Document: WT/DS291/R/Add.4 WT/DS292/R/Add.4 WT/DS293/R/Add.4 Page F-110 ANNEX F-7 REPLIES BY ARGENTINA TO QUESTIONS POSED BY THE PANEL IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING
Date: 7 March 2005
Document codes: WT/DS291/R/Add.4; WT/DS292/R/Add.4; WT/DS293/R/Add.4
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

ANNEX F-7

REPLIES BY ARGENTINA TO QUESTIONS POSED BY THE PANEL
IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING

For all parties

119. With reference to exhibit US-123 (reproduced at para. 9 of attachment II of the US
rebuttal), do the references in ISPM 11 to "indirectly affect plants [… ] by other processes such
as competition" (page 34) and "significant re duction, displacement, or elimination of other
plant species" (page 19) support the view that th e term "injurious" in the IPPC definition of
"pest" ("any species, strain or biotype of plant, animal, or pathogenic agent, injurious to plants
or plant products") should be given a broad interpretation?

We agree with the broad scope contained in S1, Annex "Comments on the scope of the IPPC in regard
to environmental risk", in Exhibit US-123, page 34. However, the important issue is the interpretation
of the term "pest" in the SPS Agreement, not the interpretation of the term "pest" in the IPPC.

However, Argentina agrees th at the term "pest" in the SPS Agreement should be given a broad
interpretation in the light of the broad interpreta tion given to the term "pest" in the IPPC and the
ISPM No. 11. The text of the ISPM No. 11 suggest s that "[t]he full range of pests covered by the
IPPC extends beyond pests directly affecting cultivated plants. The coverage of the IPPC definition
of plant pests includes weeds and other species that have indirect effects on plants, and the
Convention applies to the protection of wild flora."
1 This suggests that the phrase "injurious to plants
and plant products" should be interpreted broadly.

The broad interpretation of the term "pest" in ISPM No. 11 serves to confirm that the term "pests" in
the SPS Agreement should be given a similarly broad in terpretation. However, an organism is only a
"pest" for the purposes of the SPS Agreement and the ISPM No. 11 if it is "injurious to plants or plant
products" in the sense of causing damage to plant life or health.

120. With reference to Annex A(1)(d) of th e SPS Agreement, please answer the following
questions:

 (a) What is the meaning of the term "other damage"?

The concept of "other damage" refers to the preventi on of the situations not listed in paragraphs (a),
(b) and (c), and related to pests.

 (b) Does the term "other" imply that Annex A(1)(a) through (c) are also about
"damage"? If so, does the term "oth er damage" cover damage sustained by
plants, animals or humans other than damage to their "life or health"? Please
provide examples.

Yes. One example is damage referred to fitness.

1 Exhibit US-123, p. 34.

 (c) Is "other damage" limited to damage su stained by plants, animals or humans?
If not, please provide examples.

No, it is not limited to these damages. One example refers to microbiota.

121. With reference to Article 5.1 of the SPS Agreement, what were the relevant risk
assessment techniques developed by the relevant international organizations that the European
Communities had to take into account in the relevant period (October 1998 – August 2003)?

There were no "relevant risk assessment techniques" by relevant internationa l organizations at that
time (October 1998-August 2003).

122. Please explain your views as to the relatio nship between a Member's appropriate level of
protection and the requirement in Article 5.1 to en sure a measure is based on a risk assessment,
as appropriate to the circumstances. Is the appropriate level of protection relevant to the
conduct of the risk assessment?

In principle, we believe that appropriate level of protection and risk assessment are related. However,
this relationship must be qualified to avoid that the obligation contained in Article 5.1 becomes
meaningless.

Besides, Argentina deems that nothing in the word ing of the SPS Agreement suggest that a Member
can establish an "appropriate level of protection" disregarding risk assessment.

In this case, the EC has carried out a risk asse ssment through its own scientific committees which
found no risks in the products assessed. Hence, there is no justification for not approving or for asking
for more information.

In any case, the risk assessment as such, has to remain objective, autonomous and science-based.

123. Please assume for the sake of argument that Article 5.7 of the SPS Agreement provides
for an exception in the nature of an affirmative defence:

 (a) Could the Panel assess the merits of an y such defence without having previously
found an inconsistency with Article 2.2 of the SPS Agreement?

No.

 (b) If not, in a case such as this one where a claim of inconsistency with Article 2.2 of
the SPS Agreement is based on a claim of inconsistency with Article 5.1 of the
SPS Agreement, would it be correct for the Panel to begin its analysis with the
Article 5.1 claim, then move to the co nsequential Article 2.2 claim and finally
turn to the Article 5.7 defence?

Yes.

For all complaining parties

124. With reference to para. 19 of the Europe an Communities supplemen tary rebuttal, do
the complaining parties agree that the Panel "i s not asked to determine whether a prudent
government, in the abstract, should have behaved or not in a certain manner thus causing delay.
It merely needs to find whether, in the concrete case and in light of the factual information and
the legal arguments before the relevant authorities, that behaviour which in the end caused a
delay could justifiably have been adopted"?

We do not agree. The Panel is called to determin e whether a government has observed its obligations
under the SPS Agreement.

125. The European Communities' opening statemen t at the Panel's meeting with the experts
includes the following statements:

• "[T]he European Communities' approach is to seek more evidence to establish
whether or not there is a risk [… ] in order to make a definitive decision on the
basis of full information – even if that takes a little more time". (para. 19)

• "The European Communities reacts [to uncertainty as to the appropriate risk
management strategies ] by saying 'let's take our time and reduce the
uncertainty". (para. 17)

Do the complaining parties consider that it woul d be consistent with Annex C(1)(a) of the SPS
Agreement to delay making a definitive decision based on the approach outlined by the
European Communities? In answering this questio n, please take into account the provisions of
Article 2.2 of the SPS Agreement
2 and Article 5.7 of the SPS Agreement (adoption of provisional
measures based on available pertinent information).

As regards the first statement, Argentina does not agree because of the following reasons:

(a) In this specific WTO case, risk assessments have been carried out properly, taking into
account the past experience when dealing with agri cultural biotech products. The expected risks have
been properly analysed, so there is "sufficient" in formation to make a decision. The EC approach is,
as defined by Dr. Snow, referred to what is "nice to know". As regards the last part of the statement
("little more time") we do not agree either. The time taken has not been little. This situation began in
1998 and affected a whole group of products. With in this specific WTO case, the EC has had
"sufficient" information to assess whether there was any risk. Therefore, it is Article 2.2 that should
be applied , not Article 5.7;

(b) the expression "full information" is misleadi ng. Argentina considers the information that
enables a WTO Member to establish a sanitary or phytosanitary measure, apart from being scientific
evidence, has to be "sufficient". If a WTO Member intends to obtain "full information", it has to
amount to scientific evidence and it has to be releva nt and "sufficient". This applies to the general
obligations set forth in Article 2.2 of the SPS Agre ement, that clearly establish the requirement of

2 In EC – Hormones , the Appellate Body stated in relation to Article 2.2 that "a panel charged with
determining [...] whether 'sufficient evidence' exists to warrant the maintenance by a Member of a particular
SPS measure may, of course, and should, bear in mind that responsible, representative governments commonly
act from perspectives of prudence an d precaution where risks of irreversible , e.g. life-terminating, damage to

"sufficiency". In this specific case, Argentina considers that the EC had sufficient scientific evidence
at hand, namely the positive opinions by the EC Sc ientific Committees -which have not been refuted
by any scientific evidence-.

As regards the second statement, Argentina believes that it is not a question of "uncertainty" but about
"sufficiency". As correctly stated by the expe rts and by the WTO jurisprudence, science cannot
provide a complete and definitive assurance regardi ng risks or uncertainties. If we were to accept the
concept of uncertainty instead of "sufficiency", any WTO Member would be entitled to use it as an
excuse for not making any decision within the SPS Agreement, thus, circumventing its obligations.

126. In paragraph 10 of the EC Responses to the Questions from the Panel (16 June 2004),
the European Communities compares the definitions of risk assessment as used in the SPS
Agreement and as used in Codex, and concludes th at "It is clear that the SPS definition of risk
assessment is equivalent to 'weighing policy alternatives in the light of the results of risk
assessment' which is part of the Codex Definition to ¨'risk management'". Do you agree with
this conclusion? Please explain your response.

Argentina does not agree.

The "risk assessment" in the SPS Agreement must be science-based. Even the EC seems to agree with
this position since in its Responses to the Pane l Questions (June 2004) cites a decision of the
European Court to the effect that if the Regulat ory Committee disregards the scientific opinion "it
must provide specific reasons for its findings by comparison with those made in the opinion and its
statement of reasons must explain why it is disregarding the latter. The statement of reasons must be
of a scientific level at least commensurate with that of the opinion in question."
3

Besides, there is no scientific evidence able to contradict the EC's scientific committee opinions.

Questions not Previously Provided to the Parties

For all parties:

140. With reference to (1) Codex standards 192 and 193, (2) IPPC and (3) ISPM 11:

 (a) Are they "rules of international law applicable in the relations between the
parties [to this dispute ]" within the meaning of Article 31(3) of the Vienna
Convention on the Law of Treaties?

The IPPC 1997 is not yet in force, as the required two- thirds of the IPPC cont racting parties have not
yet deposited their instruments of acceptance of the 1979 amendment of the IPPC. Therefore,
although the IPPC 1979 could be considered "rules of international law", this is not the case with
respect to the IPPC 1997 because it has not yet come into force.
Argentina does not consider Codex Standards 192 and 193 or ISPM No. 11 to be "rules of
international law".

3 EC Responses to Panel Question, para. 57.

 (b) May they be used as additional factual evidence of the ordinary meaning of
terms contained in Annex A of the SPS Agreement, as the United States appears
to suggest in its rebuttal at para. 6 of attachment II? (The United States is
invited to provide elaboration on its statement at para. 6.)

141. With reference to Annex (B)(1) of the SPS Agreement, please answer the following
questions:

 (a) Does the term "sanitary and phytosani tary regulations" cover administrative
decisions which relate to the operation of approval procedures and which are
generally applicable?

 (b) May the phrase "sanitary and phytosanitary regulations which have been
adopted" be interpreted to encompa ss also sanitary and phytosanitary
regulations which have been adopted de facto (e.g., generally applicable decisions
which have been reached informally and which are unrecorded)?

Yes, as stated in our First Written Submission, paragraphs 57-63.

142. Please explain the meaning and rationale of the requirement in Article 2.2 that SPS
measures be "based on scientific principles" and how this is different from the requirement that
SPS measures not be maintained "without sufficient scientific evidence".

The reference in Article 2.2 to "scientific prin ciples" relates to the methodological soundness and
rigor of the scientific evidence relied upon to suppor t the measure in question. "Scientific principles"
are reflected in Articles 5.1 through 5.3 and in the definition of "risk assessment" found in
paragraph 4 of Annex A in the sense that the risk assessment must be methodologically sound,
sufficiently rigorous to meet the requirements of the definition, and must include consideration of the
factors set out in Articles 5.2 and 5.3.

The foregoing suggests that "scientific principles" as u sed in Article 2.2 relates to the use of scientific
methods of analysis, such as empiricism, objectivity , peer review and falsifiability (hypotheses can be
tested and previous results verified or refuted). It is important that the data and other information put
before the risk assessor is free from bias. In ot her words, it addresses the scientific rigor of the
knowledge relied upon by the risk assessor. This can be distinguished from the term "scientific
evidence", which focuses on the relationship between the conclusions of the risk assessment – rather
than its conduct per se – and the risk management (SPS) measure selected.

To some degree, the notion of "scientific principl es" is reflected in the requirements set out in
Article 5.2 and 5.3 with respect to the conduct of th e risk assessment, and in the definition of "risk
assessment" found in Annex A. The two provisions speci fy, to a certain degree, the types of factors
that must be included in the risk assessment, a nd the definition establishes the rigor that must be
observed in its conduct.

143. The Panel notes a number of instances where the same or a related product was
apparently submitted under separate applications fo r approval. This appears to be the case for
Monsanto Roundup Ready oilseed rape GT73 (EC-70, EC-79); Syngenta Bt 11 maize (EC-80,
EC-92, and related EC-69); Pioneer/Dow AgroSc iences Bt corn Cry1F (1507) (EC-74, EC-75,
EC-95); Monsanto Roundup Ready corn NK603 (EC-76, EC-96); Monsanto Roundup Ready
corn GA 21 (EC-78, EC-85, EC-91); and the various "stacked" products. To what extent does
the assessment by a lead CA, the relevant EC Scientific Committee and any information

provided by a notifier under one application serv e as a basis for consideration of another
application for the same or a related product?

Argentina observes that a product may have undergone different application procedures due to the EC
legislation: Directive 90/220/EEC (later replaced by Directive 2001/18/EC) and Regulation (EC)
258/97. For example, NK 603 maize did undergo an assessment under the Directives (EC-76) and
another under Regulation (EC) 258/97 (EC-96), legisla tion which has similar requirements. However,
the risk assessment can entail different approach es. This makes it difficult to establish a general
criteria. Notwithstanding, the assessment of a produ ct by one scientific committee could have served
as a basis for considering another application for the same or related product to the extent that the
risks being assessed were the same or even similar. In any case, Argentina has relied on positive
scientific opinions by the EC Scientific Committees in both proceedings (under the Directives and
under the Regulation (EC) 258/97) when both proceedings applied.

144. The Panel notes that a number of products containing the same transgenic modifications
as products at issue in this dispute were prev iously approved by the European Communities
prior to July 1998 (eg, swede rape tolerant to glufosinate ammonium (MS1, RF1) and (MS1,
RF2); swede rape tolerant to glufosinate ammonium (Topas 19/2); maize tolerant to
glufosinate ammonium (T25); maize expressing the Bt cry1A(b) gene (MON 810); maize
tolerant to glufosinate ammonium and expressi ng the Bt cry1A(b) gene (Bt-11); soybean
tolerant to glyphosate; chicory tolerant to glufosinate ammonium; maize Roundup Ready
NK603). To what extent and how were the prev ious assessments of potential risks to human,
animal or plant health and/or the environment associated with these transgenic modifications
taken into consideration in the evaluation of po tential risks arising from the products at issue
before the Panel?

Where the toxicology of the expressed protein ha d already been examined for one product (e.g.
soybean tolerant to glyphosate), this would have simplified considerably the toxicological evaluation
where the same protein was expressed by a sec ond (e.g. NK603 maize), especially (as in this
example) where the approval of the first product ha d created a history of safe consumption of the
protein. Where there were minor differences in the DNA coding sequences for the given protein, or
minor differences in the structure of the protein itself, this would require some examination.

For all complaining parties

145. With reference to para. 7 of the European Co mmunities second oral statement, is it "for
the Complainants to rebut this evidence [submi tted by the European Communities] by putting
forward arguments and evidence as to why reaso ns for delays put forward in the European
Communities' submissions are unjustified"?

We do not agree with this statement, because it assu mes that the EC has submitted evidence and that
the complainants have the burden to refute it. Th is WTO case is to be seen the other way: the
complainants have submitted scientific evidence and it was the EC, as a defendant, the party called to
try to refute this evidence or to justify its measures.

In short, it is the EC the party being asked to jus tify its measures, given that the complainants already
had put forward scientific evidence favouring approvals of agricultural biotech products.

For Argentina

146. With reference to Argentina's contention in the first part of Argentina's Second Oral
statement, 21-22 February 2005, that the European Communities' has not provided any
scientific evidence (other than that produced by the EC scientific bodies), how would Argentina
describe the studies and analysis undertaken, inter alia , by the Commission du Génie
Biomoléculaire on Cotton RRC-1445 (EC-66/Att.54); and the French AFSSA (EC-76/Att.41)
and the Commission du Génie Biomoléculaire on Maize GA-21 (EC-76/Att.43)?

Regardless the qualifications of the bodies that issued the mentioned documents, the documents
themselves cannot be regarded as scientific evidence si nce they do not contain a technical analysis of
scientific facts (like the EC scientific bodies). They do not constitute any risk assessment, they refuse
to issue a decision or they deny approval just because there was (on their opinion) lack of some
information (which apparently were not deemed necessary by the EC scientific bodies).

For instance in EC76-043, it is recognized that the application contains all the information required by
the normative 2001/18 EC.

In EC76-041 it is explicitly concluded that the A FSSA is not able to issue any judgement based on
scientific grounds, so it is evident that this is not intended to be a scientific/technical report at all.

Finally, in EC66-054, an unfavorable recommendation is based purely on alleged uncertainties.

These documents do not compare with the EC scien tific bodies documents (for instance like exhibit
EC76-attachment070), which contain a list of the pe ople involved in the analysis (which can be
recognized as competent experts), many pages of deep and thoughtfully review and evaluation of
existing evidences (instead of a minimum description of the event), and a large list of references to the
original scientific works that had been taken into account.

ANNEX F-8

REPLIES BY ARGENTINA TO ADDITIONAL QUESTIONS POSED BY THE PANEL
IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING
11 MARCH 2005

For all parties

170. With reference to EC Directive 2001/18, Annex II, Section C.2.1, please indicate for each
of the listed potential adverse effects of GM Os whether measures applied to prevent or
minimise such effects fall within the scope of A nnex A(1) of the SPS Agreement, and if so, why.
The parties are also invited to address Section D with the same question in mind.

Measures applied to prevent or minimize each of the following "potential adverse effects of GMOs",
as set forth in Directive 2001/18, Annex II, Section C.2.1, fall within the scope of Annex A(1) of the
SPS Agreement:

 – disease to humans including allergenic or t oxic effects (see for example items II.A.11.
and II.C.2(i) in Annex III A, and B 7 in Annex III B);

 – disease to animal and plants including toxic, and where appropriate, allergenic effects
(see for example items II.A.11 and II.C.2 (i) in Annex II A, and B 7 and D 8 in
Annex III B);

 – altered susceptibility to pathogens facilita ting the dissemination of infectious diseases
and/or creating new reservoirs or vectors;

Measures to protect against these three types of adver se effects fall squarely within Annex A(1)(b) of
the SPS Agreement, which refers to measures applied "to pr otect human or animal life or health …
from risks arising from … toxins or disease-causing organisms in foods, beverages or feedstuffs."
The "adverse effects" set forth above concern the potential that a GMO product could be toxic to or
cause disease in (directly or by increasing susceptib ility to disease) humans or animals, which are the
same risks as those enumerated in Annex A(1)(b). This conclusion is confirmed by each of the
following information requirements for GMO notifica tions referenced in the first two provisions
above: (1) item II.A.11 in Annex III A, which relates to "pathological traits" of GMOs, including
"infectivity, toxigencity, virulence [and] allergenicity," (2) item II.C.2(i) in Annex III A, which relates
to "considerations for human health and animal hea lth," including "toxic or allergenic effects" of
GMOs, (3) item B 7 in Annex III B, which relates to "potential interactions, relevant to the GMO …
including information on toxic effects on humans," a nd (4) item D 8 in Annex III B, which relates to
"toxic, allergenic or other harmful effects" arising from GMO crops when used for "animal
feedstuffs". For these reasons, measures to address these effects fall within the Annex A(1)(b) of the
SPS Agreement.

Measures to prevent the second and third types of adverse effects above could also fall within
Annex A(1)(a) of the SPS Agreement, which refers to measures applied "to protect animal or plant life
or health … from risks arising from the entry, establishment or spread of pests, diseases, disease-
carrying organisms or disease-causing organisms". A measure would fall under this provision if the
adverse effect to animal health that it seeks to protect against arises from exposure to a GMO product
other than a feedstuff.

Annex II, Section C.2.1 also includes the following "adverse effects":

 – effects on the dynamics of population species in the receiving environment and the
genetic diversity of each of these populations (see for example items IV B 8, 9 and 12
in Annex III A);

 – effects on biogeochemistry (biogeochemical cycles), particularly carbon and nitrogen
recycling through changes in soil decomposition of organic material (see for example
items II.A.11(f) and IV.B.15 in Annex A, and D 11 in Annex III B).

Measures to prevent these two types of adverse effect s fall within the scope of Annex A(1)(a) of the
SPS Agreement, which refers to measures applied "to protect animal or plant life or health … from
risks arising from the entry, establishment or spread of pests," or Annex A(1)(d) of the SPS
Agreement, which refers to measures applied "to prevent or limit other damage within the territory of
the Member from the entry, establishment or spread of pests." Each of these adverse effects concerns
the impact of a GMO product as a "pest," which the SPS Agreement defines to include "weed." More
specifically, these adverse effects refer to the risk that a GMO product becomes a "weed," that is, a
persistent and invasive plant that grows in envi ronments where it is not wanted and overtakes other
plant species, raising broader ecological concerns. Th e adverse effects, therefore, relate to "other
damage" caused by the "entry, establishment or spread of pests." This conclusion is confirmed by the
following information requirements for GMO notifica tions referenced in the two provisions above:
(1) items IV B 8 in Annex III A, which relates to the "potential for excessive population increase in
the environment," and (2) item IV B 9, which rela tes to the "competitive advantage of the GMOs in
relation to the unmodified [organisms]." Accordingl y, measures to prevent or minimize these adverse
effects fall within the scope of Annex A(1)(d) of the SPS Agreement.

"-compromising prophylactic or therapeutic medical, veterinary, or plant protection
treatments, for example by transfer of gen es conferring resistance to antibiotics used
in human or veterinary medicine (see for example items II.A.11(e) and II.C.2(i)(iv) in
Annex III A);"
Measures to prevent such adverse effects fall within the scope of Annex A(1)(a) of the SPS
Agreement, which refers to measures applied "to protect animal or plant life or health … from risks
arising from the entry, establishment or spread of…diseases, disease-carrying organisms or disease-
causing organisms." If the antibiotic marker gene compromises the clinical efficacy of antibiotics
used to protect animal life or health, then the measure would fall clearly within Annex A(1)(a).

171. In Japan – Apples, the Appellate Body interpreted Article 5.7 of the SPS Agreement and
notably the phrase "in cases where relevant scientific evidence is insufficient". It stated at para.
179 that:

Article 5.1 [...] informs the other provisions of Article 5, including Article 5.7.
We note, as well, that the second sentence of Article 5.7 refers to a "more
objective assessment of risks". These contextual elements militate in favour of a
link or relationship between the first requirement under Article 5.7 and the
obligation to perform a risk assessment under Article 5.1: "relevant scientific
evidence" will be "insufficient" within the meaning of Article 5.7 if the body of
available scientific evidence does not allow, in quantitative or qualitative terms,
the performance of an adequate assessment of risks as required under
Article 5.1 and as defined in Annex A to the SPS Agreement. [...] The question is
whether the relevant evidence [...] is sufficient to permit the evaluation of the
likelihood of entry, establishment or spread of, in this case, fire blight in Japan.

In this regard, please answer the following questions:
 (a) Is there a reason to believe that a lack of relevant scientific evidence could
prevent a Member from performing a risk assessment "as required under
Article 5.1 and as defined in Annex A to the SPS Agreement"? Or is it rather a
question of that Member perhaps being unable, due to the insufficiency of
scientific evidence, to conduct a fully obj ective risk assessment, such that any
measure based on that assessment might be maintained without sufficient
scientific evidence?

The short answer to the first part of Question 171(a) is yes. It is possible that a lack of relevant
scientific evidence could prevent a Member fro m performing a risk assessment as required under
Article 5.1 and as defined in para graph 4 of Annex A. In the quoted passage, Argentina understands
the Appellate Body to be indicating that the thre shold for a finding that the "relevant scientific
evidence is insufficient" and theref ore that Article 5.7 might be app licable, is linked to the obligation
to perform a risk assessment found in Article 5.1. Thus, it is only when the relevant scientific
evidence is insufficient to perform a risk assessment, as required by Article 5.1 and as defined in
paragraph 4 of Annex A of the SPS Agreement, that Article 5.7 can be successfully invoked. Earlier
in the paragraph, the Appellate Body refers to Article 5.1 as a "key discipline". The Appellate Body’s
reference to the phrase "a more objective assessment of risk" implies a connection between this phrase
and a risk assessment as defined in paragraph 4 of Annex A.

 (b) Does the phrase "more obj ective assessment of risks" in Article 5.7 support the
view that a provisional measure adopted in accordance with Article 5.7 must be
based on risk assessment, as required by Article 5.1? (Canada may wish to
elaborate further on what it has alread y said in its supplementary rebuttal in
relation to this point.)

The initial "measure adopted in acco rdance with Article 5.7" does not need to be based on a risk
assessment conforming to the same standard as that required by Article 5.1. Article 5.7 refers to the
adoption of a measure, at least initially, "on the basis of available pertinent information".

Besides, the reference in the second sentence of Ar ticle 5.7 to a "more objective" assessment of risk
implies that "on the basis of available pertinent in formation" some form of risk assessment must be
carried out, even if it does not meet the standard set out in paragraph 4 of Annex A, while the Member
gathers the scientific evidence nece ssary to complete a risk assessment according to Article 5.1 and
Annex A.4. It is also clear from the context that the "available pertinent information" refers to
scientific information concerning risks to human, animal or plant life or health.

172. Annex A(1) of the SPS Agreement suggests that "approval procedures" are SPS
measures. When a Member decides to delay the completion of such an approval procedure for
a number of days, would such action be another SPS measure within the meaning of
Annex A(1), or would such action rather need to be characterized as an application of an SPS
measure (the application of the approval procedure)?

