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  (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 Artic les 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 produc t-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 sa me 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 meani ng of Annex A(1) of the SPS Agreement . 
1671 Argentina's first written submission, paras. 374 and 450. WT/DS291/R 
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Page 868 
  
  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 90/2201672 (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.    WT/DS291/R 
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  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 a pproval, 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 258/971681, the Commission, when making a decision on a safeguard 
measure which has been notified, is assisted  for this purpose by the Regulatory Committee1682 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), 3rd paragraph of Directive 2001/18; and 
Article 12(1) of Regulation 258/97. 
1679 Article 16(1) of Directive 90/220;  Article 23(1), 3rd 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).   WT/DS291/R 
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Page 870 
  
  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.   WT/DS291/R 
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  (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.  Cana da 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 Communiti es' 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, Cana da 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.   WT/DS291/R 
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Page 872 
  
   (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 ma ize, 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.   WT/DS291/R 
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  7.2548  The United States notes that the European Commun ities 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, demonstr ate 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: WT/DS291/R 
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Page 874 
  
  (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.  WT/DS291/R 
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  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 asserti ons 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 receive d 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 thr ee 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 .  WT/DS291/R 
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Page 876 
  
  (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  In 
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.      WT/DS291/R 
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 Page 877 
  
  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 sa feguard 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 conditions1701; 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.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 878 
  
  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 th e 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 docum ents 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.  WT/DS291/R 
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 WT/DS293/R 
 Page 879 
  
  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 unders tands 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 pa rticular 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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 880 
  
  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 anim als 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 th e 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  WT/DS291/R 
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  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. WT/DS291/R 
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Page 882 
  
  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.  WT/DS291/R 
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  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 T 25 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, a nd 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. WT/DS291/R 
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Page 884 
  
  (c) DS292 (Canada)  
(d) With reference to DS292, a nd 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, a nd 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.    WT/DS291/R 
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  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; pe rsistence and invasiveness in agricultural and natural 
habitats; development of resistance; out-crossi ng; undesirable effects on management practices; 
biodiversity; monitoring; labelling; co-e xistence; 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 previo usly 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.   WT/DS291/R 
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Page 886 
  
  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 bacter ia 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 docum ents 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.  WT/DS291/R 
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  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 no ne 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 .   WT/DS291/R 
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Page 888 
  
  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
.  WT/DS291/R 
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  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 WT/DS291/R 
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Page 890 
  
  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.  WT/DS291/R 
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  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 consumer s 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 h ealth 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 a dverse 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 an imals or on the environment. WT/DS291/R 
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Page 892 
  
  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 saf eguard 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 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
  
7.2658  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.    WT/DS291/R 
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 Page 893 
  
  7.2660  Argentina notes that since the safeguard measure prev ents 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.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 894 
  
  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;  de velopment 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 as sessment on indirect and long term effects of the Bt 
toxin is missing; and (b) [t]he environmental risk assessment has been consid ered 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. 
                                                      
1730 US first written submission, para. 157. 
1731 Exhibit EC-155. 
1732 Exhibit EC-159/At. 3_trans., pages 5-6. 
1733 Exhibit EC-159/At. 30, p. 2.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 895 
  
  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 ma ize 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 conc ern 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, in cluding 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 docum ents 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 896 
  
  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, produ ced 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 .     WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 897 
  
  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 in fected 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 th e scope of Annex A(1)(a) and (b) of the SPS Agreement . WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 898 
  
  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 entr y, 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 with in 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).  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 899 
  
  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 saf eguard 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 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 
 
7.2698  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 effectivel y 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 .    
 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 900 
  
   (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 applie d 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 ex tended 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).    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 901 
  
  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 20031743 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 20031745 
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 
                                                     
 
1741 The document entitled " Motivation du moratoire, pour une période de deux ans, relative à la mise 
en marché sur le territoire français de colza génétiquement modifié tolérant aux herbicides, en application de l'Article 16 de la Directive 90/220/EEC:  Nouveaux éléments en matière d'évaluation du risque pour 
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.  WT/DS291/R 
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Page 902 
  
