WORLD TRADE  
ORGANIZATION  WT/DS291/R/Add.3 
WT/DS292/R/Add.3 
WT/DS293/R/Add.3 
29 September 2006 
 (06-4234) 
 Original:   English 
 
 
 
EUROPEAN COMMUNITIES – MEASURES AFFECTING 
THE APPROVAL AND MARKETING 
OF BIOTECH PRODUCTS 
 
 
Reports of the Panel 
  
Addendum
 
   This addendum contains Annex E to the Re ports of the Panel to be found in document 
WT/DS291/R, WT/DS292/R, WT/DS293/R.  The other annexes can be found in the following 
addenda:   – Annex C: Add.1  – Annex D: Add.2 
 – Annex F: Add.4 
 – Annex G: Add.5  – Annex H: Add.6  – Annex I : Add.7  – Annex J: Add.8  – Annex K: Add.9  WT/DS291/R/Add.3 
 WT/DS292/R/Add.3 
 WT/DS293/R/Add.3 
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  ANNEX E 
 
REPLIES BY THE PARTIES TO QUESTIONS 
POSED BY OTHER PARTIES IN THE CONTEXT 
OF THE FIRST SUBSTANTIVE MEETING  
 
Contents Page 
Annex E-1 Replies by the United States to questions posed by the European 
Communities E-2 
Annex E-2 Replies by Canada to questions posed by the European 
Communities E-4 
Annex E-3 Replies by Argentina to questions posed by the European 
Communities E-8 
Annex E-4 Replies by the European  Communities to questions posed by 
Argentina E-10 
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  ANNEX E-1 
 
REPLIES BY THE UNITED STATES 
TO QUESTIONS POSED BY THE EUROPEAN COMMUNITIES 
 
 
For all complainants
: 
 
1. Is it the position of the Complainants that new scientific information which emerges 
after a scientific committee opinion should be di sregarded?  How should a regulator react to a 
situation where sources of information other than  appointed scientific committees report the 
existence of a risk in connection with a given product?  Could you indicate the basis for your 
position in the relevant WTO agreements?  
 
112. In all the cases described above, the regulator of the WTO Member must undertake and complete its approval procedures without "undue de lay."  See SPS Agreement, Annex C(1)(A).  The 
EC has not shown that any of the scenarios in the above question justified the delays resulting from its 
moratorium on biotech approvals.   
2. Once a WTO Member has adopted an appropri ate level of protection, is it allowed to 
change its mind and adopt a higher one?  
 
113. Yes.  The United States would note, however, that a change in the level of protection would 
not justify the adoption of a general mo ratorium on all biotech approvals.   
 
3. In a federal entity, have sub-entities the right to have different appropriate levels of 
protection? If you do not agree, could you i ndicate the basis for your position in the SPS 
Agreement?  
 
114. Please see answer to Question 38(b) of the Panel . 
 
4. What would it take in your opinion for th e alleged moratorium to be removed?  Would 
the European Communities have to grant one more approval, ten more approval, or how many?  Would the European Communities have to stop asking for more information under the 
approval procedures?  Would all MS have to vote in favour of proposals to grant authorisations 
for the products at issues in the Regulatory Committees and in the Council? (see paras. 24 and 
27 of the oral statement of Canada)  
115. As the United States explained during the first substantive meeting of the Panel, questions of 
compliance are not within the Panel's terms of re ference.  Moreover, once the Dispute Settlement 
Body has adopted a finding that a WTO Member is in breach of its WTO obligations, it is up to the 
defending Member to decide how it wishes to come in to compliance with its obligations.  That said, 
the United States would expect that in order for the EC to bring its measures into compliance with its 
obligations under the SPS Agreement, the EC would have  to make decisions on agricultural biotech 
applications without undue delay.  
  WT/DS291/R/Add.3 
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  For Canada and the United States
: 
 1. Please explain why you notified the follo wing measures under both the SPS Agreement 
and the TBT Agreement: 
 – for Canada: Living Modified Organisms Regulations, document G/TBT/N/CAN/46 of 
14 October 2002 and document G/SPS/N/CAN/144 of 4 October 2002; 
 
– for the United States: Registration of Food Facilities Under the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002, document G/TBT/N/USA/32 of 13 February 2003 and document G/SPS/N/USA/691 of 6 February 2003. 
 