In a case when a Member decides to delay the co mpletion of an approval procedure once and for a
few days, it is possible to agree with the premise that we would be facing the application of the
approval procedure. However, when a Member decid es to systematically stall the approval procedure,
as done by the EC in the case at hand, in such wa y that the procedure becomes meaningless, we are
faced with the existence of another measure.

In other words, when a decision is taken with the aim of avoiding the completion of all applications
submitted under an approval procedure, as in this particular case, we are not dealing with the
application of the procedures but w ith the application of a separate me asure. In this case that separate
measure is the "de facto" moratorium.

173. May the fact that existing approval legislation does not permit a Member to adopt
certain risk management measures which that Member considers appropriate serve as a
justification, for purposes of an analysis under Annex C(1)(a) of the SPS Agreement, for
delaying approval procedures conducted pursuan t to the existing legislation? Are the
provisions of Article 27 of the Vienna Convention on the Law of Treaties relevant to such a
situation?

The fact that existing approval legislation does not permit a Member to adopt certain risk management
measures does not justify by itself a delay or suspen sion of that approval system, since that delay or
suspension must be based on scien tific evidence. However, the Member concerned is under an
obligation to make the necessary legislative changes "without undue delay" in any case , so as to be in
a position to make a final decision as quickly as possible under the circumstances.
Therefore, Article 27 of the Vienna Convention on the Law of Treaties becomes relevant only in case
of a delay or suspension that is not based on scientific evidence (undue delay).

174. With regard to Article 2.2 of the TBT Agreement:

 (a) Please explain the phrase "the risks no n-fulfilment [of a legitimate objective]
would create" and illustrate using an example.

This phrase refers to the proportionality that must exist between the measure to be adopted (and the
degree of restriction on trade it can produce) in order to fulfil a legitimate objective and the risk that is
being addressed. In other words, the stricteness of a technical regulation must be proportionate to the
risk being addressed.

A technical regulation is more restrictive than n ecessary if it does not fulfill a legitimate objective. It
is also unnecessarily restrictive if the objective is legitimate but there is a less trade-restrictive
alternative that is able to fulfill that objective.

 (b) Article 2.2 refers to "scientific informat ion" which must be taken into account in
assessing risks. Article 5.2 of the SPS Agreement, on the other hand, refers to
"scientific evidence". Are these different concepts? Why?

It should be taken into account that the phrase "scientific information" in the TBT Agreement not only
refers to issues such as health or the environment, but also to other issues such as national security and
deceptive practices.

Thus, in this context, the use of the phrase "scien tific information" is due the fact that the TBT
Agreement covers a broader scope of issues than the SPS Agreement, where the scope is only focused
on health and the environment.

The TBT should not be applied in a vacuum but to a particular situation. The situation in the present
case is referred to an approval system aimed at prot ecting against risks to health and the environment.
In that sense, "scientific informati on" must be interpreted as equal to "scientific evidence" in order to
deal properly with an approval system of such characteristics.

Moreover, by using in the assessment of risk to health and the environment just "scientific
information" instead of "scientific evidence" it woul d be difficult to scrutini ze the existence of risks
and to apply an adequate measure.

175. Are measures applied to ensure co-existence of biotech crops and non-biotech crops
covered by Annex A(1) of the SPS Agreement or do they fall, in whole or in part, outside of the
scope of Annex A(1)?

Whether the measure applied to ensure co-existence of biotech crops and non-biotech crops is covered
by Annex A(1) of the SPS Agreement depends on the purpose of the measure. In that sense, a
measure applied with the purpose of protecting pl ant life or health from risks arising from the
admixture of biotech and non-biotech seeds or crops would fall within the scope of Annex A(1) of the
SPS Agreement. On the other hand, a measure app lied solely with the purpose of reducing or
preventing the "potential economic impact" of th e admixture of biotech and non-biotech products
resulting from the imposition of labeling thresholds for GM products would not fall under the scope
of SPS Agreement.

However, it has already been demonstrated in th is dispute that the purposes of the "de facto"
moratorium and the product-specific marketing bans are health and the environment. It must be
inferred from the context in which they have been a pplied and from the declarations of high ranking
EC officials. Therefore, the EC can not assert that this has taken place outside the scope of the SPS
Agreement.

For Argentina, the United States and the European Communities

176. With reference to Austria's safeguard meas ure on Bt-176 maize, please comment on the
reference in exhibit EC-158 att. 7 to insuffi cient labelling requirements laid down in the
Commission Decision relating to the relevant produc t. In particular, what is the basis for the
concern expressed about insufficient labelling (e.g ., food safety, consumer information, etc.),
and how does the labelling issue affect the analys is of whether the Austrian safeguard measure
falls within the scope of the SPS Agreement and/or the TBT Agreement?

It is not clear what was the basis for considering that labeling was insufficient.

For all complaining parties:

178. Please indicate whether the following allege d effects of biotech products fall within any
of the subparagraphs of Annex A(1) of the SPS Agreement:

 (a) Environmental components of biodiversi ty "outside human, animal or plant life
or health, such as the ecological comple xes referred to in the Convention on
Biodiversity" (EC rebuttal, para. 266).

If humans, animals and plants comprise the universe of living things and biodiversity is concerned
with the diversity of living things, then it is diffi cult to understand what component of biodiversity is
"outside human, animal or plant life or health". A measure taken to protect the "environmental
components of biodiversity" certainly could fall with in Annex A(1), depending on the type of risks
against which the measure seeks to protect.

 (b) "A predator insect eating another insect because it is itself growing better on a
diet of Bt maize" (EC rebuttal, para. 266).

It would seem that the EC is resorting to anothe r hypothetical concern. In any case this hypothesis
would fall within Annex A(1)(d) of the SPS Agreement.

 (c) Human health risks arising from oc cupational exposure to a substance in a
biotech product that is a toxin for insects (e.g., the Bt toxin) as opposed to risks
arising from the consumption of the biot ech product (EC rebuttal, para. 316).
(The United States may elaborate on its response to Panel Question 73 or
comment on the European Communities' response).

Argentina agrees with the response of the United St ates to Panel Question 73. A measure to protect
humans against occupational exposures from Bt toxins in corn, which is consumed as either a food or
feedstuff, is subject to the SPS Agreement. Annex A(1)(b) does not specify or restrict the mode of
exposure.

179. Please comment on the European Communi ties' statement that "for the purposes
specifically of proving a 'moratorium' that app lies across the board, it does not suffice to
address only a limited selection of product applications" (EC rebuttal, footnote 212).

The EC assertion is flawed because, as a result of th e moratorium, there have been neither approvals
nor rejections. Besides, as already stated, the existence of some movement in one or more applications
does not change the situation since the procedures were never completed.

In other words, the number of the selected product applications should not be relevant because this
does not change the fact that there is a "de facto" moratorium.

For Argentina and Canada

181. With reference to Argentina's and Canada's claims in respect of the member State
safeguard measures under Article 2.1 of the TBT Agreement, do the relevant safeguard
measures apply to the relevant biotech products when imported into the territory of the
relevant member States and when produced in the relevant member States, or do they apply
only when the products are imported?

In the case of the Austrian ban on maize T25, Bt-176 and MON-810 the ordinance banned
commercialization. The Italian Ministerial Decree banning maize MON809, MON810, T25, and Bt11
specified that it was suspending the commercialization and utilizati on. In the case of Germany, the
Amendment Notice applies a suspension against maize Bt-176. Luxembourg imposes a ban on the use
and sale of maize Bt-176 through a ministerial order.

Given the broad language used, it must be assumed th at the measure applies to the relevant biotech
products when imported into the territory of th e respective Member Stat es and when they are
produced in those Member States.

For Argentina

183. With reference to para. 61 of Argentina's s upplementary rebuttal, wh at is the basis for
the assertion that Soy Lines A2704-12 and A5547-12 7 were affected by the alleged de facto
moratorium?

In that context, the reference to that product w as made in order to give an example of a product
affected by the "de facto" moratorium, which has no scientific opinion from the scientific committees.

ANNEX F-9

REPLIES BY THE EUROPEAN COMMUNITIES
TO QUESTIONS POSED BY THE PANEL
IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING
7 MARCH 2005

119. With reference to exhibit US-123 (reproduced at para. 9 of attachment II of the US
rebuttal), do the references in ISPM 11 to "indirectly affect plants [… ] by other processes such
as competition" (page 34) and "significant re duction, displacement, or elimination of other
plant species" (page 19) support the view that th e term "injurious" in the IPPC definition of
"pest" ("any species, strain or biotype of plant, animal, or pathogenic agent, injurious to plants
or plant products") should be given a broad interpretation?

1. As the European Communities has previously e xplained, a distinction must be made between
two different issues: first, the scope of the SPS Agreement, which is defined in Annex A.1 of the SPS
Agreement; second, the definition of "International st andards, guidelines and recommendations",
referred to in Annex A.3 of the SPS Agreement . The "International standards, guidelines and
recommendations" are relevant, for example, fo r the interpretation of Article 3.3 of the SPS
Agreement.

2. The second issue may be summarised as follows. Annex A.3(c) of the SPS Agreement refers
to the international standards, guidelines and reco mmendations "developed under the auspices of the
Secretariat of the International Plant Protection Convention in cooperation with regional organizations
operating within the framework of the International Plant Protection Convention". When the SPS
Agreement was adopted what was in force (at least inso far as is relevant for these panel proceedings)
was the International Plant Protection Convention approved by an FAO conference in November
1979. It entered into force on 4 April 1991, 13 days after acceptance by two-thirds of the contracting
parties. There is a subsequent text – the Intern ational Plant Protection Convention 1997, which, at
least at the date of establishment of this panel, ha d not yet been ratified by two thirds of the Members
of the IPPC, and which therefore was not in force. The 1997 IPPC's principal organ would be the
Commission on Phytosanitary Measures. Pending entry into force of the 1997 IPPC, an Interim
Commission on Phytosanitary Measures published ISPM 11 (2004). With regard to declarations and
reservations, the United States accepted the amende d Convention (the 1997 IPPC) subject to the
following understandings:

(1) Relationship to other internati onal agreements – The United States
understands that nothing in th e amended Convention is to be interpreted in a manner
inconsistent with, or alters the terms or effect of, the World Trade Organization
Agreement on the Application of Sanitary or Phytosanitary Measures ( SPS
Agreement) or other relevant international agreements.
3. There is thus an issue as regards timing. ISPM 11 (2004) was endorsed in April 2004. The
Panel in this case was established on 29 August 2003. The Complainants cannot therefore rely on the
text of ISPM 11 (2004) in order to support their claims relating to the scope of the SPS Agreement.

4. It is against this background that the European Communities would return to the first, distinct,
issue referred to above – the scope of the SPS Agreement . On this question, it is necessary to
distinguish between the general IPPC definition of "pest", and the further explanations in ISPM 11

(2004) concerning the scope of the IPPC with r espect to environmental issues, to which the
Complainants refer.

5. With regard to the general IPPC definition of "pest", it would be a legal error to simply
transpose such definition into Annex A.1 of the SPS Agreement. All that it is possible to say is that
the IPPC may provide relevant context for the purpo ses of the interpretation of the term of "pest" in
Annex A.1 of the SPS Agreement . In this respect, in the contex t of this dispute, the European
Communities has no particular difficulty with the general definition of pest in IPPC 1997 as being:

Any species, strain or biotype of plant, animal or pathogenic agent injurious to plants
or plant products.
6. In the context of the issues raised in these panel proceedings, this definition is not
significantly different from that in Article II (2) of the 1979 IPPC:

For the purposes of this Convention, the term "pest" means any form of animal or
plant life, or any pathogenic agent, injurious or potentially injurious to plants or plant
products.
7. Furthermore, the view of the European Comm unities is that, in certain circumstances, a GMO
may indeed become a pest, just as any non-GMO migh t become a pest, as indicated in its first written
submission.

8. This does not mean
, however, that all negative or potentially negative effects of GMO's are
automatically caught by the definition in Annex A of the SPS Agreement. In particular, the European
Communities remains strongly of the view that bi odiversity and environmental issues do not fall
within the scope of the SPS Agreement. The scope of the SPS Agreement and the scope of IPPC, as
elaborated by ISPM 11 (2004), are different things and should not be confused. Just because ISPM 11
(2004) tackles environmental issues does not bring environmental issues with the scope of the SPS
Agreement. It simply reflects the fact that ISPM 11 (2004) takes into account the adoption of the
Cartagena Protocol. In fact, the environmental pr ovisions in ISPM 11 (2004) rather confirm that,
absent any equivalent or similar provisions in the SPS Agreement, the scope of the SPS Agreement
does not cover environmental issues – and this is definitely confirmed by the negotiating history of
the SPS Agreement.

9. When it comes to specific i ssues, each case will have to be considered on its merits
, in order
to determine whether or not the issues fall within the scope of the SPS Agreement.

10. Turning to the first specific quotation in the question: "indirectly affect plants … by other
processes such as competition." (ISPM 11 (2004) pa ge 34) The European Communities would first
note that this "quotation" in fact takes three words in italics and in the nature of a sub-title, and links
them to other words in a different sentence. Th e phrase as presented in the question is not therefore
actually a phrase that is used in ISPM 11 (2004). Second, and more importantly, this phrase is taken
from Annex 1 of ISPM 11 (2004), which expressly relates to "environmental risks". If this is what the
question has in mind when it refers to a "broad inte rpretation", then it is hardly surprising that the
quotation suggests an environmental risk, since that is precisely what Annex 1 of ISPM 11 (2004) is
concerned with. This does not mean, however, that the presence of the word "pest" in Annex A.1 of
the SPS Agreement necessarily means that environmenta l risks are within the scope of the SPS
Agreement – and it would be legally erroneous to proceed on that basis.

11. Similar comments apply with regard to the second quotation in the question, this being taken
from page 23 of ISPM 11 (2004), from a paragraph which begins "In the case of the analysis of
environmental risks …", and which is marked "S1" in the margin – which the endorsement on page 1
of ISPM 11 (2004) confirms means that it relates to "environmental risks".

12. In short, the European Communities does not consider that Annex A.1 of the SPS Agreement
should be given either a narrow interpretation or a "b road" interpretation. It should simply be given
an interpretation consistent with its text, context and purpose. The IPPC definition of "pest" provides
context, but does not insert the word "injurious" into Annex A.1 of the SPS Agreement. Nor does the
presence of the word "injurious" in the IPPC definiti on of pest, coupled with those parts of ISPM 11
(2004) that refer to environmental risks, have as a consequence that environmental risks are brought
within the scope of the SPS Agreement. On the contrary, the text, context and purpose of the SPS
Agreement, and its negotiating history, strongly support th e view that environmental risks do not fall
within the scope of the SPS Agreement.

120. With reference to Annex A(1)(d) of th e SPS Agreement, please answer the following
questions:

 (a) What is the meaning of the term "other damage"?

 (b) Does the term "other" imply that Annex A(1)(a) through (c) are also about
"damage"? If so, does the term "oth er damage" cover damage sustained by
plants, animals or humans other than damage to their "life or health"? Please
provide examples.
 (c) Is "other damage" limited to damage su stained by plants, animals or humans?
If not, please provide examples.

13. (a) The words "other damage" must be interp reted in the light of their immediate context
and in the light of the overall purpose of the SPS Agreement. "Other damage" is not an open ended
formulation that may be used to include under the SPS Agreement any kind of negative effect arising
from the entry, establishment or spread of pests. Eiusdem generis ("of the same type") is a basic rule
of interpretation. The answer to the following two qu estions will serve to clarify what is the scope of
letter (d) of point 1 of Annex A of the SPS Agreement.

14. (b) The European Communities consider s that the term "other" implies that
Annex A(1)(a) through (c) are also about damage. The terms "other damage" cover damages resulting
from the entry or establishment or spread of pests and sustained by plants, animals or humans other
than damage to their "life or health". To give a specific example: a pest may affect the quality of a
plant product, which may be substandard, that is, of lower quality. For example, Citrus fruit quality is
affected by the presence of pests such as the Mediterranean fruit fly Ceratitis capitata. Such pests do
not threaten the life or the health of the plant , but rather affect the economic value of crops. The
Mediterranean fruit fly may still qualify as a quarantin e pest, as defined by the International Plant
Protection Convention (i.e. "quarantine pests" mean s a pest of potential economic importance to the
area endangered thereby and not yet present there, or present but not widely distributed and being
officially controlled). The economic damage resu lting from the presence of the fruit fly, would in
such a case fall under other damage as provided for in Annex A.1(d) of the SPS Agreement.

15. On fruits, any fruit flies or moths other than C. capitata
, will equally create damage to fruit
without compromising the health or development, etc. of plants. There are hundreds of fruit flies
which would have the same effect as the Mediterra nean fruit fly: for example, Anastrepha sp. fruit

flies, other Ceratitis fruit flies, Ragoletis, etc. All these pests affect the quality of the fruits they infect
but in no case compromise the life or health of the plants.

16. Another example would be the apple codling moth ( Cydia pomonella ) which is largely
present in some regions of Europe. This pest bor es holes in fruits and generates harvest loss, without
affecting the life of apple trees. This pest woul d still qualify as a quarantine organism as defined in
the IPPC in regions, for example, where it is not present and if its introduction and establishment
could result in economic damage to local production.

17. There are other pests such as scale insects, thrips, etc. whose presence may result in the
development of black mould on fruits (or e.g. cut fl owers). The presence of mould would not affect
the plant health per se, however it would affect the economic value of the crop.

18. Another example would be potato ring rot ( Clavibacter michiganensis sp. Sepenocius). This
bacteria is considered to be a quarantine organism in many countries (including in the EU where it is
subject to statutory control measures). In the EPPO book "Quarantine pests for Europe" (2nd edition)
compiling data sheets on quarantine pests for th e European Union and for the European and
Mediterranean Plant Protection Organisation (ISBN 0 85199 154 8), it is noted that (p. 989) " while
the direct economic impact of the ring rot may only be moderate, especially with modern production
system, it would constitute a major constraint on seed potato production where it does not occur, with
considerable indirect effects on trade" . The effect on trade would in fact qualify as "other damage"
under the SPS Agreement.

19. (c) Yes: "other damage" is limited to dama ge sustained by plants, animals or humans,
due to the entry, establishment or spread of pest s. It does not extend to environmental damage per se.
Environmental damage per se is not contemplated by the other terms used in Annex A or the rest of
the SPS Agreement. It is, by contrast, expressly contemplated by the TBT Agreement.

20. With regard to this latter point, the Eur opean Communities would like to recall that the
negotiating history of the SPS Agreement supports the European Communities view that Annex A.1
must be interpreted strictly and not in a broad manner (see paras. 57-59 of the European Communities
Second Written Submission).

21. In particular, the European Communities is we ll placed to argue that environmental damage is
not covered by the SPS Agreement since it was the European Commun ities itself that for some time
supported the broadening of the scope of the Agreement. Its views were resisted by the majority of
other Members and, by the time of the conclu sion of the Uruguay Round, the European Communities
had also come to the view that the SPS did not constitute the proper legal framework to address
environmental issues. As further supporting evid ence, the European Communities would mention the
GATT Secretariat's Note summarising the main points raised at the 18
th meeting of the SPS WG,
5-7 June 1990 (MTN.GNG/NG5/WGSP/W/24):

"With regard to the measure coverage, [one participant], and some other participants,
could not at this stage agree with the exclusion of consumer preferences,
environment, animal welfare and ethical a nd world considerations and considered it a
probable mistake to exclude them from a reinforced discipline"
"Other participants agreed that there was a need to deal with other issues such as
consumer preferences, environment, etc., which were already used for trade
protection, but objected that they should not be covered by an SPS discipline. Other
ways would have to be found to deal with them. It was noted that Article XX(b)

covered more than SPS measures and that it could be used for these types of
measures"
22. The issue of the scope of the SPS Agreement , in particular as far as the environment is
concerned, remained open until the end of the negotiations. Indeed, the Cover note to the SPS
Decision circulated on 20 December 1990 (also kno wn as the "Dunkel text") read as follows: "The
brackets in the note to definition 1 and in definition 4 (Annex A) are all linked to the question of
whether or not this agreement should apply to measures taken for the protection of animal welfare and
of the environment
, as well as of consumer interests and concerns". The bracketed text (which
included a reference to the environment) disappeared in the final text of the agreement, as we all
know. As a result, environmental damage per se does not fall under the scope of the SPS Agreement.

23. The European Communities stands ready to pr ovide further details on the negotiating history
of the SPS Agreement should the Panel so request.

121. With reference to Article 5.1 of the SPS Agreement, what were the relevant risk
assessment techniques developed by the relevant international organizations that the European
Communities had to take into account in the relevant period (October 1998 – August 2003)?

24. The requirement in Article 5.1 of the SPS Agreement to take into account the risk assessment
techniques developed by the relevant international organizations relates only to the assessment of the
risks to human, animal or plant life or health.

25. The European Communities has discussed at le ngth the issue of the limited scope of sanitary
or phytosanitary measures within the context of the SPS Agreement, as defined by its Annex A 1, and
in particular to the extent that it does not cover environmental risks per se (see for instance the answer
to the Question 120). Again in the context of Article 5.1 of the SPS Agreement, the same argument
applies, namely that the "risk assessment techniqu es" to be taken into account need not to include
those which address risks areas falling outside the risk s to human, animal or plant life or health and
outside the scope of its Annex A 1.

26. However, in developing and conducting its GMO approval procedures, the European
Communities takes account of all relevant risk assessme nt techniques, including those aspects that do
not relate to risks covered by the SPS Agreement. Accordingly, in order to fully inform the Panel, the
European Communities, in responding to this question, will list these techniques without
distinguishing between techniques relevant to risks coming within the scope of the SPS Agreement
and other risks.

27. The "risk assessment techniques" developed by the relevant international organizations in the
relevant time period are of two types: general "r isk assessment techniques", and specialized ones for
genetically modified (or living modified) products.

28. All the available guidance from relevant in ternational organisations on "risk assessment
techniques" which specifically address GM products, has been developed in an endeavour to cover the
relevant risks areas that need to be specifically assessed for GM products. It is however noteworthy
that not all areas are yet covered by internati onal guidance specifically designed to cover GM
products. This is the case, for instance, with GM feed safety "risk assessment techniques" and other
animal health risk assessment techniques" for GM products.

29. The available guidance documents from re levant international organisations on "risk
assessment techniques" which specifically address GM products are generally consistent with each

other: they are all based explicitly or implicitly on the Risk Analysis paradigm (which corresponds, as
discussed earlier by the European Co mmunities, to the "risk assessment techniques" referred to in the
SPS Agreement , and which includes the three components of risk analysis, i.e. the science based
assessment of the potential risks, risk management measures and risk communication).

30. Between October 1998 and August 2003, there was a lot of international activities aimed at
developing specialized "risk assessment techniques" guidance for GM products; hence several if not
most of the specialised "risk assessment techniqu es" developed by the relevant international
organisations were developed within that period of time.

31. As regards general
 "risk assessment techniques", several standards had been developed
within or before the relevant time period by relevant international or ganisations, in particular by the
Codex Alimentarius Commission, by the IPPC, and by the OIE. These include for instance, as far as
they address in part risks to human, animal or plant life or health:

32. As regards "risk assessment techniques" cove ring plant life or health, the following IPPC
general ISPM are particularly relevant ( ISPM # 06, 09, 13, and 14 are important in particular for
general risk management components of the risk analysis):

– ISPM # 02: Guidelines for pest risk analysis
– ISPM # 06: Guidelines for surveillance
– ISPM # 09: Guidelines for pest eradication programmes
– ISPM # 11 (as adopted in April 2001, which does not include environmental
risks, nor risks derived specifically from Living Modified Organisms): Pest
risk analysis for quarantine pests
– ISPM # 13: Guidelines for the notification of non-compliance and emergency
action
– ISPM # 14: The use of integrated me asures in a systems approach for pest
risk management
– ISPM # 16: Regulated non-quarantine pests: concept and application
33. As regards "risk assessment techniques" c overing animal life or health, the following OIE
general standards are particularly relevant:

– the Terrestrial Animal Health Code
– the Aquatic Animal Health Code
34. As regards "risk assessment techniques" cove ring human life or health and food safety, the
following Codex Alimentarius Commission general guidance is particularly relevant:

– The conduct of risk analysis is guided by general decisions of the Codex
Alimentarius Commission (CAC). These decisions include the Statements of
principle concerning the role of science in the Codex decision-making
process and the extent to which other factors are taken into account and the

Statements of principle relating to th e role of food safety risk assessment
(Codex Alimentarius Commission Procedural Manual; Thirteenth edition).,
as well as the Codex Working Principles for Risk Analysis.
1
– Codex Standard 193: General Standard for Contaminants and Toxins in
Foods
– CAC/RCP 1: General Principles of Food Hygiene
– CAC/RCP 54: Recommended Code of Practice on Good Animal Feeding
– CAC/GL 20: Principles for Food Import and Export Certification and
Inspection
– CAC/GL 26: Design, Operation, Assessment and Accreditation of Food
Import and Export Inspection and Certification Systems
– CAC/GL 30: Principles and Guidelines for the Conduct of Microbiological
Risk Assessment
35. As regards specialised
 "risk assessment techniques", aimed at specifically addressing risks
arising from GM products, several standards have been developed by relevant international
organisations before, within or after the re levant time period, in particular by the Codex Alimentarius
Commission, by the IPPC, by the OECD and by the Convention of Biological Diversity. These
include for instance, as far as they address in part risks to human, animal or plant life or health:

36. As regards human life and health, the Code x principles for the risk assessment of foods
derived from modern biotechnology (CAC/GL 44) a nd the Codex guidelines for the conduct of food
safety assessment of foods derived from recombin ant-DNA plants (CAC/GL 45) and for the conduct
of food safety assessment of foods produced using recombinant-DNA Microorganisms ( CAC/GL 46)
were adopted in July 2003.

