EUROPEAN COMMUNITIES – MEASURES AFFECTING THE APPROVAL AND MARKETING OF BIOTECH PRODUCTS
Document: Reports of the Panel Addendum
Date: 29 September 2006
Document codes: WT/DS291/R/Add.5; WT/DS292/R/Add.5; WT/DS293/R/Add.5; WT/DS291/R; WT/DS292/R; WT/DS293/R.
Complainant: Argentina
Respondent: EU
Third parties: Australia, Brazil, Canada, Chile, China, Taiwan, Colombia, El Salvador, Honduras, Mexico, New Zealand, Norway, Paraguay, Peru, Thailand, Uruguay, U.S.
Dispute stage: Mutually Agreed Solution
Agreements cited: Art. 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7, 8, 10.1, Annex B, Annex C  Sanitary and Phytosanitary Measures (SPS)Art. III:4, X:1, X:3(a), XI:1  GATT 1994Art. 2.1, 2.2, 2.8, 2.9, 2.11, 5.1, 5.2, 5.6, 5.8, 12  Technical Barriers to Trade (TBT)Art. 4.2  AgricultureArt. I:1  GATT 1994

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
, , 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

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

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 response 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 Article 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 obligation would render Article 5.7 meaningless.
1
In light of the nexus between Articles 2.2 and 5.1 2, 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.

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 explicitly addressed the issue of burden 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 Member 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 supported by either the context of these provisions, 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)

 (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 supported by either the context of these provisions, 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:

"these principles of interpretation neither require nor condone the imputation into a
treaty of words that are not there or the importation 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 organisational 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 assessment 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 "withstand 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 obligations 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?

 (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.

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.

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

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 the SPS or TBT Agreement should apply.

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.

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; … " ).

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 modified 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 that 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.

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 monitoring of long-term environmental and health effects
of GM products" as implied by the EC in paragraphs 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 they 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 Agreement 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 presence and food prepared at the point of sale.

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 compatibility 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 within 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.

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 Peru 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 genetic 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);

 (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.

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.