  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 va lidate 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 Fran ce 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 opi nion 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.  WT/DS291/R 
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   (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 pr operly 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 th e 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 ap plied 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-toler ance 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 Fren ch 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.    WT/DS291/R 
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Page 904 
  
  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 associat ed 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).    WT/DS291/R 
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 Page 905 
  
  7.2727  Moreover, we stated that to the extent a measur e 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 conven tional 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 th e 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 un desired can be considered as "pests".  Such plants 
include cross-breeds between GM oilseed rape a nd conventional oilseed rape which grow in a WT/DS291/R 
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Page 906 
  
  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.   WT/DS291/R 
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 Page 907 
  
  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 constitutin g 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 em bodying 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 ther efore 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 produc t, 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 WT/DS291/R 
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Page 908 
  
  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).    WT/DS291/R 
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 Page 909 
  
  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-e xistence; 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 Eu ropean 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. WT/DS291/R 
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Page 910 
  
  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 ap plied 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-toler ance 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 ad ventitious 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 911 
  
  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 measu re 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 constitutin g 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 em bodying 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.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 912 
  
  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 clear ly 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 Ins titute (Exhibit EC-158/At. 19_trans).  
1765 Exhibits US-65; ARG-13.   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 913 
  
  testing purposes in certain specified areas.
1766  This decision was notified to the Commission in 
April 2000.1767   
Is the German safeguard measur e 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 de termination, 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 le tter of 31 March 2000 (Exhibit US-65).  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 914 
  
  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 bacter ia 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 German y 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-not ed 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 915 
  
  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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 916 
  
  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-ta rget 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 sp ecific 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.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 917 
  
  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 cons idered to embody more than one SPS measure.  
                                                     
 
1771 See supra,  footnote 1753.  WT/DS291/R 
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Page 918 
  
  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 .   
  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 919 
  
   (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 me asure 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 T opas 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 Wo rks, 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). WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 920 
  
  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-e xistence; 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 20041778 
Greece highlights concerns about gene flow through polle n 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 produc t 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.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 921 
  
   
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 Top as 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 be tween 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 sc ope 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 associat ed 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 th ese wild hybrid plants, falls within  the scope of Annex A(1)(a) and 
(d) of the SPS Agreement . WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 922 
  
  Adverse environmental effects of vol unteer 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 rel ease 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 cons umption of proteins produ ced through the expression 
of modified genes, in hybrids of conventi onal 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 adde d 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  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 923 
  
  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 th e 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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 924 
  
  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 constitutin g 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 925 
  
  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 suspen sion of the commercialisation and 
utilization of certain transgenic products [Bt-11 ma ize (EC-163), MON810 maize, MON809 maize and T25 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 926 
  
  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 measure1783.  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 ma ize 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 Augu st 2000, 184 (Exhib it 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 ma ize, 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 927 
  
  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 Hea lth 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 928 
  
  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 preval ence 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 th e 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 concer n 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 929 
  
  health from risks arising from pesticide residues, and hence contaminants, in GM plants used as or in 
foods can be considered to fall with in 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 thei r 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.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 930 
  
  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 fo rm 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 constitutin g 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 931 
  
  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 sec ond 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 cl early 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, re sulting 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 th e 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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 932 
  
  (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 19961796, 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 th at 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).  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 933 
  
  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; pe rsistence 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 Communiti es 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 substan tiated 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 Eu ropean 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 
subi la modification combinée lui assurant les propriétés insecticides conférées par le gène Bt-endotoxine et une meilleure résistance à l'herbicide glufosinate-ammonium – Motivation de la décision luxembourgeoise", 
communicated to the Commission with the "Arrêté ministériel" on 17 Marc h 1997 (Exhibit EC-158/At. 9).   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 934 
  
  possible resulting decrease in effectiveness of medi cal treatments involving specific antibiotics which 
might pose a risk to the life or health of an imals 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.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 935 
  
  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 measur e 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 Governme nt.  It is also not in dispute th at 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). WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 936 
  
  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 saf eguard 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 implementi ng 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 .   
  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 937 
  
   (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 betw een 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 b asis 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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 938 
  