37. With respect to feed safety assessment specifically addressing GM products (and more
generally to animal life and health "risk assessment techniques" specifically addressing GM products),
no international guidance have been developed yet.

38. In addition, concerning plant life and health , the updated ISPM n° 11 (International Standard
for Phytosanitary Measures on Pest risk analys is for quarantine pests including analysis of
environmental risks and living modified organisms) now includes the pest risk analysis of Living
Modified Organisms, as adopted in April 2004. However, it should be noted that ISPM 11, as
discussed earlier, also covers the environmental risks that fall outside of the scope of the SPS
Agreement, as part of the pests risk analysis. Furthermore, Annex 2 of ISMP 11, specifies that " PRA
2
may constitute only a portion of the overall risk analysis for import and release of a LMO. For
example, countries may require the assessment of risks to human or animal health or the environment,
beyond that covered by the IPPC …"

39. Furthermore, as far as risks to human, animal or plant life or health are singular components
(but components only) of the more global risks to the conservation and sustainable use of biological

1 Adopted by the 26th Session of the Codex Alimentarius Commission, 2003.
2 Pest Risk Analysis, as defined in the IPPC.

diversity, and the environment at large, relevant "risk assessment techniques" are also to be found in
the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, adopted on
29 January 2000.

40. It constitutes the first international binding standard on GM products. It includes specific
provisions as regards the science based assessment of risks derived from Living Modified organisms,
as well as relevant risk management provisions. These are in particular its article 15 on the
assessment of risks and its related Annex III, wh ich provides minimum requirements for carrying out
the assessment of risk under the Protocol, and its Article 16 provides a framework for risk
management measures as part of risk analysis. Mo re detailed international guidance for risk analysis
of LMOs under the Protocol, including on risk ass essment and risk management, still needs to be
further developed. Indeed, at the first Meeting of the Parties (COP/MOP1), Decision BS-I/12 adopted
a medium term programme which includes for possi ble consideration the development of guidance
and of a framework for common approach in risk assessment and risk management.

41. It is also to be noted that the OECD has developed since the beginning of the 1980'ies a
significant number of guidance documents on "ris k assessment techniques" for recombinant DNA
technologies and products. It formulated in particular general principles of the assessment of the risks
of recombinant DNA in 1986, and an initial concept of "substantial equivalence" in 1993 as a guiding
tool for the assessment of genetically modified foods . However, the concept further evolved and is
still under current debate, as the European Commun ities has discussed in its comments on expert
advice. This concept is only a part of the safety evaluation framework as already explained.

42. The OECD Working group on the harmonisa tion of regulatory oversight of biotechnology
and the Task Force for the Safety of Novel Foods and Feeds have both decided, in the 1990s, to focus
their work on the development of science-based c onsensus documents, which are mutually acceptable
among member countries. These consensus documents address the relevant biological information of
the recipient organisms or of the introduced traits, and contain information for use during the
assessment of the risks of particular GM products or food/feed products, respectively.

43. Although the OECD may not qualify as an in ternational organisation within the meaning of
Article 5.1, the European Communities neverthele ss takes its consensus documents into account.
However, as the Panel will note from the list of OECD documents below, none of these documents
provide for unique general principles for the risk assessment of GMOs.

44. At the present time, several consensus documen ts have been published and are available on
the OECD web site (www.oecd.org
). These relate both to food safety3 and also environmental risks.4

3 These include: Consensus Document on Compositional Considerations for New Varieties of Barley
(Hordeum vulgare L.): Key Food and Feed Nutrients and Anti-Nutrients - No. 12,
2004, ENV/JM/MONO(2004)20; Consensus Document on Compositional Considerations for New Varieties of
Cotton (Gossypium hirsutum and Gossypium barbadense): Key Food and Feed Nutrients and Anti-Nutrients -
No. 11, 2004, ENV/JM/MONO(2004)16; Consensus Document on Compositional Considerations for New
Varieties of Rice (Oryza sativa): Key Food and Feed Nutrients and Anti-Nutrients - No. 10, 2004,
 ENV/JM/MONO(2004)15; Considerations for the Safety Assessmen t of Animal Feedstuffs derived from
Genetically Modified Plants - No. 9, 2003, ENV/JM/MONO(2003)10; Consensus Document on Compositional
Considerations for New Va rieties of Bread Wheat ( Triticum aestivum ): Key Food and Feed Nutrients, Anti-
Nutrients and Toxicants - No. 7, 2003, ENV/JM/MONO(2003)7; Consensus Document on Compositional
Considerations for New Varieties of Maize ( Zea Mays ): Key Food and Feed Nutrients, Anti-Nutrients and
Secondary Plant Metabolites - No. 6, 2002, ENV/JM/MONO(2002)25; Consensus Document on Compositional
Considerations for New Varieties of Potatoes: Key Food and Feed Nutrients, Anti-Nutrients and Toxicants - No.
4, 2002, ENV/JM/MONO(2002)5; Consensus Document on Compositional Considerations for New Varieties of

45. In sum, it is clear that during the peri od 1998-2003, there was tremendous international
activity to develop specific "risk assessment techni ques" for GM products, and that this guidance was
constantly evolving, incorporating as work progresses increasing numbers of relevant criteria and risk
analysis elements, even within the limited scope of risks to human, animal or plant life or health.
However, the Codex principles on the risk asse ssment of food derived fro m modern biotechnology
was not adopted until July 2003 and the revised ISPM 11 was not adopted until April 2004.

122. Please explain your views as to the relatio nship between a Member's appropriate level of
protection and the requirement in Article 5.1 to en sure a measure is based on a risk assessment,
as appropriate to the circumstances. Is the appropriate level of protection relevant to the
conduct of the risk assessment?

46. The European Communities considers that the "lev el of protection" is indeed relevant to the
conduct of a "risk assessment" within the meaning of the SPS Agreement. As a matter of fact, the
concepts of "risk assessment" and "level of protection" are interrelated. This is already clear from the
definition of risk assessment in Annex A to the SPS Agreement which calls for an evaluation of the
risks in the light of the SPS measures that might be applied.

47. In order to provide the Panel with a useful and comprehensive reply, the European
Communities would like to discuss in some detail th e reasons that may lead different WTO Members
to evaluate differently a given set of scientific data. For the sake of simplicity, the European
Communities would refer to three main reasons.

Sugar Beet: Key Food and Feed Nutrients and Antinutrients - No. 3, 2002, ENV/JM/MONO(2002)4; Consensus
Document on Compositional Considerations for New Varieties of Soybean: Key Food and Feed Nutrients and
Anti-Nutrients - No. 2, 2001, ENV/JM/MONO(2001)15
; Consensus Document on Key Nutrients and Key
Toxicants in Low Erucic Acid Rapeseed (Canola) - No. 1, 2001, ENV/JM/MONO(2001)13;
4 These include: An Introduction to the Biosafety Consensus Documents of OECD's Working Group
for Harmonisation in Biotechnology - No. 32, 2005, ENV/JM/MONO(2005)5; Consensus Document on the
Biology of Helianthus Annuus L. (Sunflower) - No. 31, 2004, ENV/JM/MONO(2004)30; Consensus Document
on the Biology of European White Birch (Betula pendula Roth) - No. 28, 2003, ENV/JM/MONO(2003)12;
Consensus Document on the Biology of Zea mays (Maize) - No. 27, 2003, ENV/JM/MONO(2003)11; Module
II: Herbicide Biochemistry, Herbicide Metabolism and the Residues in Glufosinate-Ammonium
(Phosphinothricin)-Tolerant Transgenic Plants - No. 25, 2002, ENV/JM/MONO(2002)14; Consensus Document
on the Biology of Prunus Sp. (Stone Fruits) No. 24, 2002, EN/JM/MONO(2002)13; Consensus Document on
the Biology of Pinus Strobus L. (Eastern White Pine) - No. 22, 2002, ENV/JM/MONO(2002)3; Consensus
Document on the Biology of Picea Sitchensis (Bong.) Carr. (Sitka Sp ruce) - No. 21, 2002,
ENV/JM/MONO(2002)2; Consensus Document on Information Used in the Assessment of Environmental
Applications Involving Baculoviruses - No. 20, 2002, ENV/JM/MONO(2002)1; Consensus Document on the
Biology of Beta vulgaris L. (Sugar Beet) - No. 18, 2001, ENV/JM/MONO(2001)11; Consensus Document on
the Biology of Populus L.. (Poplars) - No. 16, 2000, ENV/JM/MONO(2000)10; Consensus Document on the
Biology of Glycine max (L.) Merr. (Soybean) - No. 15, 2000, ENV/JM/MONO(2000)9; Consensus Document
on the Biology of Oryza sativa (Rice) - No. 14, 1999, ENV/JM/MONO(99)26; Consensus Document on the
Biology of Picea glauca (Moench) Voss (White Spruce) - No. 13, 1999, ENV/JM/MONO(99)25; Consensus
Document on the Biology of Picea abies (L ) Karst (Noway Spruce) - No. 12, 1999, ENV/JM/MONO(99)14
http://www.olis.oecd.org/olis/1999doc.nsf/LinkTo/env-jm-mono(99)14; Consensus Document on General
Information Concerning the Genes and Their Enzymes that Confer Tolerance to Phosphinothricin Herbicid - No.
11, 1999, ENV/JM/MONO(99)13; Consensus Document on General Information Concerning the Genes and
Their Enzymes that Confer Tolerance to Glyphosate Herbicide - No. 10, 1999, ENV/JM/MONO(99)9;
Consensus Document on the Biology of Triticum Aestivum (Bread Wheat) - No. 9, 1999,
ENV/JM/MONO(99)8 http://www.olis.oecd.org/olis/1999doc.nsf/LinkTo/env-jm-mono(99)8; Consensus
Document on the Biology of Solanum tuberosum subsp. tuberosum (Potato) - No. 8, 1997, OCDE/GD(97)143;
Consensus Document on the Biology of Brassica napus L. (Oilseed rape) - No. 7, 1997, OCDE/GD(97)63.

48. Different "objective" conditions . It is often the case that the geographical, climatic or
environmental conditions prevailing in two WTO Members are so different as to affect decisively the
conduct of a risk assessment. A given product ma y, when imported, have negative sanitary or
phytosanitary consequences for one WTO Member , while it may have no adverse consequences
whatsoever for another WTO Member. For instance, if a fruit carrying Medite rranean flies (an insect
that is deleterious for citrus fruit production) is im ported into another Member, where the climate is
cold and there is no citrus fruit production, there is si mply no risk of spread of a pest. But if the same
fruit is imported into California, that may be a reason for concern. In the case of the Member with a
cold climate, there is no need for a specific risk asse ssment with regard to Mediterranean flies. In the
case of California, there may be a need to conduct a risk assessment.

49. In the context of the present case, it is undis puted that there are objective differences between
the territories of each of the Complaining parties and the territory of the European Communities that
partly explain the differences in their respective assessments of the risks posed by GM products.

50. Different types of values and concerns . A second reason that may lead two WTO Members
to react differently to a given factual situation re lates to the values or concerns prevailing in their
respective societies. Indeed, two countries wher e the same "objective" conditions prevail may
however react differently to a given risk factor.

51. Consider for instance the case of non target ef fects of Bt crops. If country A is not at all
concerned about such effects, it will certainly not explore a wide range of issues when assessing Bt
crops for approval (e.g. whether or not Bt crops may negatively affect microfauna). However,
neighbouring country B may be con cerned about non target effects, and it will therefore address the
issue under the relevant authorisation procedures. It goes without saying that country B will need
more information to complete its assessment of th e risks of a given Bt crop. It also goes without
saying that country B will need more time to complete its authorisation procedure.

52. Different levels of protection. Two WTO Members where the same "objective" conditions
prevail, and which share the same type of values and concerns, may still react differently to a given
situation depending on the level of protection that th ey deem appropriate. This will surely affect the
conduct of a risk assessment.

53. For example, let's say that countries A a nd B are both concerned about the preservation of
farmland biodiversity. For that reason, both countr ies want to ensure that the introduction of GM
crops does not result in a significant reduction of plan t diversity in arable lands. However, country A
considers that a 25% reduction is reasonable (if ba lanced against the expected economic benefits),
while country B would consider a 10% reduction as the maximum admissible impact on the
environment. Available scientific evidence shows an expected reduction of plant diversity of between
5% and 20%. Clearly, country A can consider that information as sufficient for the purposes of its
risk assessment because the extent of the losses remains in any event below its tolerance threshold.
However, it is also clear that country B will consid er the information to be insufficient and hence it
will ask for a more detailed study before it can approve the product. In that way, the chosen level of
protection of country B directly affects the conduct of the risk assessment.

54. The Panel should therefore be careful not to curtail the freedom of WTO Members to choose
their appropriate level of protection and, accordin gly, to establish the threshold of evidence for
regulatory approval that is necessary to the achieve ment of their goals. The judgement on how much
scientific information is needed to make a given decision is mostly a matter to be determined by
reference to the specific situation of each WT O Member, the amount and quality of information

available, the novelty of the products concerne d, and the degree of the remaining scientific
uncertainties and, as explained above, its chosen level of protection.

123. Please assume for the sake of argument that Article 5.7 of the SPS Agreement provides
for an exception in the nature of an affirmative defence:

 (a) Could the Panel assess the merits of an y such defence without having previously
found an inconsistency with Article 2.2 of the SPS Agreement?

 (b) If not, in a case such as this one where a claim of inconsistency with Article 2.2 of
the SPS Agreement is based on a claim of inconsistency with Article 5.1 of the
SPS Agreement, would it be correct for the Panel to begin its analysis with the
Article 5.1 claim, then move to the co nsequential Article 2.2 claim and finally
turn to the Article 5.7 defence?

55. The European Communities considers that th e assumption referred to in this question is
legally erroneous, as it has explained in its s ubmissions. Consequently, for the European
Communities, it is not possible to answer the followi ng parts of the question in a legally meaningful
way. The relationship between Ar ticle 5.7 and Article 2.2 of the SPS Agreement being one of
exclusion, the question of whether or not there is an inconsistency with any particular obligation
found in one of those provisions is entirely independe nt of the question of whether or not there is an
inconsistency with an obligation contained in the ot her provision. The same is true with regard to
Article 5.1 of the SPS Agreement.

128. With reference to para. 17 and footnote 2 of attachment II of th e US rebuttal, does the
European Communities agree that "risks arising from" biotech plants include "risks arising
indirectly or secondarily from" biotech plants? If not, why not?

56. Whether or not the United States is correct to argue that "risks arising from" biotech plants
include "risks arising indirectly or secondarily from" biotech plants misses the point made by the
European Communities. As the European Communiti es stated at paragraph 396 of its First Written
Submission: "The words 'arising from' indicate a degr ee of causality" ("découlant" "resultantes"). But
the point which the Communities made in its Fi rst Written Submission - and which it strongly
maintains - is that the measure which is adopted must be applied for the purpose of meeting one of the
objectives identified in paragraph 1 of Annex A of the SPS Agreement. To the extent that a measure
was not adopted for one of those purposes – e.g. because it was not applied "to protect animal life or
health … from risks arising from additives, contam inants, toxins or disease-causing organisms in
foods, beverages or feedstuffs" – it cannot be an SPS measure.
5 In such a case it is wholly irrelevant
whether the effects of the additive, contaminant or toxin are direct or indirect, or primary or
secondary. The broad reading suggested by the United States cannot of itself transform a non-SPS
measure into an SPS measure. What matters is the nature of the measure and the nature of the risk.

57. Paragraph 17 and footnote 2 of attachment II of the US rebuttal, to which the question refers,
nicely illustrate the vacuum at the heart of th e Complainants' submissions: the conveniently loose
manner in which they read Annex A.1 of the SPS Agreement. The issues that are discussed in those
parts of the US rebuttal clearly relate to, or at the very least include, environmental or biodiversity
issues. And yet nowhere in these parts of its s ubmission does the United States take the trouble to
inform the reader of which specific provision of Annex A.1 of the SPS Agreement it is supposed to be

5 Each of sub-paragraphs (a) to (d) of paragraph 1 of Annex A is self-contained, each identifies one or
more objectives to be protected from a number of specified and limited risks.

referring to. The only clue that is given is in th e second sentence of paragraph 5 of attachment II of
the US rebuttal, which refers to s ub-paragraph (d) of Annex A.1 of the SPS Agreement. And that is
the point at which the US case simply collap ses, because the risks with which the European
Communities is concerned, at least in part, are not "pest" risks. The US just assumes that if A
"injures" B, A is a "pest" vis à vis B, which neither scientifically nor legally makes sense. If a GMO
crop adversely effects the biogeochemical cycle, for example, it is simply not behaving as a "pest"
within the meaning of the IPPC – and in this r espect the European Communities also refers to its
answer to question 119. These matters therefore fall outside the scope of the SPS Agreement.

129. With reference to para. 61 of Canada's rebuttal, could the Regulatory Committee
procedure have been used to establish harmoniz ed risk assessment objectives and methodology
pending the entry into force of a revised EC Directive 90/220?

58. The answer to this question is No.

59. The Regulatory Committee Procedure is a procedure of delegated decision-making.
6 It can
only be used where the law so provides.

60. Under Directive 90/220, the use of the Re gulatory Committee procedure was provided for in:

– Article 6(5) (simplified proce dure for Part B authorisations),
– Article 9(1) (Part B authorisations, format for summary of notification),
– Article 10(3) (Part C authorisations, list of Community legislation providing
for specific environmental risk assessment similar to that laid down in
Directive),
– Article 12(3) (Part C authorisations, format of summary of notifications
– Article 13(3) (Part C authorisations, objections from Member States)
– Article 16(2) (Part C authorisations, safeguard measures), and
– Article 20 (Amendments to Annexes II and III).
61. None of the above allowed for the adopti on of harmonised objectives and methodologies of a
risk assessment. In particular, Article 20, wh ich was the only provision allowing for formal
amendments to the legislation through the Regulatory Committee procedure, was limited to
"adaptations" of Annexes II and III. These annexes li st information requirements for the notification.
They do not contain any harmonised objectives or a harmonised methodology for a risk assessment.

6 The decision-making power is delegated from the legislative body(ies) to the Commission who acts
under the supervision of a Committee consisting of Me mber States representatives. There are different
forms/degrees of supervision (Comitology), the "strictest" being that of the Regulatory Committee.

130. With reference to para. 48 of Canada's supplementary rebuttal, does the European
Communities agree that it could not have been th e intention to exclude from the scope of the
SPS Agreement risks arising from allergens in fo od? If not, can the European Communities
indicate a rationale for not subjecting risks aris ing from allergens to the disciplines of the SPS
Agreement?

62. As the European Communities has explained in its written submissions, it considers that the
scope of the SPS Agreement is the result of a carefully crafted compromise, reflected in the precise
text of Annex A.1. It should not be "broadly" in terpreted, but simply inte rpreted in a manner that
gives proper weight to the text.

63. Canada's argument is essentially that all food safety issues were intended to be covered by the
SPS Agreement and that allergenicity is a food safety issue. This is an unconvincing argument. First,
food safety is not a term used in the SPS Agreement. Second, there is a continuum between food
quality and food safety issues. For example, nutritional composition is clearly a food quality issue
which may have implications for health and theref ore food safety. The line between food quality and
food safety has to be drawn somewhere and this has been done through the careful drafting of
Annex A.1

64. Furthermore, the European Communities would point out that potential allergenic effects
arising from GM plants may occur as a result of exposu re other than through food. For example, it is
well known that pollen inhalation, or contact between part of a plant and the skin of a human, may
give rise to allergic reactions. Consequently, the issu e of allergenicity is not confined to food safety.
Rather, the potential presence of allergens in the e nvironment as a result of the release of GM plants
may be considered a broader environmental issue, not specifically included in the text of Annex A.1
of the SPS Agreement.

131. To what extent did/do Directives 90/220 and 2001/18 and Regulation (EC) No 258/97
permit for the establishment of conditions on the granting of approval for product applications?

65. As regards release into the environment, both Directive 90/220 and Directive 2001/18 provide
for the possibility to make the consent for placing on the market subject to conditions. This can be
inferred from Articles 12(3) and 13(5) of Directive 90/220 and from Articles 19(1), 19(3)(a), 20(3) of
Directive 2001/18.

66. With respect to the extent to which such c onditions (could) can be established, it is important
to understand that it is the applicant who defines the conditions of use and handling in the notification
(see Article 11(1) of Directive 90/220 and 13(2)(b) of Directive 2001/18). Indeed, it is within the
limits of these conditions of use and handling only , that the authorisation can establish (additional)
conditions to address concerns that have arisen in the risk assessment. Thus, it would not be possible
for the authorities, for example, to set as a condition of the consent, the modification of the scope of
the application from cultivation to import, if the applicant didn't agree to such condition, since this is a
question of conditions of use which the applicant has to propose.

67. An example for a condition other than rela ting to use and handling established in market
authorisations adopted in previous years is specific labelling requirements.

68. As regards food use, Art 7.2 of Regulation 258/97 states that:

the decision shall define the scope of th e authorisation and shall establish, where
appropriate:

The conditions of use of the food or food ingredient. […]
69. This provision has in fact been implemented in all food product applications at stake, for
instance by setting as a condition for approval, that th e requirement to provide detection methods and
reference material be provided.

132. Please explain the approval procedure app licable for a product for which approval was
requested for feed use only. Which was the relev ant EC scientific body requested to provide an
opinion for such an application?

70. Feed use was not covered by Regulation 258/97 which applied exclusively to food use for
human consumption (see Article 1). Feed use to the extent it concerned GMOs (i.e. living
organisms), therefore, came under Directive 90/220, and later Directive 2001/18. Today, feed use is
covered by Regulation 1829/2003.

71. Feed use, under Directive 90/ 220 was often included in applica tions for either cultivation or
import and processing of GMOs. The lead Competen t Authority was responsible for carrying out the
relevant feed risk assessment, wh ich it would usually do with the he lp of national scientific advisory
bodies. At Community level, the Scientific Co mmittee on Plants was supported by experts from the
Scientific Committee on Animal Nutrition, as the rele vant scientific body to provide advice on animal
nutritional safety. The SCP's advisory opinion, therefore, would also cover feed safety aspects.

72. As has been made clear by the Panel's expe rt advice, the risk assessment of food uses and
feed uses are notably different. Target animal physiology is different from human physiology and
there are differences in what is consumed (which part of the plant, processed or unprocessed) and in
what quantities. The results of a food safety assessme nt, therefore, cannot be extrapolated to feed
safety.

133. Please explain the approval procedure app licable for a product for which approval was
requested for both food and feed use, but no t for cultivation. Which was the relevant EC
scientific body requested to provide an opinion for such an application during the period 1998
through 2003?

73. Approval for both, f ood and feed use of a GMO, during the relevant period, necessitated two
separate applications, namely one for food use under Regulation 258/97 and one for feed use (as part
of the uses covered by an application for cultiv ation or import) under Di rective 90/220 (until 17
October 2002) or Directive 2001/18 (after that date).

74. At Community level, for the application fo r food use under Regulation 258/97, the Scientific
Committee for Food was requested to provide an op inion according to Article 11. Under Directive
90/220, although there was no obligation in the legisl ation, the Scientific Committee for Plants (SCP)
was routinely consulted. As seen above under Qu estion 132, for the purposes of assessing feed safety
risks the SCP was supported by the Scientific Committee on Animal Nutrition. Under Directive
2001/18 the consultation became mandatory under Ar ticle 28 explicitly providing for the possibility
of consulting several ("relevant") Committees.

134. With respect to the EC statement in paragraph 36 of its Responses to the Questions
from the Panel (16 June 2004), is the Panel to understand that should an unintended adverse
effect be identified for a product which had been approved prior to the entry into force of
Directive 2001/18, it would be "legally impossible or at least questionable" to terminate that
authorization?

75. The European Communities would like to point out that there is a difference between having
identified an unintended adverse effect in a produc t and subjecting a product to new risk assessment
and risk management requirements. The Panel' s question is about the former, the European
Communities' reply in para. 36 of its Responses to the Questions (16 June 2004) was about the latter.

76. As regards the former, even though this was less explicit than in Directive 2001/18 (see
Article 20(3) of Directive 2001/18), there would have been no legal obstacle, under Directive 90/220,
to terminating an authorisation in a situation wher e an unintended adverse effect had been identified
for a product. Indeed, as can be inferred from Article 11(6) of Directive 90/220, there was an
obligation on the notifier "to take measures necessary to protect human health and the environment."
This can be read to encompass the obligation of ending the use of the product altogether if that is what
would be necessary to protect human health and the environment. Furthermore, the possibility for
Member States to adopt safeguard measures and fo r the Community to react to such safeguard
measures with a Community level decision (Article 16 of Directive 90/220) implies that a product can
be prohibited if unintended adverse effects have been identified.