116. The United States notified its Prior Notice of Imported Food, Administrative Detention, and 
Records proposed rules only under the SPS Agreemen t, because the rule is designed to address SPS 
risks, such as risks arising from contaminants, toxins or disease-causing organisms in foods, 
beverages or feedstuffs.  FDA notified its Regist ration of Food Facilities proposed rule under both the 
TBT and SPS agreements, because registration woul d be used to address both SPS issues, such as 
food safety, and TBT issues, such as many food labeling requirements.  For the United States
: 
 1. If a declaration of political intent by fi ve EU ministers constitutes a measure that may 
constitute a violation of the WTO Agreement on the part of the European Communities, would the same be true of a declaration by 60 Memb ers of the US Congress that they would block any 
attempt to not repeal the Byrd amendment also cons titute a violation by the US of its obligation 
to implement the Panel report in that case?  
 
117. The premise of the question is false.  The Un ited States did not argue that the "declaration of 
political intent," standing alone, constitutes a measure.  Rather, the United States submits that the EC 
in fact adopted a moratorium on biotech approvals, and that the declaration of the five EU ministers is 
compelling evidence of the existence of that me asure.  Other compelling evidence, as the United 
States has explained, includes the f act that the EC followed through on this declaration and failed to 
allow any biotech product application to move to final approval for over five years.   
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  ANNEX E-2 
 
REPLIES BY CANADA TO QUESTIONS 
POSED BY THE EUROPEAN COMMUNITIES 
  For all complainants
: 
 
1. Is it the position of the Complainants that new scientific information which emerges after a scientific committee opinion should be di sregarded?  How should a regulator react to a 
situation where sources of information other than  appointed scientific committees report the 
existence of a risk in connection with a given product?  Could you indicate the basis for your 
position in the relevant WTO agreements? 
 1. No, it is not the position of Canada that new scientific information s hould be disregarded.  
There is nothing in the SPS Agreement that precludes a Member from considering new scientific 
information.  If an SPS measure is based on a risk assessment, and new scientific information emerges 
that was not factored into that risk assessment, a Me mber is entitled to redo th e risk assessment in the 
light of the new information.  If, given this new information the conclusions of the risk assessment 
change, then the Member is en titled to change its SPS measure. 
 2. This is apparently how the safeguard pro cedures under the relevant EC approval legislation 
are supposed to work.  Following the adoption of  the Member State national bans ("safeguard 
measures"), the Commission referred the safeguard measures to an independent scientific committee 
at the community level to review the purported "new  scientific evidence" cited by the Member State 
in support of the invocation of the safeguard measure.  In all cases, the independent scientific 
committee concluded that there was no basis for th e national ban.  Had the independent scientific 
committee considered that there actually was "new scie ntific information" affecting the original risk 
assessment, then the EC may have been justified in  refusing to require the Member States to remove 
the national bans.  This, as the EC knows, was not the case. 
 
2. Once a WTO Member has adopted an appropriat e level of protection, is it allowed to 
change its mind and adopt a higher one? 
 
3. Yes.  This decision must not be arbitrary or unjustifiable and must be done in a manner 
consistent with the SPS Agreement  and, in particular, Article 5.5.  
 
3. In a federal entity, have sub-entities the right to have different appropriate levels of 
protection?  
 
If you do not agree, could you indicate  the basis for your position in the SPS Agreement ? 
 
4. Whether sub-entities in a federal entity have th e right to set different appropriate levels of 
protection is a function of the internal laws of the federal entity in question, and more particularly a 
matter of constitutional law and the division of powers ("competencies" in EC terminology) 
established within that federal entity. 
 
5. In terms of the SPS Agreement , the issue is not whether the sub-federal entities have the 
"right" to set and apply their own appropriate leve ls of protection.  The issue is whether the WTO 
Members, in setting and applying their appropriate le vels of protection – whatever their constitutional 
arrangement – do so in a ma nner consistent with the SPS Agreement .  WT/DS291/R/Add.3 
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6. This requires, inter alia , that the WTO Member concerned avoid arbitrary or unjustifiable 
distinctions in the levels of protection it considers to be appropriate in different situations that are 
comparable, if those distinctions result in discrim ination or a disguised restriction on international 
trade.  
4. What would it take in your opinion for th e alleged moratorium to be removed?  Would 
the European Communities have to grant one more approval, ten more approval, or how many?  
Would the European Communities have to stop asking for more information under the 
approval procedures?  Would all MS have to vote in favour of proposals to grant authorisations 
for the products at issues in the Regulatory Committees and in the Council? (see paras. 24 and 
27 of the oral statement of Canada) 
 7. Canada considers that there is no "magic" numbe r of approvals that has to be reached before it 
can be said that the moratorium has been lifted.  As a start, it would be helpful if the European 
Communities and its Member States acknowledged that a de facto moratorium on approvals on 
biotech products was put in place as of October 1998, and stated their commitment to lift this 
moratorium.  Given the de facto  nature of the moratorium, whether the moratorium has been lifted can 
only be determined with referenc e to demonstrable progress being ma de on individual applications at 
the Community level, with key reference points being the relevant regulatory committee.  In 
particular, speedy decisions on those applications for which multiple risk assessments have already 
been completed would be helpful.  
For Argentina and Canada
: 
 