  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, provisiona l 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.  WT/DS291/R 
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  Article 5.7, as well as with those of Articles 2.1
1801, 2.31802 and 2.41803 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 940 
  
  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 evid ence.  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 availabl e 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.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 941 
  
  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. WT/DS291/R 
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Page 942 
  
  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 th e 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 correct1814, 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" betw een 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 "insuffici ent" 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.  WT/DS291/R 
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 Page 943 
  
  demonstrate that the SPS Agreement  sets out separate and special regimes – "parallel universes", in 
the European Communities' parlance – for provision al 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, a nd in particular in paragraph 3." 
7.2951  Article 3.3 provides: 
"Members may introduce or maintain sanita ry 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 sa nitary 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. WT/DS291/R 
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Page 944 
  
  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 me asure 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 s ubject 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.  WT/DS291/R 
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  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 exempt ion 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 – name ly, 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 examinati on 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. WT/DS291/R 
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  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 defen ce, 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, th e 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 enunc iated 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 partic ular 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.  WT/DS291/R 
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  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 th at 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 illustrati on 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. WT/DS291/R 
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  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 measur es 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).    WT/DS291/R 
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  met, the measure at issue is in consistent 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 th at 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. WT/DS291/R 
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Page 950 
  
  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 meas ure 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 covere d by Article 5.7.  If, as we believ e, 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. 
1839 Panel Report, Japan – Apples , para. 8.201. 
1840 Ibid., para. 8.212. 
1841 Ibid., paras. 8.199, 8.222 and 8.224. 
1842 Appellate Body Report, Japan – Apples , footnote 316.  WT/DS291/R 
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  "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 qua lified 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. WT/DS291/R 
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  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 guida nce 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 ri sk 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. 
1846 Panel Report, Australia – Salmon , para. 8.57. 
1847Appellate Body Report, EC – Hormones , para. 104.  WT/DS291/R 
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  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 th e 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 inform ation 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 satis fies 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 el ement 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. WT/DS291/R 
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  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 consider ed 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 sci entific 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.  WT/DS291/R 
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  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 phr ase "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 B ody 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 meas ures 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.   WT/DS291/R 
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Page 956 
  
  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 rela tionship 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.  WT/DS291/R 
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  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 saf eguard 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 rele vant 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 safegua rd 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. WT/DS291/R 
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Page 958 
  
  (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 organi sms 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  WT/DS291/R 
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  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, a nd 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 "sufficien tly 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.   
1856 EC first written submission, para. 610. 
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). WT/DS291/R 
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  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 presen t 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 internationa l 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.  Cont rary 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 gene rally 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.    WT/DS291/R 
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  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 tec hniques 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 whic h the product application was originally submitted – 
the "lead CA"1863- and by the relevant EC scientific committ ee.  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 conseque nces, according to the proposed u se 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 St ate 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 asse ssments.  Thus, the review assessments need to be read 
in conjunction with the earlier (original) assessments.    WT/DS291/R 
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  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".       WT/DS291/R 
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  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 achi eve 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 protectio n 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. 
1871 Panel Report, Japan – Apples , para. 7.12. WT/DS291/R 
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Page 964 
  
  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.   WT/DS291/R 
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  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, est ablishment 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, establi shment 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 w as 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 monito r 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 re lated 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. WT/DS291/R 
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Page 966 
  
  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 m eaning 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.   WT/DS291/R 
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  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 guidan ce 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 re levant 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 ther efore 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.   WT/DS291/R 
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Page 968 
  
  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 ev idence 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 assess ments 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 safegua rd 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).   WT/DS291/R 
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  "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 thr eat 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 opinion1897 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, wh ere 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. WT/DS291/R 
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Page 970 
  
  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 exis ting 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 di fferent 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 a ppropriate 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).    WT/DS291/R 
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  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 uncertainties1904 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, whic h 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. WT/DS291/R 
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Page 972 
  
  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 recomme ndations, 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.    WT/DS291/R 
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 Page 973 
  
   (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.   WT/DS291/R 
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Page 974 
  
  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.    WT/DS291/R 
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 Page 975 
  
  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 ge netic 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. WT/DS291/R 
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Page 976 
  