77. As regards the latter, on the other hand, th e European Communities reiterates its statement
made in para. 36 of its Responses to the panel's questions (16 June 2004) that it would have been
"legally impossible or at least questionable" to terminate existing authorisations just because new
legislation was envisaged that would put in place st ricter requirements as regards risk assessment and
risk management issues.

135. In paragraph 52 of the EC Responses to the Questions from the Panel (16 June 2004)
that "Since the late '80s, the EC institutions are required to provide an explanation of the
reasons for not following the opinion of the spec ific scientific committee relevant to the matter
under consideration". Are these explanations made public or provided to the notifier
concerned?

78. The answer to this question is Yes. The explanations are made part of the decision.

79. It should be pointed out that it is a legal principle in Community law that a decision needs to
be reasoned, i.e. sufficiently motivated (see Article 253 EC Treaty).

80. This principle has been put into more conc rete terms for decisions requiring technical or
scientific evaluations in the case law and in legislati on towards the end of the eighties, early nineties.
Thus, in the case Technische Universität München v. Hauptzollamt München-Mitte the Court struck
down a decision which did not contain "a sufficient statement of the scientific reasons capable of
justifying the conclusion […]."
7 Legislation in the field of risk regulation adopted around the same
time specifically required that where a draft deci sion was not in accordance with the opinion of the

7 Case C-269/90 Technische Universität München v. Hauptzollamt München-Mitte , Judgment of the
21 November 1991, 1991 ECR 5469, para. 27.

relevant scientific committee, the Commission was to annex a detailed explanation of the reasons for
the differences.
8

136. In the context of paragraph 195 of the EC Responses to the Questions from the Panel
(16 June 2004), does the EC maintain that the appropriate level of protection that might be
relevant to a definitive action is different from the ALOP that would be relevant to a provisional
measure taken in the face of insufficient scientific evidence?

81. The principal point that the European Commun ities is making in para 195 of its replies to the
Panel's questions following the first substantive meeting is that one cannot, in the context of
Article 5.5 of the SPS Agreement, meaningfully compare the actions of the European Communities
with those of the Member States, given the diffe rent ALOPs. The European Communities further
noted that such a comparison between definitive and provisional measures might also, in principle, be
questionable. That is at least the position in the case of provisional approvals. In this respect, it
should not be forgotten that the ALOP and the risk assessment and the type of measure adopted are
intimately connected. Thus, if the measure envisaged is an unconditional definitive approval, then the
authorising authority may seek a particularly high degree of certainty – and one might say, in other
terms, that it has a relatively high ALOP. If, on the other hand, the measure envisaged is a provisional
and conditional approval, revocable in the light, for example, of the results of monitoring, then the
authority might be satisfied, for the time being, with a lower degree of certainty – and one might say,
in other words, that the ALOP is different.

137. Please explain the statement in paragra ph 195 of the EC Responses to the Questions
from the Panel (16 June 2004), that SPS 5.5 is not concerned with the consistency of the
behaviour of regional authorities within a Memb er's territory within a provisional temporal
frame of reference. Is this with respect to the consistency of different decisions by a single
regional authority, or with respect to the cons istency of decisions taken by different regional
authorities with regard to the same potential risk?

82. The comment relates to the consistency of diffe rent decisions by a single regional authority.
The point is that, over time, the available pertinen t information may well be changing, so one cannot
simply compare different provisional measures taken by the same authority at different times, and
make the bare assertion that there is an inconsistency. Furthermore, under the SPS Agreement ,
authorities are entitled to change their ALOPs over tim e, even in the absence of "new information",
simply because they reassess what objective they are tr ying to achieve, and that in itself would not
disclose any inconsistency with the SPS Agreement. Otherwise, once an ALOP had been chosen, it
would forever be "frozen" – which is cl early not something foreseen by the SPS Agreement. Finally,
every product is different, and every product needs to be considered on its merits, so it is even
possible that the same issue (such as Bt resistance) justifies a measure in one case, but not in another.

138. Please explain how the process identified in paragraphs 244-245 of the EC Responses to
the Questions from the Panel (16 June 2004) functions. In particular, is the Panel to understand
that if a request for further information co ncerns an issue which the lead CA considers has
already been fully addressed by the SCP, the lead CA may decide not to forward this request to
the notifier – but the other EC member State which submitted the request may continue to
claim that is it not satisfied due to lack of information?

8 See Article 32(1) of Regulation 2309/93 laying down Community procedures for the authorization
and supervision of medicinal products for human and veterinary se and establishing a European Agency for the
Evaluation of Medicinal Products, (OJ N° L 214 of 24.8.1993, p.1)

83. The EC considers that the Panel's understanding is correct, as far as the part of the procedure
involved is the one where the lead CA is in charge of the processing of the application. Such decision
of the lead CA is however without prejudice to a possible different action by the Commission or
another CA, at a later stage of the procedure, for the same application. In particular, if the MS that
had initially filed the request remains unsatisfied due to the lack of the information after the lead CA's
explanation of its decision not to forward the request to the applicant, it may ensue that its request is
forwarded to the applicant at a later stage in the pr ocedure or that that Member State will maintain a
reserve or express a negative opinion when the authorization for the product under question is
scrutinized by the Regulatory Committee. Two further qualifications appear, however, opportune.

84. First, this role of the lead CA may not hol d true when a Member State request is directly
before a scientific Committee, which may itself directly seek the relevant information from the
applicant, without the involvement of the lead CA.

85. Second, this does of course not preclude a Member State that has requested further
information, where such request has indeed been submitted to the applicant, from considering that the
information provided in response by the applicant is not sufficient or appropriate for the purposes of
completing a risk assessment in accordance with the provi sions of the relevant legislation. Therefore,
even in this case, that Member State could main tain a reserve or express a negative opinion when the
authorization for the product under question is scr utinized by the Regulatory Committee in the so-
called "Comitology" procedure.

139. With regard to paragraphs 293-294 of th e EC Responses to the Questions from the
Panel (16 June 2004) regarding the submission of draft measures to the Regulatory Committee,
what is the purpose of submitting such draft measures to the Regulatory Committee when the
Commission considers that they are not in a state to be considered for a final decision?

86. The Regulatory Committee of Directive 90/ 220 (the one addressed in the relevant
paragraphs 293-294 of the EC Responses to the Qu estions from the Panel of 16 June 2004), had not
only a regulatory but also an advisory role within the Comitology procedure of this Directive.
Therefore, it was important for the Commissi on to submit draft measures to the Regulatory
Committee to identify whether Member States had any outstanding concerns as regard the
Commission's draft measure in view of final adoption, and if so, what were the relevant issues that the
Member States considered to be inappropriately covered by the draft decision.

87. In the latter instance, if the Commission cons idered that the Member States were raising valid
concerns, that might or might not necessitate further assessment of risks or development of risk
management measures, or if any other relevant scientific information would have made it necessary,
the Commission may have decided to postpone the vo te and revise its draft measure, pending further
assessment or the resolution of the valid concerns.

88. In more general terms, the Panel should be aware that in the Regulatory Committees the
Commission and the Members States discuss the appli cations at length, e.g. present questions and
answers. Before voting takes place, each application might be discussed several times. The agenda of
the respective meetings indicates this also as 'discussion or exchange of views'.

140. With reference to (1) Codex standards 192 and 193, (2) IPPC and (3) ISPM 11:

 (a) Are they "rules of international law applicable in the relations between the
parties [to this dispute ]" within the meaning of Article 31(3) of the Vienna
Convention on the Law of Treaties?

 (b) May they be used as additional factual evidence of the ordinary meaning of
terms contained in Annex A of the SPS Agreement, as the United States appears
to suggest in its rebuttal at para. 6 of attachment II? (The United States is
invited to provide elaboration on its statement at para. 6.)

89. No. The European Communities refers to its reply to Question 4 from the Panel (following
the first substantive meeting with the parties). The European Communities there explained that
Codex Standards and other equivalent standards ar e highly relevant to these proceedings. They may
be considered as inter alia "international standards, guidelines and recommendations". However, the
European Communities proceeds on the basis that the Panel does not c onsider these instruments to be
binding international law instruments.

90. Furthermore, the IPPC revision on the basi s of which ISPM 11 (2004) was published had not,
at least at the date of establishment of this Panel, been ratified by the European Communities.

91. Annex A.1 of the SPS Agreement defines the scope of the SPS Agreement. It does not refer to
"International standards, guidelines and recommendations". The provisions referred to in the question
are not therefore dispositive of the meaning of words or phrases in Annex A.1 of the SPS Agreement.
However, parts of those provisions may provide releva nt context. This is not a question of "factual
evidence", but a question of context relevant for the purposes of interpretation. For example, the
European Communities has indicated (see the respon se to question 119 from the Panel) that it has no
particular difficulty with the IPPC definition of the word "pest". That does not mean that the
environmental risks described in ISPM 11 (2004) , specifically designed to reflect the Biosafety
Protocol, automatically fall within the scope of the SPS Agreement. The text of Annex A.1 of the SPS
Agreement and its negotiating history make it clear th at environmental and biodiversity risks fall
outside the defined scope of the SPS Agreement.

141. With reference to Annex (B)(1) of the SPS Agreement, please answer the following
questions:

 (a) Does the term "sanitary and phytosani tary regulations" cover administrative
decisions which relate to the operation of approval procedures and which are
generally applicable?

 (b) May the phrase "sanitary and phytosanitary regulations which have been
adopted" be interpreted to encompa ss also sanitary and phytosanitary
regulations which have been adopted de facto (e.g., generally applicable
decisions which have been reached informally and which are unrecorded)?

92. (a) It is clear from footnote 5 that what ma tters is not the formal label attached to the
measure, but the fact that it is "generally app licable" or normative in nature. A "sanitary and
phytosanitary regulation" is a type of measure that would be attacked in WTO panel proceedings "as
such", rather than "as applied". As the Appella te Body has recently observed, that is a measure
"setting forth rules or norms that are intended to ha ve general and prospective application" (Appellate

Body Report, US-Carbon Steel from Japan, para 82).
9 General normative rules of prospective
application setting forth approval procedures in abst ract terms are thus "sanitary and phytosanitary
regulations" within the meaning of Annex B of the SPS Agreement . On the other hand, a single
approval procedure, leading to an administrative decision in a specific case – such as would be
attacked "as applied" in panel proceedings, is not a "sanitary and phytosanitary regulation" within the
meaning of Annex B of the SPS Agreement.

93. Thus, the words "which relate to" in the qu estion are ambiguous. If a measure is labelled an
"administrative decision" but in fact sets out in ab stract terms "approval procedures" intended to have
general and prospective application, it is a "sanita ry and phytosanitary regulation" within the meaning
of Annex B of the SPS Agreement, and its formal label will not cha nge that conclusion. If, on the
other hand, the measure is adopted at the end of a specific administrative procedure and represents the
outcome of a specific approval procedure in relation to a specific product, it is not a "sanitary and
phytosanitary regulation" within the meaning of Annex B.

94. (b) The word "adopted" has a legal connotation. It indicates (1) someone or something
that does the adopting (2) something, such as an act or document, that is adopted and (3) some kind of
minimum procedure by which the "adoption" takes place. A thought or wish that may or may not
have formed for a moment in the mind of one or more individuals with some potential role to play in a
potential adoption procedure is not a measure; no more so if one or more such individuals articulate
such thought or wish; no more so if one or more of them write it down or if their utterances are
reported.

95. Thus, the phrase "de facto" "adoption" has no meaning, because the words "de facto" indicate
a complete absence of any formal context; whilst the word "adoption" requires it. Indeed, in this case,
the Complainants have not even plausibly alleged any one of the three constituent elements outlined
above: whatever certain individuals may or may not have said, no authority has acted; the
Complainants cannot point to any act or documen t; and the Complainants have not specified any
procedure.

96. The word "informally" is equally vitiated. A measure cannot be "informally" "adopted".
Either a measure is adopted or it is not.

97. Finally, with regard to the word "unrecord ed" the European Communities can only repeat that
it is not possible, in the Community jurisdiction, to adopt an act with legal effects that is
"unrecorded". Such a thing simply does not exist. It is a chimera – an Orwellian "thought crime" -
that persists only in the fertile imaginations of the Complainan ts, because they perceive it as
convenient for their cause.

142. Please explain the meaning and rationale of the requirement in Article 2.2 that SPS
measures be "based on scientific principles" and how this is different from the requirement that
SPS measures not be maintained "without sufficient scientific evidence".

98. Viewing this provision from the point of vi ew of definitive measures, one could consider
there to be a degree of overlap, insofar as if it were demonstrated that a particular piece of evidence
were not "scientific", it would presumably also be pos sible to argue that it was not based on scientific
principles. And if the principles underlying an experiment were shown to be not "scientific", then
presumably the "evidence" resulting from the experi ment would equally be considered not to be
"scientific". The concepts of "principle" and "evi dence" are, however, clearly different. The testing

9 See also Appellate Body Report, Japan-Agricultural Products, paras 103 to 108.

of hypothesis by controlled experiment, observation and reasoned conclusion are scientific principles.
The relative mortality rates of butterflies fed on GM and non-GM plants is scientific evidence.

99. Viewing this provision from the point of view of provisional measures, the question is in fact
very revealing and highly supportive of the position of the European Communities in this case. The
core of the parties' disagreement often turns aroun d the same point: how is one entitled to proceed if
nothing or very little is known about certain issues; and who decides what are the issues that might
require further investigation ? The European Commun ities considers that, at the frontiers of science,
and taking its ALOP into account, it is entitled to be prudent. And this position is perfectly confirmed
by the language of Article 5.7 of the SPS Agreement . The pertinent requirement here is that a
Member acts "on the basis of available pertinent in formation". Understandably, there is no reference
to "scientific evidence" because it mi ght be that there is very little or even no scientific evidence in
relation to the matter of concern. Equally, there is no reference to "scientific principles", because in
the absence of any evidence, it is hard to see what ro le the principles would have to play. The "undue
delay" provision of Annex C of the SPS Agreement must be read in the same light. That brings us to
the following point. The European Communities w as concerned, for example, about the possible
effects of a GM crop on European biogeochemical cycles. We thought there was very little scientific
evidence on this issue; we wanted to know more; a nd in the meantime, given our ALOP, we preferred
to be cautious. By attacking us under Article 2.2 of the SPS Agreement , instead of the relevant
provisions (Annex C and Article 5.7), the Complain ants simply miss the point entirely – probably
intentionally.

143. The Panel notes a number of instances where the same or a related product was
apparently submitted under separate applications fo r approval. This appears to be the case for
Monsanto Roundup Ready oilseed rape GT73 (EC-70, EC-79); Syngenta Bt 11 maize (EC-80,
EC-92, and related EC-69); Pioneer/Dow AgroSc iences Bt corn Cry1F (1507) (EC-74, EC-75,
EC-95); Monsanto Roundup Ready corn NK603 (EC-76, EC-96); Monsanto Roundup Ready
corn GA 21 (EC-78, EC-85, EC-91); and the various "stacked" products. To what extent does
the assessment by a lead CA, the relevant EC Scientific Committee and any information
provided by a notifier under one application serv e as a basis for consideration of another
application for the same or a related product?

100. The assessment of products under the envir onmental release directive (Directive 2001/18/EC
and its predecessor Directive 90/220/EEC) aims at assessing the environmental impact of the release
of the GMO as well as the possible impact of such re lease on human health or animal health (e.g. in
case of incidental consumption). The assessment of products under Regula tion 258/97 on novel food
aims at assessing the safety of th e GM food or GM food ingredients in question which are in general
not consumed as GMO (i.e. living organisms) but as pr ocessed products. Therefore, the data set to be
reviewed during the risk assessments are not identi cal. For example in the case of a novel food
application, the nutritional impact of a regular in take of the GM food should be assessed, but this
environmental impact (e.g. the issue of Bt resist ance monitoring in case of food derived from a Bt
crops) does not need to be assessed under Regulation 258/97.

101. Because of the existence of two different pieces of legislation, the assessment of applications
filed under Directive 2001/18/EC (or Directive 90/220/ EEC) and the assessment of applications filed
under Regulation 258/97 were carried out separat ely and often by different scientific bodies
encompassing different set of expertise: e.g. at EC level, such assessments were the responsibility of
respectively the Scientific Committee on Plants (S CP) for application for environmental release and
of the Scientific Committee for Food (SCF) for nove l food applications. The European Community
became rapidly aware of possible overlaps as well as possible gaps between the assessments carried
out under different sets of legislation. This has been addressed by the creation of the European Food

Safety Authority in 2003 and the creation of one single scientific panel responsible for the risk
assessment of GMOs and derived products. Pending the establishment of the European Food Safety
Authority, an informal joint working group on GMOs and derived products including experts from the
SCP, the SCF and the Scientific Committee on anim al nutrition (SCAN) was established in 2001 to
carry out the risk assessment of GMO and derived pr oducts in order to avoid duplication and gaps in
the risks assessment process.

102. In addition, it should also be noted that in order to address these possible overlaps and gaps
between the various regulatory regimes, the Eur opean Communities has recently developed a new
legislation, on GM food and feed which entered into force in April 2004 (Regulation 1829/2203 on
genetically modified food and feed) which stream lines the authorisation procedure for GMOs and
derived food and feed. This regulation has est ablished the one-door-one-key principle where
applicants can request a complete authorisation in one single application, including food and feed use
as well as cultivation. Such applications are assessed by the European Food Safety Authority.

144. The Panel notes that a number of products containing the same transgenic modifications
as products at issue in this dispute were prev iously approved by the European Communities
prior to July 1998 (eg, swede rape tolerant to glufosinate ammonium (MS1, RF1) and (MS1,
RF2); swede rape tolerant to glufosinate ammonium (Topas 19/2); maize tolerant to
glufosinate ammonium (T25); maize expressing the Bt cry1A(b) gene (MON 810); maize
tolerant to glufosinate ammonium and expressi ng the Bt cry1A(b) gene (Bt-11); soybean
tolerant to glyphosate; chicory tolerant to glufosinate ammonium; maize Roundup Ready
NK603). To what extent and how were the prev ious assessments of potential risks to human,
animal or plant health and/or the environment associated with these transgenic modifications
taken into consideration in the evaluation of po tential risks arising from the products at issue
before the Panel?

103. As explained in the response to question 14 3, the data set for the risk assessment of an
application filed under the environmental release directive and the one for a novel food application are
not identical. Products approved under Regulation 258/97 were all processed products (and therefore
were not GMOs) and have been approved under the si mplified procedure laid down in Article 5 of the
Regulation pertaining to products which have been recognised as substantially equivalent to
conventional foods. As explaine d in previous EC submissions
10 and confirmed by Dr. Nutti at the
hearing, the understanding of the concept of substa ntial equivalence has greatly evolved since 1998.
The establishment of substantial equivalence is no longer recognised to constitute a risk assessment in
itself; it is considered now to be a step of the risk assessment process as explained in Codex
guidelines for the conduct of food safety assessment of food derived from recombinant-DNA plants
(paragraph 13).

104. Applications filed unde r Directive 2001/18/EC (or its predecessor Directive 90/220/EEC),
concern the environmental release of GMOs ; in the EU definition, GMOs are living
 organisms. So,
the establishment of substantial equivalence for fo od or food ingredients derived from these GMOs
does not constitute a risk assessment for the release of the living organism itself. For example, oil
produced from GT73 has been approved under the simplified procedure of Regulation 258/97.
However, the establishment of substantial equiva lence of oil produced from GT 73 does not provide
information on the molecular characterisation of GT 73, the possible presence or not of anti-biotic
marker gene, or the fate of the GMO it-self in the environment.

10 See Comments by the European Communities on the Scientific and Technical Advice to the Panel,
paras. 51ff.

152. With reference to para. 211 of Canada's re buttal, is it correct that the "Rapporteur had
merely re-requested information that had previously been received from the applicant"?

105. No, it is not correct.

106. The entries in the chronology for the period re ferred to by paragraph 211 of Canada's rebuttal
refer to four 'exchanges' between the lead CA
11 and the notifier which follow the lead CA's
communication to the notifier of what still needed to be done with regard to the application. It is in
the light of this communication dated 22 March 2000 (EC-70/Att. 018) that the notifier writes to the
lead CA on 28 April 2000 (EC-70/Att. 019 and 020) sending "blots from three reports" (and, indeed,
these had been already transmitted to the lead CA) as well as "the exact name of Monsanto in
Europe". This second item addresses the remark by th e lead CA in its email of 22 March 2000 that
"the legal name and the registration of Monsanto need to be confirmed" and it is certainly a new
element, not of a scientific nature, but still necessar y to complete the requirements of the application
process.

107. More importantly, the second entry for this period, "Clarifications from Monsanto", dated
17 May 2000 and contained in Att. 021, is an email w ith which the notifier forwards to the lead CA a
"working document describing the modifications /addendum" it intends to do in the original
application and on which it requires the opinion of the lead CA. Such an update of the application,
although it may have contained information submitte d over the past two years, is indeed a new
element in the authorisation process because it changes the terms of the a pplication. This can also be
understood from the fact that the notifier sends it in draft format and requires the comment of the lead
CA. Lead CA that, on 19 May 2000 (third entry for this period - Att. 022), informs Monsanto that it
"will communicate its findings as soon as possible".

108. The European Communities has not been able to come in possession of the documents related
to the phone and e-mail exchanges of November 2000 on this issue. However, it can be inferred from
the letter of 12 March 2001 (Att.023) that during th is period the lead CA had indeed analysed the
update. It is, in fact, on that basis that it could conclude that "to confirm the unique molecular identity
of line GT73 a PCR detection method of GT73 should be provided to complete dossier C/NL/98/11".

153. With reference to para. 298 of Canada's rebuttal, is it correct that the document
provided in exhibit EC C-UK-94-M1-1-att.04 refers to the document provided in exhibit EC C-
UK-94-M1-1-att.03? Also, what are the dates of these two documents?

109. The European Communities reads paragraph 298 of Canada's rebuttal as meaning that it is
exhibit EC C-UK-94-M1-1-att.05 (now exhibit EC -161/Att.06) and not exhibit EC C-UK-94-M1-1-
att.04 (now exhibit EC-161/Att.05) that it is re ferred to by exhibit EC C-UK-94-M1-1-att.03 (now
exhibit EC-161/Att.04). In any case:

– exhibit EC C-UK-94-M1-1-att.03 (now exhibit EC-161/Att.04) is a note of
the French Delegation for the atten tion of the Commission of the Autumn
2003, which sets out the arguments relating to the suspension of the
commercialisation of genetically modified, herbicide resistant oilseed rape;
– exhibit EC C-UK-94-M1-1-att.04 (now exhibit EC-161/Att.05) is a note of
the French authorities, dated 8 January 2004 (see the fax which forwards it,

11 The European Communities responds to this question on the basis of the assumption that, when
Canada refers to the "rapporteur", it intends the lead CA, in this case the Netherlands.

exhibit EC-161/Att.03), in response to a letter of the Commission dated 20
October 2003. With this note the French Authorities notify to the
Commission the decree by which France ha d prolonged the suspension of the
commercialisation of genetically modified , herbicide resistant oilseed rape.
They also attach the opinion of the French Commission de Génie
Biomoléculaire of 15 July 2003 (pag es 3-5) on which such prolongation is
based;
– exhibit EC C-UK-94-M1-1-att.05 (now exhibit EC-161/Att.06) is dated
16 February 2001 (its translation is c ontained in exhibit EC-161/Att.07 and
008) and consist of an opinion of the French Commission de Génie
Biomoléculaire in which, indeed, a number of further scientific studies on
oilseed rape were identified as necessary before its commercialisation.
154. At paras. 27 and 30 of the European Communities' second oral statement, reference is
made to concerns regarding "regulatory requirements outside the scope of this dispute
(traceability and labelling)". Is it the European Communities' view that any delays that may
have occurred as a result of member States invoking the need for legislation on traceability,
labelling or coexistence were justified? Why?

110. When referring to "regulatory requirements outsi de the scope of this dispute (traceability and
labelling)" the European Communities was referring to the fact that the Complainants have not
claimed that the requirements relating to traceability and labelling set out in its GMO legislation were
unjustified. Accordingly, delays resulting from the need to satisfy these requirements cannot be
considered to be "undue" or contrary to the WTO Agreements.

155. With reference to para. 211 of Canada's re buttal, is it correct that the "Rapporteur had
merely re-requested information that had previously been received from the applicant"?

111. The European Communities has already provide d an answer to this very same issue under
question 152.

156. With reference to para. 298 of Canada's rebuttal, is it correct that the document
provided in exhibit EC C-UK-94-M1-1-att.04 refers to the document provided in exhibit EC C-
UK-94-M1-1-att.03? Also, what are the dates of these two documents?

112. The European Communities has already provide d an answer to this very same issue under
question 153.

157. In its comments on the replies from ex perts with respect to EC-70, the European
Communities notes that other data was provide d by the notifier without separate appendices –
was this information provided to the Panel, and if so, where is it to be found?