1. Do you agree with the United States' position as stated at DSB meeting of 10 December 
2003 and again implied in its oral statement of last  week (para. 56) that the burden of proof for 
Article 5.7 of the SPS Agreement  is on the Complainants and not on the European Communities 
as the defendant?   
8. Paragraph 56 of the US oral intervention does not imply that the burden of proof under 
Article 5.7 is on the complainants.  Rather, it de monstrates systematically that none of the EC 
Member State measures meets any of the four requir ements of Article 5.7.  Canada made the same 
points at paragraphs 80-85 of its Oral Statement at the first hearing.  
9. In any event, where the burden of proof falls with respect to Article 5.7 must be determined 
with reference to the text of the WTO Agreement, and the relevant jurisprudence, and not individual 
Member statements in the DSB.  
For Canada and the United States
: 
 
1. Please explain why you notified the following measures under both the SPS Agreement  
and the TBT Agreement : 
 – for Canada: Living Modified Organisms Regulations , document G/TBT/N/CAN/46 of 
14 October 2002 and document G/SPS/N/CAN/144 of 4 October 2002; 
 
– for the United States: Registration of Food Facilities Under the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 , document G/TBT/N/USA/32 of 
13 February 2003 and document G/SPS/N/USA/691 of 6 February 2003.  
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  10. Notifications of measures are made for the purposes of transparency and do not have any 
legal effect.  This has been r ecognized in the jurisprudence ( EC – Asbestos , Report of the Panel, para. 
8.60).  Canada is committed to transparency with in the WTO, and to the notification process as the 
appropriate means by which to advise WTO Members of potential regulatory changes within Canada.  
These notifications cannot in any way be interprete d as being representative of Canada's legal position 
as to which measures are covered by which WTO agreements.  
For Canada
: 
 
1. The European Communities takes note of Cana da's view that risks posed by GM plants 
are the same as or similar to risks posed by conv entionally bred plants. It also notes that in 
describing the potential risks of GMOs in its su bmission Canada does not mention the issue of 
antibiotic resistance markers? Does Canada believe  that this potential risk does not exist? 
 
If Canada is of the opinion that the risk does not exist could Canada explain why its own 
scientific expert committee (the Royal Society of  Canada) has identified  this issue to be a 
potential risk?   Does Canada not agree with its ow n scientific experts' Committee? 
 
11. Canada considers that there could be a poten tial risk, however unlikely, posed by antibiotic 
resistance markers.  This risk is typically assessed through the risk assessment process for each 
product, taking into consideration the clinical and ve terinary importance of the antibiotic in question, 
the likely occurrence of horizontal gene transfer fro m genetically modified plants to microbes and the 
potential impact of horizontal gene transfer wher e naturally occurring resistance to the relevant 
antibiotics exists in the microbial gene pool.     12. For the biotech products in question, the scien tific evidence (including that from the relevant 
EC Scientific committees) demonstrates that there is , no risk to human or animal health posed by the 
antibiotic resistance markers used in those products.  
 
2. In its Oral Statement (para. 102), CAN su ggests that the safety of the BT11, Mon810 
and BT176 maize is comparable because "they rely on the same gene for their insect resistance 
trait". This statement has flaws as regards the scientific grounds for their case by case risk 
assessment (for instance as regards the known differences between these products in respect of 
the presence or not of antibiotic resistance genes or parts thereof).  
 Would Canada not agree that, if, as a working hypothesis, it had followed an independent scientific risk assessment opinion, such as the one issued on antibiotic resistance marker genes 
of its Royal Society, it might have come to different conclusions on these three products?  
 13. Canada disagrees with the EC, if it is s uggesting that corn derived from events Bt-176, 
MON 810 and Bt-11 are not comparable situations for the purposes of Article 5.5.  14. According to the Appellate Body, whether situations are comparable for the purposes of 
Article 5.5 depends on whether they present some co mmon element or elements sufficient to render 
them comparable.
1  In Australia – Salmon , the panel concluded that: 
 
