WORLD TRADE  
ORGANIZATION  WT/DS291/R/Add.5 
WT/DS292/R/Add.5 
WT/DS293/R/Add.5 
29 September 2006 
 (06-4236) 
 Original:   English 
 
 
 
EUROPEAN COMMUNITIES – MEASURES AFFECTING 
THE APPROVAL AND MARKETING 
OF BIOTECH PRODUCTS 
 
 
Reports of the Panel 
  
Addendum
 
   This addendum contains Annex G to the Repor ts 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 E: Add.3 
 – Annex F: Add.4  – Annex H: Add.6  – Annex I : Add.7  – Annex J: Add.8  – Annex K: Add.9 
  WT/DS291/R/Add.5 
 WT/DS292/R/Add.5 
 WT/DS293/R/Add.5 
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  ANNEX G 
 
REPLIES BY THIRD PARTIES TO QUESTIONS POSED BY THE PANEL 
AND THE PARTIES 
 
Contents Page 
Annex G-1 Replies by Australia to questions  posed by the Panel and the parties G-2 
Annex G-2 Replies by the Separate Customs Territory of Taiwan, Penghu, 
Kinmen and Matsu to questions posed by the Panel and the parties G-7 
Annex G-3 Reply by El Salvador to the question posed by the United States G-9 
Annex G-4 Reply by Honduras to the question posed by the United States G-10 
Annex G-5 Replies by New Zealand to questions posed by the Panel and the 
parties G-11 
Annex G-6 Replies by Peru to questions posed by the Panel and the parties G-14 
Annex G-7 Reply by Thailand to question posed by the Panel G-16 
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  ANNEX G-1 
 
REPLIES BY AUSTRALIA TO QUESTIONS POSED BY THE PANEL 
AND THE PARTIES 
 
 
QUESTIONS POSED BY THE PANEL
 
 
For all third parties : 
 
1. With reference to pp. 27-36 of the EC first written submission, could the third parties 
please indicate whether the European Communities'  description of their own regulatory systems 
is accurate?  
 
From Australia's perspective, the accuracy of  the European Communities' description of the 
Australian regulatory system does not appear to be of any relevance to the resolution of this dispute.  Australia therefore does not wish to provide any r esponse addressing the accuracy of this description. 
 
For all complaining parties
 
 
50. With reference to Article 5.7 of the SPS Agreement, do the complaining parties agree 
with the European Communities that:   (a) Article 5.7 excludes the applicability of Article 5.1 and is not an exception 
(affirmative defence) to Article 5.1 (EC first written submission, para. 575)?  In 
answering this question, please address the relevance of the Appellate Body 
reports on Japan-Apples (footnote 316), EC – Hormones (para. 104) and EC-Sardines (para. 275) and Japan-Agricultural Products II (paras. 86 et seq)? 
 
In Australia's view, Article 5.7 operates as a qualified exemption from the obligation under Article 
5.1.  Article 5.7 is not, however, an exception (a ffirmative defence) and the burden of proof in 
establishing a claim of inconsistency with Artic le 5.7 rests with the complaining party. 
 
Qualified exemption  
 In Japan – Agricultural Products II, the Appellate Body explained 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.  An overly broad and flexible interpretation of that obliga tion would render Article 5.7 meaningless.
1  
In light of the nexus between Articles 2.2 and 5.12, Australia considers that the same reasoning can be 
applied to the relationship be tween Article 5.1 and Article 5.7: Article 5.7 operates as a qualified 
exemption from the obligation under Article 5.1 re quiring Members to ensure  their SPS measures are 
based on  an assessment of risk.  
 