113. In paragraph 423 of its Comments on the Scie ntific and Technical Advice to the Panel of 28
January 2005, the European Communities was conti nuing to analyse the documents which were the
object of Panel's question 28, i.e. the information provided by Monsanto to the Commission and
contained in Exhibit EC-70/Att.84-97. The answer is, therefore, yes, this information was provided to
the panel and it can be found in Exhibit EC-70/Att.84-97.

158. In paragraph 313 of the EC Responses to the Questions from the Panel (16 June 2004)
the European Communities states that the absence of final consent from the lead CA does not

mean that the applicant is not entitled to pla ce the product on the market. Has the product at
issue (canola/oilseed rape MS1/RF1 and MS1/RF2) been sold in all of the European
Community, including in France, and if not, why not?

114. Hybrid GM oilseed rape Ms1xRf1 and Ms1xR f2 have been approved for import, processing
and cultivation in 1996 and 1997. The approvals did not provide for any reporting or monitoring of
marketing in the European Commun ities. Accordingly, the Europ ean Communities is unable to say
whether these products have been sold in the Europ ean Communities. The applicants may be able to
provide the Panel with this information.

115. With respect to seed production, Ms1xRf1 had already been approved earlier under
Directive 90/220. Again, the lack of appropriate tools (detection and identification, or traceability and
labelling) at the time did not allow for proper monitoring of such seed production.

116. With respect to commercial cultivation, no oilseed rape varieties derived from Ms1xRf1 or
Ms1xRf2 have been registered in Member States national Catalogues or in the Common Catalogue of
varieties of agricultural plant species – which is a prerequisite for allowing their commercial
cultivation – because there has been no applica tion from companies to do so. The Panel should
however note that GMO events such as Ms1xRf1 and Ms1xRf2, once approved, should be introduced
in breeding programmes for introgression into commercial varieties which may require several years
of breeding activities.

159. With respect to the products subject to safeguard measures, can the European
Communities confirm that these products are currently permitted to be marketed, and are
being marketed, in EC member States other than those maintaining the safeguard measure?

117. Yes. They are permitted to be marketed fo r all uses, provided that the varieties derived from
these products and destined for commercial cultivation had been registered in the relevant national
catalogue of varieties of the Member State where they were aimed to be cultivated, or in the Common
Catalogue of varieties at Community level. Whethe r they were or are actually being marketed in all
Member States is a factual issue that cannot be answered in the time av ailable. Again, the applicants
should be able to provide the Panel with this information.

118. What is however known is that many of these genetically modified events (Ms1xRf1;
Bt176; …) have ceased to be commercialised in othe r countries, such as Canada or the United States,
because of the lack of commercial interests of these particular lines and their replacement with newer
transformation events.

161. With reference to paragraph 12 of the EC st atement on 22 February 2005, as of when is
MS8 x Rf3 under evaluation by the EFSA for all uses originally identified in the application?

119. As of 10 January 2005.

162. With reference to the EC response in par agraphs 345 of its responses to the questions
from the Panel (16 June 2004), please describe the appropriate level of protection sought by the
EC and its member States with respect to the products at issue in this dispute.

120. It is not possible to describe an "appropriate leve l of protection" in general terms. It is clear
from the terms of the above measures that they seek to secure a high level of protection.

163. In paragraph 239 of its Third Written Submi ssion, Canada maintains that for herbicide-
tolerant seed varieties developed through co nventional breeding or mutagenesis, an
environmental risk assessment (including on farm land biodiversity) of either the seed variety of
the associated herbicide is not required. Could the EC confirm the accuracy of this statement.

121. Under Community law, any new variety of plant (and therefore of seed) is submitted to
Council Directive 2002/53/EC of 13 June 2002 on the co mmon catalogue of varieties of agricultural
plant species.
12 This prescribes that "a variety is accepted onl y if it is distinct, stable and sufficiently
uniform. The variety must be of satisfactory value for cultivation and use" (Article 4, paragraph 1).
In the case of a genetically modified variety, howev er, paragraph 4 of the same Article provides that
"the deliberate release into the environment of th e variety shall be accepted only if all appropriate
measures have been taken to avoid adverse effects on human health and the environment."

122. This said the European Communities respect fully submits that it fails to see what the
relevance of this piece of information is. Even if one were to follow the approach suggested by
Canada at the second meeting with the Panel that th is could be relevant for a consistency assessment
under Article 5.5 of the SPS Agreement, the European Communities notes that, as this differentiation
is mandated by law and Canada has not attacked the legislation in this case 13, such distinction is
outside the terms of reference of this Panel and ca nnot therefore be assessed under Article 5.5 of the
SPS Agreement.

164. In paragraph 94 of Ca nada's second written submissi on, Canada indicates that,
according to a decision of the European Court, if the Regulatory Committee disregards the
scientific opinion of the relevant EC scientific body "it must provide specific reasons for its
findings" and it must explain why it is disregar ding the opinion of the scientific committee.
Please explain when this explanation must be provided, ie, when the Regulatory Committee
decides to seek further information on concern s already considered by the scientific committee,
or only when the Regulatory Committee takes a d ecision on the application? What explanation
must be provided by the Regulatory Committee if it decides not to vote, or if no qualified
majority it achieved in a vote?

123. Canada's assertion in paragr aph 94 of its second written submission is based on an erroneous
understanding of the Comitology procedure in gene ral as well as the case la w referred to in that
paragraph.

124. The role of a Regulatory Committee is to vote on a proposal for a decision presented by the
Commission. It cannot itself propose any decision nor amend the one proposed by the Commission.
Equally, it does not itself have any power to seek further information from the applicant. If the
Regulatory Committee does not endorse the Commission's proposal, the procedure moves up to the
next level. There is no requirement in law to motivate the vote as this is an internal procedural step.

12 Official Journal of the European Communities, N° L 193 of 20.7.2002, page 1.
13 The European Communities wishes to recall that Ca nada's request for establishment of this Panel
(WT/DS292/17 of 8 August 2003) identifies as the measures at issue in this dispute:
1. the general suspension by the EC of its own processes for the consideration of applications
for, and the granting of, approval for biotech products;
2. the failure by the EC to consider or approve, without undue delay, applications for approval of
the products identified in Annex I; and
the national measures identified in Annex II prohibiting the importation, marketing or sale of the
specified EC-approved biotech products."

125. The case law that Canada refers to applies to Community institutions adopting acts that have
(external) legal effect. These are the legislat or (Council and Parliament) or the Commission (by
virtue of direct powers in the EC Treaty or delega ted powers from the legislator), but not an auxiliary
body such as the Regulatory Committee that is merely involved in preparing such an act. The case
law, as explained above in the reply to question 1 35, is a concretisation of the legal principle in
Community law that legal acts need to be reasoned. Thus, the final decision as adopted, either by the
Commission or the Council, has to be reasoned and namely has to provide an explanation if it deviates
from advice provided by a relevant scientific committee.

165. (EC-73): It appears that all of the relevant documentation was not provided in the
context of the application contained in EC-73. However, the chronology provided by the
European Communities shows no action on this application between the 02/00 requests for
further information from the CA, and the 1/ 03 relaunch of the application under Directive
2001/18. Did the notifier fail to provide the information requested in 02/00, and if so, why?

126. The notifier did fail to provide the info rmation requested on 2 February 2002 and the
European Communities ignores why. It can only suppo se, on the basis of the letter of Bayer Crop
Science of 15 January 2003 (EC-73/Att.007) that this might be due to the numerous changes in the
ownership of the producing company as well as in the rights on the pending applications. In fact, the
initial notifier, the French pharmaceutical and chemical company Rhône-Poulenc, merged with
Hoechst to become Aventis. Hoech st was the majority shareholder of AgrEvo. As a result, AgrEvo
and Rhône-Poulenc Agro were combined into Aventis CropScience. Aventis CropScience was
bought in 2001 by the German limited liability company Bayer A.G., which created Bayer
CropScience. On 15 January 2003, Bayer CropScience then informs the lead CA that it has "assigned
to Stoneville Pedigreed Seed Company any pending regulation application for BXN Cotton seeds".

166. (EC-74): As was noted in the replies by th e experts, the complete documentation related
to this dossier was not provided to the Panel. In some instances, the attachment provided only
the titles of annexes, but not their contents. Please clarify whether the missing documentation
had been provided to the lead CA, and if so, when?

127. The European Communities assumes that the documents for which the attachments provided
only the titles of the annexes were probably provided to the lead CA as confidential, and hence not re-
transmitted, on the same date as the rest of the docum entation to which they were annexed. However,
since the European Communities has not managed to trace back a co py of such documents (otherwise
the Panel would have received it too), it cannot be more precise than this.

167. (EC-93): It appears that some of the do cumentation relevant to the safety assessment
was not provided to the Panel. Please clarify whether the missing documentation had been
provided to the lead CA, and if so, when?

128. The European Communities assumes that with this question the Panel is referring to its
questions 49 and 50 to which Dr . Nutti provided a reply stating several times that she could not find
the necessary information in the dossier.

129. Thus, in her reply to question 49 Dr. Nutti states five times that she could not find (or that the
notification did not contain) this necessary informat ion in the dossier. In all of these instances the
information she is referring to was indeed not cont ained in the dossier as it had not been submitted by
the applicant to the lead CA.

130. By contrast, in question 50, Dr. Nutti point s out that attachments 21 and 22 of EC 93 only
contain cover letters and no annexes. This is co rrect. In both instances the applicant had provided
information contained in annexes which were not su bmitted to the Panel. The information submitted,
however, did not contain the data packages referre d to in the lead CA's request contained in
Attachment 23. Equally, the original dossier (as can be seen from Att. 1) did not contain the broiler
study referred to in the same request.

168. (EC-72): The Panel notes that the chronology provided by the European Communities
shows no actions on this application betw een 12/99 (when according to the European
Communities the UK CA allegedly advised the company that the dossier required substantial
revision and clarification) and its re-submission in 1/03 under Directive 2001/18. Could the
parties please explain the lack of action?

131. The European Communities is not aware of th e reasons why the notifier did not react to the
advice that the dossier needed substantial revision and clarification before January 2003.

132. Similarly to what pointed out under answer to question 165, one of th e reasons could be the
numerous changes in the ownership of the producing company. In fact, the initial notifier, AgrEvo
was initially owned by Hoechst, which in 1999 merged with Rhône-Poulenc to become Aventis. As a
result, AgrEvo and Rhône-Poulen c Agro were combined into Aventis CropScience. Aventis
CropScience was bought in 2001 by the German limite d liability company Bayer A.G., which created
Bayer CropScience.

133. It may also be that some contacts took place between the lead CA and the notifier but that
these were not officially documented. The lette r of Bayer of 16 January 2003 accompanying the
submission of the new SNIF (EC-73/Att.015) points in this direction when it mentions an email of the
lead CA of 20 December 2002.

169. With respect to the safeguard measures invoked for Maize Bt-176, please list the
scientific evidence on which the concerns raised by Austria and Germany on potential adverse
effects on non-target organisms were based (August 2003).

134. In the following paragraphs, the European Communities again summarises the reasons given
by Austria and Germany when adopting their meas ures under Directive 90/220/EC, with particular
reference to non-target organisms. For the origin al text, the European Communities refers to the
measures and notifying letters themselves, and the fo otnotes that they contain to the scientific papers
listed below.

135. According to Austria and Germany, during the risk assessment of this GM product, the
majority of Competent Authorities from the different Member States of the Community expressed
serious concerns, mainly in relation to ampicillin re sistance, insecticidal Bt toxin and labelling, and
the associated risks for human and animal health and for the environment.

136. About 50 or more published studies up to August 2003 were reviewed in a scientific paper by
Oberhauser and Rivers in 2003 (Agbionet 5: ABN 117: 1-7). These authors state in the Abstract on
page 1 that "[a]lthough the risk to monarch butterfly larvae from most varieties of Bt maize proved to
be negligible, one variety (Event 176) posed a signifi cant threat to monarchs. Since this variety was
registered and commercialised without complete unde rstanding of its potential risk to non-target
species, we suggest several ways pre-commercialisation regulation and risk assessment might be
improved, with the hope of preventing future negativ e impacts to non-targets". In the conclusions (at
page 6) the authors state that "current EPA risk assessment requirements rely heavily on assessment

of representative non-target species… According to Murphy and Krimsky (New Genetics and Society
22: 127-143, 2003; referred to by Oberhauser and Ri vers) a lack of good data on non-target species
means that much of this research is conducted usin g indirect measurements and extrapolations from
ecological models." Since both target non-target speci es differ widely in their sensitivity to Bt toxins
(Wolt et al., 2003; Wraight et al 2003; Zangerl et al 2001 – see Oberhauser and Rivers review) and
Austria had not conducted studies on regionally - or country - appropriate target and non-target
species, Austria considers that it was justified to request studies which were relevant to Austrian non-
target species and agro-ecosystems. As the mona rch case revealed, the best available scientific risk
assessment practices can in fact serve to elucidate non-target risks, thus requiring further research and
monitoring after release.

137. According to Austria and Germany, existing conventional substances (insecticidal Bt sprays)
containing Bt toxins are not used constantly, but are applied only when necessary. In addition,
commercially available Bt sprays do not contain ac tive Bt toxins, but inactive protoxins which must
be activated in a multi-stage process, requiring a gu t environment with an alkaline pH greater than
about 9 or 10, allowing a breakdown by the digestive enzymes of insects. All of this reduces the
extent, frequency and duration of expo sure of Bt sprays. Furthermore, Bt toxins applied as sprays
onto plant surfaces and onto soils are rapidly inactivated by naturally occurring ultra-violet light in
sunlight. In contrast to the short persistence of Bt sprays, Bt toxins produced by GM crops expressing
Bt toxin 'cry' genes (e.g. maize event, 176 by root exudation and decay of plant material into the soil)
can persist in some soils (e.g. those with higher clay content) for more than 200 days (Tapp and
Stotzky 1995; Saxena, Flores and Stotzky 2002; Zwahlen et al 2003).

138. Today, about 50 "Cry" proteins are known with sequential and specific differences for certain
insects. The issues associated with the development of such GM pr oducts are therefore potentially
complex and far reaching, extending beyond the specific crop, cry gene and insect to which the
notification relates.

139. According to the Member States, the introduction of cry genes into GM crops (including the
gene cry 1A(b) in the notified maize product) cause si tuations to arise that differ from those that arise
from the conventional use of Bt sprays: there will be a permanent production of toxins all season long;
the Bt toxin will be expressed in most parts of the plant; and all Bt-plants express a modified
shortened variant (called a truncated Bt toxin) compar ed with the Bt protoxin used in Bt sprays. As
Bt maize plant material does normally get into the soil, over one or more growing seasons there may
be higher concentrations of Bt toxin compared wi th conventional use of Bt sprays. The resulting
accumulation of Bt toxins in soil may influence non -target organisms negatively, positively or have
no effect (this requires study in the receiving enviro nment) or speed up the selection of Bt resistant
non-target insects in the soil.

140. Austria and Germany considered that the qualita tive and quantitative differences of the use of
genetically modified plants expressing Bt toxins in comparison with conventional use of microbial Bt
substances in sprays were not considered sufficiently in the application, in particular when basing the
analysis on studies conducted with surrogate Bt proteins.

141. According to the Member States, in the appli cation there were no data concerning the toxicity
of maize expressing the cry 1A(b) gene for a species of Collembolan ( Folsoma candida ) that were
considered in a similar procedure conducted in th e United States. The available summary describes
the toxic effect on the tested species but gives no co mprehensible reason why this effect is negligible
in practice.

142. According to Austria and Germany, there are other possible indirect effects that may arise
through the development of resistance to Bt toxin. So far Bt toxins have been sprayed onto plants,
where they were broken down under the influence of light within a few days. By contrast, the Bt
toxins in transgenic plants are produced conti nuously over a growing season and not according to
necessity (i.e. equivalent to prophylactic use). Mo reover, the expression of Bt toxin in the plant can
be variable (depending on the GM event and its gr owing environment) and so far only one Bt toxin
variant has been produced in each GM maize event - not stacked Bt genes (as are now appearing in
Bollgard II cotton). Often, there is no tissue-specif ic expression in the GM plant, due to use of
constitutive promoters and 'leakiness ' of any more tissue-specific prom oters. This not only increases
the efficiency of the toxin to the target pest but may also speed up the development of Bt resistance in
pest insects, due to the level of exposure to the ex pressed toxin in the plant, for most or all of the
growing season. The United States itself has impo sed certain conditions before authorising the
introduction of such Bt maize products.

143. Austria and Germany consider that it is partic ularly important that there should be an Insect
Resistance Management programme to reduce resistance development in pest insects, which is
tailored to the specific regional target and non-targ et insect species and to the receiving environment
(in this case particularly the Austrian range of agro-ecosystems associated with maize production).
To authorise the product without such a programme would constitute a step backwards compared to
the United States in terms of safety for the environment and human health.

144. The Members States observe that in 1995 th e United States authorised the introduction of
genetically modified insect resistant Bt cotton, with a state-of-the-art resistance management
programme. The crop was planted out for the first time in 1996. There are, however, reports of a
serious infestation of cotton bollworm, the subject of close scientific and regulatory scrutiny. There
are several possible reasons. It may be that extr aordinary climatic conditions, including temperature,
resulted in an increased reproduction of the pest insects or in stress to the plant's metabolism, reducing
its ability to produce high levels of Bt toxin. It may be that an unstable expression of the cry gene
resulted in an inactive Bt toxin. It may be that resistance developed in the pest insects within a very
short period of time. It may be that there was an inefficient resistance management programme. As
long as the reasons for such events remain unclear the risks associated with the introduction of such
products in Austria remain unacceptably high. If such events were due in part to the development of
rapid resistance by the pest to decreased Bt toxi n production under elevated growing temperatures,
then the whole approach to GM plants with Bt toxins may require a fundamental re-thinking. A
minimum requirement would be the development of an elaborate resistance management programme
involving industry, scientists, farmers and authorities – as was done in the USA.

145. In the view of Austria and Germany, such considerations, as well as those in the previous
paragraphs, are re-enforced when it is recalled that there are already adequate maize products
available which do not have these risks associated with them. There is no reason to accept risks
which cannot at present be assessed with any sufficient degree of certainty or without further, targeted
research in typical growing conditions in the memb er state. Furthermore, once admitted to the
market, plant breeding could lead to further products (maize varieties) containing GM material that
could be disseminated without any further need for authorisation, control or labelling.

146. Germany refers specifically to the fact that the corn borer is a Lepidopteran, and that the Bt
toxin, which is expressed in both l eaves and pollen of Bt maize, might thus have a negative effect on
other Lepidoptera, as demonstrated by studies on the monarch butterfly in USA and even beyond the
order of Lepidoptera. It also points out that the Bt toxin may be present in the roots and root exudates
of Bt maize, and reach the soil by those means.

147. In respect to both Bt toxin and antibiotic r esistance Germany is particularly concerned about
the risk associated with large scale and unrestricted cu ltivation. This is because exposure to Bt toxin
and/or its metabolites by non-target organisms increases with scale of Bt maize production.

148. In this context, the followi ng papers were expressly referred to (see Austria's letter to the
Commission dated 14 February 1997 and Germany's letter to the Commission dated 18 April 2000):

Hokkanen, H. and Deacon, J. (eds) ( 1994): Special Issue: OECD Workshop on
Ecological Implications of Transgenic Crop Plants Containing Bacillus thuringiensis
Toxin Genes. In: Biocontrol Science and Technology Vol. 4
Milner, R. (ed.) (1994): Special Issue: Bacillus Thuringiensis Agric., Ecosys. Env.
Vol 49
Tapp, H. and Stotzky, G (1995): Insecticidal Activity of the Toxins from Bacillus
thuringiensis subspecies kurstaki and tene brionis Adsorbed and Bound on Pure and
Soil Clays. Appl. Env. Microbiol. 61(5), 1786-1790
Losey et al., (1999) Nature 399:214
Hilbeck et al. (Entomol. Exp. Appl. 91:305-316, 1999; Environmental Entomol
27:1255-1263, 1998; Environmental Entomol. 27:480-487, 1998)
149. Furthermore, in its letter dated 1 June 1999 to the Commission (in relation to Mon810 but
also in relation to Bt toxin and non-target organism s), Austria also referred expressly to the following
papers:

Armstrong, C.L., et al. (1995) Crop Sci. 35, 550-557
EPA (1995) Pesticide fact sheet, Bacillus thuringiensis CryIA(b) delta-endotoxin and
the genetic material necessary for its production (plasmid vector pCIB4431) in corn
Gill, S.S., et al. (1992) Annual Review of Entomology 37, 615-636
Hafex et al., (1997)
Hilbeck, A., et al. (1998a) Environmental Entomology 27, 1-8
Hilbeck, A., et al. (1998b) Environmental Entomology 27, 1255-1263
Hill, C.A. and Pinnock, D.E. (1998) Journal of Invertebrate Pathology 72, 9-20
Höfte, H., and Whiteley, H. R. (1989) Microbiloigical Review 53, 242-255
Hua, G., et al. (1998) Gene 214, 177-185
Koziel, M.G. (1993) Bio/technology 11, 194-200
Losey, J.E., et al. (1999) Nature 399, 214
Losi et al. (1996)

Riegler, M., and Stauffer, C. (1998) Rekombinante Bacillus thuringiensis Toxin
Pflanzen in Land- und Forstwirtschauft, Universität für Bodenkultur, Wien

ANNEX F-10

REPLIES BY THE EUROPEAN COMMUNITIES
TO ADDITIONAL QUESTIONS POSED BY THE PANEL
IN THE CONTEXT OF THE SECOND SUBSTANTIVE MEETING
11 MARCH 2005

170. With reference to EC Directive 2001/18, Annex II, Section C.2.1, please indicate for each
of the listed potential adverse effects of GM Os whether measures applied to prevent or
minimise such effects fall within the scope of A nnex A(1) of the SPS Agreement, and if so, why.
The parties are also invited to address Section D with the same question in mind.

A. Directive 2001/18/EC, Annex II, Section C.2.1

1. For each of the potential adverse effects listed in Directive 2001/18/EC, Annex II,
Section C.2.1, (in bold italics below), we provide a commentary on whether or not it falls within or
outside the defined scope of the SPS Agreement.

2. As a preliminary remark, the European Comm unities notes that each case will have to be
considered on its merits, as Directive 2001/18/EC, Annex II, Section C.2.1 recalls that:

Potential adverse effects of GMOs will vary from case to case […]
3. Thus, it is not possible to say, in general and abstract terms, whether or not, in all specific
cases, the matters generally referred to in Annex C. 2.1 of Directive 2001/18/EC fall entirely inside or
outside the scope of the SPS Agreement, as set out, also in general and abstract terms, in Annex A.1 of
the SPS Agreement. That said, in the commentary that follo ws, the European Communities sets out its
best effort to respond to this question in abstract terms – it being understood that each specific product
application must be considered on its merits.

– disease to humans including allergenic or toxi c effects (see for example items II.A.11. and
II.C.2(i) in Annex III A, and B 7 in Annex III B);

4. These risks are partially within a nd partially outside the scope of the SPS Agreement.

5. Disease to humans
 does not fall within Annex A.1(a), because that provision does not relate
to humans.

6. If a measure is taken to protect against human life or health from risks arising from a disease-
causing organism in food or beverage, it could fall within the scope of Annex A.1(b).
1 However, since
a GMO is not in itself a disease, nor generally considered a disease-causing organism, a measure
would not, on the basis of such reasoning alone , fall within Annex A.1(b). 2 Furthermore, if the
possible effects on human life or health did not rela te to food or beverage (but, for example, exposure
to the skin), the measure would not fall within Annex A.1(b).3

1 European Communities First Written Submission, para. 421 and 427.
2 European Communities First Written Submission, paras. 407 to 409.
3 European Communities First Written Submission, para. 398.

7. If a measure is taken to protect against human life or health from risks arising from diseases
carried by animals, plants or products thereof, it could fall within the scope of Annex A.1(c).
4
However, since a GMO is not in itself a disease, nor a disease-carrying organism, a measure would
not, on the basis of such reasoning alone, fall within Annex A.1(c).5

8. As long as the GMO would not be characterised , in the specific context of disease to humans,
as a pest, it would not fall within Annex A.1(d).
6 Furthermore, the term "other damage" in
Annex A.1(d) refers to damage other than to the life or health of humans.

9. Toxic effects on humans do not fall within Annex A.1(a), because that provision does not
relate to humans.

10. If a measure is taken to protect against human life or health from risks arising from a toxin in
food or beverage, it could fall within the scope of Annex A.1(b). That could include the toxic effects
on humans of the increased use of herbicide
7 or insecticide.8 However, since a GMO is not in itself a
toxin, a measure would not, on the basis of such reasoning alone, fall within Annex A.1(b). 9
Furthermore, if the possible effects on human life or h ealth did not relate to food or beverage (but, for
example, exposure to the skin), the meas ure would not fall within Annex A.1(b). 10 Finally, a toxin is
generally something that is not in tentionally present in fo od or beverage, and this could also take
concerns about the toxic properties of GMOs outside the scope of the SPS Agreement.11

11. Toxic effects do not fall within Annex A.1(c).

12. As long as the GMO would not be characterised , in the specific context of toxic effects on
humans, as a pest, it would not fall within Annex A.1(d).
12 Furthermore, the term "other damage" in
Annex A.1(d) refers to damage other than to the life or health of humans.