                                                      
1 EC – Hormones , para. 217.  WT/DS291/R/Add.3 
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  … in the circumstances of this dispute, we  can compare situations under Article 5.5 if 
these situations involve either a risk of ‘ent ry, establishment or spread' of the same or 
a similar disease or of the same or similar ‘associated biological and economic 
consequences' and this irrespective of wh ether they arise from the same product or 
other products.
2 
15. The Appellate Body agreed with this statement.3 
 16. This approach is equally applicable when the risks involved relate to the potential adverse 
effects on human or animal health arising from th e presence of additives, contaminants, toxins or 
disease-causing organisms in food, beverages or feedstuffs.  17. Bt-176, Bt-11 and MON810 can all be legally ma rketed as food or in food products in the EC.  
All have been assessed for potential risks relating to human toxicity, including allergenicity, and 
horizontal gene transfer of antibiotic-resistant marker  genes.  In its opinion in response to Austria's 
invocation of Article 16 of Directive 90/220 as a basi s for its national ban on MON810, the Scientific 
Committee on Plants grouped all genetically modi fied corn/maize lines derived using the CRY1A-
proteins together.  The conclusion to  its opinion with respect to Austria's invocation of Article 16 with 
respect to MON810, stated that "there is no reason to change [the Committee's] previous advice to the 
[European] Commission on the risk assessments of the Bt crops which it has evaluated to date".
4 
 
                                                      
2 Australia – Salmon , Report of the Panel, para. 8.117. 
3 Australia – Salmon , Report of the Appellate Body, para. 146. 
4 Opinion of the Scientific Committee on Plants on the Invocation by Austria of Article 16 ('safeguard' 
clause) of Council Directive 90/220/EEC with respect to the placing on the market of the Monsanto genetically 
modified maize (MON810) expressing the BT cry1a(b) gene, notification C/F/95/12-02 (Opinion expressed by 
the Scientific Committee on Plants on 24 Se ptember 1999), at p. 5. (Exhibit US-55) WT/DS291/R/Add.3 
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  ANNEX E-3 
 
REPLIES BY ARGENTINA TO QUESTIONS 
POSED BY THE EUROPEAN COMMUNITIES 
  A. For all complainants
: 
 
1. Is it the position of the Complainants that new scientific information which emerges after a scientific committee opinion should be di sregarded?  How should a regulator react to a 
situation where sources of information other than  appointed scientific committees report the 
existence of a risk in connection with a given product?  Could you indicate the basis for your 
position in the relevant WTO agreements? 
 
Argentina states that scientific evid ence -rather than a broad concept as "scientific information"- is the 
one to be regarded whenever there is any former scientific evidence at hand. A mere reference to 
information with "concerns", " possibilities", "hypothe tical risks" rather than  evidence do not match 
against scientific evidence on specific products made  on a case-by-case basis, and does not entitle any 
general measure on all agricultural biotech products  as the " de facto" moratorium by the EC. 
 
Argentina's position is based on the SPS Agreemen t, which specifically establishes that sanitary and 
phytosanitary measures be b ased on scientific evidence. 
 
2. Once a WTO Member has adopted an appropri ate level of protection, is it allowed to 
change its mind and adopt a higher one? 
 
Any Member is entitled to adopt a higher level of protection, as long as it complies with  its 
obligations under the SPS Agreement.  
3. In a federal entity, have sub-entities the right to have different appropriate levels of 
protection?   
If you do not agree, could you indicate  the basis for your position in the SPS Agreement ? 
 
This is a theoretical question, which Argentina believ es is not related to the measures at issue in this 
case. 
 
4. What would it take in your opinion for th e alleged moratorium to be removed?  Would 
the European Communities have to grant one more approval, ten more approval, or how many?  Would the European Communities have to stop asking for more information under the 
approval procedures?  Would all MS have to vote in favour of proposals to grant authorisations 
for the products at issues in the Regulatory Committees and in the Council? (see paras. 24 and 
27 of the oral statement of Canada) 
 
The question refers to implementation issues. In Ar gentina's view, these issues are not to be discussed 
at this stage. 
 