                                                      
1 Japan – Agricultural Products II ,  AB Report, para. 80. 
2 EC – Hormones, AB Report, para. 180.  WT/DS291/R/Add.5 
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  Burden of proof
 
 Article 5.7 establishes both a right and obligation of Me mbers.  It establishes a Member's right to take 
provisional sanitary or phytosanitary measures in  "cases where relevant scientific evidence is 
insufficient", subject to that Member complying with the specific obligations as set out in the 
remainder of the paragraph.  Australia consid ers that the burden of proof to establish a prima facie 
case of inconsistency with Article 5.7 rests with the complaining party.  Australia notes that the 
Appellate Body has not explicitl y addressed the issue of burde n of proof under Article 5.7.3 
 
Australia's position on the relationship between Arti cle 5.1 and 5.7 is supported by Appellate Body 
findings in EC – Hormones  and EC – Sardines .  
 In EC – Hormones , the Appellate Body discussed the existenc e of the "general-rule exception" in the 
relationship between Article 3.1 (t he general obligation) and Article  3.3 (an exception) of the SPS 
Agreement.  The Appellate Body f ound that "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 consistenc y with that provision is taken on by the 
defending party, is not avoided by simply describing that same provision as an "exception".4  T h e  
Appellate Body also found that the right of a Me mber under Article 3.3 was "an autonomous right and 
not an 'exception' from a 'general obligation' under Article 3.1.5 
 
In EC – Sardines , the Appellate Body found that, as with Article 3.1 and 3.3 of the SPS Agreement , 
there is no "general-rule exception" relationship be tween the first and second parts of Article 2.4 of 
the TBT Agreement and therefore it is for "the  complaining Member seeking a ruling on the 
inconsistency with Article 2.4 of the TBT Agreement  of the measure applied by the European 
Communities – to bear the burden of proving its claim."6   
 
Australia considers that the allocation of the burde n of proof on the complaining party for claims 
under Article 5.7 is fully consistent with the a bove-mentioned findings of the Appellate Body in EC – 
Hormones  and EC – Sardines . 
 
 (b) Article 5.6 is not "relevant" where Article 5.7 applies (EC first written 
submission, para. 612)? 
 Australia does not agree that Article 5.6 is not "relevant" where Article 5.7 applies.  In Australia's 
view, a measure adopted under Article 5.7 of the SPS Agreement is subject to all relevant disciplines 
contained in other provisions of Article 5,  including those set forth in Article 5.6. 
 Article 5.6 applies to all sanitary or phytosanitary measures, including any measures "provisionally 
adopted" under Article 5.7.  An interpretation of Ar ticle 5.7 which excluded application of Article 5.6 
to measures provisionally adopted pursuant to Article 5.7 can not be supported by the text of Articles 
5.6 and 5.7, and is not su pported by either the context of these pr ovisions, or their object and purpose. 
 
                                                     
 
3 Japan – Apples, AB Report, para. 175, footnote 316.  Panels have taken apparently conflicting 
approaches to this issue.  See Japan – Agricultural Products II , Panel Report, para. 8.58 (indicating that the 
burden was on the complaining party) and Japan – Apples, Panel Report, paras. 8.4 and 8.212 (indicating that 
the burden was on the party invoking Article 5.7) 
4 EC – Hormones, AB Report, para. 104. 
5 EC – Hormones, AB Report, para. 172 
6 EC – Sardines , AB Report, para. 275. WT/DS291/R/Add.5 
WT/DS292/R/Add.5 WT/DS293/R/Add.5 
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   (c) Article 5.7 "effectively excludes Article 5.5 (EC first written submission, 
para. 618)? 
 
Australia does not agree that Article 5.7 "effectivel y" excludes Article 5.5.  In Australia's view, a 
measure adopted under Article 5.7 of the SPS Agre ement is subject to all relevant disciplines 
contained in other provisions of Article 5,  including those set forth in Article 5.5. 
 Article 5.5 applies to all sanitary or phytosanitary measures, including any measures "provisionally 
adopted" under Article 5.7.  An interpretation of Ar ticle 5.7 which excluded application of Article 5.5 
to measures provisionally adopted pursuant to Article 5.7 can not be supported by the text of Articles 
5.5 and 5.7, and is not su pported by either the context of these pr ovisions, or their object and purpose. 
 
