occurring. For example, the document states that "it cannot be excluded that unacceptable adverse
effects on other lepidoptera species and on some other insects would occur." 1986 Similarly, the
document states that "an ecologically unacceptable deve lopment of resistance may occur in the event
of unrestricted cultivation"1987 of Bt maize. With regard to possible effects of Bt-toxin on soil micro-
organisms, the Reasons document states th at these effects "cannot be excluded". 1988 Finally, the
Reasons document notes that increased development of antibiotic resistance following uptake of the
antibiotic resistance gene contained in Bt-176 maize "cannot [be] excluded". 1989 A s n o t e d b y u s

well as in a letter from the Robert Koch Institute to Gaedertz Attorneys-at-Law on 31 March 2000 (Exhibit
US-65).
1980 Exhibit EC-158/At. 24.
1981 Exhibit EC-158/At. 25.
1982 Exhibit EC-158/At. 26.
1983 Exhibit EC-158/At. 27.
1984 Exhibit EC-158/At. 28.
1985 Exhibit EC-158/At. 29.
1986 Exhibit EC-158/At. 21, p.1.
1987 Ibid., p. 2.
1988 Ibid.
1989 Ibid.

above, the Appellate Body in Australia – Salmon clarified that a risk assessment as defined in the first
clause of Annex A(4) must evaluate the likelihood or probability of relevant risks.
1990
7.3146 Regarding the concern over the possible developm ent of antibiotic resistance, we further note
the statement in the Reasons document to the e ffect that on the basis of current knowledge,
unacceptable adverse effects are not to be expected in view of the already widespread resistance in
bacteria to the relevant antibiotics, if, as the EC approval decision envisages, the quantity of Bt-176
maize seeds which may be sown is limited to 12 tonnes/year.
1991 Thus, the Reasons document
suggests that there is only a small potential for adverse effects on human or animal health arising from
the presence of ARMG in Bt-176 maize. However, the Reasons document does not itself contain and
provide the information necessary to an evaluation of the potential for adverse effects on human or
animal health. Accordingly, we consider that the Reasons document constitutes, not a complete, self-
contained, scientific evaluation of the potential fo r adverse effects, but only part of such an
evaluation. Hence, we are of the view that the Reasons document on its own does not meet the
definition of a risk assessment as provided in the second clause of Annex A(4).
7.3147 We now turn to the scientific studies which Ge rmany relied on in respect of its safeguard
measure. The first four of these studies relate to impacts of Bt toxins on insects while the fifth
examines the use of antibiotic resist ance marker genes in transgenic plants. We recall that we have
previously examined the Losey study as well as the two 1998 Hilbeck et al. studies in the context of
our consideration of Austria's safeguard measure on MON810 maize. We recall our conclusions that
none of these studies evaluate the potential or like lihood of the occurrence of the adverse effect
identified in Germany's Reasons document. We do not consider, therefore, that any of these three
studies in themselves constitute a risk assessment, a lthough we accept that they may be of relevance
for an eventual risk assessment.
7.3148 The 1999 Hilbeck et al. document describes laboratory feeding experiments which were
carried out to study the effects of insects feedi ng on other insects which had had an artificial diet
containing Bt proteins. While the study's conc lusions highlight the importance of assessing the non-
target impacts of Bt toxins, it does not do this in th e context of the Bt-176 maize. In particular, this
study does not provide an evaluation of the like lihood of risks associated with the insects eating
Bt-176 maize plants. Nor does it evaluate the likeliho od of an outcome in the field. For example, the
study notes "field studies must be conduc ted to assess the ecological consequences"
1992 of the study's
results. We do not consider, therefore, that this study in and of itself constitutes a risk assessment,
although we accept that it may be of relevance for an eventual risk assessment.
7.3149 The fifth study, by Saxena et al., examines the potential for Bt t oxin to be released into the
soil from the roots of Bt maize. The study used a variety of Bt maize called NK4640Bt which differs
from the variety which is subject to the German safeguard measure. While the study measured the
toxin released into the soil surroundi ng the roots of maize plants, the authors note that they have "no
indication of how soil communities might be affected by Bt toxin in [...] the field" and that "[f]urther
investigations will be necessary to shed light on what might happen underground".
1993 Thus, this
study neither purports to evaluate the potential consequences associated with the release of Bt
exudates into the soil, nor provides information speci fically related to the product at issue in this
safeguard measure, Bt-176 maize. Therefore, we do not consider that this study, by itself, meets the
definition of a risk assessment as provided in Annex A(4).

1990 Appellate Body Report, Australia – Salmon, paras. 123-124.
1991 Exhibit EC-158/At. 21, p. 3.
1992 Exhibit EC-158/At. 25 p. 11.
1993 Exhibit EC-158/At. 28, p. 480.

7.3150 The final study, by the Öko-Institut e.V., pr ovides an overview of the types of antibiotics
which could be affected by the possible developmen t of resistance to antibiotics due to the use of
antibiotic resistance marker gen es in transgenic plants. The study describes the therapeutic
importance of a variety of antibiotics, but does not evaluate the likelihood that the consumption of
transgenic plants in general, much less of Bt-176 maize specifically, will lead to the spread of diseases
due to the development of resistance to the relevant antibiotics. The authors state that "the wide
dispersal of [antibiotic resistance] genes via agri culture, animal feeding and in the human food chain
provides an additional path for the development of antibiotic resistance" and that "this risk is not
negligible" as outside hospitals the resistance problem was still smaller.
1994 The study further states
that "particularly worrying" is the fact that "there are indications" that the transfer rate of antibiotic
resistance in soils can be furthered by herbicide use. 1995 The study goes on to say that because
herbicide applications are the rule in agriculture and because many AR MG in transgenic plants were
transferred together with herbicide resistance genes, this "possibly creates conditions which could [...]
have a promoting influence on the development of resistance". 1996 The study therefore recommends
that ARMG should not be used any more.
7.3151 Hence, the study by the Öko-Institut asserts that there is a potential for adverse effects on
human or animal health from the presence of ARMG in transgenic plants used as or in food/feed.
However, it does not "evaluate" that potential. Indeed, the study devotes only a few paragraphs to
transgenic plants containing ARMG as an additio nal source of possible development of antibiotic
resistance. Moreover, the study does not evaluate the likelihood of spread of diseases due to the
presence of ARMG in transgenic plants. As indicated , the study refers to possibilities, but it does not
determine likelihoods. We therefor e do not consider that this study meets the definition of a risk
assessment as provided in Annex A(4).
7.3152 In the light of the foregoing, we conclude that the above-mentioned documents relied on by
Germany to justify its safeguard measure are not ri sk assessments within the meaning of Annex A(4)
and Article 5.1.
7.3153 Furthermore, in connection with the documents relied on by Germany, we should also note
the European Communities' argument that German y's safeguard measure was based on an assessment
"appropriate to the circumstances" within the mean ing of Article 5.1. The European Communities
submits that the circumstances in the case of the German safeguard measure include the fact that,
from Germany's perspective, relevant scientific ev idence was or is insufficient. We recall our
previous consideration of the European Commun ities' argument based on the phrase "appropriate to
the circumstances" within the meaning of Article 5.1 in paragraphs 7.3031 and 7.3032 above, and
consider that our conclusions there apply mutatis mutandis to this measure.
7.3154 We have found above that the documents provi ded by the Parties in relation to Germany's
safeguard measure on Bt-176 maize on which German y relied on do not constitute a risk assessment.
However, the European Communities contends that there is a document other than the documents
relied on by Germany which constitutes a risk as sessment for Bt-176 maize. The document in
question is the "risk assessment [which] was carri ed out at the time when the original Community
consent was given" (hereafter the "original risk assessment").
1997 It is not clear from this assertion
whether the European Communities is referring to th e risk assessment conducted by the lead CA or to
any of the risk assessments which were conducted by the Scientific Committee for Pesticides (SCPE),

1994 Exhibit EC-158/At. 29, p. 28.
1995 Ibid.
1996 Ibid.
1997 EC reply to Panel question No. 107.

the Scientific Committee for Animal Nutrition (SCAN) or the SCF.
1998 In any event, we have noted
above that it is not in dispute that these documents constitute risk assessment s within the meaning of
Annex A(4) and Article 5.1.
7.3155 In addition, we note that none of the Parties has argued that, on the date of establishment of
this Panel, the risk assessments conducted by th e lead CA and the risk assessments which were
conducted by the SCPE, the SCAN or the SCF were no longer "appropriate to the circumstances". In
the light of this, and in view of our findings be low with regard to whether Germany's safeguard
measure is "based on" these risk assessments, we do not need to examine this issue further.
"Based on"
7.3156 We now turn to the question of whether, at th e time of establishment of this Panel, the
German safeguard measure on Bt-176 maize was "based on" either the risk assessment of the lead CA
or any of those conducted by the SCPE, the SCAN or the SCF.1999
7.3157 We note that the European Communities' arguments in respect of this issue were the same as
those it presented in the context of Austria's safe guard measure on T25 maize. We have addressed
these arguments above and have reached the conclusion that Austria's safeguard measure on T25
maize cannot be considered to be "based on" the risk assessments performed by the lead CA and the
SCP in relation to T25 maize. This conclusi on, and the reasoning supporting it, also apply, mutatis
mutandis, to Germany's safeguard measure on Bt-176 maize and the risk assessment performed by the
lead CA and the risk assessments which were conduc ted by the Scientific Committee for Pesticides
(SCPE), the Scientific Committee for Animal Nutri tion (SCAN) or the SCF in relation to Bt-176
maize. This is because, as in the case of Austria's safeguard measure on T25 maize:
(a) we are not aware of any divergent opinions expressed in the risk assessments which
were conducted by the lead CA and tho se which were conducted by the SCPE, the
SCAN or the SCF with regard to Bt-176 maize;
(b) the European Communities or Germany did no t explain, by reference to these risk
assessments, how and why Germany assessed the risks differently, and did not
provide a revised or supplemental assessment of the risks;
(c) the European Communities has not identified possible uncertainties or constraints in
the risk assessments in question, and has not explained why, in view of any such
uncertainties or constraints, Germany's prohi bition is warranted by the relevant risk
assessments; and
(d) there is no apparent rational relationshi p between Germany's safeguard measure,
which imposes a prohibition, and risk assessm ents which found no evidence that
Bt-176 maize will give rise to any adverse effects on human or animal health and the
environment.

1998 Exhibit EC-158/Ats. 1-3; EC-158/At. 4; EC-158/At. 5; EC-158/At. 6.
1999 We recall that we must examine as part of our analysis whether the safeguard measure is based on
any of those risk assessments, as it is not clear whet her the original risk assessment referred to by the
European Communities is the risk assessment conducted by the lead CA or those conducted by the SCPE, the
SCAN or the SCF.

7.3158 Thus, in view of our conclusion that Germany's safeguard measure on Bt-176 maize cannot be
considered to be "based on" the risk assessment pe rformed by the lead CA or the risk assessments
which were conducted by the SCPE, the SCAN or the SCF in relation to Bt-176 maize, and recalling
the fact that no other risk assessment which might reasonably support Germany's safeguard measure
has been provided to us, we find that the German safeguard measure is not based on a risk assessment
pursuant to Article 5.1.
2000
Overall conclusions
7.3159 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that, contrary to
the provisions of Article 5.1 of the SPS Agreement, the German safeguard measure on
Bt-176 maize is not based on a risk assessment.

 (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 finds that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the German safeguard measure on
Bt-176 maize is not based on a risk assessment.

7.3160 In view of our findings in the previous para graph with regard to DS291 (United States) and
DS293 (Argentina), it is necessary to examine, in addition, whether the German safeguard measure on
Bt-176 maize is consistent with the requirements of Article 5.7 of the SPS Agreement. It is only once
we have completed this additional examination that we can come to a final conclusion regarding the
consistency of the German safeguard measure on Bt-176 maize with Article 5.1 of the
SPS Agreement. We undertake the necessary examination under Article 5.7 in the next section.
(viii) Greece – Topas oilseed rape
7.3161 We now turn to the Greek safeguard measure on Topas oilseed rape. We recall that we must
determine whether Greece's measure is "based on" a ri sk assessment pursuant to Article 5.1. In this
context, the first issue we will address is whet her the documents Greece relies on to justify its
safeguard measure meet the definition of a risk assessment.
"Risk assessment"

7.3162 We start by recalling the documents on record in respect of this safeguard measure. We recall
that Greece notified its Ministerial Decision to prohibit Topas oilseed rape to the Commission in a
document dated 3 November 1998 (hereafter the "R easons document"). In this document, Greece
explained the reasons for adopting its safeguard measure on Topas oilseed rape. 2001

2000 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the German safeguard measure should be treat ed as constituting one or more SPS measures. Thus,
like the Parties, we will continue to treat this measure as constituting one single SPS measure.
2001 Exhibit EC-162/At. 4

7.3163 Furthermore, in a letter of 3 March 2004 to the Commission, Greece provides further
justification for its safeguard measure on Topas oilseed rape.
2002 In relation to this letter, we recall
that our task is to assess whether the Greek safe guard measure was based on a risk assessment as of
29 August 2003, when this Panel was established. A risk assessment completed after August 2003 in
our view would not assist the European Communities in rebutting the Complaining Parties' claim that
the Greek safeguard measure was not based on a risk assessment in August 2003. We note that the
March 2004 letter makes reference to two scientific st udies. The first study was not submitted to the
Panel. It is from the European Environment Agency and is entitled "Genetically Modified
Organisms: The significance of gene flow thro ugh pollen transfer" and dated 21 March 2002.
According to the March 2004 letter, the study charact erizes oilseed rape as a high risk crop as far as
gene transfer between crops and wild relative species is concerned. The second study is from the UK
Advisory Committee on Releases to the Envi ronment (ACRE) and is dated January 2004.
2003
According to the letter, the study concerns spring oilseed rape and confirms the March 2002 study.
The ACRE study apparently refers to adverse e ffects on biodiversity, a significant decrease of the
wild weed population and harmful effects on the higher levels of the food chain of the crop in
question as compared to conventiona l crops. Considering that the fi rst study was not submitted to us
and that the second study dates from after August 2003, we do not review these studies with a view to
determining whether they constitute a risk assess ment within the meaning of Annex A(4) and
Article 5.1.
7.3164 Finally, we note that in a letter of 17 Ma rch 2004 to the Commission, Greece refers to
additional documents in support of its saf eguard measure on Topas oilseed rape. 2004 The following
documents were submitted to us and will be taken into account:
 (i) Study by the Office of the Gene Technology Regulator (July 2002), "The biology and
ecology of canola (Brassica napus)"2005;
 (ii) Several studies that constitute part of the Farm Scale Evaluations of spring-sown
genetically modified crops (October 2003)2006;
 (iii) Study by Wilkinson et al. (2003), "Hybridization Between Brassica napus and B.
rapa on a National Scale in the United Kingdom"2007.

7.3165 Having determined the documents relied on by Greece with respect to its safeguard measure
on Topas oilseed rape, we must now determine wh ether any of these documents constitutes a "risk
assessment" within the meaning of Annex A(4) and Article 5.1 of the SPS Agreement.
7.3166 As with Austria's safeguard measure for T25 ma ize, given the concerns raised by Greece in
the context of Topas oilseed rape relating to envi ronmental risks and consumer health, we consider
that both the first and the second clause of Annex A(4) to the SPS Agreement define the "risk
assessment" to be carried out for Greece's measure on Topas oilseed rape.
7.3167 We start our examination with the Reasons doc ument notified by Greece in respect of its
safeguard measure on Topas oilseed rape. The Reasons document alleges risks for the natural
environment of Greece from spillage of seeds of Topas oilseed rape during transport. Specifically, the

2002 Exhibit EC-162/At. 6_transl.
2003 Exhibit EC-40.
2004 Exhibit EC-162/At. 7.
2005 Exhibit EC-162/At. 13.
2006 Exhibit EC-162/At. 9-11. Although the Farm Scale Evaluations were published in October 2003,
they contain the results of evaluations conducted over the 3-year period from 2000-2002.
2007 Exhibit EC-162/At. 12.

Reasons document asserts that "it is certain that the seeds will escape into the environment and will
give viable plants".
2008 It also asserts that "it is certain that [...] there will arise hybrid plants [weeds]
bearing the glufosinate tolerance gene". 2009 It further asserts that glufosinate tolerant weeds "will"
have a selective advantage over other weeds and consequently "will" dominate.2010 Also, "there exists
the risk" that, following the release of other herb icide tolerant GM plants, multiresistant weeds will
arise.2011 Finally, the resistant weeds "will" spread not only in the agricultural environment but also in
the natural environment.2012 As noted above, the Appellate Body in Australia – Salmon clarified that
a risk assessment must ev aluate the likelihood or probability of particular risks. 2013 The Reasons
document reaches conclusions regarding the likelihood of the spread of certain pests, but it reaches
these conclusions without any prior "evaluation" of relevant data and inform ation. The relevant
passages in the Reasons document are only a few para graphs long and no results from studies or tests
are contained in, or annexed to, the document. A dditionally, we note that the Reasons document does
not evaluate the likelihood of the spread of pests according to the SPS measures which might be
applied. The document only addresses the likelihood of risks in the situation where no SPS measure
is applied, i.e., where Topas oilseed rape is released into the environment. For these reasons, we are
of the view that the discussion in the Reasons document of potential environmental risks does not
constitute a risk assessment within the meaning of Annex A(4) and Article 5.1.
7.3168 The Reasons document further notes that some of the wild plant varieties at issue are
collected and consumed in Greece as food. Greece points out in this regard that if out-crossing were
to confer on these wild plant varieties the herb icide resistance trait, the consequences of the
consumption of these varieties would be unpredicta ble. Greece observes that these consequences
have not been considered in the original risk assess ment prior to the approval of Topas oilseed rape.
Thus, while the Reasons document re fers to unspecified adverse effects on human health arising from
the consumption of hybrid plants, it does not provid e any evaluation of the potential for such adverse
effects to occur. We therefore do not consider that the discussion in the Reasons document of
potential risks for the health of consumers cons titutes a risk assessment within the meaning of
Annex A(4) and Article 5.1.
7.3169 We now turn to the scientific studies relied on by Greece in respect of its safeguard measure.
The first study, by the Office of the Gene Tec hnology Regulator, focuses on the biology and ecology
of a particular variety of oilseed rape – canola, or Brassica napus – and highlights the potential for
outcrossing between this type of plant and its we edy relatives. The study states that while "the
probability of outcrossing appears to be low", the biology of canola "ensures that a substantial number
of outcrossed seeds can still be produced". 2014 Thus, the study evaluates the likelihood of outcrossing
from canola. However, it does not do so for Topas o ilseed rape, but for canola in general, including
for canola which is not genetically modified. Also, consistent with its stated objective of addressing
the biology and ecology of canola, the study does not evaluate the likelihood of the entry,
establishment or spread of undesired cross-breed s according to the SPS measures which might be
applied. We therefore do not consider that this study meets the definition of a risk assessment as
provided in Annex A(4).

2008 Exhibit EC-162/At. 4.
2009 Ibid.
2010 Ibid.
2011 Ibid.
2012 Ibid.
2013 Appellate Body Report, Australia – Salmon, paras. 123-124.
2014 Exhibit EC-162/At. 13 p. 13.

7.3170 The second set of studies report results from the Farm Scale Evaluations (FSEs) conducted in
the United Kingdom. The first of these studies, by Squire et al., summarizes the methods and results
of the FSEs. This study emphasizes the difficult y of predicting the impact of growing GM crop
varieties which are tolerant to herbicides (herea fter "GMHT crops"), due to the uncertainty about
farmer management decisions. The study notes that "predictions [...] are particularly difficult since
what happens will be strongly affected by the preference of farmers and by current economics."
2015
Another FSE study, by Haughton et al., reports results regarding the impacts of the management of
GMHT varieties on arthropods with particular refere nce to the weed vegetation that supports them.
The study summarizes the effects on arthropods acro ss a variety of GMHT crops, and notes that "the
effects were indirect and related to herbicide management".2016 The third study referenced by Greece,
by Hawes et al., seeks to determine whether differences in weed populations and biomass due to the
impact of GMHT cropping result in changes in popula tion trends of particular insects. The study's
conclusions notes that "commercialization of GMHT crops would [...] be likely to have a range of
effects on plant and invertebrate functional groups in the long-term". 2017 Each of these studies
discusses GMHT crops in general rather than fo cusing specifically on the Topas oilseed rape, and
none of these studies evaluates the likelihood of a dverse effects from the entry, establishment or
spread of GMHT crops according to the SPS meas ures which might be taken by Greece to reduce any
potential risks. We therefore do not consider that these studies meets the definition of a risk
assessment as provided in Annex A(4).
7.3171 The Wilkinson et al. study reports results regarding hybridization between two varieties of
oilseed rape, Brassica napus and B. rapa. 2018 The study provides an estimate of GM hybrid
abundance for the United Kingdom and notes that its findings help "set targets for strategies to
eliminate hybridization and represent the first step toward quantitative risk assessment on a national
scale."2019 It also states that the presence of GM hybrids is not a risk in itself and does not imply
inevitable ecological change. It notes that hybrid fitness and other factors affecting the likelihood of
ecological change should also be assessed. 2020 These statements serve to demonstrate that the study
does not take into account all factors that are relevant to an evaluation of the likelihood of
environmental change caused by gene flow. Acco rdingly, we consider that the study does not
constitute a risk assessment as defined in Annex A(4) and required by Article 5.1. We also note that
the study does not claim that the estimates it provides are valid outside mainland Britain. We
therefore do not consider that this study meets the definition of a risk assessment as provided in
Annex A(4).
7.3172 In the light of the foregoing, we conclude that the above-mentioned documents relied on by
Greece to justify its safeguard measure are not ri sk assessments within the meaning of Annex A(4)
and Article 5.1.
7.3173 Furthermore, in connection with the documents relied on by Greece, we should also note the
European Communities' argument that Greece's safeguard measure was based on an assessment
"appropriate to the circumstances" within the mean ing of Article 5.1. The European Communities
submits that the circumstances in the case of the Gr eek safeguard measure include the fact that, from
Greece's perspective, relevant scientific evidence was or is insufficient. We recall our previous

2015 Exhibit EC-162/At. 9 p. 1795.
2016 Exhibit EC-162/At. 10 p. 1875.
2017 Exhibit EC-162/At. 11 p. 1912.
2018 We understand from the application for the deliberate release of this product that Brassica napus is
the species of oilseed rape which has been modified to produce Topas oilseed rape.
2019 Exhibit EC-162/At. 12, p. 457.
2020 Ibid., p. 459.

consideration of the European Communities' argument based on the phrase "appropriate to the
circumstances" within the meaning of Article 5. 1 in paragraphs 7.3031-7. 3032 above, and consider
that our conclusions there apply mutatis mutandis to this measure.
7.3174 We have found above that the documents provided by the Par ties in relation to Greece's
safeguard measure on Topas oilseed rape on which Gr eece relied do not constitute a risk assessment.
However, the European Communities contends that there is a document other than the documents
relied on by Greece which constitutes a risk assessm ent for Topas oilseed rape. The document in
question is the "risk assessment [which] was carri ed out at the time when the original Community
consent was given" (hereafter the "original risk assessment").
2021 It is not clear from this assertion
whether the European Communities is referring to th e risk assessment conducted by the lead CA or to
that conducted by the SCP.2022 In any event, we have noted above that it is not in dispute that both of
these documents constitute risk assessments within the meaning of Annex A(4) and Article 5.1
7.3175 In addition, we note that none of the Parties has argued that, on the date of establishment of
this Panel, the risk assessments conducted by the l ead CA and the SCP were no longer "appropriate to
the circumstances". In the light of this, and in vi ew of our findings below with regard to whether
Greece's safeguard measure is "based on" these risk assessments, we do not need to examine this issue
further.
"Based on"
7.3176 We now turn to the question of whether, at th e time of establishment of this Panel, the Greek
safeguard measure on Topas oilseed rape was "based on" either the risk assessment of the lead CA or
that conducted by the SCP.2023
7.3177 We note that the European Communities' arguments in respect of this issue were the same as
those it presented in the context of Austria's safe guard measure on T25 maize. We have addressed
these arguments and have reached the conclusion that Austria's safeguard measure on T25 maize
cannot be considered to be "based on" the risk asse ssments performed by the lead CA and the SCP in
relation to T25 maize. This conclusion, and the reasoning supporting it, also apply, mutatis mutandis,
to Greece's safeguard measure on Topas oilseed rape and the risk assessments performed by the lead
CA and the SCP in relation to Topas oilseed rape . This is because, as in the case of Austria's
safeguard measure on T25 maize:
(a) we are not aware of any divergent opinions expressed in the risk assessments which
were conducted by the lead CA and the SCP with regard to Topas oilseed rape;
(b) the European Communities or Greece did not explain, by reference to these risk
assessments, how and why Greece assessed th e risks differently, and did not provide
a revised or supplemental assessment of the risks;
(c) the European Communities has not identified possible uncertainties or constraints in
the risk assessments in question, and has not explained why, in view of any such

2021 EC reply to Panel question No. 107.
2022 Exhibits EC-162/At. 1; CDA-63; US-70 (referencing original SCP risk assessment).
2023 We recall that we must examine as part of our analysis whether the safeguard measure is based on
either risk assessment, as it is not clear whether the original risk assessment referred to by the
European Communities is the risk assessment conducted by the lead CA or that conducted by the SCP.

uncertainties or constraints, Greece's prohi bition is warranted by the relevant risk
assessments; and
(d) there is no apparent rational relationship be tween Greece's safeguard measure, which
imposes a prohibition, and risk assessments which we understand found no evidence
that Topas oilseed rape will give rise to any adverse effects on human or animal
health and the environment.
7.3178 Thus, in view of our conclusion that Greece's safeguard measure on Topas oilseed rape cannot
be considered to be "based on" th e risk assessments performed by the lead CA or the SCP in relation
to Topas oilseed rape, and recalling the fact that no other risk assessment which might reasonably
support Greece's safeguard measure has been provi ded to us, we find that the Greek safeguard
measure is not based on a risk assessment pursuant to Article 5.1.
2024
Overall conclusions
7.3179 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that, contrary to
the provisions of Article 5.1 of the SPS Agreement, the Greek safeguard measure on
Topas oilseed rape is not based on a risk assessment.

 (ii) DS292 (Canada)

 With reference to DS292, and having re gard to the arguments and evidence presented
by Canada and the European Communities, the Panel finds that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Greek safeguard measure on
Topas oilseed rape is not based on a risk assessment.

7.3180 In view of our findings in the previous para graph with regard to DS291 (United States) and
DS292 (Canada), it is necessary to examine, in a ddition, whether the Greek safeguard measure on
Topas oilseed rape is consistent with the requirements of Article 5.7 of the SPS Agreement. It is only
once we have completed this additional examination that we can come to a final conclusion regarding
the consistency of the Greek safeguard measure on Topas oilseed rape with Article 5.1 of the
SPS Agreement. We undertake the necessary examination under Article 5.7 in the next section.
(ix) Italy – T25 maize, MON810 maize, MON809 maize, Bt-11 maize (EC-163)
7.3181 We now turn to the Italian safeguard measure on T25 maize, MON810 maize,
MON809 maize and Bt-11 maize (EC-163). We recall that we must determine whether Italy's
measure is "based on" a risk assessment pursuant to Article 5.1. In this context, the first issue we will
address is whether the documents Italy relies on to ju stify its safeguard measure meet the definition of
a risk assessment.