B. For Argentina and Canada
: 
 1. Do you agree with the United States' position as stated at DSB meeting of 10 December 2003 and again implied in its oral statement of last  week (para. 56) that the burden of proof for  WT/DS291/R/Add.3 
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  Article 5.7 of the SPS Agreement  is on the Complainants and not on the European Communities 
as the defendant?  
Argentina is not aware of any reference by  the US in its oral statement, paragraph 56, to any burden 
of proof allocated to the complainants' side. Neve rtheless, paragraph 56 proves that the EC did not 
satisfy the requirements of Article 5.7 of the SPS Agreement. Paragraph 56 discharges the burden of 
proof from the United States and the co-complainants. 
 
D. For Argentina
: 
 1. Argentina argues that special differenti ated treatment (SDT) obligations are not 
subordinate to other obligations.  The Euro pean Communities agrees, but could Argentina 
explain what the EC must do pursuant to SDT provisions?  Are such obligations independent of 
the issues of possible SPS risks and related risk assessments? In other words, if one forgot the 
other claims (5.1, 5.6, …), what would Argentina claim under the SDT provisions ?  
Precisely, other claims -in particular 2.2 and 5.1 of  the SPS Agreement- should not be forgotten. Even 
if the EC measure had had scientific basis, the EC would have had an obliga tion to take into account 
the interest of Argentina -being a developing count ry that produces and exports GMO's- anyway. Not 
having the EC measure any scientific support, the absence of any reference to the interest of 
developing countries (i. e. Argentina)  infringes the SPS Agreement.  
2. Is it the position of Argentina that the deci sion of the Appellate Body in the US Shrimps 
Case permitting recourse to other rules of int ernational law interpreting WTO Agreements was 
wrongly decided?   
If not, why would this approach not apply to the current case?  
 
Argentina will not make any comments on whether a decision by the Appellate Body was correct or 
not. Additionally, the EC is stating in its question something that Argentina did not express
1. In casu, 
it is not necessary to resort to other tool of inte rpretation to define the scope of the obligations 
embodied in the covered Agreements.   
                                                     
 
1 Argentina's First Oral Intervention, paragraphs 6 and 7. WT/DS291/R/Add.3 
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  ANNEX E-4 
 
REPLIES BY THE EUROPEAN COMMUNITIES 
TO QUESTIONS POSED BY ARGENTINA 
 
 
Regarding the impact of the new Directi ve 2001/18/EC on the approval procedures. 
 
1. Did the coming into force of Directive 2001/18/EC imply any step-back with respect to 
the stage of the approval procedure in which app lications were  under Directive 90/220/EEC?     
 
2. Did the applicants have to submit additional information, as a consequence from the 
coming in force of Directive 2001/18/EC? 
 
3. If yes, could the EC please precise what  this additional information consisted in? 
 
1. Please refer to the response to question 12 from the Panel to the European Communities. 
 2. The pending applications were only required to  be up-dated ("complemented"), not to be re-
submitted as a whole.  Hence all results and conclu sions reached on the existing data were still valid 
and would not be re-examined again.  However, with regard to the up-dated information a new 
assessment was required and that assessment was to fo llow the normal stages of procedure. There was 
thus no "step-back". There was rather a step forward, in terms of changes in the legislation to meet the 
legitimate concerns of scientists and legislators. Na turally pending applications were also to benefit 
from the improved rules and procedures. The additiona l information to be s ubmitted would depend on 
the precise product in question – it would be what was needed to satisfy the additional requirements of 
the new legislation.  
Regarding the evidence in addition to the scientific opinions. 
 
The EC mentions in paragraph 36
1 that the scientific opinions would require additional evidence to 
complete the risk assessment.  4. Apart from the opinions of the scientific committees, what are the other elements that the EC's authorities do consider for the approval of the respective biotech product? 
 3. Please refer to the response to questions  17 and 18 from the Panel to the European 
Communities.  4. The scientific committees give opinions on wh at they are asked. If it subsequently appears 
that further questions might be elucidated by sci entific opinion, such questions may be put to the 
committee. If an opinion of the scie ntific committee is limited or qualified in some way, the legislator 
may take the view that definitive legislative action is premature.  5. Please also refer to the response to qu estion 102 from the Panel to the European 
Communities. 
 