 (d) the sufficiency of relevant scientific evidence depends, inter alia, on a country's 
level of protection and the nature of the risks (e.g., reversibility of damage)? (see 
EC first written submission, paras. 605-606) 
 
Australia wishes to make some general points on the issue of sufficiency of scientific evidence. 
 As a threshold requirement, Article 5.7 applies "[i]n cases where rele vant scientific information is 
insufficient".  This threshold requirement is clear ly linked to the obligation under Article 5.1 for a 
measure to be based on an adequate assessment of risk.  As explained by the Appellate Body in Japan 
– Apples : 
 
"… 'relevant scientific evidence' will be 'ins ufficient' within the meaning of Article 
5.7 if the body of available scientific ev idence 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 ." 
7 
It is therefore clear that a critical question in determining the insufficiency of scientific evidence 
under Article 5.7 is whether the available relevant  scientific evidence is sufficient to permit an 
assessment of risk which is adequate for the purposes of Article 5.1.  If there is sufficient scientific 
evidence, then the measure must be based on an adequate assessment of risks which takes into 
account that evidence.  If the scien tific evidence is insufficient, then the measure may be adopted 
provisionally on the basis of "available pertinent information" (which will include, at a minimum, all of the available relevant scientific evidence).  52. Do the complainants agree with the defini tion of "an adequate risk assessment" put 
forward by the European Communities in the last  sentence of para. 604 of its first written 
submission? 
 
Australia does not agree with the definition of "a n adequate risk assessment" put forward by the 
European Communities.  In Australia's view, the expansive definition proposed by the EC goes well 
beyond a proper interpretation made in accordance with the principles of treaty interpretation 
applicable to panel proceedings as set out in Article  3.2 of the DSU.  As indicated by the Appellate 
Body in India-Patents : 
 
                                                     
 
7 Japan – Apples , AB Report, para. 179  WT/DS291/R/Add.5 
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  "these principles of interpretation neither require nor condone the imputation into a 
treaty of words that are not there or the impor tation into a treaty of concepts that were 
not intended" 8 
By way of example, Australia notes the reference to  an assessment being "delivered by a reputable 
source".  Apart from the absence of any textual suppor t for this elaboration of the definition of an 
adequate risk assessment; it is not clear what th e EC means by "reputable source".  Although a WTO 
Member would no doubt seek to ensure its risk ass essments are conducted by a competent body, the 
SPS Agreement does not impose a particular organi sational approach on Members in this regard. 
 
Another example of the extent to which the EC's definition goes beyond a proper interpretation of the 
SPS Agreement is the reference to an adequate risk assessment "that unequivocally informs the 
legislator".  Once again, there is no textual suppor t for this interpretation.  Moreover, in scientific 
matters there is often some degree of equivocation.  
Australia also notes that the EC considers a risk asse ssment must be "unlikely to be revised".  Again it 
is unclear what the EC means by "unlikely to be revised".  A risk assessment can only take account of 
the scientific evidence available at  the time it is undertaken.  However, to suggest that a risk 
assessment which does so will "withst and the passage of time" and "be unlikely to be revised" ignores 
the possibility of further relevant scientific information emerging which may require a Member to adjust its measure in order to comply with oblig ations in Articles 2 and 5 of the SPS Agreement. 
 
For the European Communities
: 
 
110. With reference to the European Communities' interpretation of Article 5.7 of the SPS 
Agreement: 
 
 (a) Please elaborate further upon why Articl e 5.6 is not "relevant" where Article 5.7 
applies? (EC first written submission, para. 612) 
  (b) Please elaborate further on why Article 5.7 "effectively" excludes Article 5.5? 
(EC first written submission, para. 618) 
 
 (c) The European Communities argues that the member State safeguard measures 
fall to be assessed under Article 5.7 and no t, as the complaining parties argue, 
Article 2.2 and 5.1 of the SPS Agreement.  Article 5.7 appears to apply only in circumstances where relevant scientific eviden ce is insufficient.  Is this an issue 
of fact?  If so, which side bears the burden of proof in respect of this issue? 
 