2024 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the Greek safeguard measure should be treated as constituting one or more SPS measures. Thus, like
the Parties, we will continue to treat this measure as constituting one single SPS measure.

"Risk assessment"

7.3182 We start by summarizing the documents on record in respect of this safeguard measure. We
recall that Italy issued a decree on 4 August 2000 suspending the trade and use of T25 maize,
MON810 maize, MON809 maize and Bt-11 maize (EC-163).2025 As stated in the Decree, the decision
by Italy to apply a safeguard measure on T25 maize, MON810 maize, MON809 maize and
Bt-11 maize (EC-163) was based on opinions issued by the Italian Superior Council of Health and
Superior Institute of Health. We recall that only th e 28 July 2000 opinion of the Superior Institute of
Health referred to in the Italia n Decree was provided to the Panel. 2026 The relevant conclusions of the
opinion of the Superior Institute of Health set out in the Decree were summarized above.
7.3183 Having determined the documents relied on by It aly with respect to its safeguard measure on
T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163), we must now determine
whether any of these documents constitutes a "r isk assessment" within the meaning of the
SPS Agreement.
7.3184 We recall that the concerns identified by Italy relate to the protection of human health from
potential risks associated with the consumption of the relevant GM maize products as well as potential
risks arising from the "environmental release" of the relevant GMOs or their products. Regarding the
latter category of risks, we consider that the first clause of Annex A(4) to the SPS Agreement provides
the applicable definition for the "risk assessment" to be carried out for Italy's safeguard measure on
T25 maize, MON810 maize, MON809 maize and Bt- 11 maize (EC-163). Regarding the former
category of risks – risks associated with the cons umption of the relevant GM maize products – we
consider that the second clause of Annex A(4) to the SPS Agreement provides the applicable
definition. We note that, unlike for the definition of risk assessment contained in the first clause of
Annex A(4), WTO jurisprudence provides little guidance on the meaning of key concepts contained in
the definition provided in the second clause. The Appe llate Body merely observed in this respect that
the first clause is substantially different from the second clause, and that the second clause requires
"only" the evaluation of the "potential" for adverse effects on human or animal health arising from the
presence of certain substances in foods, whereas the first clause requires an evaluation of the
"likelihood" of entry, establishment or spread of a pest or disease and of the associated biological and
economic consequences. 2027 We note that the dictionary defines the term "potential" as "the
possibility of something happening [...] in the future".2028
7.3185 We start with the Decree notified by Italy in respect of its safeguard measure on T25 maize,
MON810 maize, MON809 maize and Bt-11 maize (E C-163). This Decree makes reference to "an
exposé by an environmentalist association regarding to the simplified authorization procedure for the
placing on the market" 2029 of these four maize products, and assertions by the environmentalist
association that the condition of "substantial equivalence" required for the use of the simplified
procedure was not met for these products. The Decr ee also makes reference to an opinion by the
Italian Superior Institute of Health which it say s found (i) that residues of genetically modified
components (proteins) remain in the four pro ducts in question and (ii) that the technical
documentation available does not examine the releva nt GMOs in comparison to their conventional
counterparts with regard to the presence of these components. Although the Decree reports the

2025 Exhibit EC-157/At. 1.
2026 Exhibit EC-157/At. 2.
2027 Appellate Body Report, Australia – Salmon, footnote 69.
2028 The Concise Oxford Dictionary , 10th edn, J. Pearsall (ed.) (Oxford University Press, 1999),
p. 1120.
2029 Exhibit EC-157/At. 1.

ultimate conclusion of the Italian Superior Institute of Health that "there are no apparent risks to the
health of humans or livestock from the consumpti on of derivatives of the aforementioned GMOs"
2030,
the Decree states that this conclusion was reached in a context in which there were inadequacies in the
applicable risk assessment procedures. The Decree further states that since it had been established
that residues of modified components remain in th e four products, the information available from the
simplified procedure was also inadequate with regard to the risks arising from "environmental
release" of the GMOs in question, or their products.
7.3186 In our view, it is clear that the Decree does not itself provide an "evaluation" of the potential
for adverse effects on human or animal health arising from the presence of certain
substances/components (toxins, additives, etc.) in the four products in question. Similarly, the Decree
does not itself evaluate the likelihood of the est ablishment or spread of a pest due to the
"environmental release" of the relevant GMOs or their products. We therefore consider that the
Decree is not in itself a risk assessment within the meaning of Annex A(4) and Article 5.1.
7.3187 We turn next to the opinion by the Italian Superior Institute of Health of July 2000.
2031 In
assessing the possible food safety risks associated w ith the consumption of the four maize products,
the Institute comments on composition (noting an expressed presence of protein deriving from the
genetic modifications), toxicity of the products of "extraneous" genes (including Bt toxin), herbicide
residues and antibiotic resistance. The report conc ludes that "in the light of current scientific
knowledge it is this Institute's opinion that there ar e no risks to human or animal health due to the
consumption of derivatives of the GMOs indicated in the table".
2032 Finally, the Institute declined to
express an opinion regarding the risk of possible "environmental release" of the GMOs in question, or
of their products.
7.3188 In considering the Institute's opinion, we note that in relation to herbicide residues, the
Institute stated that this issue would need to be "evaluated" by the Phyto-pharmaceutical Commission
in order to determine whether regulatory action would be appropriate. Thus, it is apparent that the
Institute's opinion does not itself evaluate the potentia l for any adverse effects. Regarding toxicity
and antibiotic resistance, we note that the opini on draws conclusions regarding the potential for
adverse effects from the results of available studies and tests. These studies and tests are not annexed
to the opinion, however. The opinion merely i ndicates their results and critical conclusions.
2033
Hence, it is clear that the text of the opinion do es not itself contain and provide all the information
necessary to an evaluation of the potential for the rele vant adverse effects to occur. Accordingly, we
consider that the Institute's opinion constitutes, not a complete, self-contained, scientific evaluation of
the potential for adverse effects on human or animal health due to toxicity and the development of
antibiotic resistance, but only part of such an eval uation. We are therefore of the view that the
Institute's opinion does not meet the definition of a risk assessment as provided in the second clause
of Annex A(4). Moreover, since none of the studies or tests referenced or mentioned in the opinion
were provided to us, we cannot, and do not, express a view on whether the opinion and these studies
and tests taken together would satisfy the Annex A(4) definition of a "risk assessment".
7.3189 Regarding potential risks arising from the "envir onmental release" of the relevant GMOs or
their products, we recall that the Institute's opinion ex plicitly states that it does not address such risks.

2030 Ibid.
2031 Exhibit EC-157/At. 2.
2032 Ibid.
2033 It is pertinent to note that that the entirety of the discussion concerning toxicity and antibiotic
resistance extends over no more than one page.

It follows that the opinion does not provide an assessment of such risks which would meet the
definition of Annex A(4).
7.3190 In the light of the foregoing, we conclude that the above-mentioned documents relied on by
Italy to justify its safeguard measure are not risk assessments within the meaning of Annex A(4) and
Article 5.1.
7.3191 Furthermore, in connection with the documents relied on by Italy, we should also note the
European Communities' argument that Italy's safeguard measure was based on an assessment
"appropriate to the circumstances" within the me aning of Article 5.1. The European Communities
submits that the circumstances in the case of the It alian safeguard measure include the fact that, from
Italy's perspective, relevant scientific evidence was or is insufficient We recall our previous
consideration of the European Communities' argument based on the phrase "appropriate to the
circumstances" in paragraphs 7.3052-7.3053 above and consider that our conclusions there apply
mutatis mutandis to this measure.
7.3192 We have found above that the documents provi ded by the Parties in relation to Italy's
safeguard measure on T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163) on
which Italy relied do not constitute a risk asse ssment. However, the European Communities
contends that there is a document other than the documents relied on by Italy which constitutes a risk
assessment for T25 maize, MON810 maize, MO N809 maize and Bt-11 maize (EC-163). The
document in question is the "risk assessment [which] was carried out at the time when the original
Community consent was given" (hereafter the "original risk assessment").
2034 It is not clear from this
assertion whether the European Communities is referring to the risk assessment conducted by the lead
CA or to those conducted by the SCP. 2035 In any event, we have noted above that it is not in dispute
that both of these documents constitute risk assess ments within the meaning of Annex A(4) and
Article 5.1.
7.3193 In addition, we note that none of the Parties has argued that, on the date of establishment of
this Panel, the risk assessments conducted by the l ead CA and the SCP were no longer "appropriate to
the circumstances". In the light of this, and in vi ew of our findings below with regard to whether
Italy's safeguard measure is "based on" these risk as sessments, we do not need to examine this issue
further.
"Based on"
7.3194 We now turn to the question of whether, at the time of establishment of this Panel, the Italian
safeguard measure on T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163) was
"based on" either the risk assessment of the lead CA or those conducted by the SCP.2036
7.3195 We note that the European Communities' arguments in respect of this issue were the same as
those it presented in the context of Austria's safe guard measure on T25 maize. We have addressed
these arguments above and have reached the conclusion that Austria's safeguard measure on T25
maize cannot be considered to be "based on" the risk assessments performed by the lead CA and the

2034 EC reply to Panel question No. 107.
2035 Exhibits EC-159/Ats. 1-2; EC-160/At. 1-2; EC-163/At. 1; CDA-82, CDA-83, CDA-84 and
CDA-85; US-68 (referencing original SCP risk assessments); ARG-47 (referencing original SCP risk
assessments).
2036 We recall that we must examine as part of our analysis whether the safeguard measure is based on
either risk assessment, as it is not clear whether the original risk assessment referred to by the
European Communities is the risk assessment conducted by the lead CA or those conducted by the SCP.

SCP in relation to T25 maize. This conclusi on, and the reasoning supporting it, also apply, mutatis
mutandis, to Italy's safeguard measure on T25 maize, MON810 maize, MON809 maize and
Bt-11 maize (EC-163) and the risk assessments perform ed by the lead CA and the SCP in relation to
T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163). This is because, as in the
case of Austria's safeguard measure on T25 maize:
(a) we are not aware of any divergent opinions expressed in the risk assessments which
were conducted by the lead CA and the SCP with regard to T25 maize,
MON810 maize, MON809 maize and Bt-11 maize (EC-163);
(b) the European Communities or Italy did not explain, by reference to these risk
assessments, how and why Italy assessed the risks differently, and did not provide a
revised or supplemental assessment of the risks;
(c) the European Communities has not identified possible uncertainties or constraints in
the risk assessments in question, and has not explained why, in view of any such
uncertainties or constraints, Italy's prohibition is warranted by the relevant risk
assessments; and
(d) there is no apparent rational relationship between Italy's safeguard measure, which
imposes a prohibition, and risk assessments which we understand found no grounds
for considering that the use of T25 maize, MON810 maize, MON809 maize and
Bt-11 maize (EC-163) endangers human health or the environment.
7.3196 Thus, in view of our conclusion that Italy's safeguard measure on T25 maize,
MON810 maize, MON809 maize and Bt-11 maize (EC- 163) cannot be considered to be "based on"
the risk assessments performed by the lead CA or the SCP in rela tion to T25 maize, MON810 maize,
MON809 maize and Bt-11 maize (EC-163) and recalling the fact that no other risk assessment which
might reasonably support Italy's safeguard measure h as been provided to us, we find that the Italian
safeguard measure is not based on a risk assessment pursuant to Article 5.1.
2037
7.3197 We add that even if the favourable opinion2038 by the Superior Institute of Health of July 2000
was considered to provide a risk assessment regard ing the concerns over toxi city and development of
antibiotic resistance, Italy's decision to prohibit the marketing of the four GM maize products at issue
could not, in our view, be said to be based on th e Institute's favourable opinion. The reasons which
we have given above in relation to the risk assessments performed by the lead CA or the SCP apply,
mutatis mutandis, also to the Institute's opinion.

2037 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the Italian safeguard measure should be treat ed as constituting one or more SPS measures. Thus, like
the Parties, we will continue to treat this measure as constituting one single SPS measure.
2038 We recall that the Institute's conclusion was to the effect that there are no risks to human health due
to the consumption of these products.

Overall conclusions

7.3198 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that, contrary to
the provisions of Article 5.1 of the SPS Agreement, the Italian safeguard measure on
T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163) is not based
on a risk assessment.

 (ii) DS292 (Canada)

 With reference to DS292, and having re gard to the arguments and evidence presented
by Canada and the European Communities, the Panel finds that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Italian safeguard measure on
T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163) is not based
on a risk assessment.

 (iii) DS293 (Argentina)
2039

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communities, the Panel finds that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Italian safeguard measure on
T25 maize, MON810 maize and Bt-11 maize (EC-163) is not based on a risk
assessment.

7.3199 In view of our findings in the previous para graph with regard to DS291 (United States),
DS292 (Canada) and DS293 (Argentina), it is necessary to examine, in addition, whether the Italian
safeguard measure on T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163) is
consistent with the requirements of Article 5.7 of the SPS Agreement. It is only once we have
completed this additional examination that we can come to a final conclusion regarding the
consistency of the Italian safeguard measure on T25 maize, MON810 maize, MON809 maize and
Bt-11 maize (EC-163) with Article 5.1 of the SPS Agreement. We undertake the necessary
examination under Article 5.7 in the next section.
(x) Luxembourg – Bt-176 maize
7.3200 We now turn to Luxembourg's safeguard measure on Bt-176 maize. We recall that we must
determine whether Luxembourg's measure is "based on" a risk assessment pursuant to Article 5.1. In
this context, the first issue we will address is whether the document Luxembourg relies on to justify
its safeguard measure meet the definition of a risk assessment.

2039 We recall that unlike the complaints by the other Complaining Parties, Argentina's complaint with
regard to the Italian safeguard measure covers only thr ee products subject to the Ita lian decree of August 2000,
i.e., T25 maize, MON810 maize and Bt-11 maize.

"Risk assessment"

7.3201 We recall that only one document was submitted by the Parties in relation to Luxembourg's
safeguard measure on Bt-176 maize, namely the Reasons document. 2040 Thus, we must determine
whether this document constitutes a "risk assessment" within the meaning of the SPS Agreement.
7.3202 As with Austria's safeguard measure for Bt-1 76 maize, given the concerns raised by
Luxembourg in the context of Bt-176 maize, we c onsider that both the first and the second clause of
Annex A(4) to the SPS Agreement define the "risk assessment" to be carried out for Luxembourg's
measure on Bt-176 maize.
7.3203 In the Reasons document, Luxembourg alleges that Bt-176 maize poses risks in relation to the
development of antibiotic resistance and the developm ent of insect resistance to Bt toxin. Regarding
the development of antibiotic resistance, the R easons document refers to scientific advice from EC
scientific committees and other scientific expert s. Although Luxembourg acknowledges that these
experts indicated that there was only a small risk th at antibiotic resistance would develop due to gene
transfer to bacteria in the gut of humans or anim als, Luxembourg insists that a small risk exists,
notably in situations where the maize in question is used as animal feed, and argues that there is a
need for further study regarding the mechanism of gene transfer.
7.3204 With regard to the development of insect resist ance to Bt toxin, the Reasons document refers
to the "possible" emergence of insects resistant to the Bt toxin as "a real risk factor".2041 It emphasizes
the lack of understanding of the long-term impacts of Bt toxin on the evolution of insect resistance. It
also refers to a case of development of insect r esistance in the United States in the wake of the
introduction of GM cotton with an insecticidal trait. The Reasons document argues in this respect that
as long as the causes of the insect r esistance in the United States have not been elucidated, Bt maize
should not be cultivated.
7.3205 Thus, the Reasons document calls for, but does not itself provide, further evaluation of the
mechanism of gene transfer which might lead to th e development of antibiotic resistance and of the
risk of development of insects resistant to Bt t oxin. More particularly , the Reasons document does
not make a further evaluation of the likelihood of th e spread of diseases or target insects. Nor does it
make a further evaluation of the potential for adve rse effects on human or animal health arising from
the presence of ARMG in food. Given this, we consider that the Reasons document does not meet the
definition of a risk assessment as provided in Annex A(4).
7.3206 In the light of the foregoing, we conclude that the Reasons document, being the document
relied on by Luxembourg to justify its safeguard measure, does not constitute a risk assessment within
the meaning of Annex A(4) and Article 5.1.
7.3207 Furthermore, in connection with the document relied on by Luxembourg, we should also note
the European Communities' argument that Luxembourg's safeguard measure was based on an
assessment "appropriate to the circumstances" with in the meaning of Article 5.1. The European
Communities submits that the circumstances in the case of Luxembourg's safeguard measure include
the fact that, from Luxembourg's perspective, releva nt scientific evidence was or is insufficient We
recall our previous consideration of the Europ ean Communities' argument based on the phrase
"appropriate to the circumstances" within the mean ing of Article 5.1 in paragraphs 7.3031-7.3032
above, and consider that our conclusions there apply mutatis mutandis to this measure.

2040 Exhibit EC-158/At. 9.
2041 Ibid.

7.3208 We have found above that the only document whic h was provided by the Parties in relation to
Luxembourg's safeguard measure on Bt-176 mai ze and which Luxembourg relied on does not
constitute a risk assessment. However, the Europ ean Communities contends that there is a document
other than the document relied on by Luxembourg wh ich constitutes a risk assessment for Bt-176.
The document in question is the "risk assessment [which] was carried out at the time when the
original Community consent was given" (h ereafter the "original risk assessment").
2042 It is not clear
from this assertion whether the European Communiti es is referring to the risk assessment conducted
by the lead CA or any of the risk assessments which were conducte d by the Scientific Committee for
Pesticides (SCPE), the Scientific Committee for Animal Nutrition (SCAN) or the SCF. 2043 I n a n y
event, it is not in dispute that these documents constitute risk assessments within the meaning of
Annex A(4) and Article 5.1.
7.3209 In addition, we note that none of the Parties has argued that, on the date of establishment of
this Panel, the risk assessments conducted by th e lead CA and the risk assessments which were
conducted by the SCPE, the SCAN or the SCF were no longer "appropriate to the circumstances". In
the light of this, and in view of our findings be low with regard to whether Luxembourg's safeguard
measure is "based on" these risk assessments, we do not need to examine this issue further.
"Based on"
7.3210 We now turn to the question of whether, at the time of establishment of this Panel,
Luxembourg's safeguard measure on Bt-176 maize w as "based on" either the risk assessment of the
lead CA or that conducted by the SCPE, the SCAN or the SCF.2044
7.3211 We note that the European Communities' arguments in respect of this issue were the same as
those it presented in the context of Austria's safe guard measure on T25 maize. We have addressed
these arguments above and have reached the conclusion that Austria's safeguard measure on T25
maize cannot be considered to be "based on" the risk assessments performed by the lead CA and the
SCP in relation to T25 maize. This conclusi on, and the reasoning supporting it, also apply, mutatis
mutandis, to Luxembourg's safeguard measure on Bt- 176 maize and the risk assessments performed
by the lead CA and the SCPE, the SCAN and the SCF in relation to Bt-176 maize. This is because, as
in the case of Austria's safeguard measure on T25 maize:
(a) we are not aware of any divergent opinions expressed in the risk assessments which
were conducted by the lead CA and the SCPE, the SCAN or the SCF with regard to
Bt-176 maize;
(b) the European Communities or Luxembourg did not explain, by reference to these risk
assessments, how and why Luxembourg assessed the risks differently, and did not
provide a revised or supplemental assessment of the risks;
(c) the European Communities has not identified possible uncertainties or constraints in
the risk assessments in question, and has not explained why, in view of any such

2042 EC reply to Panel question No. 107.
2043 Exhibits EC-158/Ats. 1-3; EC-158/At. 4; EC-158/At. 5; EC-158/At. 6.
2044 As noted, we must examine as part of our anal ysis whether the safeguard measure is based on
either risk assessment, as it is not clear whether the original risk assessment referred to by the
European Communities is the risk assessment conducted by the lead CA or that conducted by the SCPE, the
SCAN or the SCF.

uncertainties or constraints, Luxembourg's prohibition is warranted by the relevant
risk assessments; and
(d) there is no apparent rational relationshi p between Luxembourg's safeguard measure,
which imposes a prohibition, and risk assessm ents which found no evidence that
Bt-176 maize will give rise to any adverse effects on human or animal health and the
environment.
7.3212 Thus, in view of our conclusion that Luxe mbourg's safeguard measure on Bt-176 maize
cannot be considered to be "based on" the risk ass essments performed by the lead CA or the SCPE,
the SCAN or the SCF in relation to Bt-176 maize, and recalling the fact that no other risk assessment
which might reasonably support Luxembourg's safeguard measure has been provided to us, we find
that Luxembourg's safeguard measure is not based on a risk assessment pursuant to Article 5.1.
2045
Overall conclusions
7.3213 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that, contrary to
the provisions of Article 5.1 of the SPS Agreement, Luxembourg's safeguard measure
on Bt-176 maize is not based on a risk assessment.

 (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 finds that, contrary to the
provisions of Article 5.1 of the SPS Agreement, Luxembourg's safeguard measure on
Bt-176 maize is not based on a risk assessment.

7.3214 In view of our findings in the previous para graph with regard to DS291 (United States) and
DS293 (Argentina), it is necessary to examine, in addition, whether Luxembourg's safeguard measure
on Bt-176 maize is consistent with the requirements of Article 5.7 of the SPS Agreement. It is only
once we have completed this additional examination that we can come to a final conclusion regarding
the consistency of Luxembourg's safeguard meas ure on Bt-176 maize with Article 5.1 of the
SPS Agreement. We undertake the necessary examination under Article 5.7 in the next section.
(d) Consistency with Article 5.7 of the SPS Agreement and final conclusion regarding
consistency with Article 5.1 of the SPS Agreement
7.3215 We have found above that none of the relevant safeguard measures meets the requirements set
out in the text of Article 5.1. As we have said, in view of this finding, it is necessary to go on to
examine whether the safeguard measures are consiste nt with the requirements of Article 5.7 of the
SPS Agreement.

2045 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, Luxembourg's safeguard measure should be tr eated as constituting one or more SPS measures. Thus,
like the Parties, we will continue to treat this measure as constituting one single SPS measure.

7.3216 To recall, Article 5.7 provides as follows:
"In cases where relevant scientific evid ence is insufficient, a Member may
provisionally adopt sanitary or phytosanitary measures on the basis of available
pertinent information, including that from the relevant international organizations as
well as from sanitary or phytosanitary measures applied by other Members. In such
circumstances, Members shall seek to obta in the additional information necessary for
a more objective assessment of risk and revi ew the sanitary or phytosanitary measure
accordingly within a reasonable period of time."
7.3217 We have explained earlier that if we were to fi nd that a safeguard measure is consistent with
the requirements of Article 5.7, Article 5.1 would not be applicable and we would consequently need
to conclude that the European Communities has not acted inconsistently with its obligations under
Article 5.1. Conversely, if we were to find th at a safeguard measure is inconsistent with the
requirements of Article 5.7, Article 5.1 would be ap plicable and, in view of our finding that none of
the safeguard measures meets the requirements set out in the text of Article 5.1, we would need to
conclude that the European Communities has ac ted inconsistently with its obligations under
Article 5.1 in respect of the relevant measure.
7.3218 Before embarking on an examination of the i ndividual safeguard measures under Article 5.7,
it is well to recall that the Appellate Body in Japan – Agricultural Products II found that there are
four requirements in Article 5.7 that must be met in order for a Member to adopt and maintain a
provisional SPS measure. More specifically, the Appellate Body stated that:
2046
"Pursuant to the first sentence of Article 5.7, a Member may provisionally adopt an
SPS measure if this measure is:
(1) imposed in respect of a situation wh ere "relevant scientific information is
insufficient"; and
(2) adopted "on the basis of available pertinent information".
Pursuant to the second sentence of Article 5.7, such a provisional measure may not be
maintained unless the Member which adopted the measure:
(1) "seek[s] to obtain the additional in formation necessary for a more objective
assessment of risk"; and
(2) 'review[s] the … measure accordingly within a reasonable period of time'."
7.3219 Furthermore, we note that, according to the A ppellate Body, the four requirements contained
in Article 5.7 are "clearly cumulative in nature". 2047 In other words, "[w]henever one of these four
requirements is not met, the measure at issue is inconsistent with Article 5.7."2048
7.3220 The Appellate Body further stated that Article 5.7 reflects the precautionary principle, and
that the precautionary principle as such has not been written into the SPS Agreement as a ground for

2046 Appellate Body Report, Japan – Agricultural Products II , para. 89. See also Appellate Body
Report, Japan – Apples, para. 176. We note regarding the first re quirement that the Appellate Body referred to
"relevant scientific information" instead of "relevant scientific evidence".
2047 Appellate Body Report, Japan – Agricultural Products II, para. 89.
2048 Ibid.

justifying an SPS measure that is otherw ise inconsistent with that Agreement.
2049 The European
Communities asserts that each of the safeguard measu res at issue in this dispute is based on the
precautionary principle. Since we examine belo w whether the relevant safeguard measures are
consistent with the requirements of Article 5.7, in view of th e aforementioned statement by the
Appellate Body, we see no need separately to examine the European Co mmunities' argument that
these measures are based on the precautionary principle.
7.3221 With this in mind, we now turn to examin e the first member State safeguard measure,
Austria's safeguard measure on T25 maize. As always, we begin with a summary of the Parties' main
arguments.
(i) Austria – T25 maize
7.3222 The United States argues that the Austrian safeguard measure on T25 maize fails to meet any
of the four requirements set out in Article 5.7. First, the scientific evidence is sufficient to perform a
risk assessment, since the Eur opean Communities itself has conduc ted positive risk assessments on
T25 maize. Second, the safeguard measure was not adopted on the basis of "available pertinent
information". The SCP reviewed the safeguard me asure and concluded that the information provided
by Austria did not warrant any change in the earlier risk assessment. Third, Austria has not sought "to
obtain the additional information necessary for a more objective assessment of risk", and there is no
information on record that Austria has sought to perform a risk assessment that would support its
measure on T25 maize. Finally, the United States alleges that neither Austria nor the Commission
have reviewed the Austrian safeguard measure within a reasonable period of time.
7.3223 Canada argues that a review of the Austrian safe guard measure and the factual and scientific
circumstances surrounding its adoption and maintenance reveal that the measure fails to satisfy any of
the four elements of Article 5.7. First, the measure was not imposed in respect of a situation where
relevant scientific information was insufficient. The opinion of the European Communities' own
scientific experts demonstrate that there was sufficient scientific ev idence to conduct a complete and
objective risk assessment. In Canada's view, what was insufficient was the scientific evidence put
forward by the European Communities or Au stria to support the safeguard measure. Second, the
measure was not adopted on the basis of "available pertinent information", since this would include
the scientific opinions of the lead CA and of the relevant EC scientific committee, which all
confirmed the safety of the product.
7.3224 With respect to the third element of Article 5.7, the requirement that the Member seek to
obtain the additional information necessary for a mo re objective assessment of risk, Canada notes that
this element is irrelevant in this case, given th e sufficiency of the scientif ic evidence available from
the European Communities' own sources. Finally, with regard to the fourth requirement, namely that
the measure must be reviewed within a reasonable period of time, Canada recalls that the European
Communities' own legislation requires that such a re view take place. However, given the absence of
"pertinent information" to support the safeguard me asure, Canada draws the conclusion that the
measure would have been lifted if such a review had been conducted. Furthermore, according to the
Appellate Body, what constitutes a "reasonable peri od of time" will be influenced by the emergence
of the additional information necessary to make a mo re objective assessment of the risk. In Canada's
view, new or additional information was not necessary in the present case to conduct a risk
assessment, as sufficient scientific evidence was in existe nce even at the time the safeguard measure
was taken.