                                                     
 
1 Oral Intervention of the European Communities in the First Audience of the Panel with the Parties, 
2 June 2004.   WT/DS291/R/Add.3 
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  6. Article 26(1) of the Biosafety Protocol provides as follows: 
 
"The Parties, in reaching a decision on im port under this Prot ocol or under its 
domestic measures implementing the Protocol, may take into account, consistent with 
their international obligations, socio-economic  considerations arising from the impact 
of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the valu e of biological diversity to indigenous and 
local communities." 
7. By virtue of their signature of the 2 000 Protocol and Article 18 of the 1969 Vienna 
Convention on the Law of Treaties, Argentina a nd Canada are bound to "refrain from acts which 
would defeat the object and purpose" of Article 26. By participating in the Protocol's Clearing House 
Mechanism the United States recognises the validity of Article 26 of the Protocol.   
8. The object and purpose of socio-economic consid erations have been ass essed by the head of 
the Indian delegation in the final negotiations of th e Biosafety Protocol. Article 26: as he puts it, "the 
fundamental purpose of Article 26 is  to empower parties of import to analyse carefully what possible 
adverse impacts the import of LMOs would have on their socio-economic conditions", and it reflected 
an exercise of "inherent sovereign powers".
2 Socio-economic considerations  include implications for 
existing patterns of agricultural practises, having re gard to the effects of biotech products for 
biodiversity.  
 
5. What is the legal basis within the SPS Agreement which allows the EC to consider 
elements additional to the opinion of the scientific committee? 
 9. Nothing in the SPS Agreement  precludes a Member from seeking scientific opinions several 
times, or on a continuous basis. Under the SPS Agreement  the level of acceptable risk is fixed by the 
Member, and is likely to influence a legislator's  view of the science available to-date, and the 
measures it is therefore appropriate to take or th e manner in which it is appropriate to proceed. The 
Appellate Body has stated that science includes the assessment of risk in human societies as they 
actually exist, in the real world, where people live and work and die. The SPS Agreement  refers 
expressly to international agreements – as to which,  please see the response to the previous question, 
and to question 11 below.  
6. With respect to the products of interest to  Argentina with positive scientific opinion -
Bt531 cotton, RRC 1445 cotton, NK603 maize and GA21 maize-: 
 
 (a) What were the elements that determined that the positive scientific opinion was 
not sufficient? 
  (b) Were those elements of a scientific nature?  
 (c) Where are those elements memorialized? 
  (d) Could the EC provide the Panel and the parties with those elements which 
determine that, up to the present, these pr oducts did not receive any approval or 
rejection? 
                                                     
 
2 Rajen Habib Khwaja, "Socio-economic considerations", in C. Bail, R. Falkner and H. Marquard, The 
Cartagena Protocol on Biosafety – Reconciling Trad e in Biotechnology with Environment and Development ?" 
(2002), 361 at 361 and 364. WT/DS291/R/Add.3 
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10. The European Communities has described in details the develo pments of each notification 
procedures, including the products which are at st ake in the Argentinean case, in its first written 
submission (Section II.D and Exhibits EC-62 to EC-110).  Further available evidence will be 
submitted to the Panel by the European Commun ities on 18 June 2004.  However, for the sake of 
clarity, the European Communities will explain agai n what happened, as requested by Argentina. 
 11. Bt531 cotton  is dealt with in section II.D.1(a)(iv) and Exhibit EC-65 of the EC first written 
submission.  There it is explained that  
 
Following the opinion of the SCP, the notifier entered in discussions with some CAs on an insect-resistance management plan and on rat feeding.
3   
 These are clearly issues of a scientific nature.   
 
 The chronology for this product then highlight s that Monsanto provided information to the 
Member States competent authorities on insect-resistance monitoring plan on 29 September 1998 (the letter is attached as attachment 18) and on 06  October 1998 a requested study on rat feeding 
(attachment 19).  Further issues, documented in att achments 20 and 21, were raised by the competent 
authorities of Denmark and the United Kingdom.   
 
 With regards to the elements necessary to determine why, up to the present, these products 
have not received any approval or rejection, the European Communities refers Argentina to the above 
mentioned parts of its first written submission.  
12. RRC 1445 cotton , is dealt with in section II.D.1(a)(v ) and Exhibit EC-66 of the EC first 
written submission.  There it is explained that   
Following the opinion of the SCP, the notifier entered in discussions with the lead CA 
on rat feeding.
4   
 This is clearly an issue of a scientific nature.   
 
 The chronology for this product then highlights that Monsanto provided further information after the opinion of the Scientific Committee on Plants that was circulated to Member States on 20 November 1998.  Further issues, documented in atta chments 20 and 21, were raised by the competent 
authorities of Denmark and the United Kingdom.   
 