Please refer to Australia's responses to question 50 posed by the Panel. 
 In addition, we would note that the threshold question for invocation of Article 5.7 is whether the 
relevant scientific evidence is in sufficient, and not whether the me asure has been characterised under 
a Member's legislative system as provisional, or provisionally adopted.  
                                                     
 
8 India – Patents , AB report, at para. 94. WT/DS291/R/Add.5 
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  QUESTIONS POSED BY THE EUROPEAN COMMUNITIES
 
 
For Australia : 
 
3. Would Australia agree with the view that Article 5.7 of the SPSP Agreement is to be 
interpreted like any other provision of the SPS Ag reement, and in particular in the context of 
the burden of proof? 
 Please refer to Australia's responses to question 50 posed by the Panel. 
 
For New Zealand
: 
 3. In New Zealand’s view, if a moratorium has been formally adopted, explicitly based on 
the justification that there is scientific uncerta inty on the risks associated with GMOs, and 
properly notified to the WTO under Article 7, would such a moratorium be compatible with 
WTO law? 
 
The compatibility of any such moratorium with WTO law would depend upon  whether relevant WTO 
obligations had been met.  In this context, of pa rticular relevance are the obligations set forth in 
Articles 2 and 5 of the SPS Agreement.  In Austra lia's view, these obligations would not necessarily 
be satisfied by the formal adopti on of a measure based on the existe nce of scientific uncertainty and 
the notification of that measure under Article 7.  
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 Compla inants and not on the European Communities 
as the defendant? 
 Please refer to Australia responses to  question 50 posed by the Panel. 
 
  WT/DS291/R/Add.5 
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  ANNEX G-2 
 
REPLIES BY THE SEPARATE CUSTOMS TERRITORY 
OF TAIWAN, PENGHU, KINMEN AND MATSU 
TO QUESTIONS POSED BY THE PANEL AND THE PARTIES  
 
 
QUESTIONS POSED BY THE PANEL
 
 
For all third parties : 
 
With reference to pp. 27-36 of the EC first wri tten submission, could the third parties please 
indicate whether the European Communities' de scription of their own regulatory systems is 
accurate?  
The question by the Panel refers to the EC's analys is of the wide variety of different approaches to 
national regulation on post– approval surveillance that appears to  exist in a number of WTO Member 
countries.  Paragraph 84 of the EC's First Written Submission mentions that, "...given the scientific 
uncertainty surrounding GMOs, many systems provide  for labelling and post ma rketing surveillance, 
thus allowing for the monitoring of long-term envi ronmental and health effects of GM products." In 
the footnote to this paragraph, the EC identifies la belling requirements that exist, for example, in 
Brazil, Japan, China, Indonesia, Korea, Saudi Arabia, Taiwan, Switzerland, Australia and New 
Zealand.  
The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu confirms that such labelling 
requirements do exist in our national regulation, bu t only for a limited number of GM products.  It 
would also be correct to state that such labelling requirements allow "... for the monitoring of long-
term environmental and health  effects of GM products." 
 
QUESTION POSED BY THE UNITED STATES  
 For all third parties
: 
 
At the third-party session, a number of third parties noted that they had systemic interests in 
this dispute.  The United States would ask whether any of these third parties would care to explain the nature of their systemic interests. 
 We note that a similar question was also raised by the Panel during the Third Party Session of the 
First Panel Meeting.  While we thank the Panel and the United States for placing such importance on 
the views of the third parties, we wish to caution against over-emphasis of the role of the third parties in this dispute. The Panel is established to resolve disputes between the complainants and the 
respondent, and to examine the matter referred to it by the complainants.  In addition, under Article 11 
of the DSU, "a panel should make an objective assessment of the matter before it , including an 
objective assessment of the facts of the case and the applicability of and conformity with the relevant 
covered agreements. " [emphasis added] 
 To the extent that the views of the third parties can help the Panel determine the applicability of and 
conformity with the relevant c overed agreements, the submissions and answers of the third parties 
should be taken into account. On the other hand, th e reasons, expressly stated or otherwise, for the 
third parties deciding to participate in this disput e, as well as the domestic legislation of the third WT/DS291/R/Add.5 
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  parties, have little bearing on the legal and factual matte r to be decided by the Panel.  In addition, the 
views of the fourteen third parties in this disput e cannot be seen to represent the views of the entire 
WTO Membership in general.  We therefore urge th e Panel to take account of the views of the third 
parties only
 as they relate to the matter referred to the Panel. 
 