13. Allergenic effects on humans
 do not fall within Annex A.1(a), because that provision does not
relate to humans. They do not fa ll within Annex A.1(b) or (c).13 They do not fall within Annex A.1(d)
for the reasons indicated above.

– disease to animals and plants including toxic, and where appropriate, allergenic effects (see
for example items II.A.11. and II.C.2(i) in Annex III A, and B 7 and D 8 in Annex III B);

14. These risks are partially within a nd partially outside the scope of the SPS Agreement.

15. The reasoning is similar to that indicated in relation to the preceding point, but here we are
concerned with animals or plants, rather than humans.

4 European Communities First Written Submission, para. 421 and 427 (by implication).
5 European Communities First Written Submission, paras. 407 to 409.
6 European Communities First Written Submission, paras. 410 to 411.
7 European Communities First Written Submission, para. 422.
8 European Communities First Written Submission, para. 428.
9 European Communities First Written Submission, para. 405.
10 European Communities First Written Submisson, para. 398.
11 European Communities First Written Submission, para. 405.
12 European Communities First Written Submission, paras. 410 to 411.
13 European Communities First Written Submission, paras. 409, 421 and 427.

16. Disease to animals
: if a measure is taken to protect an imal life or health from risks arising
from the entry, establishment or spread of diseases, disease-carrying organisms or disease-causing
organisms, it could fall within the scope of Annex A.1(a). However, since a GMO is not in itself a
disease, nor a disease-carrying organism, nor genera lly considered a disease-causing organism, a
measure would not, on the basis of such reasoning alone, fall within Annex A.1(a).14

17. If a measure is taken to protect animal life or health from risks arising from a disease-causing
organism in feedstuffs, it could fall within the scope of Annex A.1(b).
15 However, since a GMO is not
in itself a disease, a measure would not, on the basis of such reasoning alone, fall within
Annex A.1(b).16 Furthermore, if the possible effects on animal life or health did not relate to
feedstuffs (that is, farmed animals) but, for example, wild fauna, the measure would not fall within
Annex A.1(b).17

18. Animal life or health does not fall within Annex A.1(c).

19. As long as the GMO would not be characterised , in the specific context of disease to animals,
as a pest, it would not fall within Annex A.1(d).
18 Furthermore, the term "other damage" in
Annex A.1(d) refers to damage other than to the life or health of animals.

20. Toxic effects on animals do not fall within Annex A.1(a).

21. If a measure is taken to protect against animal life or health from risks arising from a toxin in
a feedstuff, it could fall within the scope of Anne x A.1(b). That could include the toxic effects on
farmed animals of the increased use of herbicide
19 or insecticide. 20 However, since a GMO is not in
itself a toxin, a measure would not, on the basis of such reasoning alone, fall within Annex A.1(b). 21
Furthermore, if the possible effects on animal life or health did not relate to feedstuffs (that is, farmed
animals) but, for example, wild fauna, the me asure would not fall within Annex A.1(b). 22 Finally, a
toxin is generally something that is not intentiona lly present in feedstuffs, and this could also take
concerns about the toxic properties of GMOs outside the scope of the SPS Agreement.23

22. Toxic effects do not fall within Annex A.1(c).

23. As long as the GMO would not be characterised , in the specific context of toxic effects on
animals, as a pest, it would not fall within Annex A.1(d).
24 Furthermore, the term "other damage" in
Annex A.1(d) refers to damage other than to the life or health of animals.

24. Allergenic effects on animals do not fall within Annex A.1(a) or (b), which do not refer to
allergens; (c), which does not refer to animal life or health;25 or (d), for the reasons indicated above.

14 European Communities First Written Submission, paras. 407 to 409.
15 European Communities First Written Submission, para. 421 and 427.
16 European Communities First Written Submission, paras. 407 to 409.
17 European Communities First Written Submission, paras. 398.
18 European Communities First Written Submission, paras. 410 to 411.
19 European Communities First Written Submission, para. 422.
20 European Communities First Written Submission, para. 428.
21 European Communities First Written Submission, para. 405.
22 European Communities First Written Submission, para. 398.
23 European Communities First Written Submission, para. 405.
24 European Communities First Written Submission, paras. 410 to 411.
25 European Communities First Written Submission, paras. 409, 421 and 427.

25. Disease to plants
: if a measure is taken to protect plant life or health from risks arising from
the entry, establishment or spread of diseases, disease-carrying organisms or diseases organisms, it
could fall within the scope of Annex A.1(a) . However, since a GMO is not in itself a disease, nor a
disease-carrying organism, nor generally considered a disease-causing organism, a measure would
not, on the basis of such reasoning alone, fall within Annex A.1(a).26

26. Plant life or health does not fall within Annex A.1(b) or (c).

27. As long as the GMO would not be characterised , in the specific context of disease to plants,
as a pest, it would not fall within Annex A.1(d).
27 Furthermore, the term "other damage" in
Annex A.1(d) refers to damage other than to the life or health of plants.

28. Toxic effects on plants
 do not fall within Annex A.1(a).

29. Plant life or health does not fall within Annex A.1(b) or (c).

30. As long as the GMO would not be characterised , in the specific context of toxic effects on
plants, as a pest, it would not fall within Annex A.1(d).
28 Furthermore, the term "other damage" in
Annex A.1(d) refers to damage other than to the life or health of plants.

– effects on the dynamics of populations of sp ecies in the receiving environment and the
genetic diversity of each of these populations (see for example items IV B 8, 9 and 12 in
Annex III A);

31. These risks are outside the scope of the SPS Agreement.

– altered susceptibility to pathogens facilitatin g the dissemination of infectious diseases
and/or creating new reservoirs or vectors;

32. Partially within and partially outside the scope of the SPS Agreement , depending on the
context.

– compromising prophylactic or therapeutic medical, veterinary, or plant protection
treatments, for example by transfer of genes conferring resistance to antibiotics used in
human or veterinary medicine (see for example items II.A.11(e) and II.C.2(i)(iv) in
Annex III A);

33. Outside the scope of the SPS Agreement, insofar as the GMO in ques tion is neither the cause
of a disease nor a pest.
29

– effects on biogeochemistry (biogeochemica l cycles), particularly carbon and nitrogen
recycling through changes in soil decomposition of organic material (see for example items
II.A.11(f) and IV.B.15 in Annex III A, and D 11 in Annex III B).

34. These risks are outside the scope of the SPS Agreement , since these are environmental
concerns.

26 European Communities First Written Submission, paras. 407 to 409.
27 European Communities First Written Submission, paras. 410 to 411.
28 European Communities First Written Submission, paras. 410 to 411.
29 European Communites First Written Submission, paras. 431 to 432.

35. The Directive further refers to adverse effects that may occur directly or indirectly through
mechanisms which may include:

– the spread of the GMO(s) in the environment,

36. These risks are outside the scope of the SPS Agreement , since this is an environmental
concern.

– the transfer of the inserted genetic material to other organisms, or the same organism
whether genetically modified or not,

37. These risks are partially within (for example, on the question of cross-breeding and volunteers
on agricultural land) and partially outside (for exampl e, on the question of anti-biotic resistance) the
scope of the SPS Agreement.

– phenotypic and genetic instability,

38. Similarly, these risks are partially with in and partially outside the scope of the SPS
Agreement, depending on the context.

– interactions with other organisms,

39. Similarly, these risks are partially with in and partially outside the scope of the SPS
Agreement, depending on the context.

– changes in management, including, where applicable, in agricultural practices.

40. Similarly, these risks are partially with in and partially outside the scope of the SPS
Agreement, depending on the context.

B. Directive 2001/18 Annex D

41. The question also refers to Annex D of the Directive.

42. With regard to Annex D.2 of the Directive, in the case of genetically modified higher plants
(GMHP), the European Communities would respond as follows.

– Likelihood of the GMHP becoming more persistent than the recipient or parental plants in
agricultural habitats or more invasive in natural habitats.

43. These risks are outside the scope of the SPS Agreement , insofar as they concern natural
habitats or environmental concerns about agro-ecosystems.
30

– Any selective advantage or disadvantage conferred to the GMHP.

44. These risks are partially within (for example, in the agricultural context) and partially outside
(for example, in the context of environment and biodiversity) the scope of the SPS Agreement ,
depending on the context.

30 European Communities First Written Submission, paras. 420, 423, 424, 429 and 430.

– Potential for gene transfer to the same or other sexually compatib le plant species under
conditions of planting the GMHP and any selective advantage or disadvantage conferred to
those plant species.

45. These risks are partially within (for example, in the agricultural context) and partially outside
(for example, in the context of environment and biodiversity) the scope of the SPS Agreement ,
depending on the context.

– Potential immediate and/or delayed environmental impact resulting from direct and
indirect interactions between the GMHP an d target organisms, such as predators,
parasitoids, and pathogens (if applicable).

46. These risks are outside the scope of the SPS Agreement , insofar as this concerns the
environment and biodiversity.

– Possible immediate and/or delayed environm ental impact resulting from direct and indirect
interactions of the GMHP with non-target or ganisms, (also taking into account organisms
which interact with target organisms), including impact on population levels of
competitors, herbivores, symbionts (where applicable), parasites and pathogens.

47. These risks are outside the scope of the SPS Agreement, since they concern the environment
and biodiversity.

– Possible immediate and/or delayed effects on human health resulting from potential direct
and indirect interactions of the GMHP and perso ns working with, coming into contact with
or in the vicinity of the GMHP release(s).

48. Please refer to the discussion regarding human health above. These risks are partially within
and partially outside the scope of the SPS Agreement , depending on the context. They are not
necessarily entirely within Annex A.1(b), since this does not necessarily relate only to food and
beverage.

– Possible immediate and/or delayed effects on animal health and consequences for the
feed/food chain resulting from consumption of the GMO and any products derived from it,
if it is intended to be used as animal feed.

49. Please refer to the discussion regarding animal health above. These risks are partially within
and partially outside the scope of the SPS Agreement, depending on the context. Feedstuffs concerns
may fall within Annex A.1(b). The consequences on the feed/food chain are more environmental, and
will often fall outside the scope of the SPS Agreement.

– Possible immediate and/or delayed effects on biogeochemical processes resulting from
potential direct and indirect interactions of th e GMO and target and non-target organisms
in the vicinity of the GMO release(s).

50. These risks are outside the scope of the SPS Agreement , insofar as this concerns the
environment and biodiversity.

– Possible immediate and/or delayed, direct and indirect environmental impacts of the
specific cultivation, management and harves ting techniques used for the GMHP where
these are different from those used for non-GMHPs.

51. These risks are outside the scope of the SPS Agreement , insofar as this concerns the
environment and biodiversity.

52. With regard to Annex D.1 of the Directive, the responses are the same or very similar as for
Annex D.2, and the European Communities does not believe that it is necessary to repeat them.
However, the European Communities stands ready to answer further questions on this point, should
the Panel so wish.

171. In Japan – Apples, the Appellate Body in terpreted Article 5.7 of the SPS Agreement and
notably the phrase "in cases where relevant scientific evidence is insufficient". It stated at para.
179 that:

Article 5.1 [...] informs the other provisions of Article 5, including Article 5.7.
We note, as well, that the second sentence of Article 5.7 refers to a "more
objective assessment of risks". These co ntextual elements militate in favour of a
link or relationship between the first requirement under Article 5.7 and the
obligation to perform a risk assessment under Article 5.1: "relevant scientific
evidence" will be "insufficient" within the meaning of Article 5.7 if the body of
available scientific evidence does not allow, in quantitative or qualitative terms,
the performance of an adequate a ssessment of risks as required under
Article 5.1 and as defined in Annex A to the SPS Agreement. [...] The question is
whether the relevant evidence [...] is sufficient to permit the evaluation of the
likelihood of entry, establishment or spread of, in this case, fire blight in Japan.
In this regard, please answer the following questions:

 (a) Is there a reason to believe that a lack of relevant scientific evidence could
prevent a Member from performing a risk assessment "as required under
Article 5.1 and as defined in Annex A to the SPS Agreement"? Or is it rather a
question of that Member perhaps being unable, due to the insufficiency of
scientific evidence, to conduct a fully obj ective risk assessment, such that any
measure based on that assessment migh t be maintained without sufficient
scientific evidence?

 (b) Does the phrase "more obj ective assessment of risks" in Article 5.7 support the
view that a provisional measure adopted in accordance with Article 5.7 must be
based on risk assessment, as required by Article 5.1? (Canada may wish to
elaborate further on what it has alread y said in its supplementary rebuttal in
relation to this point.)

53. The relevant obligation in Article 5.7 of the SPS Agreement is that a Member adopting a
provisional measure does so "on the basis of ava ilable pertinent information". There is no cross-
reference in Article 5.7 either to Article 5.1 or Annex A.4 of the SPS Agreement. There is therefore no
basis for the proposition that measures adopted on th e basis of Article 5.7 must be adopted on the
basis of a full "risk assessment" within the meaning of Article 5.1 and Annex A.4.

54. The words "more objective assessment of risk" in Article 5.7 simply imply that the action
taken "on the basis of available pertinent informa tion" is less objective than a risk assessment under
Article 5.1 and Annex A.4. That is perfectly understandable. The less scientific evidence there is in
relation to a given issue, the more likely it is that there are different scientific views, some of which
might eventually come to be considered more " objective", as more scientific evidence emerges. Until
then, and at least in retrospect, those scientific a nd other views or concerns that do not withstand the
passage of time may be considered to have been less objective.

55. It is correct that some of the issues consid ered, information and methods used, and procedures
followed by a Member when adopting a provisiona l measure under Article 5.7 may be similar as
when carrying out a risk assessment under Article 5.1 and Annex A.4 of the SPS Agreement. No
doubt, when relying on the "available pertinent inform ation" a Member may attempt in general terms
to consider, and even assess, risk . That does not mean, however, that under Article 5.7 there is a full
"risk assessment" within the meaning of Article 5.1 and Annex A.4. Where there are genuine
concerns, but little or no information, it will simply not be possible to conduct a full risk assessment
under Article 5.1 and Annex A.4, according to th e required endpoint of the risk assessment of a
particular Member, and its own acceptable level of risk. And this is particularly so if there is a desire
to act quickly, or particularly to preserve a situation from potentially irreversible consequences.

56. In other words, even if there would be a "ris k assessment" of some type under Article 5.7, that
does not mean that it constitutes a full risk assessment under Article 5.1, such as might be the basis for
a measure adopted under Article 2.2 of the SPS Agreement.

57. The final phrase of the ques tion "such that any measure based on that assessment might be
maintained without sufficient
 scientific evidence" requires special attention. The word "sufficient " in
this phrase is not being used in the sense of the opposite of the word "insufficiency ", in the first
phrase of the second sentence of the question. This re flects a core difference between the parties in
this dispute. The European Communities believes th at a measure can be adopted under Article 5.7
even if the scientific evidence is "insufficient" – that is what the text of Article 5.7 expressly provides
for. This does not mean, of course, that automatically the measure falls foul of Article 2.2, because it
is "maintained without sufficient scientific evidence" (as the Complainants would have it). The
concept of sufficiency or insuffici ency in Article 5.7 relates to the extent of the body of scientific
information, and whether or not it is enough to decide definitively, one way or the other, according to
the required endpoint of the risk assessment of a pa rticular Member, and its own acceptable level of
risk. The concept of sufficiency or insufficiency in Article 2.2 relates to the question of whether or not
the measure (presumed to be trade restrictive) is justified by the science. Thus, the only way these
provisions make sense is if they are exclusi onary – provisional measures under Article 5.7 and
definitive measures under Article 2.2.

58. The European Communities does not find anythi ng in para 179 of the Appellate Body Report
in the Japan – Apples case, which was addressing Japan's attempt to distinguish between "general"
and "specific" evidence, which contradicts this analysis. In particular, the European Communities
would again recall that this entire section of the Appellate Body Report in Japan – Apples begins with
para. 175 and footnote 316, which recall that: Japan re lied on Article 5.7 in the alternative and only in
the event that it failed on Article 2.2; that it was in this particular context that the panel in that case
assigned the burden of proof to Japan. (Indeed the United States expressly contested the assignment of
the burden of proof under Article 5.7 SPS to the defending party.)
31 By contrast, in these proceedings,
the European Communities has pointed out that th e Member State safeguard measures were adopted

31 See para. 56 of the Oral Statement of the European Communities to the first meeting of the Panel
with the Parties

pursuant to Article 5.7 of the SPS Agreement, and that the Complainants, for whatever reason, have
not invoked this provision in their requests for establishment; that the burden of proof is on the
Complainants; and the European Communities vigor ously contests the various attempts by the
Complainants to unlawfully shift the burden of proof on to the European Communities.

172. Annex A(1) of the SPS Agreement sugg ests that "approval procedures" are SPS
measures. When a Member decides to delay the completion of such an approval procedure for
a number of days, would such action be another SPS measure within the meaning of
Annex A(1), or would such action rather need to be characterized as an application of an SPS
measure (the application of the approval procedure)?

59. As the European Communities has already explained in previous submissions
32 in this case,
the SPS Agreement distinguishes between (the developmen t of) SPS measures and their application
(Article 1).

60. Approval procedures as such (i.e. the general rules of prospective application set out in a
normative act), to the extent they address risks coming under the SPS Agreement, are indeed SPS
measures as can be clearly inferred from Annex A(1).

61. Article 8 and Annex C, on the other hand, leave no doubt that it is in the context of the
application of that measure ("in the operation of …approval procedures", Artic le 8; "the procedure to
check and ensure the fulfilment of sanitary or phyt osanitary measures", Annex C) that "decisions" to
delay and other procedural steps are examined for their compatibility with the SPS Agreement.

62. Indeed, if every delay - that is: a failure to act - were considered to constitute an SPS measure
– that is: an action to be reviewed unde r Article 5 and other provisions of the SPS Agreement – the
undue delay provision in Annex C(1)(a) would be devoid of any meaning.

173. May the fact that existing approval legislation does not permit a Member to adopt
certain risk management measures which that Member considers appropriate serve as a
justification, for purposes of an analysis under Annex C(1)(a) of the SPS Agreement, for
delaying approval procedures conducted pursuan t to the existing legislation? Are the
provisions of Article 27 of the Vienna Convention on the Law of Treaties relevant to such a
situation?

63. The European Communities is not quite sure which scenario this question addresses: Read
literally, it seems to refer to a situation where an application procedure would have been delayed (put
on hold) on the grounds that certain risk manage ment measures, which would appear necessary, could
not be required from the applicant for want of a lega l basis in the existing legislation. The European
Communities is not aware of a specific instance wh ere this has been the case. Indeed, as it has
described at length, the whole point of the inte rim approach was precisely to request these risk
management measures (with the agreement of the a pplicant) in order not to delay the application
procedure until the entry into force of the new legislation.

64. However, if the question were to be underst ood this way, it would generally raise the issue of
whether a procedure can be put on hold while the entr y into force of new legislation is awaited. As
has been pointed out before, the European Comm unities and the Complainants seem to share the

32 First Written Submission, paras. 466ff ; Second Written Submission paras. 269ff.

view, in this regard, that such delays, subject to reasonable limits can be considered a justification for
procedural delays.
33

65. The question may also be read to refer to the delays caused by the actual requests for such
risk management measures not explicitly provided for in the existing legislation. The question would
then more generally be whether such delays are "undue" because there was no (explicit) legal basis in
existing law to impose such requirements. As it has argued before, the European Communities takes
the view that such requests need to be assessed on th eir own merits, that is, the Panel is to examine
whether they were scientifically justified in the case at hand. 34 Delays caused by such requests would
not be "undue" by the sheer fact that domestic law does not (explicitly) provide for such requests.

66. As regards the relevance of Article 27 of th e Vienna Convention, that provision states the
following:

A party may not invoke the provisions of its in ternal law as justification for its failure
to perform a treaty. This rule is without prejudice to article 46.
67. Article 27, thus, excludes the possibility for a pa rty to an agreement to refer to its domestic
law in order to derogate from an obligation it has und ertaken. In the present case, however, this is not
the situation.

68. In the present case, the obligation is not to cause "undue delays." The issue is what is
"undue", and thus, what the content of the obligation is. That notion is to be determined in WTO law
and is neither derived from nor dependent on domestic law. The European Communities has put
forward a number of factual reasons to explain these delays. It is for the Panel to assess these reasons.
The European Communities takes the vi ew that they are not "undue." It has not argued that they are
justified even though they would be "undue" under the SPS Agreement (which is the scenario
envisaged by Article 27).

69. However, the Panel's question may aim at asses sing, in the light of the principle expressed in
Article 27, whether it is possible to invoke a WTO inc onsistent aspect of domestic law to argue that a
delay is not undue. The European Communities w ould have the following comments on this reading
of the question: What is possible or not possible under domestic law is a question of fact which the
Panel must take into account in assessing whether a delay is undue. Of course, a Member cannot rely
on WTO-inconsistent requirements of domestic law to justify a delay but such inconsistency must be
established and cannot be presumed. If the Compla inants thought that the EC GMO legislation was
incompatible with the SPS Agreement because it contains requirements with which they disagree or
does not provide for options which they would like to see, they could have made such a claim and
made the necessary arguments. They have not done so and so the EC GMO legislation must be
accepted as is for the purposes of assessing what may be undue.

33 EC Second Written Submission, para. 281 point c.
34 See for example First Written Submission, para. 490.

174. With regard to Article 2.2 of the TBT Agreement:

 (a) Please explain the phrase "the risks no n-fulfilment [of a legitimate objective]
would create" and illustrate using an example.

 (b) Article 2.2 refers to "scientific informat ion" which must be taken into account in
assessing risks. Article 5.2 of the S PS Agreement, on the other hand, refers to
"scientific evidence". Are these different concepts? Why?

70. The European Communities agre es that the words "non-fulfilment" in Article 2.2 of the TBT
Agreement refer back to the word "fulfil" in Article 2.2, which in turn refers to a "legitimate
objective". Thus, if a "legitimate objective" were not "fulfilled", that might "create a risk". That risk
must be taken into account when determining whet her or not a technical regulation is more trade
restrictive than necessary.

71. For example, a technical regulation may require all electrical plugs to be correctly fused. The
legitimate objective is that, in the event of a surg e of current, the fuse should blow, rather than the
plug catch fire. The risk created by the plug catching fire would be that a building might be damaged
or destroyed, and persons might be injured or killed. These risks must be taken into account when
assessing whether or not the technical regulation is more trade restrictive than necessary.

72. As another example, a technical regulati on may require that a product specification (for
instance on a label) lays down the range of technical values or other technical conditions within which
a product may be properly used to achieve its end use purpose. For instance, a light bulb may specify
the proper voltage of use, or a battery may specify valid end date of use, or a mobile telephone may
specify the range of temperature and humidity for proper use. The risk of not providing or displaying
this information here would be improper use or ma lfunction of the product, which may itself lead to
technical difficulties for the user, economic loss fo r the user, or commercial impact, including civil
liability incurred by the producer, due to possible deceptive practices.

73. Thus the trade effect must be weighed agains t the seriousness, severity, irreversability etc of
the consequences of non-fulfilment of the objective in assessing consistency with Article 2.2. of the
TBT Agreement.

175. Are measures applied to ensure co-existen ce of biotech crops and non-biotech crops
covered by Annex A(1) of the SPS Agreement or do they fall, in whole or in part, outside of the
scope of Annex A(1)?

74. As mentioned the Commission Recommendation of 23 July 2003 on guidelines for the
development of national strategies and best practices to ensure the coexistence of genetically modified
crops with conventional and organic farming (ECO J N° L189 of 29 July 2003), for the European
Communities, the concept of coexistence refers to the ability of farmers to make a practical choice
between conventional, organic or GM crop produc tion in compliance with the legal obligation for
labelling and/or purity standard. The issue of co existence concerns the potential economic loss and
impact of the admixture of approved GM crops with non-GM crops. As a result, measures taken with
respect to co-existence of GMO and non-GMO crops and products fall outside the scope of the SPS
Agreement.

75. In case where specific segregation measures are needed to protect the environment or human
health (for instance in the case of a GM plant ai med at producing pharmaceuticals – potentially toxic
to humans – to be segregated from the food chain), such measures would be prescribed in the final

consent of the authorisation procedure of Di rective 2001/18/EC or Regulation (EC) 1829/2003. In
such a case and only in such a case, the said segregation measures would fall within the scope of the
SPS Agreement , in so far as the risk involved falls within the scope of Annex A.1 of the SPS
Agreement.

176. With reference to Austria's safeguard meas ure on Bt-176 maize, please comment on the
reference in exhibit EC-158 att. 7 to insuffi cient labelling requirements laid down in the
Commission Decision relating to the relevant produc t. In particular, what is the basis for the
concern expressed about insufficient labelling (e.g ., food safety, consumer information, etc.),
and how does the labelling issue affect the analys is of whether the Austrian safeguard measure
falls within the scope of the SPS Agreement and/or the TBT Agreement?