 With regards to the elements necessary to determine why, up to the present, these products 
have not received any approval or rejection, the European Communities refers Argentina to the above 
mentioned parts of its first written submission.  13. NK603 maize  is dealt with in section II.D.1(a)(xv) and Exhibit EC-76 of the EC first written 
submission.  There it is explained that  
 
Following the positive opinion rendered by EFSA, in February this year the Commission has presented a draft decision for market authorisation of the product to 
the Regulatory Committee.  In the absen ce of a qualified majority vote in the 
                                                     
 
3 EC first written submission, para. 225. 
4 EC first written submission, para. 232.  WT/DS291/R/Add.3 
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  Committee, the Commission has presented its  proposal for a decision authorising 
NK603 to the Council on 26 March.  The C ouncil's position on this draft decision is 
expected for late June.
5   
 No issue was therefore raised on the sufficiency  the opinion of EFSA and the notification is 
proceeding steadily through the various steps of the procedure foreseen in the EC legislation towards 
a decision.    14. GA21 maize  is dealt with in section II.D.2(a)(i) and Exhibit EC-91 of the EC first written 
submission.  There it is explained that the Scie ntific Committee on Food gave its opinion February 
2002 and that   
In view of the pending legislative proposal for "Food and Feed" Monsanto, in June 2002 on a voluntary basis committed to pr oviding detection and validation methods 
for its product in collaboration with the Co mmission's Joint Research Centre (JRC).  
The amount of data and material and the circumstances of their submission to the JRC had to be negotiated and laid down in  an agreement, the conclusion of which 
took a considerable amount of time (Februar y 2003).  All the necessary data were 
received in proper condition in mid-Septembe r of 2003.  The pre-validation study was 
initiated in October and coul d be concluded only after Monsanto delivered the full 
data set in the end of November.  So me additional testing on the method and 
materials was carried out in early 2004 th e collaborative study of method validation 
was launched on the 14/04/2004 and is foreseen  to be finished by the end of June 
2004.
6 
 In this case, therefore, the elements which determined the insuffici ency of the scientific 
committee's opinion related to the issues of detection and validati on methods, which were 
requirements to be included in the new legisla tion and on whose importance the applicant agreed.  
The relevant correspondence with Monsanto on these issues is recorded in the chronology and in its 
attachment.  
Regarding the "case by case" assessment 
 
7. How do the EC explain that, if the assessment of agricultural biotech products is to be 
made on a "case by case" basis, there has been  not a single approval for over five years? How 
does the EC explain, as it confirmed in the oral hearing,  that during the same period there has been no rejection either? 
 
15. For each product the explanation for the time elapsed is different. The European Communities 
refers in this respect to the summaries in its firs t written submission. If there is something in any one 
of these summaries that is unclear to Argentina, the European Communities i nvites Argentina to pose 
a specific question, to which the European Communities would be happ y to give a specific response. 
It is, in any event, inaccurate to state that there ha ve been no approvals or rejections for five years. 
The European Communities refers in this respect to paras. 547 to 552 of its first written submission. 
 
                                                     
 
5 EC first written submission, para. 284. 
6 EC first written submission, para. 304. WT/DS291/R/Add.3 
WT/DS292/R/Add.3 WT/DS293/R/Add.3 
Page E-14 
  
  8. In paragraph 36 of the EC's Oral Statement during the first substantive meeting  of the 
Panel with the parties, the EC stated the following:  
".. the views of the European Communities' scientific committees, now 
regrouped under the European Food Safety Authority, have no formal overriding effect on the opinions of th e corresponding nati onal committees ..." 
Upon a question by the Panel in that meeting on whether there was any hierarchy between the 
different scientific committees, the EC answered: 
 
"There is no hierarchy in science" 
Afterwards, in its answer to question number 1 by the Panel, the EC held that after the positive 
opinion of the Scientific Committee on Food on the Bt 11 maize, there were three opinions by national scientific committees (France, Austria and Belgium) which rejected the opinion of the 
SCF, and that after the rejection of one of those national opinions (the Austrian) by the EFSA, 
the Commission, despite the fact that the Regu latory Committee had not issued its opinion, 
upheld  the opinion of the SCF.   (a) How do the EC explain that there is no "hierarchy in science" when the 
Commission gave priority to the scientific opinion of the EFSA? 
 