This being said, the matter of substance in this di spute presents new issues not previously considered 
by the Panel or Appellate Body.  Added to that, th e general subject of biotech products in itself is 
highly controversial in the public eye.  The outcome  of this case may thus have wide-ranging effects.  
We are therefore particularly interested in monito ring the progress of this case in order to be fully 
aware of the possible consequences. 
 
QUESTION POSED BY THE EUROPEAN COMMUNITIES  
 For all third parties
: 
 
Does the SPS or TBT Agreement apply to a single legal instrument that is simultaneously pursuing objectives both covered and no t covered under the SPS or TBT Agreement? 
[paraphrase]  
The answer to this question depends on whether the single legal instrument can be described as a 
sanitary and phytosanitary measure and/or a tec hnical measure under the SPS or TBT Agreement.  If 
this is the case, the SPS or TBT Agreements should not be deprived of their applicability, even if the 
legal instrument is pursuing objectives beyond the scope  of these two Agreements.  The role of the 
Panel, under this scenario, is to determine how and to what extent the SPS or TBT Agreements cover 
the legal instrument, not whether th e SPS or TBT Agreement should apply. 
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  ANNEX G-3 
 
REPLY BY EL SALVADOR 
TO THE QUESTION POSED BY THE UNITED STATES 
  QUESTION POSED BY THE UNITED STATES
 
 
To all third parties : 
  At the third party session, a number of third parties noted that they had systemic interests in this dispute.  The United States would ask whether any of these third parties would care to explain the nature of their systemic interests. 
  El Salvador stated that it has a systemic inter est in this dispute particularly when it comes to 
the Panel's interpretation of the various provisions of the Agreemen t on Technical Barriers to Trade 
and the Agreement on Sanitary and Phytosanitary Measures that have come under consideration. 
  This is particularly significant in view of the fact that El Salvador is  currently working on a 
possible reform of its regulations as are other de veloping country Members – a fact mentioned by 
some of the third parties in the meeting with by the Panel.   Although El Salvador currently has trans itional regulations govern ing biotech products, 
efforts are being made at the national level to define new conditions for these products in keeping 
with the country's WTO commitments.   
  Thus, any decisions reached by the Panel provide an important frame of reference for the work being conducted by the Salvadoran authorities.   WT/DS291/R/Add.5 
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  ANNEX G-4 
 
REPLY BY HONDURAS 
TO THE QUESTION POSED BY THE UNITED STATES 
  QUESTION POSED BY THE UNITED STATES
 
 
To all third parties : 
 
 At the third-party session, a number of third parties noted that they had systemic 
interests in this dispute.  The United States would ask whether any of these third parties would care to explain the nature of their systemic interests. 
  At the third-party session, Honduras submitted that it had a systemic interest in this dispute 
because, like all WTO Members, it is interested in the interpretation and proper application of the 
rules negotiated by Members, in particular the inte rpretation and proper application of the provisions 
relating to the Agreement on Sanitary and Phyt osanitary Measures, the Agreement on Technical 
Barriers to Trade, and the GATT 1994. 
 
 Specifically, it is of interest to Honduras that  panels and, where a ppropriate, the Appellate 
Body, when examining sanitary and phytosanitary measures in the framework of dispute settlement 
proceedings, should do so in the light of scientific prin ciples, and that they should ensure that there is 
scientific evidence for maintaining the measure, as stipulated in Article 2.2 of the Agreement on 
Sanitary and Phytosanitary Measures ( " … is based on scientific principles and is not maintained 
without sufficient scientific evidence … " ), and Article 5.1 ( " … 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 organisations" ). 
  Similarly, care must be taken to ensure that th e approval procedures at issue in a given dispute 
are conducted without unjustified delay, as stipulated  in Article 8 of the Agreement on Sanitary and 
Phytosanitary Measures ( "Members shall observe the provisions of Annex C in the operation of 
control, inspection and a pproval procedures … " ), and Annex C(i)(a)  ("Members shall ensure, with 
respect to any procedure to check and ensure the fu lfilment of sanitary or phytosanitary measures, 
that:  (a) such procedures are undertaken and completed without undue delay and in no less 
favourable manner for imported products  than for like domestic products; … " ). 
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  ANNEX G-5 
 