2049 Appellate Body Report, EC – Hormones, para. 124.

7.3225 Argentina argues that the Austrian safeguard me asure does not meet any of the four
requirements of Article 5.7. First, the scientific evidence was not in sufficient, since at least two
positive scientific opinions were expressed on T25 ma ize, including one which specifically rejected
the information provided by Austria in support of the measure. Second, Austria did not base its
measure on the "available pertinent information", since it disregarded the positive scientific opinions
of the scientific committee. Third, Austria has not sought to obtain further information necessary for
a more objective risk assessment, be cause the information provided in th is case is not consistent with
the positive scientific opinions given by the scientific committee. Finally, with respect to the fourth
requirement of Article 5.7, Argentina notes that Austria did not review its safeguard measure.
7.3226 The European Communities argues that the Austrian safeguard measure meets the four
requirements of Article 5.7. First, the European Communities asserts that relevant scientific evidence
was insufficient. According to the European Communities, the concept of "insufficiency" in
Article 5.7 is "relational" and must therefore refer to the matters of concern to the legislator.
Specifically, "insufficient" means "insufficient" fo r the production of a risk assessment adequate for
the purposes of the legislator who must decide whet her a measure should be applied, provisionally or
otherwise, for one of the reasons enumerated in Annex A(1) of the SPS Agreement. The European
Communities defines a risk assessment which is ade quate as one which has been "delivered by a
reputable source, [which] unequivocally informs the legi slator about what the risk is with a sufficient
degree of precision, and [which] has withstood the passage of time and is unlikely to be revised".
2050
7.3227 In support of its view, the European Communities submits that the sufficiency of the evidence
cannot be examined in a vacuum, but has to be exam ined in relation to the protection goals sought by
legislators. The European Communities argues that it is artificial to suppose that there is some kind of
magic moment at which the available science becom es sufficient for all purposes. In the European
Communities' view, the actions of a legislator in response to available scientific evidence are a
function of what that particular legislator is c oncerned about. Thus, in the European Communities'
view, the higher the level of acceptable risk, the more likely it is that the legislator may conclude,
within a relatively short period of time, that the scientific evidence is sufficient and that no provisional
measure is therefore necessary. The lower the leve l of acceptable risk, the more likely it may be that
the legislator may continue to consider, for a relatively long period of time, that the scientific
evidence is insufficient, and that a measure is warranted. 2051 In other words, according to the
European Communities, the sufficiency of the scientific evidence must be examined in relation to the
level of acceptable risk of the legislators.
7.3228 Applying these considerations to the Austrian safeguard measure on T25 maize, the European
Communities submits that, having regard to the specifi c concerns of Austria's legislators in adopting
that measure, Austria's legislators were entitled to conclude that relevant scientific evidence was
insufficient for their purposes.
7.3229 Furthermore, the European Communities contends that Austria has adopted and maintained
its safeguard measure on the basis of "availa ble pertinent information", which includes, inter alia, the
information contained in the original notificatio n, as well as the various relevant scientific
discussions, papers and opinions. With respect to the third requirement of Article 5.7, the European
Communities argues that both Austria and the Eu ropean Communities are engaged in an ongoing
process by which they are seeking to obtain add itional information necessary for a more objective
assessment of the risk through ongoing research and the constant development of science.

2051 The European Communities considers that this an alysis is confirmed by the words "reasonable
period of time" in Article 5.7.

7.3230 Finally, the European Communities notes that th e measure is subject to a process of review
within a reasonable period of time, and that such review is still ongoing both at Community and
member State levels.
2052 According to the European Communities, the determination of what
constitutes a "reasonable period of time" pursuant to Ar ticle 5.7 depends on all the circumstances. In
the present case, for instance, assessments are being made of long-te rm effects, in relation to changes
that may have a permanent effect, and that are being introduced at an exponential rate as compared to
the past. These circumstances may justify a Member requiring a relatively long period of time to
review its provisional measure.
2053 The European Communities finds support for this view in the
Appellate Body's statement that "responsible , representative governments commonly act from
perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to
human health are concerned". 2054 The European Communities di fferentiates the present case from
Japan-Apples, arguing that GMO technology is still at th e frontiers of scie nce and its future
consequences (compared to a case like fire blight ) are highly uncertain – and potentially more far-
reaching. The European Communities argues that the relevant risks are more than the mere
theoretical uncertainty that always remains si mply because science can never provide absolute
certainty that a given substance will never have adverse effects.2055
7.3231 The Panel notes that in presenting arguments with respect to the four requirements of
Article 5.7, the Parties started with the first requirement, i.e. whether the Austrian safeguard measure
was imposed in respect of a situation where "rel evant scientific evidence [w as] insufficient". The
Panel, too, will begin its analysis with the first requirement.2056
"Insufficiency of relevant scientific evidence"
7.3232 We recall that pursuant to the first requiremen t, a Member must not provisionally adopt an
SPS measure except in a case "where relevant scienti fic evidence is insufficient". Before examining
the Austrian safeguard measure in the light of this requirement, we need to address two issues:
(i) whether the sufficiency of the scientific evid ence must be assessed by reference to Austria's
appropriate level of sanitary or phytosanitary prot ection and (ii) whether the sufficiency of the
scientific evidence is to be judged at the time of a doption of the Austrian safeguard measure or at the

2052 We recall that the US argument that a requirement that measures be "constantly subject to review"
does not meet the requirement that th e measures be reviewed within a reasonable period of time of their
adoption. US second written submission, para. 100.
2053 The European Communities submits that the present case is very different, fo r example, from that
before the panel in Japan – Apples.
2054 Appellate Body Report, EC – Hormones, para. 124.
2055 The European Communities notes in its first writte n submission (para. 608) that "[t]he present case
is, for example, very different from the circumstances of the Japan – Apples case. That case concerned a
disease (fire blight) with a relatively narrow spectrum of possible consequences (compared to GMOs generally).
The panel found that the disease had been known and studied for some 200 years – the GMO techniques with
which this case is concerned are far mo re recent than that. The panel also found that there was a high quantity
and quality of scientific evidence expressing strong and increasing confidence in the conclusion. In other
words, the matter could fairly be described as no longer being at the frontiers of science, but rather to have
passed into the realms of conventional scientific wisdom – an operational hypothesis unlikely to be disturbed
other than by some revolutionary and currently totally unforeseeable new scie ntific discovery. That is not at all
the circumstances of the present case. GMO technology is still at or close to the frontiers of science and its
future consequences (compared to a case like fire blight) highly uncertain – and potentially much more far
reaching."
2056 We note that the panel in Japan – Apples also began its inquiry with the first requirement, an
approach not faulted by the Appellate Body. Panel Report, Japan – Apples, para. 8.214.

time of review by this Panel, i.e., at the time this Panel's terms of reference were fixed. We will
examine these issues in turn.
Relevance of the appropriate level of sanitary or phytosanitary protection from risks
7.3233 We recall the European Communities' contentio n in paragraph 7.3227 above that in assessing
the sufficiency of relevant scientif ic evidence, regard must be had to the protection goals pursued by
legislators. In considering this contention, we recall as an initial matter that the Appellate Body in
Japan – Apples clarified the meaning of the phrase "where relevant scientific evidence is insufficient".
According to the Appellate Body, the notion of "i nsufficiency" implies a relationship between the
scientific evidence and something else. On that basis, the Appellate Body determined that "'relevant
scientific evidence' will be 'insufficient' within the meaning of Article 5.7 if the body of available
scientific evidence does not allow, in quantitative or qualitative terms, the performance of an adequate
assessment of risks as required under Article 5.1 and as defined in Annex A to the
SPS Agreement".
2057 It appears that in the Appellate Bo dy's view scientific evidence could be
considered to be insufficient in qualitative terms for instance when it is inconclusive or unreliable.2058
7.3234 The European Communities argues that the conc ept of "insufficiency" in Article 5.7 is
"relational" and must, therefore refer to the matters of concern to the legislator. We are not persuaded
by this argument. While the Appellate Body has said that the notion of "i nsufficiency" implies a
"relationship" between the scientific evidence and something else, it nowhere said that the notion of
"insufficiency" implies a relationship between the scientific evidence and the matters of concern to the
legislator. The Appellate Body identified, a nd acknowledged the existen ce of, only one relevant
relationship: that between the scientific evidence and the obligation to perform a risk assessment
under Article 5.1.
7.3235 We note that the Appellate Body in Japan – Apples referred to the insufficiency of available
scientific evidence to perform an "adequate" assessment of risks. The European Communities appears
to rely on the Appellate Body's use of the term "adequate", for it argues that an "adequate" assessment
of risks is one which is "adequate for the purposes of the legislator". The Appellate Body failed to
define or explain the term "adequate". Moreover, the term "adequate" nowhere appears in Article 5.1,
Article 5.7 or Annex A(4). In these circumstances, we are not convinced that we should attach much
significance to this term. 2059 Indeed, the term "adequate" may have been intended as nothing more
than a reference to the definition in Annex A(4). On this view, a risk assessment would be "adequate"
if it meets the standard and definition provided in Annex A(4).
7.3236 If we were nonetheless to try to give independe nt meaning to the term "adequate", the second
sentence of Article 5.7 appears to us to be in structive. That sentence makes clear that in
circumstances where relevant scientific evidence is insufficient and a Member has provisionally
adopted an SPS measure, the Member concerned mu st seek to obtain the additional information
necessary for a "more objective assessment of risk". We have observed earlier that we take the phrase
"a more objective assessment of risk", considered as a whole, to refer to a risk assessment which
satisfies the definition provided in Annex A(4), or at least which is closer to satisfying the definition
in Annex A(4) than consideration of "available pe rtinent information". Also, Article 5.1 requires SPS
measures to be based on a risk assessment within the m eaning of Annex A(4). On that basis, it can be

2057 Appellate Body Report, Japan – Apples, para. 179.
2058 Ibid., para. 185.
2059 This view is supported by the fact that three paragraphs later in its report on Japan – Apples , the
Appellate Body dropped the term "adequate", referring only to "an assessment of risks, as required under
Article 5.1 and as defined in Annex A". Appellate Body Report, Japan – Apples, para. 182.

argued that the Appellate Body's reference to "an adequate assessment of risks as required by
Article 5.1 and as defined in Annex A" (emphasis added) should be understood as a reference to "a
more objective assessment of risks as required by Article 5.1 and as defined in Annex A".
7.3237 Clearly, neither of the two above-noted interp retations of the term "adequate" supports the
conclusion that in referring to an "adequate" risk assessment, the Appellate Body intended to suggest
that a risk assessment had to be adequate for the purposes of a Member's legislator. The two
above-noted interpretations support the conclusion that, in the view of the Appellate Body, relevant
scientific evidence is insufficient w ithin the meaning of Article 5.7 if the body of available scientific
evidence does not allow, in quantitative or qualitative terms, the performance of a risk assessment as
required under Article 5.1 and as defi ned in Annex A(4). At any rate, this is the interpretation of the
concept of "insufficiency" in Article 5.7 which we believe to be correct.
7.3238 The European Communities argues that it is artific ial to suppose that there is some kind of
magic moment at which the available science becom es sufficient for all purposes. In the European
Communities' view, the actions of a legislator in response to available scientific evidence are a
function of what that particular legislator is c oncerned about. We would agree that it must be
determined on a case-by-case basis whether the body of available scientific evidence is insufficient to
permit the performance of a risk assessment. Bu t we are not convinced that the protection goals
pursued by a legislator are relevant to such a dete rmination. The protection goals of a legislator may
have a bearing on the question of which risks a Member decides to assess with a view to taking
regulatory action, if necessary. And a legislator's protection goals are certainly relevant to the
determination of the measure – or as the European Communities puts it, the "actions" – to be taken for
achieving a Member's level of protection against risk. Yet there is no apparent link between a
legislator's protection goals and the task of assessing the existence and magnitude of potential risks.
7.3239 We note that the European Communities defines a risk assessment which is adequate for the
purposes of a Member's legislator as one which has been "delivered by a reputable source, [which]
unequivocally informs the legislator about what the risk is with a sufficient degree of precision, and
[which] has withstood the passage of time and is unlikely to be revised".
2060 We have already
expressed the view that the question to be answered in an Article 5.7 inquiry is not whether relevant
scientific evidence permits the performance of a risk assessment adequate for the purposes of a
legislator, but whether it permits the performance of a risk assessment as required under Article 5.1
and as defined in Annex A(4). Nonetheless, we must examine whether the kind of risk assessment the
European Communities considers adequate is consis tent with the kind of risk assessment required
under Article 5.1 and defined in Annex A(4).
7.3240 We note in this respect that a risk assessment as required under Article 5.1 and as defined in
Annex A(4) may set forth diverging scientific opinions coming from qualified and respected sources
and, to that extent, need not necessarily inform a Member "unequivocally" about risks. A risk
assessment as defined in Annex A(4) should normal ly address the "degree of precision", or level of
confidence, with which the relevant risks can be , or have been, assessed and the circumstances in
which the assessment may need to be "revised". 2061 Also, the "passage of time" may be a limiting

2060 Ibid.
2061 It is instructive to note what is stated in this regard in pertinent risk assessment techniques
developed by relevant international organizations. Thus, the Codex Working Principles for Risk Analysis for
Application in the Framework of the Codex Alimentarius provide that "[c]onstra ints, uncertainties and
assumptions having an impact on the risk assessment shoul d be explicitly considered at each step in the risk
assessment and documented in a transparent manner". Codex Alimentarius Commission, Working Principles
for Risk Analysis for Application in the Framework of the Codex Alimentarius (adopted in June/July 2003),

factor which might warrant a revision of an existing risk assessment. However, where a risk
assessment has been performed, and that risk assessment meets the standard and definition of
Annex A(4), it does not cease to be a risk assessme nt within the meaning of Annex A(4) merely
because a particular Member judges that the risks ha ve not been assessed with a "sufficient" degree of
precision, that the assessment has not "withstood" the p assage of time, and that it is "likely" that the
assessment may need to be revised at some point in the future. If there are factors which affect
scientists' level of confidence in a risk assessment they have carried out
2062, this may be taken into
account by a Member in determining the measure to be applied for achieving it s appropriate level of
protection from risks. Thus, consistent with th e foregoing remarks, we consider that it would be
improper to apply the European Communities' defi nition of an "adequate" risk assessment for the
purposes of an analysis of whether relevant scientif ic evidence is insufficient to perform a risk
assessment. We observe that this view is consiste nt with risk assessment techniques established by
relevant international organizations. For instance, the Working Principles for Risk Analysis for
Application in the Framework of the Codex Alimentarius state that "[t]he report of the risk assessment
should indicate any constraints, uncertainties, assump tions and their impact on the risk assessment.
Minority opinions should also be recorded. The r esponsibility for resolving the impact of uncertainty
on the risk management decision lies with the risk manager, not the risk assessors". 2063 Along similar
lines, the Codex Principles for the Risk Analysis of Foods Derived from Modern Biotechnology state
that "[r]isk managers should take into account the uncertainties iden tified in the risk assessment and
implement appropriate measures to manage these uncertainties". 2064 Similarly, the IPPC's ISPM #11
(2001) states in relevant part that "[t]he un certainty noted in the assessments of economic
consequences and probability of introduction should also be consid ered and included in the selection
of a pest management option". 2065 The quoted passage stayed th e same in the 2004 version of
ISPM #11, which applies specifically to living modified organisms.
7.3241 Based on its view that a risk assessment must be adequate for the purposes of a Member's
legislator, the European Communities argues that a Member with a high appropriate level of
protection may justifiably consider that the availa ble body of scientific evid ence is insufficient to
permit the assessment of risks with a degree of precision which it would find adequate, while a
Member with a lower appropriate level of protecti on may consider that the same body of evidence is
sufficient to perform an adequate risk assessment. In other words, the European Communities argues
that in determining whether relevant scientific evidence is insufficient within the meaning of
Article 5.7, regard must be had to a Member's appropriate level of protection.

Section III, Codex Procedural Manual, 14 th edition, 2004, para. 23. Similarly, the IPPC's ISPM #11
(2001) states in relevant part that "[e]stimation of the probability of introduction of a pest and of its economic
consequences involves many uncertainties. [...] It is im portant to document the areas of uncertainty and the
degree of uncertainty in the assessmen t, and to indicate where expert judg ement has been used". IPPC, ISPM
#11 : Pest Risk Analysis for Quarantine Pests, April 2001, para. 2.4. The quoted passage stayed the same in the
2004 version of ISPM #11, which applies specifically to living modified organisms. Finally, the principles of
risk assessment of the OIE Terrestrial Animal Health Code provide in relevant part that "[r]isk assessments
should document the uncertainties, the assumptions made, an d the effect on these on the final risk estimate".
OIE, Terrestrial Animal Health Code, 2002, Article 1.3.2.3, para. 5.
2062 E.g., a limited body of relevant scientific evidence may be such a factor.
2063 Codex Alimentarius Commission, Working Principles for Risk Analysis for Application in the
Framework of the Codex Alimentarius (adopted in June/July 2003), Section III, Codex Procedural Manual, 14 th
edition, 2004, para. 25.
2064 Codex Alimentarius Commission, Principles for the Risk Analysis of Foods Derived from Modern
Biotechnology (adopted in June/July 2003), CAC/GL 44-2003, para. 18.
2065 IPPC, ISPM #11: Pest Risk Analysis for Quarantine Pests, April 2001, para. 3.

7.3242 There can be no doubt that a Member's appropr iate level of protection is relevant to
determining the SPS measure to be applied, if any, to protect that Member from risks. Article 5.3 of
the SPS Agreement refers to the determination of "the measure to be applied for achieving the
appropriate level of sanitary or phytosanitary protec tion from [...] risk", and Article 5.6 relates to the
establishment or maintenance of "[SPS] measures to achieve the appropriate level of sanitary or
phytosanitary protection".
7.3243 In contrast, the definition of the term "risk ass essment" in Annex A(4) does not indicate that a
Member's appropriate level of protection is pertin ent to an assessment of the existence and magnitude
of risks.
2066 Also, Annex A(5) to the SPS Agreement states that the concept of the appropriate level of
protection is referred to by some Members as the con cept of the "acceptable level of risk". We do not
think that scientists need to know a Member's "acceptable level of ri sk" in order to assess objectively
the existence and magnitude of a risk. 2067 Furthermore, neither Article 5.2 2068 nor Article 5.3 2069
suggests that a Member's appropriate level of protection may be relevant to the assessment of risks.
7.3244 We note that Article 5.1 provides that SPS measures must be based on an assessment of risks
which is "appropriate to the circumstances". The European Communities appears to suggest that an
importing Member's appropriate level of protection is a relevant circumstance within the meaning of
Article 5.1.2070 In our view, an importing Member may not reject an existing risk assessment which
meets the definition of Annex A(4) as not "appropriat e to [its] circumstances" on the basis that this
risk assessment indicates constraints or uncertainti es, and that this would not enable the Member
concerned to determine "with a sufficient degree of precision" whether a particular type of measure
would in fact achieve its appropriate level of protec tion. As we have said, if there are factors which
affect scientists' level of confidence in a risk asse ssment they have carried out, an importing Member
may take this into account in determining the measur e to be applied for achieving its appropriate level
of protection.2071
7.3245 Finally, we note the European Communities' argument that the phrase "within a reasonable
period of time" in the second sentence of Article 5. 7 supports its view that the importing Member's
appropriate level of protection is relevant to determining whethe r available scientific evidence is

2066 We note that Annex A(4) in part defines a "risk assessment" as "the evaluation of the likelihood of
entry, establishment or spread of a pest or disease within the territory of an importing Member according to the
sanitary or phytosanitary measures which might be applied". We are not convinced that a Member's appropriate
level of protection is relevant to identifying "the sanitary or phytosanitary measures which might be applied". In
any event, even if this were the case, we do not see how this could affect whether an assessment of the existence
and magnitude of risks could be carried out.
2067 We note in this regard that in Australia – Salmon the Appellate Body also underlined the
importance of distinguishing carefully "between the evaluation of 'risk' in a risk assessment and the
determination of the appropriate level of protection". Appellate Body Report, Australia – Salmon, para. 125.
2068 Article 5.2 provides that "[i]n the assessment of risks, Members shall take into account available
scientific evidence; relevant processes and producti on methods; relevant inspection, sampling and testing
methods; prevalence of specific diseases or pests; existence of pest- or disease-free areas; relevant ecological
and environmental conditions; and quarantine or other treatment".
2069 Article 5.3 provides in relevant part that "[i]n assessing the risk to animal or plant life or health [...],
Members shall take into account as relevant economic factors: the potential damage in terms of loss of
production or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or
eradication in the territory of the importing Member ; and the relative cost-effectiveness of alternative
approaches to limiting risks".
2070 EC reply to Panel question No. 107.
2071 It should also be recalled that to the extent a risk assessment sets out a minority opinion from a
qualified and respected source, an importing Member may also be justified in basing a measure to achieve its
appropriate level of protection on that minority opinion.

insufficient within the meaning of Article 5.7 to perform a risk assessment. The second sentence of
Article 5.7 requires that Members seek to obtain the information necessary for a more objective
assessment of risk and review provisional SPS measu res accordingly within a reasonable period of
time. In Japan – Agricultural Products II , the Appellate Body stated that what constitutes a
"reasonable period of time" depends, inter alia , on the difficulty of obtaining the information
necessary for a more objective assessment of risk.
2072 We think that in cases where additional
information obtained by a Member is objectively sufficient to perform "a more objective assessment
of risk", the phrase "review [...] within a reasonable period of time" would not provide a justification
for delaying the performance of su ch an assessment on the grounds that an assessment incorporating
the additional information would not allow the im porting Member to determine "with a sufficient
degree of precision" whether a measure different from its provisional measure would achieve its
appropriate level of protection. Here again, we consider that if there are factors which affect
scientists' level of confidence in "a more objec tive assessment of risk" they have performed, the
importing Member may take this into account when reviewing its provisional measure in the light of
the "more objective assessment". Thus, we are unable to accept the European Communities' argument
concerning the phrase "within a reasonable period of time".
7.3246 Based on the above considerations, we are una ble to agree with the European Communities
that in the context of Article 5.7 the insufficiency of relevant scien tific evidence must be assessed by
reference to the appropriate leve l of protection of the importing Me mber. More particularly, we do
not agree that we need to have regard to Aust ria's appropriate level of protection in examining
whether relevant scientific evidence was sufficient to perform a risk assessment for T25 maize as
required under Article 5.1 and as defined in Annex A(4).
Time at which insufficiency of relevant scientific evidence is to be assessed
7.3247 We now turn to analyse the second issue, i.e., whether the insufficiency of relevant scientific
evidence, which is a prerequisite for invoking the ex ception under Article 5.7, is to be judged at the
time of adoption of the Austrian safeguard measure or at the time this Panel's terms of reference were
fixed.
7.3248 The first sentence of Article 5.7 provides that "[i]n cases where relevant scientific evidence is
insufficient", a Member may provisionally "adopt" an SPS measure on the basis of available pertinent
information. Thus, the text of the first sen tence establishes a clear link between the required
insufficiency of relevant scientific evidence and the adoption of a provisiona l SPS measure which is
based on available pertinent information.
7.3249 The second sentence of Article 5.7 provides that "[i]n such circumstances", i.e., in
circumstances where an SPS meas ure has been provisionally adopted consistently with the
requirements of the first sentence of Article 5.7, the relevant Member must seek to obtain the
additional information necessary for a more objectiv e assessment of risk and review the measure
accordingly within a reasonable period of time. It is apparent from the conjunction "[i]n such
circumstances" as well as the nature of the requirements laid down in the second sentence of
Article 5.7 that that sentence establishes under what conditions an SPS measure which has been
provisionally adopted may be maintained.
7.3250 The Appellate Body appears to share the view that the first sentence of Article 5.7 is
concerned with the adoption of provisional SPS measures while the second sentence is concerned
with the maintenance of such measures. In Japan – Agricultural Products II , the Appellate Body

2072 Appellate Body Report, Japan – Agricultural Products II, para. 93.

stated that "[p]ursuant to th e first sentence of Article 5.7, a Member may provisionally adopt an SPS
measure if this measure [meets the two requirements set out in the first sentence]" and that "[p]ursuant
to the second sentence of Article 5.7, such a provisional measure may not be maintained unless the
Member which adopted the measure [complies with the two requirements set out in the second
sentence]".
2073 Subsequently, in Japan – Apples , the Appellate Body confirmed that the two
requirements set out in the second sentence of Article 5.7 "relate to the maintenance of a provisional
[SPS] measure and highlight the provisional nature of measures adopted pursuant to Article 5.7".2074
7.3251 Reinforcing our view that the first sentence of Article 5.7 relates to the adoption of
provisional SPS measures, but not to their maintenan ce, is the immediate context of Article 5.7.
Article 5.6 provides in relevant part that "when establishing or maintaining [SPS] measures to
achieve the appropriate level of [...] protection, Members shall ensure that such measures are not more
trade-restrictive than required" (emphasis added). Li kewise, Article 5.8 stipulates in relevant part that
"[w]hen a Member has reason to belie ve that a specific [SPS] measure introduced or maintained by
another Member is constraining [...] its exports and the measure is not based on the relevant
international standards, guidelines or recommendations [...], an explanation of the reasons for such
[SPS] measure may be requested and shall be provide d" (emphasis added). Since Articles 5.6 and 5.8
explicitly refer to the "maintenance" of SPS m easures in addition to th e "establishment" or
"introduction" of SPS measures, we think it may be justifiably assumed that the absence of a reference
to the "maintenance" of a provisional SPS measure in the first sentence is intentional, and that
"maintenance" is indeed covered by the second sentence of Article 5.7.
7.3252 Article 2.2 of the SPS Agreement is also part of the context of the first sentence of Article 5.7.
To recall, Article 2.2 states in part that SPS measures may not be " maintained without sufficient
scientific evidence, except as provided for in paragr aph 7 of Article 5" (emphasis added). We note
the absence of a reference to the "adoption" of SPS measures without sufficient scientific evidence.
Logic suggests that if an SPS measure may not be ma intained without sufficient scientific evidence, it
may also not be adopted without sufficient scientific evidence. This view draws support from the first
sentence of Article 5.7, which explicitly refers to the "adoption" of provisional SPS measures. We
recall in this respect that Article 5.7 provides for a qualified exemption from the obligation under
Article 2.2 not to maintain SPS measures without suff icient scientific evidence. Having said this, we
do not consider that, conversely, it may be deduced from the reference to the "maintenance" of an SPS
measure in Article 2.2 that the first sentence of Artic le 5.7 implies a reference to the "maintenance" of
a provisional SPS measure. As we have noted, we think that the second sentence of Article 5.7 sets
forth the applicable requirements relating to the maintenance of a provisional SPS measure.
Moreover, we have noted that in marked contrast with the first sentence of Article 5.7, other
provisions of the same Article – we have identifie d Article 5.6 and Article 5.8 – explicitly refer to
both the establishment, or introduction, of SPS measures in addition to their maintenance.
7.3253 Since the phrase "[i]n cases where relevant scientif ic evidence is insufficient" is part of the
first sentence of Article 5.7, and since the above considerations lead us to conclude that the
requirements contained in the first sentence relate only to the adoption of a provisional SPS measure,
we are of the view that a determination of whether a particular case is a case "where relevant scientific
evidence is insufficient" must be made by reference to the time the relevant provisional SPS measure
was adopted.
7.3254 Consideration of the alternative view strengthens rather than undermines our view. Indeed, if
it were assumed that, contrary to our view, it is to be assessed at the time of review by a panel whether

2073 Appellate Body Report, Japan – Agricultural Products II, para. 89 (emphasis added).
2074 Appellate Body Report, Japan – Apples, footnote 318 (emphasis in original).