 (b) On the contrary, if the EC holds that there is no hierarchy in science, how could 
it be affirmed,  in consistence with th e SPS Agreement, that the opinions of the 
EC's own scientific committees be rejected? 
 16. Please refer to the response to questions  17 and 18 from the Panel to the European 
Communities.  17. The European Communities does not always and sy stematically give priority to any particular 
scientific opinion – it considers and weighs them a ll, taking into account any legislative changes 
designed to meet the legitimate concerns of scientists and legislators. 
 
Regarding the "Inter-Service Consultation" 
 
9. Is the period of suspension during the "Inter-Service Consultation" regulated 
anywhere? 
 
10. If not, and given that the "Inter-Service Consultation" implies more than two years of suspension for two products of interest of  Argentina -Bt531 cotton and RRC 1445 cotton-, in 
what provision of the SPS Agreement  the EC beli eves  that "Inter-Service Consultations"  are  
based on? 
 18. Argentina will know that in a government admi nistration competence for the various different 
activities of government is generally broken down in  a structured way to make it manageable – as in 
any large organization with a diversified portfolio . Argentina will also know that, along these lines, 
the European Commission is divided up into abou t 40 departments or services. Argentina will also 
know than when a new matter comes to be consid ered, one or two departments or services will 
generally take the lead role, and co-ordinate with  the other interested services. "Inter-service 
consultations" are, as the name suggests, the pr ocess by which the "lead" services consult with the 
other interested services. When a matter is in inter-service consultation, one may say that the  WT/DS291/R/Add.3 
 WT/DS292/R/Add.3 
 WT/DS293/R/Add.3 
 Page E-15 
  
  organization is "thinking about" the problem. The time necessary is a function of the nature of the 
problem. See generally the Commission Rules of Procedure ( Official Journal of the European 
Communities  L 308/26 of 8.12.2000, as amended and implemented). 
 
19. This process takes place in the context of th e control, inspection a nd approval procedures 
referred to in Annex C SPS Agreement . 
 20. For more details, the European Communities re fers Argentina to its response to question 94 
from the Panel to the European Communities. 
 
Regarding the precautionary principle 
 
11. Given that the EC state that the precauti onary principle has become a general principle 
of international law
7, what is the formal source -creating International Law- that determines 
that "the precautionary principle is a general principle of International Law"? 
 
21. The precautionary principle is a general princi ple of international law applicable to decision-
making in relation to biotech products (GMOs).   
22. The 1992 Convention on Biological Diversity obliges Contracting parties "to regulate, 
manage or control the risks associat ed with the use and release of living modified organisms resulting 
from biotechnology" (Article 8(g)). In the preamble  to that Convention the parties note that "where 
there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty 
should not be used as a reason for postponing measures to avoid or minimize such a threat".  The 
Contracting Parties thus accept the language of th e precautionary approach (see Principle 15 of the 
Rio Declaration on Environment and Development). Ar gentina, Canada and the EU are parties to the 
1992 Convention, and the United States is a signatory (and is thus bound to "refrain from acts which 
would defeat the object and purpose" of the 1992 Convention: see 1969 Vienna Convention on the 
Law of Treaties, Article 18).   
23. The precautionary principle is then expressly applied in the 2000 Biosafety Protocol. Article 1 
states that the Protocol's objective is to be pur sued "in accordance with the precautionary approach 
contained in Principle 15 of the Rio Declarati on on Environment and Deve lopment" (see generally 
First Written Submission by the European Communiti es, paras. 105-108, and ain particular Articles 
10(6) and 11(8) of the 2000 Protocol). The EU is  a party to the 2000 Protocol and Argentina and 
Canada are signatories. The United States is  pa rticipating in the Protocol's Clearing-House 
Mechanisms (under Articles 11 and 20) and must th erefore be taken to have no objection to the 
precautionary principle is applicable (for the protection of biodiversity) as treaty or customary international law to decision-making in relation to biotech products. As such the principle must be 
relied upon in construing and applying WTO law.  As one leading commentator has put it: 
 
"WTO law thus requires that measures based upon the precautionary principle or any 
other rule of the protocol must respond to the needs of conserving biodiversity."
8 
__________ 
                                                      
7 Oral Intervention of the European Communities in the First Audience of the Panel with the Parties, 
2 June 2004, paragraph 56. 
8 Thomas Cottier, "Implications for trade law and policy: towards convergence and integration", in 
C. Bail, R. Falkner and H. Marquard, The Cartagena Protocol on Biosafety – Reconciling Trade in 
Biotechnology with Environment and Development ?" (2002), 467 at 475.