  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 assess ments 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 th e 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 977 
  
  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 un der 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 978 
  
   (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 carn ea (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 probabili ty 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 979 
  
  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 c onclusion 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 980 
  
  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).  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 981 
  
  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 th e 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 982 
  
  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 th e 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 un der 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 we re 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 983 
  
  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 Anne x A(4) and Article 5.1. 
1957 Exhibit EC-161/At. 2, p. 2. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 984 
  
  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 wh ether 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 modi fied 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 co existence 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.  WT/DS291/R 
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 WT/DS293/R 
 Page 985 
  
  However, this is addressed, in the context of the BEC report, with respect to all herbicide tolerant 
oilseed rape varieties and not specifically those whic h 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 acc ount 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 986 
  
  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, a nd 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 b ased 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 me asure as constituting one single SPS measure.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 987 
  
  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.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 988 
  
  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 Top as 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 SC P 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, a nd 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 989 
  
  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 un der 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 me asure 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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 990 
  
  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 wh ich 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 991 
  
  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 lik elihood 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 adve rse 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 releva nce 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 992 
  
  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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 993 
  
  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 ma ize 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 994 
  
  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 a ddition, 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 un der 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 saf eguard 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  WT/DS291/R 
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  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.  WT/DS291/R 
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  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 w eeds 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 on ly 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 m eaning 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 eff ects 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 bi ology of canola "ensures th at 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.  WT/DS291/R 
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  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 rela ted 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.  WT/DS291/R 
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Page 998 
  
  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 asse ssments 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 SC P 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.  WT/DS291/R 
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  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 un der 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 me asure as constituting one single SPS measure.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1000 
  
  "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 guidan ce 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.  WT/DS291/R 
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 WT/DS293/R 
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  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 A nnex 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.   WT/DS291/R 
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Page 1002 
  
  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 referri ng 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.  WT/DS291/R 
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  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 me asure 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1004 
  
  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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1005 
  
  "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 c onsider 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 me asure, 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1006 
  
  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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1007 
  
  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 un der 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.   WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1008 
  
  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 specifica lly, 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 i ssue 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.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1009 
  
  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 meas ure 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.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1010 
  
  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 Au stria 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 sci entific 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.  
                                                      
2050 EC first written submission, para. 604. 
2051 The European Communities considers that this an alysis is confirmed by  the words "reasonable 
period of time" in Article 5.7.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1011 
  
  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 analys is 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 revolutiona ry 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1012 
  
  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 sanita ry 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 rele vant 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 sci entific 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" assessme nt 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, th e 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.   WT/DS291/R 
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  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 evid ence 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 mu st 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), WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1014 
  
  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 Memb er's appropriate level of protection.   
                                                                                                                                                                     
Section III, Codex Procedural Manual, 14th 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, 14th 
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.     WT/DS291/R 
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  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 5.22068 nor Article 5.32069 
suggests that a Member's appropriate level of protecti on 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 achie ving 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 th e territory of an importin g Member according to the 
sanitary or phytosanitary measures which might be applie d".  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 ho w 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. WT/DS291/R 
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Page 1016 
  
  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 una ble 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 releva nt 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.  WT/DS291/R 
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 Page 1017 
  
  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 se t 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 measur es 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). WT/DS291/R 
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Page 1018 
  
  "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 a dditional 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 meas ure "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 requir ements in the second sentence of Article 5.7.  WT/DS291/R 
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  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 informati on 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 , WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1020 
  
  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 Commun ities, 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 oblig ations 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 majo rity view is based on a risk assessme nt 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.    WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1021 
  
  that, by maintaining the measure in ques tion, the European Communities has acted 
inconsistently with its obliga tions 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 oblig ations 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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1022 
  
  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 sci entific 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,  assess ments 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 
                                                      
2084 EC first written submission, para. 604. 
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 requiremen t 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1023 
  
  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 revolutiona ry 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.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1024 
  
  Annex A(4) and Article 5.1 of the SPS Agreement .
2092   We recall in this regard that the European 
Communities does not suggest otherwise2093.  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 Commun ities, 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1025 
  
  that, by maintaining the measure in ques tion, the European Communities has acted 
inconsistently with its obliga tions 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 obliga tions 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 in formation 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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1026 
  