"relevant scientific evidence is insufficient", the second sentence of Article 5.7 would effectively
become redundant. If a Member invoking the exception set out in Article 5.7 had to demonstrate that
at the time of review by a panel relevant scien tific evidence was insuffici ent to perform a risk
assessment as required under Article 5.1 and as defi ned in Annex A(4), there would be no apparent
need to require that Member to seek to obtain additional information and to review its provisional SPS
measure; the Member concerned would have ever y incentive to do so even in the absence of a
requirement as it might be called on to defend its measure at any time.
2075 What is more, if that
Member succeeded in demonstrating that relevant sci entific evidence was insuffi cient, we fail to see
what purpose would be served by requiring that Memb er to demonstrate, in addition, that at some
earlier point in time it had sought additional information and reviewed its measure.
7.3255 We have concluded that the sufficiency of re levant scientific evidence should be assessed at
the time a provisional measure was adopted. This conclusion warrants some elaboration, to avoid
possible misinterpretation. First of all, we are not suggesting that evidence which establishes that, at
some point between the time of adoption of a pr ovisional SPS measure and the time a panel's terms of
reference were fixed, relevant scientific evidence became sufficient, or was still insufficient, to
perform a risk assessment as required under Ar ticle 5.1 and as defined in Annex A(4), is a priori
irrelevant to an Article 5.7 inquiry. To the cont rary, such evidence may be relevant to an inquiry
under the second sentence of Article 5.7. It ma y shed light on whether the Member invoking the
exception under Article 5.7 has complied with the requirement to "seek to obtain the additional
information necessary for a more objective risk ass essment". Alternatively, such evidence may be
relevant to a determination of whether the Member invoking the exception under Article 5.7 has
conducted a "review" of its provisional measure "within a reasonable period of time".
7.3256 Secondly, there is no incongruity between our appr oach to the European Communities' claim
under Article 5.7 and our approach to the Compla ining Parties' claim under Article 5.1 and their
consequential claim under Article 2.2. It is true that in analysing these latter claims, we have
reviewed the situation as it existed at the time the Panel's terms of reference were fixed. However,
our approach to Article 5.7 is in keeping with, and gives meaning to, the two sentences of Article 5.7.
As we see it, a Member maintaining a provisional SPS measure cannot make a successful claim of
justification under Article 5.7 if that measure has not been adopted consistently with the requirements
of the first sentence of Article 5.7. Furthermore, if in our analysis we reach the issue of whether the
Austrian safeguard measure meets the requirement s of the second sentence of Article 5.7, which
relates to the maintenance of a provisional SPS measur e, we will examine this issue in the light of the
situation as it existed when our te rms of reference were set. In other words, in the context of any
inquiry under the second sentence of Article 5.7, we will follow the approach we adopted in respect of
the Complaining Parties' claims under Article 5.1 and 2.2.
7.3257 Thirdly, our approach does not have as a conse quence that a provisional SPS measure which
has been adopted consistently with the requireme nts of the first sentence of Article 5.7 may be
maintained indefinitely. The requirement in the second sentence of Article 5.7 that a Member
"review" a provisional SPS measure in our view implies that once sufficient relevant scientific
evidence has been obtained and a risk assessment meeting the definition of Annex A(4) has been

2075 In contrast, if, as we think, the sufficiency of scientific evidence is to be assessed at the time a
provisional SPS measure was adopted, a Member which could demonstrate that, at the time it adopted its
provisional SPS measure, relevant scientific evidence was insufficient would not have an obvious incentive to
seek additional information and review its measure in th e absence of a requirement to do so. Our view gives
purpose to the inclusion of such explicit requirements in the second sentence of Article 5.7.

carried out
2076, the provisional SPS measure must be withdrawn or modified if it cannot be "based on"
the risk assessment in question. We note in this regard that the dictionary defines the noun "review"
as "a formal assessment of something with the intention of instituting change if necessary". 2077 We
also recall that the Appellate Body in Japan – Apples observed that the requirement to review
provisional SPS measures "highlights the provisional nature of measures adopted pursuant to
Article 5.7".2078 This observation implies that a Member is required to withdraw or modify a
provisional measure if the review establishes that th e measure is no longer justified. Indeed, were it
otherwise, the requirement to review a provi sional SPS measure would be inconsequential and
meaningless.
(ii) Austria's safeguard measure on T25 maize
7.3258 Turning now to Austria's safeguard measure on T25 maize, we note the Complaining Parties'
argument that relevant scientific evidence coul d not have been insufficient to conduct a risk
assessment at the time of adoption of the Austrian safeguard measure, since a risk assessment was
conducted by the SCP on the basis of the information provided by Austria in support of its measure.
7.3259 We recall that Austria adopted its safeguard me asure on T25 maize in April 2000. Following
Austria's notification of the measure, the Commiss ion requested the SCP to analyse the information
provided by Austria in support of its measure in or der to determine whether this information would
cause the SCP to consider that the product constituted a risk to human health or the environment. The
SCP in its opinion of November 2000 concluded th at the information provided by Austria did not
constitute new scientific information which would change the original ri sk assessment which it had
carried out in the context of the EC approval procedure concerning T25 maize. 2079 Thus, as we
understand it, the SCP effectively reviewed its original risk assessment in the light of the information
presented by Austria and confirmed its original risk assessment. 2080
7.3260 We have found above that both the SCP opinions delivered in the context of relevant EC
approval procedures – the original assessments– and the SCP opinions delivered after the adoption of
the relevant member State safeguard measures – the review assessments – are risk assessments within
the meaning of Annex A(4) and Article 5.1 of the SPS Agreement.2081 We recall in this regard that the
European Communities does not suggest otherwise. 2082 In the light of this, we agree with the

2076 We recall that a risk assessment as required under Article 5.1 and as defined in Annex A(4) could
also be carried out by another Member or an international organization.
2077 The Concise Oxford Dictionary , 10th edn, J. Pearsall (ed.) (Oxford University Press, 1999),
p. 1225.
2078 Appellate Body Report, Japan – Apples, footnote 318 (emphasis in original).
2079 Exhibits US-56; CDA-77 and 87; ARG-45 and ARG-46.
2080 Exhibits US-56 (referencing original SCP assessment); CDA-75 and -87; ARG-45 and -46
(referencing original SCP assessment).
2081 We recall that the review assessments are generally in the nature of supplemental assessments and
thus need to be read in conjunction with the original assessments.
2082 It is pertinent to recall in this context that in defending the Austrian safeguard measure against the
Complaining Parties' claims under Article 5.1, the Euro pean Communities essentially argued that Austria acted
on the basis of new scientific information which pres ented a view divergent from the mainstream scientific
opinion reflected in the original risk assessment. It may be that in making this argument the European
Communities meant to refer to the SCP's original risk a ssessment. However, the fact that Austria may have
disagreed with the SCP's original a ssessment, and possibly also with the SCP's subsequent review assessment,
would not imply that the SCP's review and original assessments are not risk assessments as required under
Article 5.1 and as defined in Annex A(4). The Appellate Body has made it clear that a risk assessment as
required under Article 5.1 "[c]ould set out both the prevailing view representing the 'mainstream' of scientific
opinion, as well as the opinions of scientists taking a divergent view". Appellate Body Report, EC – Hormones,

Complaining Parties that the SCP's review asse ssment of T25 maize, and the SCP's original
assessment of T25 maize (which, as noted, was confirmed by the SCP's review assessment), serves to
demonstrate that at the time of adoption of the Au strian safeguard measure, the body of available
scientific evidence permitted the performance of a risk assessment as required under Article 5.1 and
as defined in Annex A(4). We consider, therefore, that the Complaining Parties have established a
presumption that Austria's safeguard measure was im posed in respect of a situation where relevant
scientific evidence was not insufficient. This pr esumption has not been effectively rebutted by the
European Communities.
2083
7.3261 As we pointed out above, the Appellate Body fo und that whenever one of the requirements of
Article 5.7 is not met, the measure at issue is inc onsistent with this provision. Thus, as it has been
established that Austria's safeguard measure on T25 ma ize was not adopted consistently with the first
requirement of Article 5.7, we conclude that that measure is inconsistent with Article 5.7.
Overall conclusions
7.3262 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Communities, the Panel finds that the Austrian
safeguard measure on T25 maize is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure on
T25 maize is not based on a risk assessment, the Panel reaches the final conclusion
that, by maintaining the measure in ques tion, the European Communities has acted
inconsistently with its obligations under Article 5.1.

 (ii) DS292 (Canada)

 With reference to DS292, and having re gard to the arguments and evidence presented
by Canada and the European Communities, the Panel finds that the Austrian
safeguard measure on T25 maize is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure on
T25 maize is not based on a risk assessment, the Panel reaches the final conclusion

para. 184. Thus, the mere fact that the scientists taki ng a divergent view do not agree with the majority view
does not necessarily mean that the majority view is based on a risk assessment which does not meet the standard
and definition set out in Annex A(4). In any event, as noted, the European Communities does not argue that the
SCP's original and review assessments of T25 maize are not risk assessments as required under Article 5.1 and
as defined in Annex A(4).
2083 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the Austrian safeguard measure should be tr eated as constituting one or more SPS measures. Thus,
like the Parties, we will continue to treat this measure as constituting one single SPS measure.

that, by maintaining the measure in ques tion, the European Communities has acted
inconsistently with its obligations under Article 5.1.

 (iii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communiti es, the Panel finds that the Austrian
safeguard measure on T25 maize is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure on
T25 maize is not based on a risk assessment, the Panel reaches the final conclusion
that, by maintaining the measure in ques tion, the European Communities has acted
inconsistently with its obligations under Article 5.1.

(iii) Austria – Bt-176 maize
7.3263 We now turn to Austria's safeguard measure applied with respect to Bt-176 maize. We note
the arguments of the Parties in respect of this measure.
7.3264 The United States argues that the Austrian safeguard measure on Bt-176 maize fails to meet
any of the four requirements set out in Article 5.7. First, the scientific evidence is sufficient to
perform a risk assessment, sin ce the European Communities itself has conducted positive risk
assessments on Bt-176 maize. Second, the safeguard measure was not adopted on the basis of
"available pertinent information". The SCF and the Scientific Committee for Pesticides, Food and
Animal Nutrition (SCPE) reviewed the safeguard measure and concluded that the information
provided by Austria did not warrant any change in the earlier risk assessment. Third, Austria has not
sought "to obtain the additional information necessar y for a more objective assessment of risk", and
there is no information on record that Austria h as sought to perform a risk assessment that would
support its measure on Bt-176 maize. Finally, the United States alleges that neither Austria nor the
Commission have reviewed the Austrian safeguard measure within a reasonable period of time.
7.3265 Argentina argues that the Austrian safeguard me asure does not meet any of the four
requirements of Article 5.7. First, the scientific evidence was not in sufficient, since at least two
positive scientific opinions were expressed on Bt-176 maize, including one which specifically rejected
the information provided by Austria in support of the measure. Second, Austria did not base its
measure on the "available pertinent information", since it disregarded the positive scientific opinions
of the scientific committee. Third, Austria has not sought to obtain further information necessary for
a more objective risk assessment, be cause the information provided in th is case is not consistent with
the positive scientific opinions given by the scientific committee. Finally, with respect to the fourth
requirement of Article 5.7, Argentina notes that Austria did not review its safeguard measure.
7.3266
The European Communities argues that the Austrian safeguard measure meets the four
requirements of Article 5.7. First, the European Communities asserts that relevant scientific evidence
was insufficient. According to the European Communities, the concept of "insufficiency" in
Article 5.7 is "relational" and must therefore refer to the matters of concern to the legislator.
Specifically, "insufficient" means "insufficient" fo r the production of a risk assessment adequate for
the purposes of the legislator who must decide whet her a measure should be applied, provisionally or
otherwise, for one of the reasons enumerated in Annex A(1) of the SPS Agreement. The European
Communities defines a risk assessment which is ade quate as one which has been "delivered by a

reputable source, [which] unequivocally informs the legi slator about what the risk is with a sufficient
degree of precision, and [which] has withstood the passage of time and is unlikely to be revised.
2084
7.3267 In support of its view, the European Communities submits that the sufficiency of the evidence
cannot be examined in a vacuum, but has to be exam ined in relation to the protection goals sought by
legislators. The European Communities argues that it is artificial to suppose that there is some kind of
magic moment at which the available science becom es sufficient for all purposes. In the European
Communities' view, the actions of a legislator in response to available scientific evidence are a
function of what that particular legislator is c oncerned about. Thus, in the European Communities'
view, the higher the level of acceptable risk, the more likely it is that the legislator may conclude,
within a relatively short period of time, that the scientific evidence is sufficient and that no provisional
measure is therefore necessary. The lower the leve l of acceptable risk, the more likely it may be that
the legislator may continue to consider, for a relatively long period of time, that the scientific
evidence is insufficient, and that a measure is warranted. 2085 In other words, according to the
European Communities, the sufficiency of the scientific evidence must be examined in relation to the
level of acceptable risk of the legislators.
7.3268 Applying these considerations to the Aust rian safeguard measure on Bt-176 maize, the
European Communities submits that, having regard to the specific concerns of Austria's legislators in
adopting that measure, Austria's legislators were entit led to conclude that relevant scientific evidence
was insufficient for their purposes.
7.3269 Second, the European Communities contends that Austria has adopted and maintained its
safeguard measure on the basis of "availabl e pertinent information", which includes, inter alia , the
information contained in the original notificatio n, as well as the various relevant scientific
discussions, papers and opinions. With respect to the third requirement of Article 5.7, the European
Communities argues that both Austria and the Eu ropean Communities are engaged in an ongoing
process by which they are seeking to obtain add itional information necessary for a more objective
assessment of the risk through ongoing research and the constant development of science.
7.3270 Finally, the European Communities notes that th e measure is subject to a process of review
within a reasonable period of time, and that such review is still ongoing both at Community and
member State levels. 2086 According to the European Communities, the determination of what
constitutes a "reasonable period of time" pursuant to Ar ticle 5.7 depends on all the circumstances. In
the present case, for instance, assessments are being made of long-term effects, in relation to changes
that may have a permanent effect, and that are be ing introduced at an exponential rate as compared to
the past. These circumstance may justify a Member requiring a relatively long period of time to
review its provisional measure. 2087 The European Communities finds support for this view in the
Appellate Body's statement that "responsible , representative governments commonly act from
perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to
human health are concerned". 2088 The European Communities di fferentiates the present case from
Japan-Apples, arguing that GMO technology is still at th e frontiers of scie nce and its future

2085 The European Communities considers that this an alysis is confirmed by the words "reasonable
period of time" in Article 5.7.
2086 We recall that the US arguments that a requirement that measures be "constantly subject to review"
does not meet the requirement that the m easures are in fact reviewed within a reasonable period of time of their
adoption. US second written submission, para. 100.
2087 The European Communities submits that the present case is very different, fo r example, from that
before the panel in Japan – Apples.
2088 Appellate Body Report, EC – Hormones, para. 124.

consequences (compared to a case like fire blight ) are highly uncertain – and potentially more far-
reaching. The European Communities argues that the relevant risks are more than the mere
theoretical uncertainty that always remains si mply because science can never provide absolute
certainty that a given substance will never have adverse effects.
2089
"Insufficiency of relevant scientific evidence"
7.3271 The Panel will begin its analysis with the first requirement of Article 5.7. 2090 In other words,
we will consider whether the safeguard measure in question was imposed in respect of a situation
where "relevant scientific evidence [was] insufficient". Initially, we recall that we do not agree with
the European Communities that in th e context of Article 5.7, the insufficiency of relevant scientific
evidence must be assessed by reference to the appropriate level of protection of the importing
Member. We also recall our view that the suffi ciency of relevant scientific evidence should be
assessed at the time a provisional measure was adopted, not at the time of review by this Panel. The
United States and Argentina argue in this regard th at in the case of Austria's safeguard measure on
Bt-176 maize, relevant scientific evidence could not have been insufficient to conduct a risk
assessment at the time of adoption of the Austrian safeguard measure, since risk assessments were
conducted by EC scientific committees on the basis of the information provided by Austria in support
of its measure.
7.3272 We recall that Austria adopted its safeguard measure on Bt-176 maize in February 1997.
Following Austria's notification of the measure, th e Commission requested the SCF, the Scientific
Committee for Animal Nutrition (SCAN) and the Sc ientific Committee for Pesticides (SCPE) to
analyse the information provided by Austria in support of its measure in order to determine whether
this information would cause these Committees to c onsider that the product constituted a risk to
human health or the environment. The SCF in its opinion of March 1997, the SCAN in its opinion of
April 1997 and the SCPE in its opinion of May 1997 concluded that the information provided by
Austria did not constitute new scientific inform ation which would change the original risk
assessments which they had carried out in the co ntext of the EC approval procedure concerning
Bt-176 maize.
2091
7.3273 We have found above that both the opinions by EC scientific committees which were
delivered in the context of relevant EC approva l procedures – the original assessments – and the
opinions by EC scientific committees which were deliv ered after the adoption of the relevant member
State safeguard measures – the review assessments – are risk assessments within the meaning of

2089 The European Communities notes in its first writte n submission (para. 608) that "[t]he present case
is, for example, very different from the circumstances of the Japan – Apples case. That case concerned a
disease (fire blight) with a relatively narrow spectrum of possible consequences (compared to GMOs generally).
The panel found that the disease had been known and studied for some 200 years – the GMO techniques with
which this case is concerned are far mo re recent than that. The panel also found that there was a high quantity
and quality of scientific evidence expressing strong and increasing confidence in the conclusion. In other
words, the matter could fairly be described as no longer being at the frontiers of science, but rather to have
passed into the realms of conventional scientific wisdom – an operational hypothesis unlikely to be disturbed
other than by some revolutionary and currently totally unforeseeable new scie ntific discovery. That is not at all
the circumstances of the present case. GMO technology is still at or close to the frontiers of science and its
future consequences (compared to a case like fire blight) highly uncertain – and potentially much more far
reaching."
2090 We note that the panel in Japan – Apples also began its inquiry with the first requirement, an
approach not faulted by the Appellate Body. Panel Report, Japan – Apples, para. 8.214.
2091 Exhibits US-57, -58 and -66; ARG-43.

Annex A(4) and Article 5.1 of the SPS Agreement.
2092 We recall in this regard that the European
Communities does not suggest otherwise 2093. In the light of this, we ag ree with the United States and
Argentina that the 1997 SCF, SCAN and SCPE revi ew assessments of Bt-176 maize, and the SCF,
SCAN and SCPE original assessments of Bt-176 ma ize (which, as noted, were confirmed by the
review assessments), serve to demonstrate that at the time of adoption of the Austrian safeguard
measure, the body of available scientific evidence permitted the performance of a risk assessment as
required under Article 5.1 and as de fined in Annex A(4). We consider, therefore, that the United
States and Argentina have established a presumption th at Austria's safeguard measure was imposed in
respect of a situation where relevant scientific ev idence was not insufficient. This presumption has
not been effectively rebutted by the European Communities2094.
7.3274 As we pointed out above, the Appellate Body fo und that whenever one of the requirements of
Article 5.7 is not met, the measure at issue is inc onsistent with this provision. Thus, as it has been
established that Austria's safeguard measure on Bt- 176 maize was not adopted consistently with the
first requirement of Article 5.7, we conclude that that measure is inconsistent with Article 5.7.
Overall conclusions
7.3275 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Communities, the Panel finds that the Austrian
safeguard measure on Bt-176 maize is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure on
Bt-176 maize is not based on a risk assessment, the Panel reaches the final conclusion

2092 We recall that the review assessments are generally in the nature of supplemental assessments and
thus need to be read in conjunction with the original assessments.
2093 It is pertinent to recall in this context that in defending the Austrian safeguard measure against the
Complaining Parties' claims under Article 5.1, the Euro pean Communities essentially argued that Austria acted
on the basis of new scientific information which pres ented a view divergent from the mainstream scientific
opinion reflected in the original risk assessments. It may be that in making this argument the European
Communities meant to refer to the original risk assessm ents by the SCF, the SCAN and the SCPE. However,
the fact that Austria may have disagr eed with these' original assessments, and possibly also with the subsequent
review assessment by the SCP, would not imply that thes e committees' assessments are not risk assessments as
required under Article 5.1 and as defined in Annex A(4). The Appellate Body has made it clear that a risk
assessment as required under Article 5.1 "could set out both the prevailing view representing the 'mainstream' of
scientific opinion, as well as the opinions of scientis ts taking a divergent view". Appellate Body Report, EC –
Hormones, para. 184. Thus, the mere fact that the scientists taking a divergent view do not agree with the
majority view does not necessarily m ean that the majority view is base d on a risk assessment which does not
meet the standard and definition set out in Annex A(4). In any event, as noted, the European Communities does
not argue that the original and review assessments of Bt-176 maize are not risk assessments as required under
Article 5.1 and as defined in Annex A(4).

2094 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the Austrian safeguard measure should be tr eated as constituting one or more SPS measures. Thus,
like the Parties, we will continue to treat this measure as constituting one single SPS measure.

that, by maintaining the measure in ques tion, the European Communities has acted
inconsistently with its obligations under Article 5.1.

 (ii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communiti es, the Panel finds that the Austrian
safeguard measure on Bt-176 maize is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure on
Bt-176 maize is not based on a risk assessment, the Panel reaches the final conclusion
that, by maintaining the measure in ques tion, the European Communities has acted
inconsistently with its obligations under Article 5.1.

(iv) Austria – MON810 maize
7.3276 We now turn to Austria's safeguard measure a pplied with respect to MON810 maize. We
note the arguments of the Parties in respect of this measure.
7.3277 The United States argues that the Austrian safeguard measure on MON810 maize fails to
meet any of the four requirements set out in Article 5.7. First, the scientific evidence is sufficient to
perform a risk assessment, sin ce the European Communities itself has conducted positive risk
assessments on MON810 maize. Second, the safeguard measure was not adopted on the basis of
"available pertinent information". The SCP review ed the safeguard measure and concluded that the
information provided by Austria did not warrant any change in the earlier risk assessment. Third,
Austria has not sought "to obtain the additional information necessary for a more objective assessment
of risk", and there is no information on record th at Austria has sought to perform a risk assessment
that would support its measure on MON810 maize. Finally, the United States alleges that neither
Austria nor the Commission have reviewed the Au strian safeguard measure within a reasonable
period of time.
7.3278 Argentina argues that the Austrian safeguard me asure does not meet any of the four
requirements of Article 5.7. First, the scientific evidence was not in sufficient, since at least two
positive scientific opinions were expressed on MON810 maize, including one which specifically
rejected the information provided by Austria in support of the measure. Second, Austria did not base
its measure on the "available pertinent informatio n", since it disregarded the positive scientific
opinions of the scientific committee. Third, Austria has not sought to obtain further information
necessary for a more objective risk assessment, beca use the information provided in this case is not
consistent with the positive scientific opinions given by the scientific committee. Finally, with
respect to the fourth requirement of Article 5.7, Argentina notes that Austria did not review its
safeguard measure.
7.3279 The European Communities
 argues that the Austrian safeguard measure meets the four
requirements of Article 5.7. First, the European Communities asserts that relevant scientific evidence
was insufficient. According to the European Communities, the concept of "insufficiency" in
Article 5.7 is "relational" and must therefore refer to the matters of concern to the legislator.
Specifically, "insufficient" means "insufficient" fo r the production of a risk assessment adequate for
the purposes of the legislator who must decide whet her a measure should be applied, provisionally or
otherwise, for one of the reasons enumerated in Annex A(1) of the SPS Agreement. The European

Communities defines a risk assessment which is ade quate as one which has been "delivered by a
reputable source, [which] unequivocally informs the legi slator about what the risk is with a sufficient
degree of precision, and [which] has withstood the passage of time and is unlikely to be revised.
2095
7.3280 In support of its view, the European Communities submits that the sufficiency of the evidence
cannot be examined in a vacuum, but has to be exam ined in relation to the protection goals sought by
legislators. The European Communities argues that it is artificial to suppose that there is some kind of
magic moment at which the available science becom es sufficient for all purposes. In the European
Communities' view, the actions of a legislator in response to available scientific evidence are a
function of what that particular legislator is c oncerned about. Thus, in the European Communities'
view, the higher the level of acceptable risk, the more likely it is that the legislator may conclude,
within a relatively short period of time, that the scientific evidence is sufficient and that no provisional
measure is therefore necessary. The lower the leve l of acceptable risk, the more likely it may be that
the legislator may continue to consider, for a relatively long period of time, that the scientific
evidence is insufficient, and that a measure is warranted. 2096 In other words, according to the
European Communities, the sufficiency of the scientific evidence must be examined in relation to the
level of acceptable risk of the legislators.
7.3281 Applying these considerations to the Austri an safeguard measure on MON810 maize, the
European Communities submits that, having regard to the specific concerns of Austria's legislators in
adopting that measure, Austria's legislators were entit led to conclude that relevant scientific evidence
was insufficient for their purposes.
7.3282 Second, the European Communities contends that Austria has adopted and maintained its
safeguard measure on the basis of "availabl e pertinent information", which includes, inter alia , the
information contained in the original notificatio n, as well as the various relevant scientific
discussions, papers and opinions. With respect to the third requirement of Article 5.7, the European
Communities argues that both Austria and the Eu ropean Communities are engaged in an ongoing
process by which they are seeking to obtain add itional information necessary for a more objective
assessment of the risk through ongoing research and the constant development of science.
7.3283 Finally, the European Communities notes that th e measure is subject to a process of review
within a reasonable period of time, and that such review is still ongoing both at Community and
member State levels. 2097 According to the European Communities, the determination of what
constitutes a "reasonable period of time" pursuant to Ar ticle 5.7 depends on all the circumstances. In
the present case, for instance, assessments are being made of long-te rm effects, in relation to changes
that may have a permanent effect, and that are be ing introduced at an exponential rate as compared to
the past. These circumstance may justify a Member requiring a relatively long period of time to
review its provisional measure. 2098 The European Communities finds support for this view in the
Appellate Body's statement that "responsible , representative governments commonly act from
perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to
human health are concerned". 2099 The European Communities di fferentiates the present case from

2096 The European Communities considers that this an alysis is confirmed by the words "reasonable
period of time" in Article 5.7.
2097 We recall that the United States' argument that a requirement that measures be "constantly subject
to review" does not meet the requirement that the measures are in fact reviewed within a reasonable period of
time of their adoption. US second written submission, para. 100.
2098 The European Communities submits that the present case is very different, fo r example, from that
before the panel in Japan – Apples.
2099 Appellate Body Report, EC – Hormones, para. 124.