76. The Austrian safeguard measure on Bt-176 refe rs to "insufficient labelling requirements" as
one of the "reasons for Austria's decision to prohi bit the use and sale" of the Bt-176 GM maize lines.
In particular, the cover letter of the notification of the Austria reasons for its safeguard measure
(Exhibit EC-158 att.7) states that "furthermore, Au stria maintains its position that the labelling laid
down in the Commission's Decision is insufficient. Consumers should be informed precisely about the
fact that this product has been genetically modified."

77. There are two labelling issues addressed in the Austrian statement (the insufficiency of the
labelling laid down in the Commission Decision, a nd the insufficient labelling for the purpose of
precise consumer information), neith er of which is covered by the SPS Agreement , as explained
below.

78. The first concern (the insufficiency of the labelling laid down in the Commission Decision)
relates to an issue which is also referred to in the Austrian reasons for its safeguard measure (Exhibit
EC-158 att.7), namely "the unclear possibilities of the use of the herbicide resistance [by the farmer]."
This issue is independent and not re lated to any component of the risk analysis process of the risks to
human, animal or plant life or health at stake in th e Austrian provisional measure, but rather refers to
a labelling requirement aimed at ensuring that the ap propriate information is provided to the end user,
ie the farmers, as regards the proper technical use of the product.

79. The Commission Decision
35 authorising the placing on the market of Bt-176 laid down the
following labelling requirement for seed packages of this product (paragraph 3 of Article 1 of the
Decision):

3. Without prejudice to other labelling re quired by Community legislation, the
label of each package of seeds shall indicate that the product:
 – protects itself against corn borers, and

– has increased tolerance to the herbicide glufosinate-ammonium.
80. To properly understand the basis for this first Austrian concern, it is necessary to explain the
technical basis for the requirement that "the labe l should indicate that the plants have increased

35 Commission Decision 97/98/EC, see Exhibit US-97. Commission Decision 97/98/EC of 23 January
1997 concerning the placing on the market of genetical ly modified maize (Zea mays L.) with the combined
modification for insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the
herbicide glufosinate ammonium pursuant to Council Directive 90/220/EEC.

tolerance to the herbicide glufosinate ammonium" (fifth recital, 7
th indent of the Decision), which
aims at providing appropriate technical information on the product to the end user.

81. Indeed, the introduction, in this particular Bt-176 transformation event, of one copy of the bar
gene, encoding a phosphinothricin acetyltransferase which confers increased tolerance to the
herbicide glufosinate ammonium, was not
 aimed at conferring herbicide tolerance to the end product,
as a relevant agronomic trait of the GM plant, but w as rather introduced as the genetic tool to be used
in vitro , in the genetic engineering process, at the stage of the selection of the proper GM
transformation events, in the early steps of the development of this particular Bt-176 product36.

82. The presence in this Bt-176 transfor mation event of the prokaryotic gene bla (conferring
resistance to the antibiotic ampicillin) was unintentio nal (it is present in the plant as a consequence of
the accidental integration of some elements of th e backbone of the bacterial vector plasmid), and
could not have been used in this case as a plant genetic tool to select the desired transformation
events, as it was only controlled under a prokaryotic (b acterial) promoter that could not have been
used in the plant itself.

83. As a collateral consequence of th e introduction in the plant of this bar gene, the regenerated
Bt-176 GM lines had an increased tolerance to th e herbicide glufosinate ammonium due to the
presence of this gene. But the bar gene was not expressed at a le vel which would have proved
efficient for its use as an agronomic trait in the field, and herbicide tole rance was therefore not
claimed by the applicant as one of the commercial traits of this Bt-176 product in its notification.

84. However, should the farmer or any other end user have used glufosinate ammonium for any
purpose, in the presence of this Bt-176 GM maize (as a current crop or as volunteers in subsequent
crops in rotation or in non-agricultural land), the re sidual tolerance to this herbicide in this maize
would have lead the farmer to encounter unexpected technical and/or agronomical problems with this
herbicide related to imporper specifi cations for the use of this herbicide on Bt-176, if he had not been
informed through an appropriate technical labe lling requirement of the presence of this increased
tolerance to this herbicide in Bt-176, which was th e reason for the inclusion of the relevant labelling
requirement in the Commission Decision.

85. The basis of this first Austrian concern w as therefore the following: the labelling requirement
provided in the Commission Decision did ensure that the end users of the Bt-176 seeds were indeed
informed of the increased tolerance to this herbicide of this particular maize, so that they could
address some of the technical issues related to the potential use of glufosinate ammonium in the
presence of Bt-176. However, without further speci fication, the information provided could have
misled, in Austria's opinion, the end user, and let him or her believe that one could in fact exploit this
increased herbicide tolerance as an agronomic tr ait on this Bt-176 product, because the labelling
requirement did not address the issue of separate herbicide registration procedures, and even more
importantly, because the labelling requirement did not mention, as a further technical labelling
specification, that this increased tolerance was improper and/or insufficient to be used as an
agronomic trait to select the Bt-176 maize. Austria felt that both of these two technical issues should
also have been included in the labelling requireme nt of the Commssion Decisi on for Bt-176, for the
benefit of the technical information of the end user.

36 The generation of a GM plant through genetic engineering techniques requires the fulfilment of three
necessary steps, ie (i) the introduction of foreign D NA in the genome of a parent plant cell line, (ii) the
selection, usually in vitro, of the desired GM transformation events, an d (iii) the regeneration from the selected
transformed plant cells of the new GM fertile plants. It is the second step which is at stake here.

86. The second concern (the insufficient labelling fo r the purpose of effective and fair consumer
information) is also an issue that is independent an d not related to any component of the risk analysis
process to tackle any of the risks to human, animal or plant life or health, which may be at stake in the
Austrian provisional measure.

87. Indeed, the Commission Decision for this product states (fifth recital, 6
th indent) that "there
are no safety grounds for mentioning on the label th at the product has been obtained by genetic
modification techniques".

88. However, the legitimate objec tive of consumer information (ie that an accurate and effective
information on the fact that a product is geneti cally modified should have been provided to the
consumers and other users of GM products) had been intensely debated within the European
Communities since 1996. This concern was only finally clarified at the time of the application in April
2004 of Regulations 1829/2003/EC and 1830/2003/EC, which complete d the labelling requirements
for GM products now set out in the legislation, by providing, together with Directive 2001/18/EC,
compulsory consumer and other end user informa tion on the genetically modified character of GM
products, independently of safety concerns. Th ese labelling provisions aimed at addressing the
legitimate objective of ensuring the possibility for th e expression of consumers' and other end users'
choices and preferences, and to ensure that these GM products would be marketed in a transparent,
fair and commercial way.

89. As early as the end of 1996/the beginning of 1997, and before the publication of the
Commission Decision for this product, Directive 97/35/EC
37 was elaborated and adopted, to amend
Annex III of Directive 90/220/EEC in order to include specifications for compulsory labelling
requirements for consumer and other user information, as a part of the additional information required
in the case of notification for placing on the market of genetically modified organisms (GMOs).
Directive 97/35 introduced the following requirement in part C of Annex III of Directive 90/220/EEC:

C. The following information shall be pr ovided in the notification, in accordance
with Article 11 of [] Directive [90/220]:
Proposed labelling. This must include in a label or an accompanying
document an indication that the pr oduct contains, or consists of
genetically modified organisms. In the case of products to be placed
on the market in mixtures with non-genetically modified organisms,
information on the possibility that the genetically modified
organisms may be present, is sufficient.
90. Although this provision was later viewed as insufficient by the European Communities
legislator, in particular as regards the case of mixtures or adventitious presence of GMOs with non-
genetically modified organisms (and was comp lemented by further, more precise, labelling
requirements in Directive 2001/18/EC, and Regulations 1829 and 1830/2003/EC), this initial, generic,
labelling requirement of GM products, for the purpose of consumer and other end user information,
was not
 addressed in the Commission Decision 97/98/EC authorising the Bt-176 product, and this
perceived gap was the basis of the second concern of the Austrian reference to insufficient labelling
requirements.

37 Commission Directive 97/35/EC of 18 June 1997 adapting to technical progress for the second time
Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms.

91. As has been clearly explained above, neither of the two Austrian concerns addresses any food
safety concerns, nor risks to human, animal or pl ant life or health, nor even any safety issues in
general.

92. As is stated in Annex A.1 of the SPS Agreement, "Sanitary or phytosanitary measures include
all relevant [ ] requirements [ ] including, inter alia , [ ] labelling requirements di rectly related to food
safety".

93. It is therefore obvious that these two concerns are not covered by the SPS Agreement, and, at
least as far as they are concerned, do not qualif y the Austrian provisional safeguard measure as a
sanitary or phytosanitary measure.

94. On the contrary, the reasons concerning labe lling that the Austrian authorities referred to
when notifying the safeguard measure to the Community are clearly matters that could be covered by
the TBT Agreement.

95. The Austrian safeguard measure in itself is not a technical regulation for all the reasons
already explained by the European Communities.
38 However, it goes without saying that once such
labelling requirements would be integrated in th e general normative legislation, they would be
covered by the concept of "technical regulation" referred to in the TBT Agreement . The first
requirement (the technical specification of the pr oduct as regard the proper use of the increased
tolerance to the herbicide) would be covered by the notion of a " document which lays down product
characteristics", and the first and second requirements (lab elling requirements for consumer and end
user information) would both be covered by the notion of the " labelling requirements as they apply to
a product, process or production method ", both notions being referred to in the above mentioned
definition of a technical regulation in the TBT Agreement.

96. Both issues address the legitimate objectiv es, referred to in Article 2.2 of the TBT Agreement,
of the prevention of deceptive practices, which incl udes effective and accurate consumer and end user
information. Both issues also include the consid eration of the relevant intended end-uses of the
product, which is also referred to in the same provision of the TBT Agreement.

97. Without prejudice to the further analysis of the coverage by the SPS Agreement, the TBT
Agreement, or the GATT of the other reasons of the Austrian safeguard measure, the consequence of
the analysis of the two claims of insufficiency of labelling requirements, as two of Austria's reasons
for its measure, is that it is obvious that this Austrian provisional measure falls, at least in part, outside
the scope of the SPS Agreement, as they stand. They would, once integrated in the general normative
legislation, also become "technical regulations" within the meaning of the TBT Agreement.

177. At para. 336 of Canada's first written submission and paras. 570 and 544-545 of
Argentina's first written submission, the allegation is made that certain member State safeguard
measures are inconsistent with Article 2.1 of the TBT Agreement because imported biotech
products subject to the safeguard measures are treated less favourably than like domestic non-
biotech product varieties which may be sold freely in the relevant member States. Do the
United States and the European Communities sha re the interpretation of the concept of less
favourable treatment underlying Argentina's and Canada's claims? In answering this question,
please discuss the relevance of para. 100 of the Appellate Body report on EC – Asbestos. If it is
relevant, could the United States and the Euro pean Communities (a) indicate whether they

38 EC First Written Submission, paras. 642ff.

agree with the interpretation offered at para . 100, and (b) explain in detail how this
interpretation could be applied in practice?

98. The European Communities does not agree with Argentina and Canada. The underlying issue
first has to be considered from the perspective of the general legislation. The Complainants do not
assert that the European Communities general legisla tion regarding GMOs is inconsistent with the
SPS Agreement or the TBT Agreement, and understandably so. It is perfectly reasonable for a Member
to have different general legi slation relating to GMOs and non- GMOs. This is so because GMO
products and non-GMO products, as groups of products, cannot be consid ered like products. This is
also consistent with the relevant international standards and norms, including the Biosafety Protocol
which all distinguish between GMO and non GM pr oducts, which would , in particular, make such
distinction also consistent with Article 2.4 of the TBT Agreement. This being so, the analysis does not
change in the context of a Member State safeguard measure. This case is not about discrimination
between imported products and domestic products. It is about whether or not the European
Communities has complied with certain specific obligations under the WTO Agreement and the
covered agreements, in relation to certain speci fic GMO product applications. As the Panel's own
independent experts repeatedly observed, nothing is going to be clarified as long as the Complainants
insist on comparing "apples and pears".

99. It is also noteworthy in this context that international norms, such as the Biosafety Protocol,
recognise the necessity to distinguish GMO and non GMO product, independently of any safety
concern, by requiring for instance that all living modified organisms that are intended for intentional
introduction into the environment, whether found safe or not, be clearly identified as living modified
organisms on an accompanying document (Article 18.2 (c)).

100. Since the issue of "less favourable treatment" mu st arise in relation to like products, the fact
that GMOs and non-GMOs are not like products mean s that there can be no issue of "less favourable
treatment" within the meaning of Article 2.1 of the TBT Agreement in this case, as alleged by the
Complainants.

101. As regards the Appellate Body Report in EC-Asbestos, the European Communities would like
to make the following comments. First, the analysis there set out relates to Article III:4 of the
GATT 1994, not Article 2.1 of the TBT Agreement. Second, the Appellate Body correctly observes (at
para. 88) that each provision where the term "like produc t" is used must be interpreted in light of the
context, and object and purpose of the provision at issue. Third, the Appellate Body does not state that
the competitive relationship in the marketplace between products is the only criterion. It is particularly
evident that this is so when the underlying issue is a long term concern of general interest to society
(such as effects on the environment or biodiversity) that may not be sufficiently taken into account by
more short term "economic" market forces. As one Member of the Appellate Body stressed in his
concurring statement in that case, a purely economi c assessment of likeness is not always appropriate.
In any event, the Appellate Bo dy clearly states that not " all products which are in some competitive
relationship are "like products" under Article III:4" (para.99 of the report; italics as in the original).

102. Furthermore, the European Communities recalls that the Appellate Body is discussing the
issue of "less favourable treatment" under Article III:4 of the GATT 1994. However, the Appellate
Body did not consider the point in great detail beca use the panel's findings on this point had not been
appealed. However, the European Communities consid ers that the approach sketched out in para.100
is a sound one. Indeed, a finding of "likeness" do es not by any means lead to a finding of "less
favourable treatment". As the Appellate Body put it, " a Member may draw distinctions between
products which have been found to be "like" without, for that reason alone, according to the group of
"like" domestic products "less favourable treatment" than that accorded to the group of "like"

domestic products ". Therefore, it rests upon a complaining party to prove that imported goods are
treated less favourably than the like domestic products. The European Communities would also like to
point out that, when examining a measure under Artic le III:4, a Panel is not obliged to follow any
specific order of analysis of the several conditions set out in Article III:4.

103. In addition, in para. 100 of its Report, the Appellate Body makes clear that a finding of "less
favourable treatment" requires an analysis not of individual products, but of the "group" of imported
products and the "group" of domestic products. Theref ore, even if one leav es aside for one moment
the issue of "likeness", it is not possible to narro w down the comparison to imported GM products, on
the one hand, and to domestic conve ntional counterparts, on the other hand. As a matter of fact, the
comparison must logically start with a comparison between imported and domestic GM products , as
those are the goods that are affected by the natio nal safeguard measures. But the fact is that the
national safeguard measures affect the production of GM products within certain parts of the EC in
the same way as they affect the import of those very same products from other WTO Members: GM
products whose authorisation has been provisionally suspended by an EC Member State cannot either
be produced or imported into the territory of that Member State.

198. Please comment on para. 37 of Canada's seco nd oral statement where it is said that
"there is no a priori reason why cultivation ca nnot be introduced on a smaller and progressive
scale" and that this has been "demonstrated to be a feasible option".

104. The context in which Canada has made this remark is not entirely clear, as Canada refers
vaguely to "some of the EC Member State questions " which allegedly would have been based "on the
presumption that the product necessarily will be cultivated on a large scale."

105. As a general remark, if an application is for unlimited cultivation, the risk assessment will
obviously consider the possible eff ects of such unlimited cultivation, that is, of cultivation on a large
scale.

106. Assuming that those "some Member State questions" may have been about assessing large
scale effects through field studies, the issue here would be the following: rather than delaying the
authorisation process by a request for additional data on large scale effects through field studies
should the product not be authorised on a limited scal e with a requirement to provide (that kind of
data) data through monitoring?

107. There is a difference between a field study and a (limited) commercial cultivation and it is
precisely for that reason that the EC legislation distinguishes between field study authorisations
(Part B of Directive 90/220 and later 2001/18) and au thorisations for any other release into the
environment (Part C of Directive 90/220 and late r 2001/18). The difference is one of degree of
control. Cultivation conditions for field studies ar e very closely defined, including the location of
where the crop is grown, buffer zones, crop protecti on, reproductive isolation conditions etc. This
degree of control would be needed in order to (1) obtain the desired data and at the same time (2)
contain any potential risks. Commercial cultivation is usually not subject to such strict conditions and
this for the very good reason that, if it were, the au thorisation would effectively be one under Part B
and not Part C. Commercial cultivation, therefore, even if done only on a restricted scale, does not
provide the same possibilities of control. On the other hand, the Panel should note that large scale
trials have been carried out in the EU, for exam ple the UK Farm Scale Evaluation. These trials have
provided scientific information which incidently we re not fully expected but which in any case would
not have been obtained under commercial cultivation.

108. Any release of GMOs into the environment ra ising an issue of irreversibility, choosing the
stricter option of requiring field studies and hen ce exercising greater control over the cultivation,
therefore, is a question of choice of the acceptable threshold of risk.

199. Please comment on para. 62 of Canada's second oral statement where it is said that "[i]f
the concern is that the herbicide used in conjunction with Ms8/Rf3 will be too effective, the
simple answer is to encourage or require, as a co ndition of use, that farmers apply the herbicide
in a manner that leaves more weeds in the field".

109. This assertion by Canada, in pa ragraph 62 of its Second Oral Statement, concerns the positive
responses given by the Panel's experts to the scientif ic validity of the Belgian's request for additional
information on ecological effects of Ms8/Rf3 on agricultural systems.
39 Such assertion appears, to the
eyes of the European Communities, as a desperate last attempt to redress a lost argument. More
substantially, there are several levels at which the European Communities can comment on such an
assertion.

110. From a scientific point of view, as Canada itself recognises in the very same paragraph, the
Panel's experts recognised the legitimacy of such a request, and therefore of such a concern, on the
part of the Belgian authority.
40 Far from being a matter of "more weeds in the field", it has to do with
how to preserve biodiversity and it is strictly de pendant on the specificities of the crop species and
varieties and of the regions in which these are grown.

111. From a practical point of view, Canada's as sertion is completely out of reality. On the one
hand, how can be realistically conceived that a farmer which buys GM HT seeds, and pays a premium
for them precisely because they are herbicide-resist ant (and so herbicide can be used at any time and
in any quantity without fear of damaging the crop), would accept on a voluntary basis to limit the use
of the herbicide? This issue can therefore not be left to the good willingness of individuals and it must
therefore be dealt with by the regulatory authorities.

112. On the other hand, even though from the regulatory point of view it might be theoretically
feasible to limit to some extent the rate of use of the herbicide, while achieving an acceptable level of
efficacy, any such kind of requirements would in pr actice be as ineffective as a voluntary measure.
Indeed, such requirements would be extremely difficult to enforce or let alone police.

113. In that connection, from a strictly WTO point of view, the European Communities would
point out that, as far as the risks associated w ith GM HT crops are phytosanitary risks, the SPS
Agreement recognises that problems of control and fraud ar e legitimate factors that can be taken into
account by risk assessors/managers.
41

200. With reference to para. 20 of the Eu ropean Communities' second oral statement
(concerning Bt cotton 531), is the European Communities asserting that the applicant was
formally required or requested to submit the in formation in question? If so, please provide
support.

39 Question 19 to Panel's experts, which refers to Exhibit EC-63/Att.149.
40 See Responses by Dr. Andow, Squire and Snow to question 19, and Comments by the European
Communities on the Scientific and Technical Advice to the Panel, paragraphs 364 and ff, as well as more
generally on the persistence of HT crops, paragraph 154 and ff.
41 Appellate Body Report, EC – Hormones , para. 205; and Panel report, Japan – Apples ,
paragraph 8.161.

114. Paragraph 20 of the European Communities' Second Oral Statement addresses the comments
by the United States that "nothing in the record in dicates that the applicant was ever requested to
submit additional information to address Member States objections, nor that the basis of these
objections was ever even notified to the applicant,"
42 and by Argentina, that "information provided by
the EC in CD Roms does not mention any specific requ est by the EC to the ap plicant to provide this
information."43 These comments refer, respectively, to the period before February 1999 and to a letter
by the applicant of 25 July 2002.

115. In paragraph 20, the European Communiti es is indeed asserting that the applicant was
formally requested to submit the informati on in question. It is normal procedure,
44 in fact, that any
request, comment or objection by a Member State on an application is automatically forwarded,
through the lead CA, to the applicant.

116. In the specifics of Bt cotton 531, the comments and objections of the Member States raised
before February 1999 are contained in Exhibit EC-6 5/Att.16 to 25, 27, 31 to 41, 65. A simple reading
of the correspondence of the applican t demonstrates that the applicant referred always to "questions"
raised by the Member States and that its answ ers were punctually reflecting such objections.
45 For
instance, with its letter of 3 rd February 1998, Monsanto forwards "responses to most of the questions
raised during the discussion of the dossier … by representatives of the Competent Authorities in the
Commission on 27 th January." 46 In that meeting, the Competent Authorities discussed all their
comments and objections sent that far 47. Hence it is clear that all objections and comments had been
brought to its attention.

117. Similarly inapposite is the remark of Argentina with regard to the letter of 25 July 2002. With
this letter Monsanto was transmitting the updated mo lecular characterisation. Monsanto could not
ignore that objections based on the lack of certain mo lecular data were formulated by Member States
as of the very beginning of this application.
48 Furthermore, by then Directive 2001/18 had been
adopted and was about to enter into force and, as mentioned several times, applicants were updating
their dossiers to match the new requirements.

201. With regard to glufosinate tolerant soybea n (AgrEvo) (EC-71), do the provision(s) of the
relevant EC regulations prohibit the submission of applications for approvals to more than one
EC member State? If so, please identify the relevant provision(s).

118. The relevant provision is to be found in Ar ticle 13, paragraph 1, of Directive 2001/18, which
requires that:

Before a GMO or a combination of GMOs as or in products is placed on the market, a
notification shall be submitted to the comp etent authority of the Member State where
such a GMO is to be placed on the market for the first time." (emphasis added)

42 US Supplementary Rebuttal, para. 44.
43 Supplementary Rebuttal of Argentina, page 17.
44 See also Answers to the Questions by the Pa nel Posed During and After the Second Substantive
Meeting with the Parties, answer to question 138, para. 83 and ff.
45 See, for instance, Exhibit EC-65/Att.28 and 49.
46 Exhibit EC-65/Att.28.
47 See, for instance, the comments from the UK CA of 23 January 1998 (Exhibit EC-65/Att.18), where
it is stated that the CA "will participate to the technical meeting on the 27 th January to discuss these issues
further".
48 See, for instance, Exhibit EC-65/Att.16, 18, 19.

119. The same provision existed in Directive 90/220/EEC.

120. However, a company has always the possibilit y to withdraw an application from a Member
State, and submit a dossier to another Member Stat e. Furthermore, a negative assessment opinion of a
lead competent authority, or a rejection of an application at community level, is without prejudice to
the resubmission of the same application in anothe r Member States. These situations are all provided
for in whereas 35, 36 and 38 of Directive 2001/18/EC.

I. INTRODUCTION
1. The European Communities here comments on the responses of the Complainants ("the
Responses") to the questions from the Panel whic h have been asked during and after the second
susbtantive meeting of the Parties. The European Communities is con scious that there have now been
extensive written pleadings in these proceedings, and does not wish to repeat the matters which have
already been fully addressed by the Parties. In many respects the Complainants have simply repeated
their earlier arguments of law and fact. It is apparent from the Responses that the differences between
the views of the Complainants and the European Communities are clear and have very significant
implications. In particular, the broad and extens ive approach to interpretation relied upon by the
Complainants will extend the scope of the SPS Agreement into areas which the drafters of that
Agreement did not intend.

2. Rather than repeat the differences between th e parties – or reiterate arguments already made –
the European Communities considers that it would be more useful to comment on the approaches
taken by the Complainants on some of the key issues which remain outstanding.

3. Accordingly, in these Comments the Europ ean Communities will not proceed by addressing
in numerical order each and every Response given by each of the Complainants to each particular
question. Instead, the European Communities comments on categories of questions and on those
Responses which merit attention because they indicat e a material and generic difference of approach.
In proceeding in this way the European Co mmunities wishes to stress two points. First
, and for the
avoidance of doubt, it maintains in their totality a ll of the legal and factual arguments which have
been raised at earlier phases of these proceedings: th e fact that no comment is given to a particular
Response cannot be taken as an indication that the European Communities is agreeing with the
Response. Second , in adopting this approach, the Europ ean Communities will go directly to the
Complainants Responses and will refrain from adva ncing any arguments that go beyond the issues
specifically discussed in those Responses.

II. THE SCOPE OF THE SPS AGREEMENT (ANNEX A.1): COMMENTS ON
QUESTIONS 119, 120, 127, 170, 175, 176, 178, 180, 182, 187, 188, 191, 192
4. The issue of the scope of the SPS Agreement is one where it is easy to contrast the several
approaches followed by the parties. The parties' re plies to the Panel's questions show that those
approaches are fundamentally different.