REPLIES BY NEW ZEALAND 
TO QUESTIONS POSED BY THE PANEL AND THE PARTIES  
 
 
QUESTION POSED BY THE PANEL
 
 
For all third parties :1 
 
1. With reference to pp. 27-36 of the EC first written submission, could the third parties 
please indicate whether the European Communities'  description of their own regulatory systems 
is accurate? 
 
Paragraph 73 of the First Written Submission of the EC variously refers to New Zealand putting in 
place a "temporary ban" and a "statutory moratori um" on commercial release of genetically modified 
organisms (GMOs) which "lasted several years".  This is not an accurate description of the New Zealand situation.  Before any new organi sm, including a GM organism, can be imported, 
developed or released in New Zealand, it must first undergo a safety assessment by the Environmental 
Risk Management Authority (ERMA), a regulatory agency established under the Hazardous 
Substances and New Organisms Act 1996 (HSNO).    In 2000 the Government established a Royal Commi ssion of Inquiry on Genetic Modification to 
inquire into and report on the strategic options av ailable to enable New Zealand to address genetic 
modification issues.  During the period of the Royal Commission's inquiry, a voluntary moratorium 
on all applications for the release of genetically modi fied organisms, and for new field trials of GMOs 
was introduced by relevant industry and research gr oups in New Zealand.  At the conclusion of its 
deliberations the Royal Commission was satisfied th at New Zealand's basic regulatory framework was 
appropriate, but suggested a number of enhancements.   
 
After considering the Royal Commission's Report, the Government decided there was a need to 
restrict the release of GM organisms into the New Zealand environment for a two-year period to give 
the Government a fixed period of time to implemen t regulatory changes and to undertake other work 
recommended by the Royal Commission.  Approved human and veterinary GMO medicines and GM 
organisms approved under emergency provisions in the HSNO Act were exempt from the restricted 
period.  New Zealand legislation enhancing the re gulatory framework for GM organisms was passed 
by the New Zealand Parliament in late 2003 and th e two-year restricted period ended as scheduled on 
29 October 2003.  Changes in the new legislation included the introduction of a new category of approvals that enables conditions to be attached  to the release of new organisms, including GM 
organisms, into the environment.  It also st reamlined procedures for low risk GM organisms, 
particularly GMO medicines. 
 
As required by the WTO SPS Agreement  and the WTO TBT Agreement , the two-year restricted period 
on the release of GM organisms into the envi ronment was notified to both the WTO SPS Committee 
and the WTO TBT Committee.  As no applications had been made under HSNO for the release of a 
GM organism into the New Zealand environment, no historic trade was affected by the restriction.  
Contained field tests of both GM plants and animals had been conducted for some years, and these 
continued during the restricted period.  In additio n the restriction did not affect processed GM foods 
and ingredients, which are permitted after safety  assessment and approval by the Australia and 
                                                     
 
1 New Zealand has not responded to questions not specifically addressed at New Zealand. WT/DS291/R/Add.5 
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Page G-12 
  
  New Zealand Food Regulation Ministerial Council.  There are at present over 20 GM food varieties 
approved for sale in New Zealand.  Labelling of GM foods
2 is a separate regulatory process from the 
safety assessment and approval process and provides the consumer with choice after the safety of food 
has been assessed.  It is not to allow for "the mon itoring of long-term environmental and health effects 
of GM products" as implied by the EC in paragr aphs 84 and 85 of its First Written Submission.   
 Paragraph 79 of the First Written Submission of the EC contains an inaccurate representation of 
Section 7 of the Hazardous Substances and New Organi sms Act.  Section 7 of that Act provides that 
"All persons exercising functions, powers and duties under the Act … shall take into account the need 
for caution in managing adverse effects where there is a scientific and technical uncertainty about 
those effects".  
QUESTIONS POSED BY THE EUROPEAN COMMUNITIES
 