Japan - Apples , arguing that GMO technology is still at th e frontiers of scie nce and its future
consequences (compared to a case like fire blight ) are highly uncertain – and potentially more far-
reaching. The European Communities argues that the relevant risks are more than the mere
theoretical uncertainty that always remains si mply because science can never provide absolute
certainty that a given substance will never have adverse effects.
2100
"Insufficiency of relevant scientific evidence"
7.3284 The Panel will begin its analysis with the first requirement of Article 5.7. 2101 In other words,
we will consider whether the safeguard measure in question was imposed in respect of a situation
where "relevant scientific evidence [was] insufficient". Initially, we recall that we do not agree with
the European Communities that in th e context of Article 5.7, the insufficiency of relevant scientific
evidence must be assessed by reference to the appropriate level of protection of the importing
Member. We also recall our view that the suffi ciency of relevant scientific evidence should be
assessed at the time a provisional measure was adopted, not at the time of review by this Panel. The
United States and Argentina argue in this regard th at in the case of Austria's safeguard measure on
MON810 maize, relevant scientific evidence could not have been insufficient to conduct a risk
assessment at the time of adoption of the Austrian safeguard measure, since risk assessments were
conducted by the EC scientific committees on the basis of the information provided by Austria in
support of its measure.
7.3285 We recall that Austria adopted its safeguard measure on MON810 maize in June 1999.
Following Austria's notification of the measure, th e Commission requested the SCP to analyse the
information provided by Austria in support of its measure in order to determine whether this
information would cause the SCP to consider that the product constituted a risk to human health or the
environment. The SCP in its opinion of Septembe r 1999 concluded that the information provided by
Austria did not constitute new scientific informati on which would change the original risk assessment
which it had carried out in the context of th e EC approval procedure concerning MON810 maize.
2102
Thus, as we understand it, the SCP effectively reviewed its original risk assessment in the light of the
information presented by Austria and confirmed its original risk assessment.
7.3286 We have found above that both the opinions by the EC scientific committees which were
delivered in the context of relevant EC approva l procedures – the original assessments – and the
opinions by EC scientific committees which were deliv ered after the adoption of the relevant member
State safeguard measures – the review assessments – are risk assessments within the meaning of

2100 The European Communities notes in its first writte n submission (para. 608) that "[t]he present case
is, for example, very different from the circumstances of the Japan – Apples case. That case concerned a
disease (fire blight) with a relatively narrow spectrum of possible consequences (compared to GMOs generally).
The panel found that the disease had been known and studied for some 200 years – the GMO techniques with
which this case is concerned are far mo re recent than that. The panel also found that there was a high quantity
and quality of scientific evidence expressing strong and increasing confidence in the conclusion. In other
words, the matter could fairly be described as no longer being at the frontiers of science, but rather to have
passed into the realms of conventional scientific wisdom – an operational hypothesis unlikely to be disturbed
other than by some revolutionary and currently totally unforeseeable new scie ntific discovery. That is not at all
the circumstances of the present case. GMO technology is still at or close to the frontiers of science and its
future consequences (compared to a case like fire blight) highly uncertain – and potentially much more far
reaching."
2101 We note that the panel in Japan – Apples also began its inquiry with the first requirement, an
approach not faulted by the Appellate Body. Panel Report, Japan – Apples, para. 8.214.
2102 Exhibits US-55 and ARG-44.

Annex A(4) and Article 5.1 of the SPS Agreement.
2103 We recall in this regard that the European
Communities does not suggest otherwise. 2104 In the light of this, we ag ree with the United States and
Argentina that the SCP's 1999 review assessment of MON810 maize, and the SCP's original
assessment of MON810 maize (which, as noted, were confirmed by the review assessments), serve to
demonstrate that at the time of adoption of the Au strian safeguard measure, the body of available
scientific evidence permitted the performance of a risk assessment as required under Article 5.1 and
as defined in Annex A(4). We consider, theref ore, that the United States and Argentina have
established a presumption that Austria's safeguard measure was imposed in respect of a situation
where relevant scientific evidence was not insuffici ent. This presumption has not been effectively
rebutted by the European Communities.2105
7.3287 As we pointed out above, the Appellate Body fo und that whenever one of the requirements of
Article 5.7 is not met, the measure at issue is inc onsistent with this provision. Thus, as it has been
established that Austria's safeguard measure on MON810 maize was not adopted consistently with the
first requirement of Article 5.7, we conclude that that measure is inconsistent with Article 5.7.
Overall conclusions
7.3288 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Communities, the Panel finds that the Austrian
safeguard measure on MON810 maize is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure on
MON810 maize is not based on a risk assessment, the Panel reaches the final
conclusion that, by maintaining the measure in question, the European Communities
has acted inconsistently with its obligations under Article 5.1.

2103 We recall that the review assessments are generally in the nature of supplemental assessments and
thus need to be read in conjunction with the original assessments.
2104 It is pertinent to recall in this context that in defending the Austrian safeguard measure against the
Complaining Parties' claims under Article 5.1, the Euro pean Communities essentially argued that Austria acted
on the basis of new scientific information which pres ented a view divergent from the mainstream scientific
opinion reflected in the original risk assessment. It may be that in making this argument the European
Communities meant to refer to the SCP's original risk a ssessment. However, the fact that Austria may have
disagreed with the SCP's original a ssessment, and possibly also with the SCP's subsequent review assessment,
would not imply that the SCP's review and original assessments are not risk assessments as required under
Article 5.1 and as defined in Annex A(4). The Appellate Body has made it clear that a risk assessment as
required under Article 5.1 "could set out both the prev ailing view representing the 'mainstream' of scientific
opinion, as well as the opinions of scientists taking a divergent view". Appellate Body Report, EC – Hormones,
para. 184. Thus, the mere fact that the scientists taki ng a divergent view do not agree with the majority view
does not necessarily mean that the majority view is based on a risk assessment which does not meet the standard
and definition set out in Annex A(4). In any event, as noted, the European Communities does not argue that the
SCP's original and review assessments of MON810 maize are not risk assessments as required under Article 5.1
and as defined in Annex A(4).
2105 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the Austrian safeguard measure should be tr eated as constituting one or more SPS measures. Thus,
like the Parties, we will continue to treat this measure as constituting one single SPS measure.

 (ii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communiti es, the Panel finds that the Austrian
safeguard measure on MON810 maize is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Austrian safeguard measure on
MON810 maize is not based on a risk assessment, the Panel reaches the final
conclusion that, by maintaining the measure in question, the European Communities
has acted inconsistently with its obligations under Article 5.1.

(v) France – MS1/RF1 oilseed rape (EC-161)
7.3289 We now turn to France's safeguard measure a pplied with respect to MS1/RF1 oilseed rape
(EC-161). We note the arguments of the Parties in respect of this measure.
7.3290 The United States argues that the French safeguard measure on MS1/RF1 oilseed rape
(EC-161) fails to meet any of the four requirements set out in Article 5.7. First, the scientific
evidence is sufficient to perform a risk assessm ent, since the European Communities itself has
conducted positive risk assessments on MS1/RF1 oilseed rape (EC-161). Second, the safeguard
measure was not adopted on the basis of "available pertinent information". The SCP reviewed the
safeguard measure and concluded that the information provided by France did not warrant any change
in the earlier risk assessment. Third, France has not sought "to obtain the additional information
necessary for a more objective assessment of risk", a nd there is no information on record that France
has sought to perform a risk assessment that w ould support its measure on MS1/RF1 oilseed rape
(EC-161). Finally, the United States alleges that neither France nor the Commission have reviewed
the French safeguard measure within a reasonable period of time.
7.3291 Canada argues that a review of the French safeguard measure and the factual and scientific
circumstances surrounding its adoption and maintenance reveal that the measure fails to satisfy any of
the four elements of Article 5.7. First, the measure was not imposed in respect of a situation where
relevant scientific information was insufficient. The opinion of the European Communities' own
scientific experts demonstrate that there was sufficient scientific ev idence to conduct a complete and
objective risk assessment. In Canada's view, what was insufficient was the scientific evidence put
forward by the European Communities or Fr ance to support the safeguard measure. Second, the
measure was not adopted on the basis of "available pertinent information", since this would include
the scientific opinions of the lead CA and of the relevant EC scientific committee, which all
confirmed the safety of the product.
7.3292 With respect to the third element of Article 5.7, the requirement that the Member seek to
obtain the additional information necessary for a mo re objective assessment of risk, Canada notes that
this element is irrelevant in this case, given th e sufficiency of the scientif ic evidence available from
the European Communities' own sources. Finally, with regard to the fourth requirement, namely that
the measure must be reviewed within a reasonable period of time, Canada recalls that the European
Communities' own legislation requires that such a re view take place. However, given the absence of
"pertinent information" to support the safeguard me asure, Canada draws the conclusion that the
measure would have been lifted if such a review had been conducted. Furthermore, according to the
Appellate Body, what constitutes a "reasonable peri od of time" will be influenced by the emergence

of the additional information necessary to make a mo re objective assessment of the risk. In Canada's
view, new or additional information was not necessary in the present case to conduct a risk
assessment, as sufficient scientific evidence was in existe nce even at the time the safeguard measure
was taken.
7.3293 The European Communities argues that the French safeguard measure meets the four
requirements of Article 5.7. First, the European Communities asserts that relevant scientific evidence
was insufficient. According to the European Communities, the concept of "insufficiency" in
Article 5.7 is "relational" and must therefore refer to the matters of concern to the legislator.
Specifically, "insufficient" means "insufficient" fo r the production of a risk assessment adequate for
the purposes of the legislator who must decide whet her a measure should be applied, provisionally or
otherwise, for one of the reasons enumerated in Annex A(1) of the SPS Agreement. The European
Communities defines a risk assessment which is ade quate as one which has been "delivered by a
reputable source, [which] unequivocally informs the legi slator about what the risk is with a sufficient
degree of precision, and [which] has withstood the passage of time and is unlikely to be revised.
2106
7.3294 In support of its view, the European Communities submits that the sufficiency of the evidence
cannot be examined in a vacuum, but has to be exam ined in relation to the protection goals sought by
legislators. The European Communities argues that it is artificial to suppose that there is some kind of
magic moment at which the available science becom es sufficient for all purposes. In the European
Communities' view, the actions of a legislator in response to available scientific evidence are a
function of what that particular legislator is c oncerned about. Thus, in the European Communities'
view, the higher the level of acceptable risk, the more likely it is that the legislator may conclude,
within a relatively short period of time, that the scientific evidence is sufficient and that no provisional
measure is therefore necessary. The lower the leve l of acceptable risk, the more likely it may be that
the legislator may continue to consider, for a relatively long period of time, that the scientific
evidence is insufficient, and that a measure is warranted. 2107 In other words, according to the
European Communities, the sufficiency of the scientific evidence must be examined in relation to the
level of acceptable risk of the legislators.
7.3295 Applying these considerations to the French safeguard measure on MS1/RF1 oilseed rape
(EC-161), the European Communities submits that, havi ng regard to the specific concerns of France's
legislators in adopting that measure, France's legi slators were entitled to conclude that relevant
scientific evidence was insufficient for their purposes.
7.3296 Second, the European Communities contends that France has adopted and maintained its
safeguard measure on the basis of "availabl e pertinent information", which includes, inter alia , the
information contained in the original notificatio n, as well as the various relevant scientific
discussions, papers and opinions. With respect to the third requirement of Article 5.7, the European
Communities argues that both France and the Euro pean Communities are engaged in an ongoing
process by which they are seeking to obtain add itional information necessary for a more objective
assessment of the risk through ongoing research and the constant development of science.
7.3297 Finally, the European Communities notes that th e measure is subject to a process of review
within a reasonable period of time, and that such review is still ongoing both at Community and

2107 The European Communities considers that this an alysis is confirmed by the words "reasonable
period of time" in Article 5.7.

member State levels.
2108 According to the European Communities, the determination of what
constitutes a "reasonable period of time" pursuant to Ar ticle 5.7 depends on all the circumstances. In
the present case, for instance, assessments are being made of long-term effects, in relation to changes
that may have a permanent effect, and that are be ing introduced at an exponential rate as compared to
the past. These circumstances may justify a Member requiring a relatively long period of time to
review its provisional measure.
2109 The European Communities finds support for this view in the
Appellate Body's statement that "responsible , representative governments commonly act from
perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to
human health are concerned". 2110 The European Communities di fferentiates the present case from
Japan-Apples, arguing that GMO technology is still at th e frontiers of scie nce and its future
consequences (compared to a case like fire blight ) are highly uncertain – and potentially more far-
reaching. The European Communities argues that the relevant risks are more than the mere
theoretical uncertainty that always remains si mply because science can never provide absolute
certainty that a given substance will never have adverse effects.2111
"Insufficiency of relevant scientific evidence"
7.3298 The Panel will begin its analysis with the first requirement of Article 5.7. 2112 In other words,
we will consider whether the safeguard measure in question was imposed in respect of a situation
where "relevant scientific evidence [was] insufficient". Initially, we recall that we do not agree with
the European Communities that in th e context of Article 5.7, the insufficiency of relevant scientific
evidence must be assessed by reference to the appropriate level of protection of the importing
Member. We also recall our view that the suffi ciency of relevant scientific evidence should be
assessed at the time a provisional measure was adopted, not at the time of review by this Panel. The
United States and Canada argue in this regard th at in the case of France's safeguard measure on
MS1/RF1 oilseed rape (EC-161), relevant scientific evidence could not have been insufficient to
conduct a risk assessment at the time of adoptio n of the French safeguard measure, since risk
assessment were conducted by EC scientific committ ees on the basis of the information provided by
France in support of its measure.

2108 We recall that the United States' argument that a requirement that measures be "constantly subject
to review" does not meet the requirement that the measures are in fact reviewed within a reasonable period of
time of their adoption. US second written submission, para. 100.
2109 The European Communities submits that the present case is very different, fo r example, from that
before the panel in Japan – Apples.
2110 Appellate Body Report, EC – Hormones, para. 124.
2111 The European Communities notes in its first writte n submission (para. 608) that "[t]he present case
is, for example, very different from the circumstances of the Japan – Apples case. That case concerned a
disease (fire blight) with a relatively narrow spectrum of possible consequences (compared to GMOs generally).
The panel found that the disease had been known and studied for some 200 years – the GMO techniques with
which this case is concerned are far mo re recent than that. The panel also found that there was a high quantity
and quality of scientific evidence expressing strong and increasing confidence in the conclusion. In other
words, the matter could fairly be described as no longer being at the frontiers of science, but rather to have
passed into the realms of conventional scientific wisdom – an operational hypothesis unlikely to be disturbed
other than by some revolutionary and currently totally unforeseeable new scie ntific discovery. That is not at all
the circumstances of the present case. GMO technology is still at or close to the frontiers of science and its
future consequences (compared to a case like fire blight) highly uncertain – and potentially much more far
reaching."
2112 We note that the panel in Japan – Apples also began its inquiry with the first requirement, an
approach not faulted by the Appellate Body. Panel Report, Japan – Apples, para. 8.214.

7.3299 We recall that France adopted its safeguard measure on MS1/RF1 oilseed rape (EC-161) in
November 1998. Following France's notification of the measure, the Comm ission requested the SCP
to analyse the information provided by France in s upport of its measure in order to determine whether
this information would cause the SCP to consider th at the product constituted a risk to human health
and the environment. The SCP in its opinion of May 1999 concluded that the information provided
by France did not change the environmental assessment provided by the SCP in 1998 in the context of
the approval procedure concerning a similar hy brid oilseed rape, MS8/RF3 oilseed rape.
2113 Thus, as
we understand it, the SCP effectively reviewed its earlier risk assessment for MS8/RF3 oilseed rape in
the light of the information presented by France and confirmed that assessment.
7.3300 We have found above that both the opinions by the EC scientific committees which were
delivered in the context of relevant EC approva l procedures – the original assessments – and the
opinions by EC scientific committees which were deliv ered after the adoption of the relevant member
State safeguard measures – the review assessments – are risk assessments within the meaning of
Annex A(4) and Article 5.1 of the SPS Agreement.2114 We recall in this regard that the European
Communities does not suggest otherwise. 2115 In the light of this, we ag ree with the United States and
Canada that the SCP's 1999 review assessment of MS1/RF1 oilseed rape (EC-161), serves to
demonstrate that at the time of adoption of the French safeguard measure, the body of available
scientific evidence permitted the performance of a risk assessment as required under Article 5.1 and
as defined in Annex A(4). We consider, therefore, that the United States and Canada have established
a presumption that France's safeguard measure was im posed in respect of a situation where relevant
scientific evidence was not insufficient. This pr esumption has not been effectively rebutted by the
European Communities.2116
7.3301 As we pointed out above, the Appellate Body fo und that whenever one of the requirements of
Article 5.7 is not met, the measure at issue is inc onsistent with this provision. Thus, as it has been
established that France's safeguard measure on MS1/RF1 oilseed rape (EC-161) was not adopted
consistently with the first requirement of Article 5. 7, we conclude that that measure is inconsistent
with Article 5.7.

2113 We recall that the SCP was not consulted by the Commission before MS1/RF1 oilseed rape was
approved, hence the SCP's reliance on the assessment concerning MS8/RF3 oilseed rape. Exhibits US-61 and
CDA-69.
2114 We recall that the review assessments are generally in the nature of supplemental assessments and
thus need to be read in conjunction with the original assessments.
2115 It is pertinent to recall in this context that in defending the French safeguard measure against the
Complaining Parties' claims under Article 5.1, the Eu ropean Communities essentially argued that France acted
on the basis of new scientific information which pres ented a view divergent from the mainstream scientific
opinion reflected in the original risk assessment. It may be that in making this argument the European
Communities meant to refer to the SCP's or iginal risk assessment with regard to MS8/RF3 oilseed rape .
However, the fact that France may have disagreed with the SCP's original assessment, and possibly also with the
SCP's subsequent review assessment, would not imply that the SCP's review and original assessments are not
risk assessments as required under Article 5.1 and as defined in Annex A(4). The Appellate Body has made it
clear that a risk assessment as required under Article 5.1 "could set out both the prevailing view representing the
'mainstream' of scientific opinion, as well as the opinions of scientists taking a divergent view". Appellate Body
Report, EC – Hormones, para. 184. Thus, the mere fact that the sc ientists taking a divergent view do not agree
with the majority view does not nece ssarily mean that the majority view is based on a risk assessment which
does not meet the standard and definition set out in Annex A(4). In any event, as noted, the European
Communities does not argue that the relevant SCP assessments of MS1/RF1 oilseed rape are not risk
assessments as required under Article 5.1 and as defined in Annex A(4).
2116 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the French safeguard measure should be treated as constituting one or more SPS measures. Thus, like
the Parties, we will continue to treat this measure as constituting one single SPS measure.

Overall conclusions

7.3302 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that the French
safeguard measure on MS1/RF1 oilseed ra pe (EC-161) is not consistent with
Article 5.7 of the SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the French safeguard measure on
MS1/RF1 oilseed rape (EC-161) is not based on a risk assessment, the Panel reaches
the final conclusion that, by maintaining the measure in question, the European
Communities has acted inconsistently with its obligations under Article 5.1.

 (ii) DS292 (Canada)

 With reference to DS292, and having re gard to the arguments and evidence presented
by Canada and the European Communities, th e Panel finds that the French safeguard
measure on MS1/RF1 oilseed rape (EC-161) is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the French safeguard measure on
MS1/RF1 oilseed rape (EC-161) is not based on a risk assessment, the Panel reaches
the final conclusion that, by maintaining the measure in question, the European
Communities has acted inconsistently with its obligations under Article 5.1.

(vi) France – Topas oilseed rape
7.3303 We now turn to France's safeguard measure app lied with respect to Topas oilseed rape. We
recall the arguments of the Parties in respect of this measure.
7.3304 The United States argues that the French safeguard me asure on Topas oilseed rape fails to
meet any of the four requirements set out in Article 5.7. First, the scientific evidence is sufficient to
perform a risk assessment, sin ce the European Communities itself has conducted positive risk
assessments on Topas oilseed rape. Second, the safeguard measure was not adopted on the basis of
"available pertinent information". The SCP review ed the safeguard measure and concluded that the
information provided by France did not warrant any change in the earlier risk assessment. Third,
France has not sought "to obtain the additional info rmation necessary for a more objective assessment
of risk", and there is no information on record that France has sought to perform a risk assessment that
would support its measure on Topas oilseed rape. Finally, the United States alleges that neither
France nor the Commission have reviewed the French safeguard measure within a reasonable period
of time.
7.3305 Canada argues that a review of the French safeguard measure and the factual and scientific
circumstances surrounding its adoption and maintenance reveal that the measure fails to satisfy any of
the four elements of Article 5.7. First, the measure was not imposed in respect of a situation where
relevant scientific information was insufficient. The opinion of the European Communities' own

scientific experts demonstrate that there was sufficient scientific ev idence to conduct a complete and
objective risk assessment. In Canada's view, what was insufficient was the scientific evidence put
forward by the European Communities or Fr ance to support the safeguard measure. Second, the
measure was not adopted on the basis of "available pertinent information", since this would include
the scientific opinions of the lead CA and of the relevant EC scientific committee, which all
confirmed the safety of the product.
7.3306 With respect to the third element of Article 5.7, the requirement that the Member seek to
obtain the additional information necessary for a mo re objective assessment of risk, Canada notes that
this element is irrelevant in this case, given th e sufficiency of the scientif ic evidence available from
the European Communities' own sources. Finally, with regard to the fourth requirement, namely that
the measure must be reviewed within a reasonable period of time, Canada recalls that the European
Communities' own legislation requires that such a re view take place. However, given the absence of
"pertinent information" to support the safeguard me asure, Canada draws the conclusion that the
measure would have been lifted if such a review had been conducted. Furthermore, according to the
Appellate Body, what constitutes a "reasonable peri od of time" will be influenced by the emergence
of the additional information necessary to make a mo re objective assessment of the risk. In Canada's
view, new or additional information was not necessary in the present case to conduct a risk
assessment, as sufficient scientific evidence was in existe nce even at the time the safeguard measure
was taken.
7.3307 The European Communities argues that the French safeguard measure meets the four
requirements of Article 5.7. First, the European Communities asserts that relevant scientific evidence
was insufficient. According to the European Communities, the concept of "insufficiency" in
Article 5.7 is "relational" and must therefore refer to the matters of concern to the legislator.
Specifically, "insufficient" means "insufficient" fo r the production of a risk assessment adequate for
the purposes of the legislator who must decide whet her a measure should be applied, provisionally or
otherwise, for one of the reasons enumerated in Annex A(1) of the SPS Agreement. The European
Communities defines a risk assessment which is ade quate as one which has been "delivered by a
reputable source, [which] unequivocally informs the legi slator about what the risk is with a sufficient
degree of precision, and [which] has withstood the passage of time and is unlikely to be revised.
2117
7.3308 In support of its view, the European Communities submits that the sufficiency of the evidence
cannot be examined in a vacuum, but has to be exam ined in relation to the protection goals sought by
legislators. The European Communities argues that it is artificial to suppose that there is some kind of
magic moment at which the available science becom es sufficient for all purposes. In the European
Communities' view, the actions of a legislator in response to available scientific evidence are a
function of what that particular legislator is c oncerned about. Thus, in the European Communities'
view, the higher the level of acceptable risk, the more likely it is that the legislator may conclude,
within a relatively short period of time, that the scientific evidence is sufficient and that no provisional
measure is therefore necessary. The lower the leve l of acceptable risk, the more likely it may be that
the legislator may continue to consider, for a relatively long period of time, that the scientific
evidence is insufficient, and that a measure is warranted. 2118 In other words, according to the
European Communities, the sufficiency of the scientific evidence must be examined in relation to the
level of acceptable risk of the legislators.

2118 The European Communities considers that this an alysis is confirmed by the words "reasonable
period of time" in Article 5.7.

7.3309 Applying these considerations to the French safeguard measure on Topas oilseed rape, the
European Communities submits that, having regard to the specific concerns of France's legislators in
adopting that measure, France's legislators were entitle d to conclude that relevant scientific evidence
was insufficient for their purposes.
7.3310 Second, the European Communities contends that France has adopted and maintained its
safeguard measure on the basis of "availabl e pertinent information", which includes, inter alia , the
information contained in the original notificatio n, as well as the various relevant scientific
discussions, papers and opinions. With respect to the third requirement of Article 5.7, the European
Communities argues that both France and the Euro pean Communities are engaged in an ongoing
process by which they are seeking to obtain add itional information necessary for a more objective
assessment of the risk through ongoing research and the constant development of science.
7.3311 Finally, the European Communities notes that th e measure is subject to a process of review
within a reasonable period of time, and that such review is still ongoing both at Community and
member State levels.
2119 According to the European Communities, the determination of what
constitutes a "reasonable period of time" pursuant to Ar ticle 5.7 depends on all the circumstances. In
the present case, for instance, assessments are being made of long-term effects, in relation to changes
that may have a permanent effect, and that are being introduced at an exponential rate as compared to
the past. These circumstances may justify a Member requiring a relatively long period of time to
review its provisional measure.
2120 The European Communities finds support for this view in the
Appellate Body's statement that "responsible , representative governments commonly act from
perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to
human health are concerned". 2121 The European Communities di fferentiates the present case from
Japan - Apples , arguing that GMO technology is still at th e frontiers of scie nce and its future
consequences (compared to a case like fire blight ) are highly uncertain – and potentially more far-
reaching. The European Communities argues that the relevant risks are more than the mere
theoretical uncertainty that always remains si mply because science can never provide absolute
certainty that a given substance will never have adverse effects.2122

2119 We recall that the US arguments that a requirement that measures be "constantly subject to review"
does not meet the requirement that the measures are in fact reviewed within a reasonable period of time of their
adoption. US second written submission, para. 100.
2120 The European Communities submits that the present case is very different, fo r example, from that
before the panel in Japan – Apples.
2121 Appellate Body Report, EC – Hormones, para. 124.
2122 The European Communities notes in its first writte n submission (para. 608) that "[t]he present case
is, for example, very different from the circumstances of the Japan – Apples case. That case concerned a
disease (fire blight) with a relatively narrow spectrum of possible consequences (compared to GMOs generally).
The panel found that the disease had been known and studied for some 200 years – the GMO techniques with
which this case is concerned are far mo re recent than that. The panel also found that there was a high quantity
and quality of scientific evidence expressing strong and increasing confidence in the conclusion. In other
words, the matter could fairly be described as no longer being at the frontiers of science, but rather to have
passed into the realms of conventional scientific wisdom – an operational hypothesis unlikely to be disturbed
other than by some revolutionary and currently totally unforeseeable new scie ntific discovery. That is not at all
the circumstances of the present case. GMO technology is still at or close to the frontiers of science and its
future consequences (compared to a case like fire blight) highly uncertain – and potentially much more far
reaching."