  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 sci entific 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 
                                                      
2095 EC first written submission, para. 604. 
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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1027 
  
  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 th e 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 assessme nt 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 revolutiona ry 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1028 
  
  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 MON 810 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 Commun ities, 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 majo rity view is based on a risk assessme nt 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1029 
  
   
 (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 informa tion 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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1030 
  
  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 sci entific 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 insuffi cient 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 
                                                      
2106 EC first written submission, para. 604. 
2107 The European Communities considers that this an alysis is confirmed by  the words "reasonable 
period of time" in Article 5.7.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1031 
  
  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,  assess ments 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 revolutiona ry 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1032 
  
  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 ear lier 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 a nd 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 ha ve 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1033 
  
  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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1034 
  
  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 sci entific 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.  
                                                      
2117 EC first written submission, para. 604. 
2118 The European Communities considers that this an alysis is confirmed by  the words "reasonable 
period of time" in Article 5.7.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1035 
  
  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,  assess ments 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 requiremen t 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 revolutiona ry 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." WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1036 
  
  "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 informati on 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 assessme nt 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 majo rity view is based on a risk assessme nt 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).  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1037 
  
  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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1038 
  
  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 th at 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 sci entific 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.  
                                                      
2128  EC first written submission, para. 604. 
2129 The European Communities considers that this an alysis is confirmed by  the words "reasonable 
period of time" in Article 5.7.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1039 
  
  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 insufficien t 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,  assess ments 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 requir ement 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 revolutiona ry 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." WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1040 
  
  "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 th e 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 Germ any 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 majo rity view is based on a risk assessme nt 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).   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1041 
  
  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 obligati ons 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 oblig ations 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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1042 
  
  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 in formation 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     
                                                      
2139 EC first written submission, para. 604.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1043 
  
  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 sci entific 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,  assess ments 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 requiremen t 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1044 
  
  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 informati on 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 sup port 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 assessme nt 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 revolutiona ry 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  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1045 
  
  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 majo rity view is based on a risk assessme nt 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.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1046 
  
  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 app lied 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 b asis 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 It aly 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.   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1047 
  
  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 p assage 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 sci entific 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1048 
  
  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,  assess ments 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 fro ntiers 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 scien tific 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1049 
  
  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 concerned2159, 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1050 
  
  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.  
  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1051 
  
  (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 p assage 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 sci entific 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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1052 
  
  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 insuffi cient 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 resear ch 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,  assess ments 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 requiremen t 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 fro ntiers 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 scien tific discovery.  That is not at all the circumstances of the present case.   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1053 
  
  "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-1 76 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 pr ovided 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, WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1054 
  
  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 obligati ons 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   WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1055 
  
    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 obligati ons 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 acc ount 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 altern ative 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 c onclusion 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 WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1056 
  
  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 le vel 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1057 
  
  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 c onclusion 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1058 
  
   (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 favour able 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1059 
  
  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 referre d 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 thir d 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 ma intaining 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1060 
  
  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 th e 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 safegua rd 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 Commun ities, 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1061 
  
  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 Commun ities, 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 ar e 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. WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1062 
  
  (i) Evaluation 
7.3405  The Panel  recalls that it has already reached the c onclusion 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 cumu lative 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  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1063 
  
  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 Artic le 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 meani ng of Annex A(1) of the SPS Agreement . WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1064 
  
   (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 saf eguard 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.  WT/DS291/R 
 WT/DS292/R 
 WT/DS293/R 
 Page 1065 
  
  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. 
                                                     
 
2183 Panel Reports, EC – Hormones (US) , para. 8.272; EC – Hormones (Canada) , para. 8.275.  WT/DS291/R 
WT/DS292/R WT/DS293/R 
Page 1066 
  
  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 cl aims 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 Commun ities, 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. 
 
                                                      
2184 Panel Reports, EC – Hormones (Canada) , para. 8.275; Australia – Salmon , para. 8.185; Japan – 
Apples , paras. 8.328-8.329.