 
For New Zealand : 
 
1. In para. 2.02 of your third party submission you state that  
 
… the EC's regulatory approvals processes have been adopted by the EC for the 
purpose of providing protection from one or more of these risks.  Both the 
moratorium and the product-specific marketing bans which affect the implementation of these processes are thus  sanitary or phytosanitary measures 
within the meaning of the SPS Agreement. 
Do you consider that any measure that "aff ects the implementation" of an SPS approvals 
system is also an SPS measure?   
Whether a measure is an SPS measure depends on whet her the measure falls within the scope of the 
SPS Agreement  as set out in Article 1 and Annex A of that Agreement.  The statement reproduced 
above relates to the factual issue of what th e purpose of the moratorium and product-specific 
marketing bans is.  In this instance evidence provide d by the Complainants shows that they have the 
same purpose as the approval processes that th ey affect and are thus SPS measures.   
 
2. At para. 1.07 of your third party statement you state that  
 
Insofar as the EC's product-specific marketing bans may not be subject to the 
provisions of the SPS Agreement, the Agree ment on Technical Barriers to Trade 
(the TBT Agreement) would apply as argued  in the alternative by Canada and 
Argentina.   
Do you accept the apparent view of the Comp lainants that a measure falling under the TBT 
Agreement will cease to do so as so on as the prevention of an SPS risk is added to the objectives 
of the measure? 
 
New Zealand would refer the EC to Article 1.5 of the TBT Agreement  which provides that the 
provisions of the TBT Agreement  do not apply to sanitary and phytosanitary measures as defined in 
Annex A of the SPS Agreement . 
 
                                                     
 
2 Labelling of GM foods is required where there is novel DNA or protein present in the final food.  
Exceptions are provided, inter alia, for unintended pr esence and food prepared  at the point of sale.  WT/DS291/R/Add.5 
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  3. In New Zealand's view, if a moratorium has been formally adopted, explicitly based on 
the justification that there is scientific uncerta inty on the risks associated with GMOs, and 
properly notified to the WTO under Article 7, would such a moratorium be compatible with 
WTO law?  
New Zealand does not consider that a view on the co mpatibility of a measure with the requirements of 
the WTO Agreements can be given in the abstract.  Any measure would have to be examined in light 
of the substantive provisions of the SPS Agreement  including Articles 2.2, 5.1, 5.5 and 5.6.  As far as 
New Zealand is aware, the EC has not made the argument that its moratorium has been formally 
adopted, or that it is explicitly based on the jus tification of scientific uncertainty on the risks 
associated with GMOs, or that it has been properly notified under Article 7.  
4. Does New Zealand think that delays should be notified to the WTO under Article 7 of 
the SPS Agreement?  
That would depend on whether, as a matter of fact, wh at was being referred to as a 'delay' was in fact 
an SPS measure or a change to an SPS measure w ithin the meaning of Article 7 and Annex B. 
 
5. We note that New Zealand only concludes th at the EC has failed to comply with Articles 
7 and 8 of the SPS Agreement.  Does that mean that New Zealand agrees that other provisions 
such as Articles 5.1, 5.5 and 5.6 are not applicable for addressing delays? 
 
New Zealand concluded in its written submission  that "the [moratorium and product-specific 
marketing bans] are also more trade restrictive than necessary to achieve the appropriate level of 
protection from risks which may arise from biotech products".
3  New Zealand believes, therefore, that 
the EC has failed to comply with the obligations set out in Articles 2.2, 5.1, 5.5 and 5.6 of the SPS 
Agreement .  
 
QUESTION POSED BY THE UNITED STATES  
 
For all third parties : 
 
1. At the third-party session, a number of third parties noted that they had systemic 
interests in this dispute.  The United States would ask whether any of these third parties would care to explain the nature of their systemic interests.   
 
As set out in its submission, "As both a significan t producer and exporter of agricultural products, 
New Zealand has a strong interest in ensuring that the delicate balance of rights and obligations set out in the WTO Agreements, especially the SPS Agreement , is maintained".
4  New Zealand is 
pursuing this systemic interest through its participa tion as a third party in the current dispute (and has 
similarly participated in a number of other disputes that have sought to clarify the provisions of the 
SPS Agreement ). 
 