"Insufficiency of relevant scientific evidence"

7.3312 The Panel will begin its analysis with the first requirement of Article 5.7. 2123 In other words,
we will consider whether the safeguard measure in question was imposed in respect of a situation
where "relevant scientific evidence [was] insufficient". Initially, we recall that we do not agree with
the European Communities that in th e context of Article 5.7, the insufficiency of relevant scientific
evidence must be assessed by reference to the appropriate level of protection of the importing
Member. We also recall our view that the suffi ciency of relevant scientific evidence should be
assessed at the time a provisional measure was adopted, not at the time of review by this Panel. The
United States and Canada argue in this regard th at in the case of France's safeguard measure on
Topas oilseed rape, relevant scientific evidence coul d not have been insufficient to conduct a risk
assessment at the time of adoption of the French safeguard measure, sin ce a risk assessment was
conducted by the SCP on the basis of the information provided by France in support of its measure.
7.3313 We recall that France adopted its safegua rd measure on Topas oilseed rape in
November 1998. Following France's notification of the measure, the Comm ission requested the SCP
to analyse the information provided by France in s upport of its measure in order to determine whether
this information would cause the SCP to consider th at the product constituted a risk to human health
or the environment. The SCP in its opinion of Ma y 1999 concluded that the information provided by
France did not constitute new scientific information which would change the original risk assessment
carried out by the SCP in the context of the EC approval procedure concerning Topas oilseed rape.2124
Thus, as we understand it, the SCP effectively reviewed its original risk assessment in the light of the
information presented by France and confirmed its original risk assessment.
7.3314 We have found above that both the SCP opinions delivered in the context of relevant EC
approval procedures – the original assessments – and the SCP opinions delivered after the adoption of
the relevant member State safeguard measures – the review assessments – are risk assessments within
the meaning of Annex A(4) and Article 5.1 of the SPS Agreement. 2125 We recall in this regard that
the European Communities does not suggest otherwise. 2126 In the light of this, we agree with the
United States and Canada that the SCP's 1999 review assessment of Topas oilseed rape and the SCP's
original assessment of Topas oilseed rape (whi ch, as noted, was confirmed by the SCP's review

2123 We note that the panel in Japan – Apples also began its inquiry with the first requirement, an
approach not faulted by the Appellate Body. Panel Report, Japan – Apples, para. 8.214.
2124 Exhibits US-62; CDA-65.
2125 We recall that the review assessments are generally in the nature of supplemental assessments and
thus need to be read in conjunction with the original assessments.
2126 It is pertinent to recall in this context that in defending the French safeguard measure against the
Complaining Parties' claims under Article 5.1, the Eu ropean Communities essentially argued that France acted
on the basis of new scientific information which pres ented a view divergent from the mainstream scientific
opinion reflected in the original risk assessment. It may be that in making this argument the European
Communities meant to refer to the SCP's original risk assessment. However, the fact that France may have
disagreed with the SCP's original a ssessment, and possibly also with the SCP's subsequent review assessment,
would not imply that the SCP's review and original assessments are not risk assessments as required under
Article 5.1 and as defined in Annex A(4). The Appellate Body has made it clear that a risk assessment as
required under Article 5.1 "could set out both the prev ailing view representing the 'mainstream' of scientific
opinion, as well as the opinions of scientists taking a divergent view". Appellate Body Report, EC – Hormones,
para. 184. Thus, the mere fact that the scientists taki ng a divergent view do not agree with the majority view
does not necessarily mean that the majority view is based on a risk assessment which does not meet the standard
and definition set out in Annex A(4). In any event, as noted, the European Communities does not argue that the
SCP's original and review assessments of Topas oilseed rape are not risk assessments as required under
Article 5.1 and as defined in Annex A(4).

assessment), serve to demonstrate th at at the time of adoption of the French safeguard measure, the
body of available scientific evidence permitted the performance of a risk assessment as required under
Article 5.1 and as defined in Annex A(4). We consider, therefore, that the United States and Canada
have established a presumption that France's safeguard measure was imposed in respect of a situation
where relevant scientific evidence was not insuffici ent. This presumption has not been effectively
rebutted by the European Communities.
2127
7.3315 As we pointed out above, the Appellate Body fo und that whenever one of the requirements of
Article 5.7 is not met, the measure at issue is inc onsistent with this provision. Thus, as it has been
established that France's safeguard measure on Topas oilseed rape was not adop ted consistently with
the first requirement of Article 5.7, we conclude that that measure is inconsistent with Article 5.7.
Overall conclusions
7.3316 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that the French
safeguard measure on Topas oilseed rape is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the French safeguard measure on
Topas oilseed rape is not based on a risk assessment, the Panel reaches the final
conclusion that, by maintaining the measure in question, the European Communities
has acted inconsistently with its obligations under Article 5.1.

 (ii) DS292 (Canada)

 With reference to DS292, and having re gard to the arguments and evidence presented
by Canada and the European Communities, th e Panel finds that the French safeguard
measure on Topas oilseed rape is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the French safeguard measure on
Topas oilseed rape is not based on a risk assessment, the Panel reaches the final
conclusion that, by maintaining the measure in question, the European Communities
has acted inconsistently with its obligations under Article 5.1.

(vii) Germany – Bt-176 maize
7.3317 We now turn to Germany's safeguard measure a pplied with respect to Bt-176 maize. We
recall the arguments of the Parties in respect of this measure.

2127 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the French safeguard measure should be treated as constituting one or more SPS measures. Thus, like
the Parties, we will continue to treat this measure as constituting one single SPS measure.

7.3318 The United States argues that the German safeguard me asure on Bt-176 maize fails to meet
any of the four requirements set out in Article 5.7. First, the scientific evidence is sufficient to
perform a risk assessment, sin ce the European Communities itself has conducted positive risk
assessments on Bt-176 maize. Second, the safeguard measure was not adopted on the basis of
"available pertinent information". The SCP review ed the safeguard measure and concluded that the
information provided by Germany did not warrant any change in the earlier risk assessment. Third,
Germany has not sought "to obtain the additional information necessary for a more objective
assessment of risk", and there is no information on record that Germany has sought to perform a risk
assessment that would support its measure on Bt-176 maize. Finally, the United States alleges that
neither Germany nor the Commission have review ed the German safeguard measure within a
reasonable period of time.
7.3319 Argentina argues that the German safeguard m easure does not meet any of the four
requirements of Article 5.7. First, the scientific evidence was not in sufficient, since at least two
positive scientific opinions were expressed on Bt-176 maize, including one which specifically rejected
the information provided by Germany in support of the measure. Second, Germany did not base its
measure on the "available pertinent information", since it disregarded the positive scientific opinions
of the scientific committee. Third, Germany has not sought to obta in further information necessary
for a more objective risk assessment, because the info rmation provided in this case is not consistent
with the positive scientific opinions gi ven by the scientific committee. Finally, with respect to the
fourth requirement of Article 5.7, Argentina notes that Germany did not review its safeguard measure.
7.3320 The European Communities argues that the German safeguard measure meets the four
requirements of Article 5.7. First, the European Communities asserts that relevant scientific evidence
was insufficient. According to the European Communities, the concept of "insufficiency" in
Article 5.7 is "relational" and must therefore refer to the matters of concern to the legislator.
Specifically, "insufficient" means "insufficient" fo r the production of a risk assessment adequate for
the purposes of the legislator who must decide whet her a measure should be applied, provisionally or
otherwise, for one of the reasons enumerated in Annex A(1) of the SPS Agreement. The European
Communities defines a risk assessment which is ade quate as one which has been "delivered by a
reputable source, [which] unequivocally informs the legi slator about what the risk is with a sufficient
degree of precision, and [which] has withstood the passage of time and is unlikely to be revised.
2128
7.3321 In support of its view, the European Communities submits that the sufficiency of the evidence
cannot be examined in a vacuum, but has to be exam ined in relation to the protection goals sought by
legislators. The European Communities argues that it is artificial to suppose that there is some kind of
magic moment at which the available science becom es sufficient for all purposes. In the European
Communities' view, the actions of a legislator in response to available scientific evidence are a
function of what that particular legislator is c oncerned about. Thus, in the European Communities'
view, the higher the level of acceptable risk, the more likely it is that the legislator may conclude,
within a relatively short period of time, that the scientific evidence is sufficient and that no provisional
measure is therefore necessary. The lower the leve l of acceptable risk, the more likely it may be that
the legislator may continue to consider, for a relatively long period of time, that the scientific
evidence is insufficient, and that a measure is warranted. 2129 In other words, according to the
European Communities, the sufficiency of the scientific evidence must be examined in relation to the
level of acceptable risk of the legislators.

2129 The European Communities considers that this an alysis is confirmed by the words "reasonable
period of time" in Article 5.7.

7.3322 Applying these considerations to the Germ an safeguard measure on Bt-176 maize, the
European Communities submits that, having regard to the specific concerns of Germany's legislators
in adopting that measure, Germany's legislators we re entitled to conclude th at relevant scientific
evidence was insufficient for their purposes.
7.3323 Second, the European Communities contends that Germany has adopted and maintained its
safeguard measure on the basis of "availabl e pertinent information", which includes, inter alia , the
information contained in the original notificatio n, as well as the various relevant scientific
discussions, papers and opinions. With respect to the third requirement of Article 5.7, the European
Communities argues that both Germany and the European Communities are engaged in an ongoing
process by which they are seeking to obtain add itional information necessary for a more objective
assessment of the risk through ongoing research and the constant development of science.
7.3324 Finally, the European Communities notes that th e measure is subject to a process of review
within a reasonable period of time, and that such review is still ongoing both at Community and
member State levels.
2130 According to the European Communities, the determination of what
constitutes a "reasonable period of time" pursuant to Ar ticle 5.7 depends on all the circumstances. In
the present case, for instance, assessments are being made of long-term effects, in relation to changes
that may have a permanent effect, and that are being introduced at an exponential rate as compared to
the past. These circumstance may justify a Member requiring a relatively long period of time to
review its provisional measure.
2131 The European Communities finds support for this view in the
Appellate Body's statement that "responsible , representative governments commonly act from
perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to
human health are concerned". 2132 The European Communities di fferentiates the present case from
Japan-Apples: arguing that GMO technology is still at the frontiers of science and its future
consequences (compared to a case like fire blight ) are highly uncertain – and potentially more far-
reaching. The European Communities argues that the relevant risks are more than the mere
theoretical uncertainty that always remains si mply because science can never provide absolute
certainty that a given substance will never have adverse effects.2133

2130 We recall that the United States' arguments that a requirement that measures be "constantly subject
to review" does not meet the requirement that the measures are in fact reviewed within a reasonable period of
time of their adoption. See US second written submission, para. 100.
2131 The European Communities submits that the present case is very different, fo r example, from that
before the panel in Japan – Apples.
2132 Appellate Body Report, EC – Hormones, para. 124.
2133 The European Communities notes in its first writte n submission (para. 608) that "[t]he present case
is, for example, very different from the circumstances of the Japan – Apples case. That case concerned a
disease (fire blight) with a relatively narrow spectrum of possible consequences (compared to GMOs generally).
The panel found that the disease had been known and studied for some 200 years – the GMO techniques with
which this case is concerned are far mo re recent than that. The panel also found that there was a high quantity
and quality of scientific evidence expressing strong and increasing confidence in the conclusion. In other
words, the matter could fairly be described as no longer being at the frontiers of science, but rather to have
passed into the realms of conventional scientific wisdom – an operational hypothesis unlikely to be disturbed
other than by some revolutionary and currently totally unforeseeable new scie ntific discovery. That is not at all
the circumstances of the present case. GMO technology is still at or close to the frontiers of science and its
future consequences (compared to a case like fire blight) highly uncertain – and potentially much more far
reaching."

"Insufficiency of relevant scientific evidence"

7.3325 The Panel will begin its analysis with the first requirement of Article 5.7. 2134 In other words,
we will consider whether the safeguard measure in question was imposed in respect of a situation
where "relevant scientific evidence [was] insufficient". Initially, we recall that we do not agree with
the European Communities that in th e context of Article 5.7, the insufficiency of relevant scientific
evidence must be assessed by reference to the appropriate level of protection of the importing
Member. We also recall our view that the suffi ciency of relevant scientific evidence should be
assessed at the time a provisional measure was adopted, not at the time of review by this Panel. The
United States and Argentina argue in this regard th at in the case of Germany's safeguard measure on
Bt-176 maize, relevant scientific evidence could not have been insufficient to conduct a risk
assessment at the time of adoption of the German safeguard measure, sin ce a risk assessment was
conducted by the SCP on the basis of the information provided by Germany in support of its measure.
7.3326 We recall that Germany adopted its safegua rd measure on Bt-176 maize in March 2000.
Following Germany's notification of the measure, th e Commission requested the SCP to analyse the
information provided by Germany in support of it s measure in order to determine whether this
information would cause the SCP to consider that the product constituted a risk to human health or the
environment. The SCP in its opinion of Septembe r 2000 concluded that the information provided by
Germany did not constitute new scientific inform ation which would change the original risk
assessment which the SCPE had carried out in the context of the EC approval procedure concerning
Bt-176 maize.2135 Thus, as we understand it, the SCP effec tively reviewed its original risk assessment
in the light of the information presented by Germany and confirmed its original risk assessment.
7.3327 We have found above that both the opinions by the EC scientific committees which were
delivered in the context of relevant EC approva l procedures – the original assessments – and the
opinions by EC scientific committees which were deliv ered after the adoption of the relevant member
State safeguard measures – the review assessments – are risk assessments within the meaning of
Annex A(4) and Article 5.1 of the SPS Agreement.2136 We recall in this regard that the European
Communities does not suggest otherwise. 2137 In the light of this, we ag ree with the United States and
Argentina that the SCP's 2000 review assessmen t of Bt-176 maize, and the SCPE's original

2134 We note that the panel in Japan – Apples also began its inquiry with the first requirement, an
approach not faulted by the Appellate Body. Panel Report, Japan – Apples, para. 8.214.
2135 Exhibits US-66; ARG-43.
2136 We recall that the review assessments are generally in the nature of supplemental assessments and
thus need to be read in conjunction with the original assessments.
2137 It is pertinent to recall in this context that in defending the German safeguard measure against the
Complaining Parties' claims under Article 5.1, the European Communities essentially argued that Germany
acted on the basis of new scientific information wh ich presented a view divergent from the mainstream
scientific opinion reflected in the original risk assessment. It may be that in making this argument the European
Communities meant to refer to the SCPE's original risk assessment. However, the fact that Germany may have
disagreed with the SCPE's original a ssessment, and possibly also with the SCP's subsequent review assessment,
would not imply that the SCP's review and original assessments are not risk assessments as required under
Article 5.1 and as defined in Annex A(4). The Appellate Body has made it clear that a risk assessment as
required under Article 5.1 "could set out both the prev ailing view representing the 'mainstream' of scientific
opinion, as well as the opinions of scientists taking a divergent view". Appellate Body Report, EC – Hormones,
para. 184. Thus, the mere fact that the scientists taki ng a divergent view do not agree with the majority view
does not necessarily mean that the majority view is based on a risk assessment which does not meet the standard
and definition set out in Annex A(4). In any event, as noted, the European Communities does not argue that the
SCP's original and review assessments of Bt-176 maize are not risk assessments as required under Article 5.1
and as defined in Annex A(4).

assessment of Bt-176 maize (which, as noted, was conf irmed by the SCP's review assessment), serve
to demonstrate that at the time of adoption of the German safeguard measure, the body of available
scientific evidence permitted the performance of a risk assessment as required under Article 5.1 and
as defined in Annex A(4). We consider, theref ore, that the United States and Argentina have
established a presumption that Germany's safeguard measure was imposed in respect of a situation
where relevant scientific evidence was not insuffici ent. This presumption has not been effectively
rebutted by the European Communities.
2138
7.3328 As we pointed out above, the Appellate Body fo und that whenever one of the requirements of
Article 5.7 is not met, the measure at issue is inc onsistent with this provision. Thus, as it has been
established that Germany's safeguard measure on Bt-1 76 maize was not adopted consistently with the
first requirement of Article 5.7, we conclude that that measure is inconsistent with Article 5.7.
Overall conclusions
7.3329 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that the German
safeguard measure on Bt-176 maize is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the German safeguard measure on
Bt-176 maize is not based on a risk assessment, the Panel reaches the final conclusion
that, by maintaining the measure in ques tion, the European Communities has acted
inconsistently with its obligations under Article 5.1.

 (ii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communiti es, the Panel finds that the German
safeguard measure on Bt-176 maize is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the German safeguard measure on
Bt-176 maize is not based on a risk assessment, the Panel reaches the final conclusion
that, by maintaining the measure in ques tion, the European Communities has acted
inconsistently with its obligations under Article 5.1.

(viii) Greece – Topas oilseed rape
7.3330 We now turn to Greece's safeguard measure app lied with respect to Topas oilseed rape. We
recall the arguments of the Parties in respect of this measure.

2138 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the German safeguard measure should be treat ed as constituting one or more SPS measures. Thus,
like the Parties, we will continue to treat this measure as constituting one single SPS measure

7.3331 The United States argues that the Greek safeguard measure on Topas oilseed rape fails to
meet any of the four requirements set out in Article 5.7. First, the scientific evidence is sufficient to
perform a risk assessment, sin ce the European Communities itself has conducted positive risk
assessments on Topas oilseed rape. Second, the safeguard measure was not adopted on the basis of
"available pertinent information". The SCP review ed the safeguard measure and concluded that the
information provided by Greece did not warrant any change in the earlier risk assessment. Third,
Greece has not sought "to obtain the additional information necessary for a more objective assessment
of risk", and there is no information on record that Greece has sought to perform a risk assessment
that would support its measure on Topas oilseed rape. Finally, the United States alleges that neither
Greece nor the Commission have reviewed the Greek safeguard measure within a reasonable period
of time.
7.3332 Canada argues that a review of the Greek safeguard measure and the factual and scientific
circumstances surrounding its adoption and maintenance reveal that the measure fails to satisfy any of
the four elements of Article 5.7. First, the measure was not imposed in respect of a situation where
relevant scientific information was insufficient. The opinion of the European Communities' own
scientific experts demonstrate that there was sufficient scientific ev idence to conduct a complete and
objective risk assessment. In Canada's view, what was insufficient was the scientific evidence put
forward by the European Communities or Fr ance to support the safeguard measure. Second, the
measure was not adopted on the basis of "available pertinent information", since this would include
the scientific opinions of the lead CA and of the relevant EC scientific committee, which all
confirmed the safety of the product.
7.3333 With respect to the third element of Article 5.7, the requirement that the Member seek to
obtain the additional information necessary for a mo re objective assessment of risk, Canada notes that
this element is irrelevant in this case, given th e sufficiency of the scientif ic evidence available from
the European Communities' own sources. Finally, with regard to the fourth requirement, namely that
the measure must be reviewed within a reasonable period of time, Canada recalls that the European
Communities' own legislation requires that such a re view take place. However, given the absence of
"pertinent information" to support the safeguard me asure, Canada draws the conclusion that the
measure would have been lifted if such a review had been conducted. Furthermore, according to the
Appellate Body, what constitutes a "reasonable peri od of time" will be influenced by the emergence
of the additional information necessary to make a mo re objective assessment of the risk. In Canada's
view, new or additional information was not necessary in the present case to conduct a risk
assessment, as sufficient scientific evidence was in existe nce even at the time the safeguard measure
was taken.
7.3334 The European Communities argues that the Greek safeguard measure meets the four
requirements of Article 5.7. First, the European Communities asserts that relevant scientific evidence
was insufficient. According to the European Communities, the concept of "insufficiency" in
Article 5.7 is "relational" and must therefore refer to the matters of concern to the legislator.
Specifically, "insufficient" means "insufficient" fo r the production of a risk assessment adequate for
the purposes of the legislator who must decide whet her a measure should be applied, provisionally or
otherwise, for one of the reasons enumerated in Annex A(1) of the SPS Agreement. The European
Communities defines a risk assessment which is ade quate as one which has been "delivered by a
reputable source, [which] unequivocally informs the legi slator about what the risk is with a sufficient
degree of precision, and [which] has withstood the passage of time and is unlikely to be revised.2139

7.3335 In support of its view, the European Communities submits that the sufficiency of the evidence
cannot be examined in a vacuum, but has to be exam ined in relation to the protection goals sought by
legislators. The European Communities argues that it is artificial to suppose that there is some kind of
magic moment at which the available science becom es sufficient for all purposes. In the European
Communities' view, the actions of a legislator in response to available scientific evidence are a
function of what that particular legislator is c oncerned about. Thus, in the European Communities'
view, the higher the level of acceptable risk, the more likely it is that the legislator may conclude,
within a relatively short period of time, that the scientific evidence is sufficient and that no provisional
measure is therefore necessary. The lower the leve l of acceptable risk, the more likely it may be that
the legislator may continue to consider, for a relatively long period of time, that the scientific
evidence is insufficient, and that a measure is warranted.
2140 In other words, according to the
European Communities, the sufficiency of the scientific evidence must be examined in relation to the
level of acceptable risk of the legislators.
7.3336 Applying these considerations to the Greek safeguard measure on Topas oilseed rape, the
European Communities submits that, having regard to the specific concerns of Greece's legislators in
adopting that measure, Greece's legislators were entitle d to conclude that relevant scientific evidence
was insufficient for their purposes.
7.3337 Second, the European Communities contends that Greece has adopted and maintained its
safeguard measure on the basis of "availabl e pertinent information", which includes, inter alia , the
information contained in the original notificatio n, as well as the various relevant scientific
discussions, papers and opinions. With respect to the third requirement of Article 5.7, the European
Communities argues that both Greece and the European Communities are engaged in an ongoing
process by which they are seeking to obtain add itional information necessary for a more objective
assessment of the risk through ongoing research and the constant development of science.
7.3338 Finally, the European Communities notes that th e measure is subject to a process of review
within a reasonable period of time, and that such review is still ongoing both at Community and
member State levels.
2141 According to the European Communities, the determination of what
constitutes a "reasonable period of time" pursuant to Ar ticle 5.7 depends on all the circumstances. In
the present case, for instance, assessments are being made of long-term effects, in relation to changes
that may have a permanent effect, and that are being introduced at an exponential rate as compared to
the past. These circumstances may justify a Member requiring a relatively long period of time to
review its provisional measure. 2142 The European Communities finds support for this view in the
Appellate Body's statement that "responsible , representative governments commonly act from
perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to
human health are concerned". 2143 The European Communities di fferentiates the present case from
Japan - Apples , arguing that GMO technology is still at th e frontiers of scie nce and its future
consequences (compared to a case like fire blight ) are highly uncertain – and potentially more far-
reaching. The European Communities argues that the relevant risks are more than the mere

2140 The European Communities considers that this an alysis is confirmed by the words "reasonable
period of time" in Article 5.7.
2141 We recall that the US arguments that a requirement that measures be "constantly subject to review"
does not meet the requirement that the measures are in fact reviewed within a reasonable period of time of their
adoption. US second written submission, para. 100.
2142 The European Communities submits that the present case is very different, fo r example, from that
before the panel in Japan – Apples.
2143 Appellate Body Report, EC – Hormones, para. 124.

theoretical uncertainty that always remains si mply because science can never provide absolute
certainty that a given substance will never have adverse effects.
2144
"Insufficiency of relevant scientific evidence"
7.3339 The Panel will begin its analysis with the first requirement of Article 5.7. 2145 In other words,
we will consider whether the safeguard measure in question was imposed in respect of a situation
where "relevant scientific evidence [was] insufficient". Initially, we recall that we do not agree with
the European Communities that in th e context of Article 5.7, the insufficiency of relevant scientific
evidence must be assessed by reference to the appropriate level of protection of the importing
Member. We also recall our view that the suffi ciency of relevant scientific evidence should be
assessed at the time a provisional measure was adopted, not at the time of review by this Panel. The
United States and Canada argue in this regard that in the case of Greece's safeguard measure on
Topas oilseed rape, relevant scientific evidence coul d not have been insufficient to conduct a risk
assessment at the time of adoption of the Greek safeguard measure, since a risk assessment was
conducted by the SCP on the basis of the information provided by Greece in support of its measure.
7.3340 We recall that Greece adopted its safe guard measure on Topas oilseed rape in
September 1998. Following Greece's notification of the measure, the Commission requested the SCP
to analyse the information provided by Greece in support of its measure in order to determine whether
this information would cause the SCP to consider th at the product constituted a risk to human health
or the environment. The SCP in its opinion of Ma y 1999 concluded that the information provided by
Greece did not constitute new scientific information which would change the original risk assessment
carried out by the SCP in the context of the EC approval procedure concerning Topas oilseed rape.2146
Thus, as we understand it, the SCP effectively reviewed its original risk assessment in the light of the
information presented by Greece and confirmed its original risk assessment.
7.3341 We have found above that both the SCP opinions delivered in the context of relevant EC
approval procedures – the original assessments – and the SCP opinions delivered after the adoption of
the relevant member State safeguard measures – the review assessments – are risk assessments within
the meaning of Annex A(4) and Article 5.1 of the SPS Agreement.2147 We recall in this regard that the
European Communities does not suggest otherwise. 2148 In the light of this, we agree with the

2144 The European Communities notes in its first writte n submission (para. 608) that "[t]he present case
is, for example, very different from the circumstances of the Japan – Apples case. That case concerned a
disease (fire blight) with a relatively narrow spectrum of possible consequences (compared to GMOs generally).
The panel found that the disease had been known and studied for some 200 years – the GMO techniques with
which this case is concerned are far mo re recent than that. The panel also found that there was a high quantity
and quality of scientific evidence expressing strong and increasing confidence in the conclusion. In other
words, the matter could fairly be described as no longer being at the frontiers of science, but rather to have
passed into the realms of conventional scientific wisdom – an operational hypothesis unlikely to be disturbed
other than by some revolutionary and currently totally unforeseeable new scie ntific discovery. That is not at all
the circumstances of the present case. GMO technology is still at or close to the frontiers of science and its
future consequences (compared to a case like fire blight) highly uncertain – and potentially much more far
reaching."
2145 We note that the panel in Japan – Apples also began its inquiry with the first requirement, an
approach not faulted by the Appellate Body. Panel Report, Japan – Apples, para. 8.214.
2146 Exhibits US-70; CDA-73.
2147 We recall that the review assessments are generally in the nature of supplemental assessments and
thus need to be read in conjunction with the original assessments.
2148 It is pertinent to recall in this context that in defending the Greek safeguard measure against the
Complaining Parties' claims under Article 5.1, the Eu ropean Communities essentially argued that Greece acted
on the basis of new scientific information which pres ented a view divergent from the mainstream scientific

United States and Canada that the SCP's 1999 review assessment of Topas oilseed rape, and the SCP's
original assessment of Topas oilseed rape (whi ch, as noted, was confirmed by the SCP's review
assessment), serve to demonstrate th at at the time of adoption of the Greek safeguard measure, the
body of available scientific evidence permitted the performance of a risk assessment as required under
Article 5.1 and as defined in Annex A(4). We consider, therefore, that the United States and Canada
have established a presumption that Greece's safeguard measure was imposed in respect of a situation
where relevant scientific evidence was not insuffici ent. This presumption has not been effectively
rebutted by the European Communities.
2149
7.3342 As we pointed out above, the Appellate Body fo und that whenever one of the requirements of
Article 5.7 is not met, the measure at issue is inc onsistent with this provision. Thus, as it has been
established that Greece's safeguard measure on Topas oilseed rape was not adopted consistently with
the first requirement of Article 5.7, we conclude that that measure is inconsistent with Article 5.7.
Overall conclusions
7.3343 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that the Greek
safeguard measure on Topas oilseed rape is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Greek safeguard measure on
Topas oilseed rape is not based on a risk assessment, the Panel reaches the final
conclusion that, by maintaining the measure in question, the European Communities
has acted inconsistently with its obligations under Article 5.1.

 (ii) DS292 (Canada)

 With reference to DS292, and having re gard to the arguments and evidence presented
by Canada and the European Communities, the Panel finds that the Greek safeguard

opinion reflected in the original risk assessment. It may be that in making this argument the European
Communities meant to refer to the SCP's original risk assessment. However, the fact that Greece may have
disagreed with the SCP's original a ssessment, and possibly also with the SCP's subsequent review assessment,
would not imply that the SCP's review and original assessments are not risk assessments as required under
Article 5.1 and as defined in Annex A(4). The Appellate Body has made it clear that a risk assessment as
required under Article 5.1 "could set out both the prev ailing view representing the 'mainstream' of scientific
opinion, as well as the opinions of scientists taking a divergent view". Appellate Body Report, EC – Hormones,
para. 184. Thus, the mere fact that the scientists taki ng a divergent view do not agree with the majority view
does not necessarily mean that the majority view is based on a risk assessment which does not meet the standard
and definition set out in Annex A(4). In any event, as noted, the European Communities does not argue that the
SCP's original and review assessments of Topas oilseed rape are not risk assessments as required under
Article 5.1 and as defined in Annex A(4).
2149In view of this finding, it is not necessary to revisit the issue of whether, given its multiple purposes,
the Greek safeguard measure should be treated as co nstituting one or more SPS measures. Thus, like the
Parties, we will continue to treat this measure as constituting one single SPS measure.

measure on Topas oilseed rape is not consistent with Article 5.7 of the
SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Greek safeguard measure on
Topas oilseed rape is not based on a risk assessment, the Panel reaches the final
conclusion that, by maintaining the measure in question, the European Communities
has acted inconsistently with its obligations under Article 5.1.