                                                      
3 Third Party Submission of New Zealand 24 May 2004, paragraph 3.02. 
4 Third Party Submission of New Zealand 24 May 2004, paragraph 1.04. WT/DS291/R/Add.5 
WT/DS292/R/Add.5 WT/DS293/R/Add.5 
Page G-14 
  
  ANNEX G-6 
 
REPLIES BY PERU 
TO QUESTIONS POSED BY THE PANEL AND THE PARTIES 
  QUESTION POSED BY THE PANEL
 
 
For all third parties : 
 
 With reference to pp. 27 to 36 of the EC first submission, could the third parties please 
indicate whether the European Communities' de scription of their own regulatory system is 
accurate? 
  The legislation in force in Peru is Law No. 27104 of 12 May 1999 on the prevention of risks 
related to the use of biotechnology, the regulatio ns of which were approved by Supreme Decree 
No. 108-2002-PCM of 28 October 2002.   By means of this Law, Peru lays down the rules governing biosafety with a view to protecting 
human health, the environment and biological dive rsity; promoting safety in biotechnology research 
and development and in its applications for th e production and provision of services; regulating, 
managing and controlling the risks arising from the contained use and deliberate release of living 
modified organisms (LMOs); regulating trade in a nd the marketing of LMOs at both domestic and 
international level; and facilitati ng international technology transfer in accordance with the 
international agreements to which Pe ru is or will become a signatory. 
 
QUESTION POSED BY THE UNITED STATES
 
 For all third parties
: 
 
 At the third-party session, a number of third parties noted that they had systemic 
interests in this dispute.  The United States would ask whether any of these parties would care to explain the nature of their systemic interests.  
 Peru became a third party to this dispute ow ing to its interest in participating in the 
discussions warranted thereby on th e issues specified in the requests by Argentina, Canada and the 
United States for the establishment of a panel.   Peru considers the development and applicati on of biotechnology and ge netic engineering and 
the resulting activities to be important in the light of their possible effects in areas such as health, 
agriculture, mining, environmental conservation and biodiversity, inter alia , particularly at the 
economic, commercial and administrative level. 
  Peru has an ongoing systemic interest in th e proper implementation and interpretation of the 
WTO Agreements. Of interest in this particular  case is the analysis by the Panel of the legal 
consistency of the implementation of European Community legislation with the provisions of the 
WTO Agreement on the Application of Sanitary and Phytosanitary Measures, especially with regard 
to the following:   (1) The procedures for the deliberate release  into the environment of  agricultural 
biotechnology products (for purposes other than their being placed on the market);   WT/DS291/R/Add.5 
 WT/DS292/R/Add.5 
 WT/DS293/R/Add.5 
 Page G-15 
  
  
 (2) the procedures for the placing on the mark et of agricultural biotechnology products as 
 products or ingredients in products; 
 
 (3) the procedures for novel foods and their ingredients. WT/DS291/R/Add.5 
WT/DS292/R/Add.5 WT/DS293/R/Add.5 
Page G-16 
  
  ANNEX G-7 
 
REPLY BY THAILAND TO THE QUESTION POSED BY THE PANEL 
 
 QUESTION POSED BY THE PANEL
 
 For all third parties
: 
 
 With reference to pp. 27 to 36 of the EC first submission, could the third parties please 
indicate whether the European Communities' de scription of their own regulatory system is 
accurate?  
 At present, Thailand bans a total of 89 types of biotech plants under the Plant Quarantine Act, 
B.E. 2507(1964).  The first such ban was issued  for 40 biotech plants on 4 March 2000, and the 
second was recently issued on 14 October 2003 for 49 a dditional biotech plants.  However, the ban 
does not extend to imports of pr epared food products which u se these crops as ingredients.  
Furthermore, importation of soy beans and corn as raw materials for the processing of animal or 
human food, or for industrial purposes is allowed. 
 
__________