(ix) Italy – T25 maize, MON810 maize, MON809 maize, Bt-11 maize (EC-163)
7.3344 We now turn to Italy's safeguard measure applied with respect to T25 maize, MON810 maize,
MON809 maize and Bt-11 maize (EC-163). We recall th e arguments of the Parties in respect of this
measure.
7.3345 The United States argues that the Italian safeguard measure on T25 maize, MON810 maize,
MON809 maize and Bt-11 maize (EC-163), fails to m eet any of the four requirements set out in
Article 5.7. First, the scientific evidence is sufficient to perform a risk assessment, since the
European Communities itself has conducted positive risk assessments on the products concerned.
Second, the safeguard measure was not adopted on the basis of "available pertinent information". The
SCF reviewed the safeguard measure and concluded that the information provided by Italy did not
warrant any change in the earlier risk assessment. Third, Italy has not sought "to obtain the additional
information necessary for a more objective assessment of risk", and there is no information on record
that Italy has sought to perform a risk assessme nt that would support its measure on the products
concerned. Finally, the United States alleges that neither Italy nor the Commission have reviewed the
French safeguard measure within a reasonable period of time.
7.3346 Canada argues that a review of the Italian safeguard measure and the factual and scientific
circumstances surrounding its adoption and maintenance reveal that the measure fails to satisfy any of
the four elements of Article 5.7. First, the measure was not imposed in respect of a situation where
relevant scientific information was insufficient. The opinion of the European Communities' own
scientific experts demonstrate that there was sufficient scientific ev idence to conduct a complete and
objective risk assessment. In Canada's view, what was insufficient was the scientific evidence put
forward by the European Communities or Italy to support the safeguard measure. Second, the
measure was not adopted on the basis of "available pertinent information", since this would include
the scientific opinions of the lead CA and of the relevant EC scientific committee, which all
confirmed the safety of the product.
7.3347 With respect to the third element of Article 5.7, the requirement that the Member seek to
obtain the additional information necessary for a mo re objective assessment of risk, Canada notes that
this element is irrelevant in this case, given th e sufficiency of the scientif ic evidence available from
the European Communities' own sources. Finally, with regard to the fourth requirement, namely that
the measure must be reviewed within a reasonable period of time, Canada recalls that the European
Communities' own legislation requires that such a re view take place. However, given the absence of
"pertinent information" to support the safeguard me asure, Canada draws the conclusion that the
measure would have been lifted if such a review had been conducted. Furthermore, according to the
Appellate Body, what constitutes a "reasonable peri od of time" will be influenced by the emergence
of the additional information necessary to make a mo re objective assessment of the risk. In Canada's
view, new or additional information was not necessary in the present case to conduct a risk
assessment, as sufficient scientific evidence was in existe nce even at the time the safeguard measure
was taken.

7.3348 Argentina argues that the Italian safeguard measure
2150 does not meet any of the four
requirements of Article 5.7. First, the scientific evidence was not in sufficient, since at least two
positive scientific opinions were expressed on th e products concerned, including one which
specifically rejected the information provided by Italy in support of the measure. Second, Italy did
not base its measure on the "available pertinent information", since it disregarded the positive
scientific opinions of the scientific committee. Third, Italy has not sought to obtain further
information necessary for a more objective risk assessm ent, because the information provided in this
case is not consistent with the positive scientif ic opinions given by the scientific committee. Finally,
with respect to the fourth requirement of Article 5.7, Argentina notes that Italy did not review its
safeguard measure.
7.3349 The European Communities argues that the Italian safeguard measure meets the four
requirements of Article 5.7. First, the European Communities asserts that relevant scientific evidence
was insufficient. According to the European Communities, the concept of "insufficiency" in
Article 5.7 is "relational" and must therefore refer to the matters of concern to the legislator.
Specifically, "insufficient" means "insufficient" fo r the production of a risk assessment adequate for
the purposes of the legislator who must decide whet her a measure should be applied, provisionally or
otherwise, for one of the reasons enumerated in Annex A(1) of the SPS Agreement. The European
Communities defines a risk assessment which is ade quate as one which has been "delivered by a
reputable source, [which] unequivocally informs the legi slator about what the risk is with a sufficient
degree of precision, and [which] has withstood the passage of time and is unlikely to be revised.
7.3350 In support of its view, the European Communities submits that the sufficiency of the evidence
cannot be examined in a vacuum, but has to be exam ined in relation to the protection goals sought by
legislators. The European Communities argues that it is artificial to suppose that there is some kind of
magic moment at which the available science becom es sufficient for all purposes. In the European
Communities' view, the actions of a legislator in response to available scientific evidence are a
function of what that particular legislator is c oncerned about. Thus, in the European Communities'
view, the higher the level of acceptable risk, the more likely it is that the legislator may conclude,
within a relatively short period of time, that the scientific evidence is sufficient and that no provisional
measure is therefore necessary. The lower the leve l of acceptable risk, the more likely it may be that
the legislator may continue to consider, for a relatively long period of time, that the scientific
evidence is insufficient, and that a measure is warranted. 2151 In other words, according to the
European Communities, the sufficiency of the scientific evidence must be examined in relation to the
level of acceptable risk of the legislators.
7.3351 Applying these considerations to the Italian safeguard measure on the products concerned, the
European Communities submits that, having regard to the specific concerns of Italy's legislators in
adopting that measure, Italy's legislators were entitle d to conclude that relevant scientific evidence
was insufficient for their purposes.
7.3352 Second, the European Communities contends that Italy has adopted and maintained its
safeguard measure on the basis of "availabl e pertinent information", which includes, inter alia , the
information contained in the original notificatio n, as well as the various relevant scientific
discussions, papers and opinions. With respect to the third requirement of Article 5.7, the European

2150 We recall that unlike the complaints by the other Complaining Parties, Argentina's complaint with
regard to the Italian safeguard measure covers only thr ee products subject to the Ita lian decree of August 2000,
i.e., T25 maize, MON810 maize and Bt-11 maize.
2151 The European Communities considers that this an alysis is confirmed by the words "reasonable
period of time" in Article 5.7.

Communities argues that both Italy and the Eu ropean Communities are engaged in an ongoing
process by which they are seeking to obtain add itional information necessary for a more objective
assessment of the risk through ongoing research and the constant development of science.
7.3353 Finally, the European Communities notes that th e measure is subject to a process of review
within a reasonable period of time, and that such review is still ongoing both at Community and
member State levels.
2152 According to the European Communities, the determination of what
constitutes a "reasonable period of time" pursuant to Ar ticle 5.7 depends on all the circumstances. In
the present case, for instance, assessments are being made of long-term effects, in relation to changes
that may have a permanent effect, and that are being introduced at an exponential rate as compared to
the past. These circumstances may justify a Member requiring a relatively long period of time to
review its provisional measure.
2153 The European Communities finds support for this view in the
Appellate Body's statement that "responsible , representative governments commonly act from
perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to
human health are concerned". 2154 The European Communities di fferentiates the present case from
Japan-Apples, arguing that GMO technology is still at th e frontiers of scie nce and its future
consequences (compared to a case like fire blight ) are highly uncertain – and potentially more far-
reaching. The European Communities argues that the relevant risks are more than the mere
theoretical uncertainty that always remains si mply because science can never provide absolute
certainty that a given substance will never have adverse effects.2155
"Insufficiency of relevant scientific evidence"
7.3354 The Panel will begin its analysis with the first requirement of Article 5.7. 2156 In other words,
we will consider whether the safeguard measure in question was imposed in respect of a situation
where "relevant scientific evidence [was] insufficient". Initially, we recall that we do not agree with
the European Communities that in th e context of Article 5.7, the insufficiency of relevant scientific
evidence must be assessed by reference to the appropriate level of protection of the importing
Member. We also recall our view that the suffi ciency of relevant scientific evidence should be
assessed at the time a provisional measure was adopted, not at the time of review by this Panel. The
Complaining Parties argue in this regard that in the case of Italy's safeguard measure on T25 maize,
MON810 maize, MON809 maize and Bt-11 maize (E C-163), relevant scientific evidence could not

2152 We recall that the United States' argument that a requirement that measures be "constantly subject
to review" does not meet the requiremen t that the measures are in fact revi ewed within a reasonable period of
time of their adoption.
2153 The European Communities submits that the present case is very different, fo r example, from that
before the panel in Japan – Apples.
2154 Appellate Body Report, EC – Hormones, para. 124.
2155 The European Communities notes that "[t]he presen t case is, for example, very different from the
circumstances of the Japan – Apples cas e. That case concerned a disease (fi re blight) with a relatively narrow
spectrum of possible consequences (compared to GMOs generally). The panel found that the disease had been
known and studied for some 200 years – the GMO techniques with which this case is concerned are far more
recent than that. The panel also fo und that there was a high quantity and quality of scientific evidence
expressing strong and increasing confidence in the conclusion. In other words, the matter could fairly be
described as no longer being at the frontiers of science, but rather to have passed into the realms of conventional
scientific wisdom – an operational hypothesis unlikely to be disturbed other than by some revolutionary and
currently totally unforeseeable new scientific discovery. That is not at all the circumstances of the present case.
GMO technology is still at or close to the frontiers of science and its future consequences (compared to a case
like fire blight) highly uncertain – and potentially much more far reaching."
2156 We note that the panel in Japan – Apples also began its inquiry with the first requirement, an
approach not faulted by the Appellate Body. Panel Report, Japan – Apples, para. 8.214.

have been insufficient to conduct a risk assessment at the time of adoption of the Italian safeguard
measure, since a risk assessment was conducted by the SCF on the basis of the information provided
by Italy in support of its measure.
7.3355 We recall that Italy adopted its safegua rd measure on T25 maize, MON810 maize,
MON809 maize and Bt-11 maize (EC-163) in August 2000. Following Italy's notification of the
measure, the Commission requested the SCF to anal yse the information provided by Italy in support
of its measure in order to determine whether this information would cause the SCF to consider that the
products in question constituted a risk to human h ealth. The SCF in its opinion of September 2000
concluded that the information provided by Italy di d not provide grounds for considering that the use
of the products in question endange rs human health. Thus, as we understand it, the SCF effectively
confirmed the original risk assessments carried out by the SCP in the context of the EC approval
procedures concerning the products concerned.
7.3356 We have found above that both the opinions by the EC scientific committees which were
delivered in the context of relevant EC approva l procedures – the original assessments – and the
opinions by EC scientific committees which were deliv ered after the adoption of the relevant member
State safeguard measures – the review assessments – are risk assessments within the meaning of
Annex A(4) and Article 5.1 of the SPS Agreement.
2157 We recall in this regard that the European
Communities does not suggest otherwise. 2158 In the light of this, we agree with the Complaining
Parties that the SCF's 2000 review assessment of the products concerned 2159, and the SCF's original
assessment of the products concerned (which, as noted, was confirmed by the SCF's review
assessment), serve to demonstrate that at the time of adoption of the Italian safeguard measure, the
body of available scientific evidence permitted the performance of a risk assessment as required under
Article 5.1 and as defined in Annex A(4). We consider, therefore, that the Complaining Parties have
established a presumption that Italy's safeguard measure was imposed in respect of a situation where
relevant scientific evidence was not insufficient. This presumption has not been effectively rebutted
by the European Communities.2160
7.3357 As we pointed out above, the Appellate Body fo und that whenever one of the requirements of
Article 5.7 is not met, the measure at issue is inc onsistent with this provision. Thus, as it has been

2157 We recall that the review assessments are generally in the nature of supplemental assessments and
thus need to be read in conjunction with the original assessments.
2158 It is pertinent to recall in this context that in defending the Italian safeguard measure against the
Complaining Parties' claims under Article 5.1, the Euro pean Communities essentially argued that Italy acted on
the basis of new scientific information which presented a view divergent from the mainstream scientific opinion
reflected in the original risk assessments. It may be that in making this argument the European Communities
meant to refer to the SCP's original ri sk assessments. However, the fact th at Italy may have disagreed with the
SCP's original risk assessments, a nd possibly also with the SCF's subsequent review assessment, would not
imply that these review and original assessments are not risk assessments as required under Article 5.1 and as
defined in Annex A(4). The Appellate Body has made it clear that a risk assessment as required under
Article 5.1 "could set out both the prevailing view repres enting the 'mainstream' of scientific opinion, as well as
the opinions of scientists taking a divergent view". Appellate Body Report, EC – Hormones, para. 184. Thus,
the mere fact that the scientists taking a divergent view do not agree with the majority view does not necessarily
mean that the majority view is base d on a risk assessment which does not meet the standard and definition set
out in Annex A(4). In any event, as noted, the European Communities does not argue that the original and
review assessments of the products concerned are not risk assessments as required under Article 5.1 and as
defined in Annex A(4).
2159Exhibits US-68; CDA-86 and ARG-47.
2160 In view of this finding, it is not necessary to revisit the issue of whether, given its multiple
purposes, the Italian safeguard measure should be treat ed as constituting one or more SPS measures. Thus, like
the Parties, we will continue to treat this measure as constituting one single SPS measure.

established that Italy's safeguard measure on the products concerned was not adopted consistently
with the first requirement of Article 5.7, we c onclude that that measure is inconsistent with
Article 5.7.
Overall conclusions

7.3358 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Comm unities, the Panel finds that the Italian
safeguard measure on T25 maize, MON810 maize, MON809 maize and Bt-11 maize
(EC-163) is not consistent with Article 5.7 of the SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Italian safeguard measure on
T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163) is not based
on a risk assessment, the Panel reaches the final conclusion that, by maintaining the
measure in question, the European Commun ities has acted inconsistently with its
obligations under Article 5.1.

 (ii) DS292 (Canada)

 With reference to DS292, and having re gard to the arguments and evidence presented
by Canada and the European Communities, th e Panel finds that the Italian safeguard
measure on T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163)
is not consistent with Article 5.7 of the SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Italian safeguard measure on
T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163) is not based
on a risk assessment, the Panel reaches the final conclusion that, by maintaining the
measure in question, the European Commun ities has acted inconsistently with its
obligations under Article 5.1.

 (iii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communiti es, the Panel finds that the Italian
safeguard measure on T25 maize, MON810 maize and Bt-11 maize (EC-163) is not
consistent with Article 5.7 of the SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, the Italian safeguard measure on
T25 maize, MON810 maize, MON809 maize and Bt-11 maize (EC-163) is not based
on a risk assessment, the Panel reaches the final conclusion that, by maintaining the
measure in question, the European Commun ities has acted inconsistently with its
obligations under Article 5.1.

(x) Luxembourg – Bt-176 maize
7.3359 We now turn to Luxembourg's safeguard measur e applied with respect to Bt-176 maize. We
recall the arguments of the Parties in respect of this measure.
7.3360 The United States argues that Luxembourg's safeguard measure on Bt-176 maize fails to
meet any of the four requirements set out in Article 5.7. First, the scientific evidence is sufficient to
perform a risk assessment, sin ce the European Communities itself has conducted positive risk
assessments on Bt-176 maize. Second, the safeguard measure was not adopted on the basis of
"available pertinent information". The SCF and th e Scientific Committee for Pesticides reviewed the
safeguard measure and concluded that the inform ation provided by Luxembourg did not warrant any
change in the earlier risk assessment. Third, Luxembourg has not sought "to obtain the additional
information necessary for a more objective assessment of risk", and there is no information on record
that Luxembourg has sought to perform a risk assessment that would support its measure on
Bt-176 maize. Finally, the United States alleges that neither Luxembourg nor the Commission have
reviewed Luxembourg's safeguard measure within a reasonable period of time.
7.3361 Argentina argues that Luxembourg's safeguard measure does not meet any of the four
requirements of Article 5.7. First, the scientific evidence was not in sufficient, since at least two
positive scientific opinions were expressed on Bt-176 maize, including one which specifically rejected
the information provided by Luxembourg in support of the measure. Second, Luxembourg did not
base its measure on the "available pertinent inform ation", since it disregarded the positive scientific
opinions of the scientific committee. Third, Luxembourg has not sought to obtain further information
necessary for a more objective risk assessment, beca use the information provided in this case is not
consistent with the positive scientific opinions given by the scientific committee. Finally, with
respect to the fourth requirement of Article 5.7, Argentina notes that Luxembourg did not review its
safeguard measure.
7.3362 The European Communities argues that Luxembourg's safe guard measure meets the four
requirements of Article 5.7. First, the European Communities asserts that relevant scientific evidence
was insufficient. According to the European Communities, the concept of "insufficiency" in
Article 5.7 is "relational" and must therefore refer to the matters of concern to the legislator.
Specifically, "insufficient" means "insufficient" fo r the production of a risk assessment adequate for
the purposes of the legislator who must decide whet her a measure should be applied, provisionally or
otherwise, for one of the reasons enumerated in Annex A(1) of the SPS Agreement. The European
Communities defines a risk assessment which is ade quate as one which has been "delivered by a
reputable source, [which] unequivocally informs the legi slator about what the risk is with a sufficient
degree of precision, and [which] has withstood the passage of time and is unlikely to be revised.
7.3363
In support of its view, the European Communities submits that the sufficiency of the evidence
cannot be examined in a vacuum, but has to be exam ined in relation to the protection goals sought by
legislators. The European Communities argues that it is artificial to suppose that there is some kind of
magic moment at which the available science becom es sufficient for all purposes. In the European
Communities' view, the actions of a legislator in response to available scientific evidence are a
function of what that particular legislator is c oncerned about. Thus, in the European Communities'
view, the higher the level of acceptable risk, the more likely it is that the legislator may conclude,
within a relatively short period of time, that the scientific evidence is sufficient and that no provisional
measure is therefore necessary. The lower the leve l of acceptable risk, the more likely it may be that
the legislator may continue to consider, for a relatively long period of time, that the scientific

evidence is insufficient, and that a measure is warranted.
2161 In other words, according to the
European Communities, the sufficiency of the scientific evidence must be examined in relation to the
level of acceptable risk of the legislators.
7.3364 Applying these considerations to the Luxem bourg safeguard measure on Bt-176 maize, the
European Communities submits that, having regard to the specific concerns of Luxembourg's
legislators in adopting that measure, Luxembourg's le gislators were entitled to conclude that relevant
scientific evidence was insufficient for their purposes.
7.3365 Furthermore, the European Communities c ontends that Luxem bourg has adopted and
maintained its safeguard measure on the basis of "available pertinent information", which includes,
inter alia , the information contained in the original notification, as well as the various relevant
scientific discussions, papers and opinions. With respect to the third requirement of Article 5.7, the
European Communities argues that both Luxembourg and the European Communities are engaged in
an ongoing process by which they are seeking to ob tain additional information necessary for a more
objective assessment of the risk through ongoing research and the constant development of science.
7.3366 Finally, the European Communities notes that th e measure is subject to a process of review
within a reasonable period of time, and that such review is still ongoing both at Community and
member State levels. 2162 According to the European Communities, the determination of what
constitutes a "reasonable period of time" pursuant to Ar ticle 5.7 depends on all the circumstances. In
the present case, for instance, assessments are being made of long-term effects, in relation to changes
that may have a permanent effect, and that are being introduced at an exponential rate as compared to
the past. These circumstances may justify a Member requiring a relatively long period of time to
review its provisional measure.
2163 The European Communities finds support for this view in the
Appellate Body's statement that "responsible , representative governments commonly act from
perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to
human health are concerned". 2164 The European Communities di fferentiates the present case from
Japan-Apples, arguing that GMO technology is still at th e frontiers of scie nce and its future
consequences (compared to a case like fire blight ) are highly uncertain – and potentially more far-
reaching. The European Communities argues that the relevant risks are more than the mere
theoretical uncertainty that always remains si mply because science can never provide absolute
certainty that a given substance will never have adverse effects.2165

2161 The European Communities considers that this an alysis is confirmed by the words "reasonable
period of time" in Article 5.7.
2162 We recall that the US arguments that a requirement that measures be "constantly subject to review"
does not meet the requirement that the measures are in fact reviewed within a reasonable period of time of their
adoption.
2163 The European Communities submits that the present case is very different, fo r example, from that
before the panel in Japan – Apples.
2164 Appellate Body Report, EC – Hormones, para. 124.
2165 The European Communities notes that "[t]he presen t case is, for example, very different from the
circumstances of the Japan – Apples case. That case concerned a disease (fire blight) with a relatively narrow
spectrum of possible consequences (compared to GMOs generally). The panel found that the disease had been
known and studied for some 200 years – the GMO techniques with which this case is concerned are far more
recent than that. The panel also fo und that there was a high quantity and quality of scientific evidence
expressing strong and increasing confidence in the conclusion. In other words, the matter could fairly be
described as no longer being at the frontiers of science, but rather to have passed into the realms of conventional
scientific wisdom – an operational hypothesis unlikely to be disturbed other than by some revolutionary and
currently totally unforeseeable new scientific discovery. That is not at all the circumstances of the present case.

"Insufficiency of relevant scientific evidence"

7.3367 The Panel will begin its analysis with the first requirement of Article 5.7. 2166 In other words,
we will consider whether the safeguard measure in question was imposed in respect of a situation
where "relevant scientific evidence [was] insufficient". Initially, we recall that we do not agree with
the European Communities that in th e context of Article 5.7, the insufficiency of relevant scientific
evidence must be assessed by reference to the appropriate level of protection of the importing
Member. We also recall our view that the suffi ciency of relevant scientific evidence should be
assessed at the time a provisional measure was adopted, not at the time of review by this Panel. The
United States and Argentina argue in this regard that in the case of Luxembourg's safeguard measure
on Bt-176 maize, relevant scientific evidence could not have been insufficient to conduct a risk
assessment at the time of adoption of Luxembourg' s safeguard measure, since risk assessments were
apparently conducted by EC scientific committees on the basis of the information provided by
Luxembourg in support of its measure.2167
7.3368 We recall that Luxembourg adopted its safeguard measure on Bt-176 maize in February 1997.
Following Luxembourg's notification of the measure , the Commission apparently did not request the
Scientific Committee for Pesticides (SCPE), th e Scientific Committee for Animal Nutrition
(SCAN) and the SCF to analyse the information provided by Luxembourg in support of its measure in
order to determine whether this information w ould cause these Committees to consider that the
product constituted a risk to human health or the environment. However, in response to a question
from the Panel, the European Communities indi cated that the Commission relied on the opinions
provided by these committees in relation to Austria's safeguard measure on Bt-176 maize. 2168 T o
recall, the SCF in its opinion of March 1997, the SCAN in its opinion of April 1997 and the SCPE in
its opinion of May 1997 concluded that the inform ation provided by Austria did not constitute new
scientific information which would change the original risk assessments which they had carried out in
the context of the EC approval procedure concerning Bt-176 maize.2169
7.3369 We have found above that both the opinions by EC scientific committees which were
delivered in the context of relevant EC approva l procedures – the original assessments – and the
opinions by EC scientific committees which were deliv ered after the adoption of the relevant member
State safeguard measures – the review assessments – are risk assessments within the meaning of
Annex A(4) and Article 5.1 of the SPS Agreement.2170 We recall in this regard that the European
Communities does not suggest otherwise. 2171 In the light of this, we consider that the 1997 SCF,

GMO technology is still at or close to the frontiers of science and its future consequences (compared to a case
like fire blight) highly uncertain – and potentially much more far reaching."
2166 We note that the panel in Japan – Apples also began its inquiry with the first requirement, an
approach not faulted by the Appellate Body. Panel Report, Japan – Apples, para. 8.214.
2167 The United States and Argentina have provided a document indicating that EC scientific
committees were consulted on Luxembourg's safeguard measure. Exhibits US-107; ARG-6. The United States
has indicated, however, that it was unable to locate any opinion by an EC scientific committee on Luxembourg's
safeguard measure.
2168 EC reply to Panel question No. 106.
2169 Exhibits US-57, -58 and -66; ARG-43.
2170 We recall that the review assessments are generally in the nature of supplemental assessments and
thus need to be read in conjunction with the original assessments.
2171 It is pertinent to recall in this context that in defending the Austrian safeguard measure against the
Complaining Parties' claims under Article 5.1, the Euro pean Communities essentially argued that Austria acted
on the basis of new scientific information which pres ented a view divergent from the mainstream scientific
opinion reflected in the original risk assessments. It may be that in making this argument the European
Communities meant to refer to the original risk assessm ents by the SCF, the SCAN and the SCPE. However,

SCAN and SCPE review assessments of Bt-176 ma ize, and the SCF, SCAN and SCPE original
assessments of Bt-176 maize (which, as noted, were confirmed by the review assessments), serve to
demonstrate that at the time of adoption of L uxembourg's safeguard measure, the body of available
scientific evidence permitted the performance of a risk assessment as required under Article 5.1 and
as defined in Annex A(4). We consider, therefore, that these review assessments establish a
presumption that Luxembourg's safeguard measure was imposed in respect of a situation where
relevant scientific evidence was not insufficient. This presumption has not been effectively rebutted
by the European Communities.
2172
7.3370 As we pointed out above, the Appellate Body fo und that whenever one of the requirements of
Article 5.7 is not met, the measure at issue is inc onsistent with this provision. Thus, as it has been
established that Luxembourg's safeguard measure on Bt-176 maize was not adopted consistently with
the first requirement of Article 5.7, we conclude that that measure is inconsistent with Article 5.7.
Overall conclusions
7.3371 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Communities, the Panel finds that
Luxembourg's safeguard measure on Bt-176 mai ze is not consistent with Article 5.7
of the SPS Agreement.

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, Luxembourg's safeguard measure on
Bt-176 maize is not based on a risk assessment, the Panel reaches the final conclusion
that, by maintaining the measure in ques tion, the European Communities has acted
inconsistently with its obligations under Article 5.1.

 (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 finds that Luxembourg's
safeguard measure on Bt-176 maize is not consistent with Article 5.7 of the
SPS Agreement.

the fact that Austria may have disagr eed with these' original assessments, and possibly also with the subsequent
review assessment by the SCP, would not imply that thes e committees' assessments are not risk assessments as
required under Article 5.1 and as defined in Annex A(4). The Appellate Body has made it clear that a risk
assessment as required under Article 5.1 "could set out both the prevailing view representing the 'mainstream' of
scientific opinion, as well as the opinions of scientis ts taking a divergent view". Appellate Body Report, EC –
Hormones, para. 184. Thus, the mere fact that the scientists taking a divergent view do not agree with the
majority view does not necessarily m ean that the majority view is base d on a risk assessment which does not
meet the standard and definition set out in Annex A(4). In any event, as noted, the European Communities does
not argue that the original and review assessments of Bt-176 maize are not risk assessments as required under
Article 5.1 and as defined in Annex A(4).

2172In view of this finding, it is not necessary to revisit the issue of whether, given its multiple purposes,
Luxembourg's safeguard measure should be treated as constituting one or more SPS measures. Thus, like the
Parties, we will continue to treat this measure as constituting one single SPS measure

 In view of this finding, as well as the Panel's previous finding that, contrary to the
provisions of Article 5.1 of the SPS Agreement, Luxembourg's safeguard measure on
Bt-176 maize is not based on a risk assessment, the Panel reaches the final conclusion
that, by maintaining the measure in ques tion, the European Communities has acted
inconsistently with its obligations under Article 5.1.

(e) Consistency with Article 5.6 of the SPS Agreement
7.3372 The Panel now turns to address Canada's and Argentina's claims of inconsistency under
Article 5.6 of the SPS Agreement.
7.3373 We recall that Article 5.6 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."
7.3374 Canada argues the EC member State safeguard measures are inconsistent with Article 5.6
because they are more trade-restrictive than requi red to achieve the EC's appropriate level of
protection. The fact that Article 2.2 includes the phrase that measures should be "applied only to the
extent necessary to protect human, animal or plant life or health" highlights the relationship between
Article 2.2 and Article 5.6. Given this relationship, and the fact that Article 5.6 is a more specific
expression of the general obligation found in the clause in Article 2.2, a measure that is found to be in
violation of Article 5.6 must also be presumed to violate Article 2.2. Therefore, these measures must
also be presumed to violate Article 2.2.
7.3375 Argentina argues that (a) the EC member States ha d alternative sanitary or phytosanitary
measures available, other than bans; (b) it was possi ble to achieve an appropriate level of protection
using these alternative measures; and (c) these alternative measures would have been significantly less
restrictive than a ban on biotech agricultural products already approved by the European
Communities. Therefore, Argentina contends that the bans at the level of some member States violate
Article 5.6 of the SPS Agreement. Argentina also argues, however, th at in the interests of procedural
economy a finding by the Panel that the relevant me mber State safeguard me asures are inconsistent
with Articles 5.1 and 2.2 will obviate the need for a further finding by the Panel that the safeguard
measures are inconsistent with Article 5.6.
7.3376 The European Communities argues that Article 5.6 is not relevant to the specific rule
provided for in Article 5.7. The appropriate level of protection referred to in Article 5.6 refers to that
established pursuant to Article 5.1. Even if Article 5.6 were relevant to the application of Article 5.7,
the necessity of the measure would have to be judge d by reference to the insufficiency of scientific
evidence, and the reasonable period of time necessary. Furthermore, because the appropriate level of
protection of the Community and the member Stat es differs, even if they agreed on the science
underlying the measure, they might still disagree on the measures to be taken.
(i) Evaluation
7.3377 The Panel recalls that it has already reached the conclusion that the safeguard measures being
challenged by Canada and Argentina, respectively, ar e inconsistent with Article 5.1 in that they are
not based on a risk assessment. In view of our findings on Canada's and Argentina's claims under

Article 5.1, we cannot presume that the import prohibitions made effective through the relevant
safeguard measures could eventually, that is after appropriate implementing ac tion, be maintained as
they are. In these circumstan ces, we see no need to examine, and offer additional findings on,
whether the existing safeguard measures are also inc onsistent with Article 5.6. Accordingly, we
exercise judicial economy with regard to Canada's and Argentina's claims under Article 5.6.
(ii) Overall conclusions
7.3378 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 th e safeguard measures which are being
challenged by Canada are inconsis tent with Article 5.6 of the SPS Agreement.
Accordingly, the Panel offers no findings under Article 5.6.

 (ii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communiti es, the Panel concludes that it is not
necessary to make findings on whether th e safeguard measures which are being
challenged by Argentina are incons istent with Article 5.6 of the SPS Agreement.
Accordingly, the Panel offers no findings under Article 5.6.

(f) Consistency with Article 5.5 of the SPS Agreement
7.3379 The Panel next proceeds to address Canada's a nd Argentina's claims of inconsistency under
Article 5.5 of the SPS Agreement.
7.3380 We recall that Article 5.5 provides in relevant part:
"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."
7.3381 Canada notes that its claim under Article 5.5 is pr esented in the alternative, that is in the
event that the relevant member States' appropriate level of protection is that reflected in these member
States' safeguard measures. Canada argues that th e product-specific marke ting bans meet all three
elements that are required to establish a violation of Article 5.5. First, the European Communities has
adopted different appropriate levels of sanitary and phytosanitary prot ection in "different situations"
that are comparable.
2173 Canada notes that the European Communities has adopted different
appropriate levels of sanitary and phytosantiary protection in at least three different situations: (i)
EC-approved biotech products that are subject to th e EC member State national measures; (ii) other
EC-approved biotech products; and (iii) non-biot ech varieties of the products in item. Second, those

2173 Article 5.5 of the SPS Agreement. See also, Appellate Body Report, EC – Hormones, para. 214.

different appropriate levels of prot ection are "arbitrary or unjustifiable."
2174 Third, the measures
embodying those differences, the product-specific marketing bans, result in "discrimination or a
disguised restriction on international trade.
7.3382 Argentina argues that the bans on the safeguard measures by EC member States are
inconsistent with Article 5.5 of the SPS Agreement since the three "elements" in Article 5.5 have been
shown to have been violated cumulatively. Furthe rmore, the effect of the bans imposed by some
member States on the biotechnology-producing countries is significant and adverse, inasmuch as it
falls unfairly on imports. Argentina also argues, howe ver, that in the interests of procedural economy
a finding by the Panel that the relevant member State safeguard measures are inconsistent with
Articles 5.1 and 2.2 will obviate the need for a further finding by the Panel that the safeguard
measures are inconsistent with Article 5.5.
7.3383 The European Communities argues that Article 5.7 contains an express rule that effectively
excludes Article 5.5. The European Communities cons iders that the member State measures to which
Canada refers must be assessed by reference to Article 5.7 rather than Article 5.5. There is no basis
for concluding that the member States have acted in consistently with Article 5.5. Furthermore, the
European Communities observes that consistency with Article 5.5 of the SPS Agreement should be
evaluated in the context of the conduct of the European Communities. The European Communities
has not behaved in an arbitrary manner or made unjus tifiable distinctions such as those referred to in
Article 5.5.
(i) Evaluation
7.3384 The Panel recalls that it has already reached the conclusion that the safeguard measures being
challenged by Canada and Argentina, respectively, ar e inconsistent with Article 5.1 in that they are
not based on a risk assessment. In view of our findings on Canada's and Argentina's claims under
Article 5.1, we cannot presume that the import prohibitions made effective through the relevant
safeguard measures could eventually, that is after appropriate implementing ac tion, be maintained as
they are. In these circumstan ces, we see no need to examine, and offer additional findings on,
whether the European Communities acted inconsiste ntly with its obligations under Article 5.5 in
respect of the existing safeguard measures whic h embody particular levels of protection.
Accordingly, we exercise judicial economy with regard to Canada's and Argentina's claims under
Article 5.5.
(ii) Overall conclusions
7.3385 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 th e safeguard measures which are being
challenged by Canada are inconsis tent with Article 5.5 of the SPS Agreement.
Accordingly, the Panel offers no findings under Article 5.5.

2174 Ibid.

 (ii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communiti es, the Panel concludes that it is not
necessary to make findings on whether th e safeguard measures which are being
challenged by Argentina are incons istent with Article 5.5 of the SPS Agreement.
Accordingly, the Panel offers no findings under Article 5.5.

(g) Consistency with Article 2.2 of the SPS Agreement
7.3386 The Panel now addresses the Complaining Parties' claims of inconsistency under Article 2.2
of the SPS Agreement.
7.3387 We recall that Article 2.2 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."
7.3388 The United States argues that a violation of Article 5.1 can be presumed to imply a violation
of the more general provision of Article 2.2. The only risk assessments put forth for the banned
products are the positive scientific assessments rend ered by member States to which the products
were submitted, and then by the European Commun ities' own scientific committees. In the case of
each member State ban, these favourable assessments were reaffirmed when the scientific committees
considered and rejected the information provided by the member States. Thus, the member State
measures do not bear a "rational relationship" to the European Communities' positive risks
assessment, and are not "based on" a risk assessment, in violation of Article 5.1 and thus Article 2.2.
7.3389 Canada argues that a violation of Article 5.1 can be presumed to imply a violation of the
more general provision of Article 2.2.
2175 Canada has already argued that the product-specific
marketing bans are not "based on" risk assessments and are therefore inconsistent with Article 5.1. It
can therefore be presumed that the product-specific marketing bans also violate the requirements of
Article 2.2 that SPS measures be based on "scientif ic principles" and "not maintained without
sufficient scientific evidence". Canada argues that since the pr oduct-specific marketing bans are
inconsistent with Article 5.6 because they are more trade-restrictive than required to achieve the
European Communities' appropriate level of protec tion, these measures must also be presumed to
violate Article 2.2.
7.3390 Argentina argues that the inconsistency of the member State bans with Article 2 arises due to
an inconsistency between these bans and Article 5. In addition, the lack of rational relationship
between the member State safeguard measures and the scientific evidence renders these measures
inconsistent with Article 2.2. 2176 The member State bans are not supported by scientific evidence.
Furthermore, Article 2.2 requires that a measure be applied "only to the extent necessary," while also
requires that it be based on "sufficient scientific ev idence," whether it is to be implemented or to be
maintained. Consequently, the member State bans also conflict with Article 2.2, and cannot be
justified under the exception of Article 5.7.

2175 Canada refers to, e.g., Appellate Body Report, Australia – Salmon, paras. 137-138.
2176 Argentina refers to Appellate Body Report, Japan – Agricultural Products, para. 73.

7.3391 The European Communities argues that Article 2.2 excludes from its scope of application
the kinds of situations covered by Article 5.7.
2177 Article 5.7, rather than Article 2.2, is the provision
to which Canada should have referred in order to properly understand the justification for the member
State measures. "Necessity" can only be judged with in a relevant time frame, taking into account any
insufficiency in scientific evidence. Scientific principles include the principle that conclusions should
be based on repeatable experiment, observation and the collection of data over time. Measures
adopted on the basis of Article 5.7 are based on sci entific principles, because they are based on the
need to allow sufficient time for su fficient scientific evidence to be collected. There is therefore no
basis for the Panel to conclude that the member Stat e measures are inconsistent with Article 2.2 of the
SPS Agreement.
7.3392 The Panel begins its examination by recalling that Article 2.2 contains three distinct
requirements: (i) the requirement that SPS measures be applied only to the extent necessary to protect
human, animal or plant life or health, (ii) the requirement that SPS measures be based on scientific
principles, and (iii) the requirement that SPS measure s not be maintained without sufficient scientific
evidence. It is appropriate to analyse separately the first requirement, on the one hand, and the second
and third requirements, on the other hand.
(i) First requirement of Article 2.2
7.3393 Canada and Argentina allege that the safeguard measures they are challenging are
inconsistent with the first requirement of Article 2.2.
7.3394 We recall that we have already reached the conclusion that the safeguard measures being
challenged by Canada and Argentina, respectively, ar e inconsistent with Article 5.1 in that they are
not based on a risk assessment. In view of our findings on Canada's and Argentina's claims under
Article 5.1, we cannot presume that the import prohibitions made effective through the relevant
safeguard measures could eventually, that is after appropriate implementing ac tion, be maintained as
they are. In these circumstan ces, we see no need to examine, and offer additional findings on,
whether the existing safeguard measures are also inconsis tent with the first requirement in Article 2.2.
Accordingly, we exercise judicial economy with re gard to Canada's and Argentina's claims under the
first requirement in Article 2.2.
(ii) Second and third requirements of Article 2.2
7.3395 All three Complaining Parties allege that the safeguard measures they are challenging are
inconsistent with the second and third requirements of Article 2.2.
7.3396 Here as well, we begin by recalling that we have already reached the conclusion that the
safeguard measures challenged by the Complaining Par ties are inconsistent with Article 5.1 in that
they are not based on a risk assessment. In Australia – Salmon , the Appellate Body agreed with the
panel in that case that in the ev ent an SPS measure is not based on a risk assessment as required in
Article 5.1, this measure can be presumed, more ge nerally, not to be based on scientific principles or
not to be maintained without sufficient scientific evidence within the meaning of Article 2.2. The
Appellate Body concluded on that basis that "by maintaining an import prohibition on fresh, chilled or
frozen ocean-caught Pacific salmon, in violation of Ar ticle 5.1, Australia has, by implication, also

2177 The European Communities refers to Appellate Body Report, EC – Hormones, para. 104, in respect
of Articles 3.1 and 3.3 of the SPS Agreement. The European Communities notes that Article 3.1 contains
language essentially identical to that in Article 2.2.

acted inconsistently with Article 2.2 of the SPS Agreement".
2178 We consider that the same logic and
presumption are applicable in the present case. Accordingly, we find that by maintaining the
challenged safeguard measures inconsistently with Article 5.1, the European Communities has, by
implication, also acted inconsistently with the second and third requirements in Article 2.2.
(iii) Article 5.7
7.3397 We have determined above that the releva nt safeguard measures are inconsistent, by
implication, with the second and third requirement s in Article 2.2. Before coming to a final
conclusion, however, we address whether the safeguard measures are consistent with the requirements
of Article 5.7 of the SPS Agreement.
7.3398 We have found earlier that the safeguard measures at issue are not consistent with Article 5.7.
This finding applies also to our analysis under Article 2.2, and so we confirm it here. Accordingly,
there can be no doubt that the second and third requirements in Article 2.2 are applicable to the
safeguard measures.
2179 This in turn confirms that these measures are contrary to Article 2.2,
inasmuch as they are inconsistent, by impli cation, with the second and third requirements in
Article 2.2.
(iv) Overall conclusions
7.3399 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Communities, the Panel concludes that by
applying, inconsistently with Article 5.1 of the SPS Agreement, the safeguard
measures which the United States is challe nging, the European Communities has, by
implication, also acted inconsistently with the second and third requirements in
Article 2.2 of the SPS Agreement.

 (ii) 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 as follows:

(a) It is not necessary to make findings on whether the safeguard measures which
are being challenged by Canada are incons istent with the first requirement of
Article 2.2 of the SPS Agreement. Accordingly, the Panel offers no findings
with regard to the first requirement in Article 2.2 of the SPS Agreement.

(b) By applying, inconsistently with Article 5.1 of the SPS Agreement, the
safeguard measures which Canada is challenging, the European Communities

2178 Appellate Body Report, Australia – Salmon, paras. 137-138.
2179 We recall that, earlier, we have left open whether Article 5.7 acts as a qualified exemption from the
second requirement in Article 2.2. In view of our finding that none of the safeguard measures are consistent
with Article 5.7, the issue is without practical significance for our analysis under Article 2.2, and so we do not
address it further.

has, by implication, also acted inco nsistently with the second and third
requirements in Article 2.2 of the SPS Agreement.

 (iii) 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 as follows:

(a) It is not necessary to make findings on whether the safeguard measures which
are being challenged by Argentina are in consistent with the first requirement
of Article 2.2 of the SPS Agreement. Accordingly, the Panel offers no
findings with regard to the first requirement in Article 2.2 of the
SPS Agreement.

(b) By applying, inconsistently with Article 5.1 of the SPS Agreement, the
safeguard measures which Argentina is challenging, the European
Communities has, by implication, also acted inconsistently with the second
and third requirements in Article 2.2 of the SPS Agreement.

(h) Consistency with Article 2.3 of the SPS Agreement
7.3400 The Panel finally addresses Canada's and Ar gentina's claims of inconsistency under
Article 2.3 of the SPS Agreement.
7.3401 We recall that Article 2.3 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."
7.3402 Canada notes that in Australia-Salmon, the Panel stated that a violation of Article 5.5 "can be
presumed to imply a violation of the more general Article 2.3".
2180 In the case at hand, Canada has
demonstrated that the EC member State nationa l measures are inconsistent with the European
Communities obligations under Article 5.5. By imp lication, therefore, these measures also violate
Article 2.3.
7.3403 Argentina argues that as the member State bans have been shown to be inconsistent with
Article 5.5, they also violate Article 2.3. Argen tina also argues, however, that in the interests of
procedural economy a finding by the Panel that th e relevant member State safeguard measures are
inconsistent with Articles 5.1 and 2.2 will obviate th e need for a further finding by the Panel that the
safeguard measures are inconsistent with Article 2.3.
7.3404 The European Communities argues that since the member State measures are not
inconsistent with Article 5.5, they are not inconsistent with Article 2.3.

2180 Canada refers to Panel Report, Australia – Salmon, para. 8.109. According to Canada, the
Appellate Body upheld this statement. See Appellate Body Report, Australia – Salmon, para. 178.

(i) Evaluation
7.3405 The Panel recalls that it has already reached the conclusion that the safeguard measures being
challenged by Canada and Argentina, respectively, ar e inconsistent with Article 5.1 in that they are
not based on a risk assessment. In view of our findings on Canada's and Argentina's claims under
Article 5.1, we cannot presume that the import prohibitions made effective through the relevant
safeguard measures could eventually, that is after appropriate implementing ac tion, be maintained as
they are. In these circumstan ces, we see no need to examine, and offer additional findings on,
whether the existing safeguard measures are also inc onsistent with Article 2.3. Accordingly, we
exercise judicial economy with regard to Canada's and Argentina's claims under Article 2.3.
(ii) Overall conclusions
7.3406 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 th e safeguard measures which are being
challenged by Canada are inconsis tent with Article 2.3 of the SPS Agreement.
Accordingly, the Panel offers no findings under Article 2.3.

 (ii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communiti es, the Panel concludes that it is not
necessary to make findings on whether th e safeguard measures which are being
challenged by Argentina are incons istent with Article 2.3 of the SPS Agreement.
Accordingly, the Panel offers no findings under Article 2.3.

3. Analysis of the safeguard measures in the light of the TBT Agreement
7.3407 The Panel now turns to address Canada's and Ar gentina's claims of inconsistency under the
TBT Agreement. The United States did not present claims under the TBT Agreement.
7.3408 Canada considers that the safeguard measures 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 safeguard measures at is sue are not SPS measures, then Canada submits, in
the alternative, that these measures are "technical regulations", as that term is defined in the
TBT Agreement, and therefore subject to the requirements of that Agreement. Furthermore, in
Canada's view, these measures are inconsistent with Ar ticle 2.1, Article 2.2, and Articles 2.9.1, 2.9.2
and 2.9.3 of the TBT Agreement.
7.3409 Furthermore, Canada states that to the extent that the Panel determines that parts of the
measure 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.
7.3410 Argentina considers that the Panel should examin e the measures Argentina is challenging
under the SPS Agreement. However, if the Panel concludes that it should not examine these measures
under the SPS Agreement, Argentina submits, in the alternative, that the safeguard measures at issue

are "technical regulations", as that term is defined in the TBT Agreement, and therefore subject to the
requirements of that Agreement. Furthermore, in Argentina's view, by instituting bans on specific
biotech products, these measures have violated Ar ticles 2.1, 2.2, 2.9.1, 2.9.2 and 2.9.4 of the
TBT Agreement.
7.3411 The European Communities considers that, given the reasons on which the relevant
safeguard measures are based, they fall in part within the scope of the SPS Agreement and in part
outside the scope of the SPS Agreement. The European Communities does not agree, however, that
the relevant safeguard measures are subject to the provisions of the TBT Agreement. In the European
Communities' view, these measures are not "techni cal regulations" within the meaning of the
TBT Agreement. For this and other reasons, the European Communities considers that these measures
cannot be inconsistent with Article 2 of that Agreement.
(a) Evaluation
7.3412 The Panel begins its examination with Canada's claims. Canada has stated that if the Panel
determines that parts of the relevant safeguard measures are covered by the TBT Agreement in
addition to the SPS Agreement, Canada's claims under the TBT Agreement are to be considered
cumulative rather than alternative. We have f ound, however, that each of the safeguard measures
challenged by Canada constitutes in its entirety an "SPS measure" within the meaning of Annex A(1)
of the SPS Agreement and hence falls to be assessed under that Agreement. In view of this finding
and Article 1.5 of the TBT Agreement
2181, we do not consider that part s of the relevant safeguard
measures are covered by the TBT Agreement. Consequently, we should tr eat Canada's claims under
Articles 2.1, 2.2 and 2.9 of the TBT Agreement as alternative claims. Since Canada's alternative
claims are relevant only in the ev ent that we decide that the relevant safeguard measures are not
subject to the SPS Agreement, and since this is not what we have decided, we see no need to address
Canada's alternative claims under Articles 2.1, 2.2 and 2.9 of the TBT Agreement further.
7.3413 Argentina's claims under the TBT Agreement are presented in the alte rnative, in the event the
Panel finds that the relevant safeguard measures should not be examined under the SPS Agreement.
We have found, however, that each of the safe guard measures challenged by Argentina should be
assessed in the light of the SPS Agreement. In these circumstances, we see no need to address
Argentina's alternative claims under Articles 2.1, 2.2 and 2.9 of the TBT Agreement further.
(b) Overall conclusions
7.3414 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 th e safeguard measures which are being
challenged by Canada are inconsistent with Articles 2.1, 2.2 or 2.9 of the
TBT Agreement. Accordingly, the Panel offers no findings under Article 2.1, 2.2 or
2.9 of the TBT Agreement.

2181 We recall that Article 1.5 states that the provisions of the TBT Agreement do not apply to SPS
measures within the meaning of Annex A(1) of the SPS Agreement.

 (ii) DS293 (Argentina)

 With reference to DS293, and having re gard to the arguments and evidence presented
by Argentina and the European Communiti es, the Panel concludes that it is not
necessary to make findings on whether th e safeguard measures which are being
challenged by Argentina are inconsistent with Articles 2.1, 2.2 or 2.9 of the
TBT Agreement. Accordingly, the Panel offers no findings under Article 2.1, 2.2 or
2.9 of the TBT Agreement.

4. Analysis of the safeguard measures in the light of the GATT 1994
7.3415 The Panel now turns to address the Complaining Parties' claims of inconsistency under the
GATT 1994. Canada and Argentina have presente d claims under Article III:4 of the GATT 1994.
The United States and Canada have presented claims under Article XI:1 of the GATT 1994. The
Panel first addresses the claims under Article III:4.
(a) Consistency with Article III:4 of the GATT 1994
7.3416 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."
7.3417 Canada claims that Austria's safeguard measure on T25 maize, France's safeguard measures
on Topas oilseed rape and MS1/RF1 oilseed rape (EC-161), and Italy's safeguard measure on
MON810 maize, MON809 maize, Bt-11 (EC-163) and T25 maize fall within the scope of the GATT
1994 and are inconsistent with the European Communities' obligations under Article III:4.
2182
7.3418 According to Canada, these four safeguard measures all are "laws, regulations or
requirements laws, regulations or requirements affecting the internal sale, offering for sale, purchase,
and distribution" of the biotech products concerne d; the biotech products subject to these safeguard
measures are "like" domestically produced non-biotech products in the light of four criteria put forth
by the Appellate Body; and the imported biotech products concerned are accorded treatment less
favourable than that accorded like non-biotech product s of national origin. Therefore, Canada argues
that the four safeguard measures constitute a vi olation of the European Communities' national
treatment obligations under Article III:4.
7.3419 Argentina claims that Austria's safeguard measures on T25 maize, Bt-176 and MON810
maize, Germany's safeguard measure on Bt-176 ma ize, Italy's safeguard measure on MON810 maize,
Bt-11 (EC-163) and T25 maize, and Luxembourg's safeguard measure on Bt-176 maize fall within the
scope of the GATT 1994 and are inconsistent with the European Communities' obligations under
Article III:4.
7.3420 According to Argentina, the biotech products subject to the safeguard measures and non-
biotech agricultural products are "like" within the meaning of Article III:4 of the GATT 1994; the

2182 Austria's measure on T25 maize, France's measures on Topas and MS1/RF1 oilseed rape, and
Italy's measure on MON810, MON809, Bt-11 and T25 maize.

safeguard measures at issue are a "law, regulation or requirement" affecting "their [the products']
internal sale, offering for sale, purchase, transpor tation, distribution, or use"; and the treatment
accorded to the imported (biotech) product is "less favourable" than accorded to the ("non-biotech")
domestic product.
(i) Evaluation
7.3421 The Panel notes that Canada's claim under Article I II:4 concerns four of the five safeguard
measures challenged by Canada, namely, (i) Austria – T25 maize, (ii) France – MS1/RF1 oilseed rape
(EC 161), (iii) France – Topas oilseed rape, and (iv) Italy – Bt-11 maize (EC-163), MON809 maize,
MON810 maize and T25 maize. Argentina's clai m under Article III:4 concerns all six safeguard
measures challenged by Argentina.
7.3422 We recall that we have already reached the conclusion that the aforementioned safeguard
measures being challenged by Canada and Argentina, respectively, are inconsistent with Article 5.1
and, by implication, the second and th ird requirements in Article 2.2 of the SPS Agreement. In these
circumstances, we see no need to examine, and offer additional findings on, whether the relevant
safeguard measures are also inconsistent with Article III:4. Accordingly, as did previous panels in
similar situations
2183, we exercise judicial economy with regard to Canada's and Argentina's claims
under Article III:4.
(ii) Overall conclusions
7.3423 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 th e safeguard measures 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 Communiti es, the Panel concludes that it is not
necessary to make findings on whether th e safeguard measures which are being
challenged by Argentina are inconsistent with Article III:4 of the GATT 1994.
Accordingly, the Panel offers no findings under Article III:4.

(b) Consistency with Article XI:1 of the GATT 1994
7.3424 The Panel now turns to address the United Stat es' and Canada's claim under Article XI:1 of
the GATT 1994.

7.3425 Article XI:1 of the GATT 1994 provides:
"No prohibitions or restrictions other than duties, taxes or other charges, whether
made effective through quotas, import or export licences or other measures, shall be
instituted or maintained by any contracting party on the importation of any product of
the territory of any other contracting party or on the exportation or sale for export of
any product destined for the territory of any other contracting party."
7.3426 The United States claims that the Greek safeguard meas ure on Topas oilseed rape violates
Article XI:1 of the GATT 1994. According to th e United States, the terms of the Greek measure
make it unambiguously clear that the measure is an "import ban": "We prohibit the importing into the
territory of Greece of seeds of the genetically m odified rape-plant line bearing reference number
C/UK/95/M5/1", and therefore, as an import ban, th e Greek measure is a prima facie violation of
Article XI:1.
7.3427 Canada claims that Greece's safeguard measure violates Article XI:1. According to Canada,
as an import ban, the Greek ministerial decision constitutes an "other measure" provided for by
Article XI of the GATT 1994, and, by the terms of that measure, Greece has both instituted and is
maintaining a complete import prohibition on Topas oilseed rape seeds, contrary to Article XI:1.
(i) Evaluation
7.3428 The Panel notes that the United States' claim under Article XI:1 concerns one of the nine
safeguard measures challenged by it, namely, Gre ece – Topas oilseed rape. Canada's claim under
Article XI:1 is in respect of the same Greek safeguard measure.
7.3429 We recall that we have already reached the conclusion that the aforementioned safeguard
measures being challenged by the United States and Canada, respectively, are inconsistent with
Article 5.1 and, by implication, the second an d third requirements in Article 2.2 of the
SPS Agreement. In these circumstances, we see no need to examine, and offer additional findings on,
whether the relevant safeguard measures are also inc onsistent with Article XI:1. Accordingly, as did
previous panels in similar situations
2184, we exercise judicial economy with regard to the United
States' and Canada's claims under Article XI:1.
(ii) Overall conclusions
7.3430 In the light of the above, the Panel reaches the following overall conclusions:
 (i) DS291 (United States)

 With reference to DS291, and having re gard to the arguments and evidence presented
by the United States and the European Communities, the Panel concludes that it is not
necessary to make findings on whether th e safeguard measures which are being
challenged by the United States are inconsiste nt with Article XI:1 of the GATT 1994.
Accordingly, the Panel offers no findings under Article XI:1.

Apples, paras. 8.328-8.329.