5. The European Communities notes that the Co mplainants recognize th at their claims are
dependent upon the adoption of a broad interpretation of the terms identified:

• "Argentina agrees that the term "pest" in the SPS Agreement should be given a broad
interpretation in the light of the broad interp retation given to the term "pest" in the IPPC
and the ISPM No. 11" (Argentina's reply to Question 119)

• "[T]he broad definition given to the term "pest" in ISPM No.11 confirms that the
ordinary meaning of the term "pest" in the SPS Agreement, in its context and in the light
of the object and purpose of the SPS Agreement, should be given a broad interpretation "
(Canada's reply to Question 119)

6. The European Communities, on its side, reite rates that all processes of interpretation must
follow the requirements of the Vienna Convention, and that it can never be a question of broad or

narrow interpretations as such. Applying the requi rements of the Vienna Convention leads inevitably
to the conclusion that the text, context and purpose of the SPS Agreement, as well as its negotiating
history and the application of relevant principl es of treaty interpretation (and in particular the
principle of expressio unius est exclusio alterius (to express one thing is to exclude another)), which is
relevant in relation to the failure of the negotia tors to include the environment as such in the SPS
Agreement, strongly support the conclusion that, for inst ance, environmental risks as such do not fall
within the scope of the SPS Agreement.

7. Incidentally, while Canada admits that the Panel should make use of supplementary means of
interpretation, as foreseen in Article 32 of the 1969 Vienna Convention (see Canada's replies to
Questions 119 and 140), it has failed to address " the preparatory work of the treaty and the
circumstances of its conclusion ". The other Complainants also make no effort to address the
negotiating history of the SPS Agreement , surely because the negotiating history of the SPS
Agreement clearly demonstrates that it was not the intention of the drafters to include the protection of
the environment as such within the disciplines of th at text. It is the European Communities which has
provided the Panel with the key elements as regards this particular aspect.
1

8. The Complainants also ignore the consequen ces which their approach will plainly have in
extending the application of the SPS Agreement to measures and acts which were never intended to be
subject to it. This is obvious, for instance, when the United States affirms rather astonishingly that
Annex A(1)(d) could apply to measure to prevent da mage other than damage to plants, animals or
humans (see US reply to Question 120, subpart (b) a nd (c)), without further qualification. The United
States fails to discuss how this odd interpreta tion would fit in the overall scheme of the SPS
Agreement. As a matter of fact, the Preamble of the SPS Agreement refers exclusively to " human,
animal or plant life or health "
2. As the European Communities has explained, in the light of the
context and purpose of the SPS Agreement , as well as its negotiating history, the terms "other
damage" must refer to damage that is closely relate d (i.e. that is of a similar kind) to damage to
human, animal or plant life or health. This is a basic rule of interpretation. The European
Communities has shown that there are dozens of exam ples where pests cause damage in particular to
fruits without compromising in any way the life or hea lth of the plant. There is therefore no need to
look for eccentric examples, as Canada does in its reply to Question 120 (e.g. " effects ... on
recreational uses, tourism "), and it would be legally incorr ect to broaden the scope of the SPS
Agreement to cover measures addressing risks concerning ecological processes, for the reasons
already explained.

9. When examining concretely the interpreta tion given by the Complainants to the 4 sub-
paragraphs (a to d) of Annex A.1 of the SPS Agreement, it is clear that they are in plain disagreement
on the meaning of the relevant terms and on their a pplication to the case at hand. The resolution of
their differences is principally a matter of treat y intrepretation, which sh ould be conducted in
accordance with Articles 31 and 32 of the Vienna Convention. In this connection, the European
Communities wishes to make the following points:

10. First of all
, the Complainants disagree on which would be the relevant paragraphs of Annex
A.1 to assess the potential adverse effects listed in Annex II of Directive 2001/18 (see their replies to
Question 170). For instance, Argentina considers th at disease to humans, animal and plants, including
toxic and allergenic effects " fall squarely within Annex A(1)(b) of the SPS Agreement "; Canada in
principle shares that view, but it adds that some of those risks " also could fall within Annex A(1)(a) of

1 See the Reply of the European Communities to Question 120, as well as the EC Second Written
Submission, paras. 57-59.
2 First Recital of the Preamble of the SPS Agreement.

the SPS Agreement"; the United States considers that those ri sks fall under Annex A.1(c) (in so far as
humans are concerned) and Annex A.1(a).

11. Second
, the Complainants also advance differing in terpretations to specific terms of Annex
A.1. For instance, although Canada considers that the United States' interpretation of the term
"additive" is " linguistically plausible ", it does not actually support the interpretation (see Canada's
reply to Question 180). Further on, Canada suggests that antibiotic marker genes "might be considered
contaminants" (see reply to Question 180). This is in open contradiction with the United States'
interpretation3, which, in any event, maintains that th e risks relating to antibiotic marker genes
generally fall within paragraph 1(a), even thou gh that paragraph does not make any reference to
additives or contaminants (see US reply to Questi on 170, para.10). In any event, the European
Communities recalls its position that antibiotic resi stant marker genes cannot be considered as
"additives" or "contaminants". 4 The European Communities further notes that, contrary to the United
States' views, the technological purpose of antibiotic marker genes is not "to aid in the manufacture of
the food from the biotech plant " (see US reply to Question 191(a)(i)). They are generally present by
accidental integration of bacterial vector sequences . If at all, antibiotic marker genes aid in the
process of selection of the GM plants themselves (not the food).

12. Third
, the United States goes as far as contradicting itself in the very same paragraph, when it
states without any reasoning that " [w]hile the United States would not typically consider toxic and
allergenic effects to be diseases, measures taken to address concerns that a biotech plant might cause
disease to humans would appear to fall squarely within the scope of paragraph 1(c) – "to protect
human life or health ... from risks arising from diseases carried by ... plants or products thereof " (see
US reply to Question 170, para. 3). In this regard , the European Communities definitely agrees that
toxic and allergenic effects are not "diseases". The European Communities would further note that the
United States considers that concerns that a GM plant " might cause disease " (sic) would fall under
paragraph 1(c), which in fact deals with diseases " carried by animals, plants or products thereof ".
This is yet another example of the United States' di sregard for the basic rules of treaty interpretation,
in particular the wording of the treaty, as there is no doubt that Annex A.1 the SPS Agreement
distinguishes between "diseases", diseases "caused" by an organism and diseases "carried" by an
organism (see, for instance, Annex.1(a): "to protect animal or plant life or health ... from risks arising
from ... diseases, disease-carrying organisms or disease-causing organisms "). Lastly, it is enough to
point out that the United States seems to suggest that the terms of the SPS Agreement should in the
context of this particular dispute be interprete d in a manner that it would not typically consider
correct.

13. Fourth , the broad, untenable interpretation of the te rm "pest" illustrates clearly the fact that
the Complainants most often put forward mere unsubstantiated assertions, which are unsupported by a
rigorous reading of the SPS Agreement. The United States claims, for instance, that allergic and toxic
effects on humans would be " risks to human health arising from the entry, establishment or spread of
pests". The United States refers specifically to " toxic or allergic effects arising from occupational or
residential exposures" (see reply to Question 170, para.4). However, the European Communities fails
to see why a GMO should be necessarily be qualified as a "pest" in those circ umstances. Indeed, a
GM plant can provoke occupational allergies regardl ess of its invasiveness or persistence. It could
provoke occupational allergies even under contro lled cultivation conditions, as the allergenicity
depends on the intrinsic characteristics of the plant other than its weediness potential 5. The United

3 Argentina appears not to have replied to Question 180.
4 See, for example, EC First Written Submission, paras 399 to 404.
5 The same applies to potential impacts on biogeo chemical cycles (see US reply to Question 170,
para.13).

States again contradicts itself when it affirms that a measure aimed at preventing human health risks
arising from occupational exposure to a substance that is a toxin for insects " would fall within the
scope of paragraph A(1)(b) " – see US reply to Question 178(c). Si milar considerations apply to the
allegations by Argentina and Canada (see their replies to Question 170).

14. Fifth
, on some occasions, the Complainants' di sregard for the actual wording of the SPS
Agreement is even more egregious. For instance, Argen tina, Canada and the United States consider
that measures to prevent the risks arising from antibiotic marker genes, which can compromise
"prophylactic or therapeutic medical, veterinary, or plant protection treatments", fall within the scope
of Annex A(1)(a) of the SPS Agreement (see their replies to Question 170). The European
Communities would simply note that Annex A.1(a) refers only to animal or plant life or health, so it is
not clear at all which is the relevance of that parapraph to the loss of effectiveness of "medical
treatments" (that is, treatments for humans).

15. Finally
, the Complainants often argue that some of the potential risks relevant for a risk
assessment under Directive 2001/18 are not relevant in the context of the present dispute because " the
question is ... whether the risks that the EC has rai sed with respect to the products at issue in this
dispute, either in whole or in part, fall within the Scope of the SPS Agreement " (US reply to Question
178(a), para.50). The Complainants seem to forget that they have challenged (wrongly) an alleged
"general moratorium" that w ould apply to all GM products, beyond the specific product applications
examined by the EC authorities. The European Co mmunities has made clear that no such thing as a
"general moratorium" is applied. In any even t, if the Complainants' views on the "general
moratorium" were upheld, the "products at issue in this dispute" would be all GM products, and
therefore all potential risks ought to be considered.

16. Aside from the above issues, the Complainants also make a number of arguments regarding
the relationship between the SPS Agreement and other WTO Agreements (in particular GATT 1994
and the TBT Agreement ). Their main point seems to be that the obligations contained in the WTO
Agreement are "generally cumulative", and that the fact that a measu re may pursue several legitimate
objectives, some of which are not SPS objectives, is not relevant to their coverage under the SPS
Agreement (Canada's reply to Question 175, paras.32, 38). The European Communities will not repeat
its extensive arguments on this issue. At this stage, it is enough to recall that the European
Communities does not have any particular problem with the suggestion that measures that pursue
multiple objectives, some of which are SPS objectives, fall partly under the scope of the SPS
Agreement. The real point is a different one: in a nutshell, if a measure pursues two different
objectives, one of which is deemed legitimate by a Panel and one of which is not, the Member that
adopted the measure is under no obligation to withdr aw it. In other words, if those two objectives are
to be assessed under two different WTO Agreements (for instance, the SPS Agreement and the TBT
Agreement), a recommendation to withdraw the measure can only be made after an examination under
the two Agreements.

17. As regards the question of whether co-existence concerns come under the scope of the SPS
Agreement (Question 175), the European Communities notes that all parties agree that the economic
risks arising from the mere admixture of approved GM crops with non GM crops do not come under
the scope of the SPS Agreement. Disagreement only exists with rega rd to whether such concerns are
legitimate under other WTO Agreements and if so, how that fact would affect an assessment of a
measure under the SPS Agreement (see immediately above).

III. THE RELEVANT OBLIGATIONS UNDER THE SPS AGREEMENT –
APPLICATION OF SPS MEASURES: COMMENTS ON QUESTIONS 125, 172, 186
18. The Complainants fail to draw any meani ngful distinction between a measure and its
application. This is particularly evident in thei r replies to Question 172. All Complainants seem to
agree that a decision to delay an appli cation procedure may well constitute a case of application of an
SPS measure (Canada, para. 15, US para. 30, ARG fi rst paragraph). All three, however, then argue,
that such a decision to delay may nevertheless, unde r certain circumstances, constitute a distinct SPS
measure. The criteria they offer differ widely, bu t have in common that they are useless for the
purposes of distinguishing between a measure and the application of a measure. The US proposes to
distinguish between delaying for a day or a week a nd delaying for an indefinite period of time.
Applied to the facts of the present case such a crite rion simply does not make any sense: There were a
number of requests for additional information that delayed the application procedure. How long the
delay would take depended entirel y on the nature of the additional information requested and the
applicant's ability and willingness to provide it. It is simply not possible, for the requesting authority,
to determine (much less impose) how long the delay will be.

19. Canada invites the Panel to assess whether "the source of the dela y supersedes the approval
procedure as the measure that exerts effective control over subject matter of the … product
applications." One feels tempted to wish the Pane l good luck in giving meaning to such grandiose
sounding notions as "superseding", and "exerting effective control over subject matter."

20. By contrast the approach offered by Ar gentina seems simple: Delays cease to be the
application of an SPS measure when they occur "systematically." However, how the Panel is
supposed to assess whether a "decision" to delay the completion of an approval procedure for a
number of days is of the "systematic" kind or not, Argentina leaves open.

21. All three Complainants, finally, share the inabilit y to apply any logic in their approaches. If,
as they claim, the delays that have occu rred in the present case actually constitute a distinct SPS
measure, why then are these very same delays challenged at the same time as the application of an
SPS measure?

22. This lack of logic is due to the Complain ants' further failure to make any meaningful
distinction between an action and a failure to act. Obligations under the SPS Agreement (or any other
WTO agreement for that matter) are either "negative" ones, that is an obligation not to undertake/to
refrain from a certain action, or they are "positive" ones, that is an obligation to undertake a certain
action. In order to be subject to an obligation conduct must be qualified as either action or inaction.
Action and inaction are mutually exclusive concepts . Annex C 1(a) contains an obligation to act
without undue delay. The conduct it addresses, con sequently, is failure to act, not action. By
contrast, Articles 5.1 or 5.7 contain negative obligat ions and thus address a conduct that is action (i.e.
the adoption of a trade-restrictive SPS measure).
6

23. Canada's failure to grasp this difference is pa rticularly blatant in its reply to Question 125.
That question is about the concept of "undue delays" in Annex C 1(a) in the context of a precautionary
approach. While eagerly discussing "undue delays" as "a failure to make a decision" in Question 186
(see para. 59), for the purposes of its reply to Questi on 125, Canada qualifies them as a "decision not
to complete the approval procedure" which "amounts to a ban on the product." That ban, then,
according to Canada, must satisfy the requirements of Article 5.7 in order not to be qualified as an
"undue delay" under Annex C 1(a). By contrast, the United States seems to be more aware of the

6 See EC First Written Submission, paras. 463ff.

schizophrenia of qualifying something as failure to act and as action at the same time, and, thus, more
prudently, proposes to assimilate the "effects" of delays to that of the adoption of a ban (see para. 19).
Article 5.7, under the US proposal, could then be "r elevant context to be examined in deciding how to
apply the "undue delay" provision under Annex C", but would not be directly applicable.
7

24. It may be that the Complainants are starting to realise that a measure consisting of a decision
not to approve a product for a period would be a provisional measure to which Article 5.7 SPS
Agreement would be applicable. However, they cannot a llege a violation of Article 5.7 because they
have not based any claim on this provision.

25. As stated in its second oral statement at the second meeting of the Panel with the Parties, the
European Communities holds the view that the precau tionary principle as such (and not Article 5.7)
should be of relevance when assessing whether a delay is undue.
8

IV. THE SPS AGREEMENT - SCIENTIFIC EVIDENCE, RISK ASSESSMENTS AND
ARTICLE 5.7: COMMENTS ON QUESTIONS 122, 123, 125, 126, 142
26. In response to Question 122, the European Communities explained that the ALOP may be
relevant to the conduct of a risk assessment, taking into account different objective conditions,
different types of values or concerns, or different levels of protection. According to Argentina, the
"appropriate level of protection and risk assessment are related", whilst according to the United States
they are "distinct". According to Canada, "the appr opriate level of protection (ALOP) is not directly
relevant to the conduct of the risk assessment. It is, however, relevant once the risk assessment has
been completed and, assuming that a risk has been identified, a risk management measure has to be
selected." Canada concludes that "whether the chosen level of protection is low or high does not affect
the risk assessor's need to have sufficient informatio n at his or her disposal to come to a conclusion
that is as certain as possible. A risk assessment t hat is characterized by significant uncertainty as to
the likelihood or magnitude of adverse effects occurring is less helpful to the risk manager, regardless
of the level of protection sought to be achieved because it is less likely to serve as an accurate
predictor with respect to whether that level of protection will actually be achieved."

27. The European Communities therefore notes th at the Complainants are not in agreement:
Argentina and the United States take diametrically opposed views, whilst Canada effectively agrees
with the European Communities. Canada effectiv ely agrees with the European Communities because
it acknowledges that a risk assessment may be more or less helpful to a risk manager according to the
extent to which it is characterised by significant unc ertainty. Canada attempts but fails to avoid the
inevitable logical consequence: given this premise, it is evident that a risk manager with a lower level
of concern will be satisfied with a less developed risk assessment than a risk manager with a higher
level of concern.

28. In response to Question 123, the European Communities explained that it considered the
underlying premise to be legally erroneous, and re ferred to its previous s ubmissions concerning the
relationship between Article 5.7 and 2.2 and 5.1 of the SPS Agreement. Argentina replies "no" to the
first part of the question and "yes" to the second part of the question. Canada, on the other hand,
considers that it would be "technically" possible to consider Article 5.7 first, but "naturally" preferable
to consider Article 2.2 first. Remarkably, Canada considers that any measure adopted under Article

7 See also US reply to Question 173 in para. 34, where the US suggests "an analogy to provisional
measures under Article 5.7."
8 Second Oral Statement of the European Communitie s to the Second Meeting of the Panel with the
Parties, para. 54.

5.7 is "ipso facto" inconsistent with Articles 2.2 and 5.1. Canada offers an incomplete summary of the
precise circumstances of the appeal in the Japan-Apples case. Taking a slightly different line, the
United States considers that it would be "possible" but not "practicable" to first consider Article 5.7,
unless the European Communities first concedes an inconsistency with Articles 2.2 and 5.1, and that it
would be most "efficient" to first consider Articles 2.2 and 5.1.

29. The European Communities concludes that th e Complainants are not in agreement amongst
themselves. The European Communities re-iterates its view that the legal point is the exclusionary
nature of the relationship betwee n the provisions. This is not a qu estion of what is "technically"
possible or "natural" or "possible" or "practical" or "efficient". Rather, the legal question is to be
settled by applying customary rules of interpreta tion of international law to the text of the SPS
Agreement. The European Communities believes that this view is shared by the Appellate Body.

30. The heart of the problem is burden of proof. The European Communities believes that, faced
with a request for authorisation of a new product, an d faced with a legitimate concern, the absence or
insufficiency of scientific evidence may justify a s ituation in which, provisionally, the new product is
not approved. The European Comm unities believes that the burden of proving that the new product is
safe falls on the applicant, just as the burden of proving that any provisional measure is unjustified
because the scientific evidence is complete and demo nstrates that the new product is safe, falls on the
Complainants. The Complainants cannot shirk-off th e burden of proof that falls on their shoulders by
invoking, instead of Article 5.7 (on the basis of which the provisional measure has been adopted)
Article 2.2 – twisting the word "sufficient" in Article 2.2 to make it refer to the quantity, rather than
the quality, of the scientific reasoning. The proof of that is that the European Communities agrees
with the Complainants (as it has already stated) that, where it has adopted provisional measures, it has
done so precisely because the science is insuffici ent for the purposes of the specific legislator. To
accept the Complainants' reasoning would be to shift the burden of proof on to the Member adopting
the provisional measure, as opposed to the Member bringing the case under the DSU. And that would
constitute a legal error.

31. With regard to Question 125, Argentina's answer, by implication, accepts the premise
reflected in the Panel's question concerning the relevant legal framework and analytical approach : the
relevance of the precautionary principle in th e context of Annex C.1(a) – and (but only
 if there would
be a measure) Article 5.7. Argentina merely confines itself to asserting that, in fact, at the date of
establishment of this Panel, the science was, on all points, sufficient and mean t that the only possible
course of action for the European Communities w as an immediate definitive approval. Argentina
asserts that the concerns referred to by the Eur opean Communities are no different from the residual
uncertainty inherent in all science. Canada essentia lly takes the same line, but with the additional
assertion that the European Communities has not invoke d Article 5.7 other than in relation to the
safeguard measures. That is not correct. The Europ ean Communities position is that if the Panel were
to make the (in the opinion of the European Co mmunities) legal error of finding that the product
specific delays were measures or that something generally referred to by the Complainants as the
"moratorium" existed, then, indeed, the relevant provision of the SPS Agreement would be Article 5.7,
that being the provision relevant to provisional situ ations, in which the science is as yet insufficient
for a final decision to be taken. However, since th e issue is one of delays, not measures, the correct
approach would be to assess the situation under An nex C.1 (giving due account to the precautionary
principle), not Article 5.7 (see above Comments un der Section III). The United States avoids the
question as "too vague and general" and returns to its erroneous assertions about the alleged
"moratorium". It states that "broad generalisa tions" are not helpful when considering individual
products – a statement with which the European Communities wholeheartedly agrees. It goes on to
assert that the European Communities considers that Member can delay "indefinitely" on the basis of
"theoretical" risks.

32. The European Communities concludes that all the Complainants appear to be generally in
agreement about the correct analytical framework – it is just a question of considering the facts in
each case.

33. The European Communities would respectfully recall the advice provided to the Panel by the
independent experts; the meeting with the experts; and the subsequent comments by the European
Communities. The European Communities believes that it is not possible to dismiss out of hand, as
the Complainants seek to do, that scientific advice as "theoretical" or as relating to, or equivalent to,
the residual uncertainty that may always be present in science.

34. With regard to Question 126, the European Communities notes that, on the question of risk
assessments, and particularly risk management, all of the Complainants urge the Panel to ignore the
Codex. The European Communities be lieves that it was and is entitled to refer to the Codex for this
purpose, and that to find otherwise would constitute a legal error.

35. With regard to Question 142, the European Communities explained both the similarities and
differences between scientific "evidence" and scientif ic "principles", placing its response also in the
context of Article 5.7. The Complainants broadly agree – but once again entirely miss the point about
Article 5.7.

36. In summary, the European Communities notes th at on these issues, such as the sufficiency or
insufficiency of the science, burden of proof, and provisionality or the precautionary principle, which
in many respect go to the core of this case, the Co mplaints remain, in many important respects, in
disagreement amongst themselves. In truth, the asserti ons they make seek to set at naught the advice
from the independent experts, and to steer the Panel towards the wrong provisions of the SPS
Agreement. The European Communities would respectfu lly request the Panel to reject the
Complainants' arguments on these points.

V. THE TBT AGREEMENT: COMMENTS ON QUESTIONS 174 AND 181
37. The European Communities notes that the Un ited States has expressly declined to answer
Question 174, on the interpretation of Article 2.2 of the TBT Agreement, on the grounds that the issues
in dispute are governed by the SPS Agreement and not the TBT Agreement. The three other parties are
in agreement in recognising the n eed to answer the question. Canada and Argentina do not appear to
challenge the view of the European Communities that a "trade effect must be weighed against the
seriousness, severity, irreversibility, etc. of the consequences of non-fulfilment of the objective in
assessing consistency with Article 2.2 of the TBT Agreement."

38. However, as regards the meaning and scope of the terms "scientific information" in
Article 2.2 of the TBT Agreement , Argentina and Canada appear to be in disagreement (see their
replies to Question 174(b)). Argentina consid ers that "scientific information" in the TBT Agreement
refers to a broader range of matters than health or environment matters, such as "national security"
and "deceptive practices". Argentina also considers that "scientific information" is to be interpreted as
being "equal to "scientific evidence"". Canada a dopts a different approach, concluding that "the
distinction between "scientific evidence" in Article 5.2 of the SPS Agreement and "scientific
information" in Article 2.2 of the TBT Agreement relates to the differences in the respective
obligations of the two agreements for measures to have a factual and/or scientific basis."

39. The European Communities consid ers that the drafters of the SPS Agreement and the TBT
Agreement must have intended to use the concepts of "scientific evidence" and "scientific

information" to mean different things, or they wo uld not have distinguished between the use of the
terms. The European Communities notes that Canada appears to share this view (and notes that
Canada is inconsistent with its own approach to treaty interpretati on when elsewhere in its replies it
proposes the view that the SPS Agreement must be interpreted to include effects on biodiversity and
the environment, notwithstanding the fact that the drafters of the SPS Agreement purposely
 did not
include the term "environment", which is in turn found in the TBT Agreement).

40. With regard to Article 2.1 of the TBT Agreement, both Argentina and Canada agree that the
Member State safeguard measures apply to the releva nt GM products when imported into the territory
of the respective Member States and when they ar e produced in those Member States. The parties
seem therefore to agree that th e Member State safeguard measures cannot be considered to be
discriminating in any way against imported GM prod ucts (see replies to Question 181). Furthermore,
the European Communities notes the c onfirmation by Canada that it does not claim that the Greek
measure violates Article 2.1 of the TBT Agreement . In this context, the European Communities
reaffirms its position that " it is clear that the nature and aim of the Greek measure does not differ
from those of the other national measures "
9, contrary to Canada's a llegations regarding the " explicit
wording of the measure ". Indeed, Canada entirely misses the point, as it is obvious that the Greek
measure is entitled "import ban" merely because only an import authorisation had previously been
granted at EC level. The reality is that in Greece, the production, import, marketing or use of the
product at stake is not authorised . Therefore, the Greek measure si mply re-establishes the situation
that existed before the EC approval was granted, a nd that situation certainly applies to import in the
same way as to domestic production. The Panel shoul d look at the situation prevailing in Greece as a
whole, and not simply make legal findings on a measure on the basis of its "label".

VI. THE BURDEN OF PROOF: COMMENTS ON QUESTIONS 145 AND 146
41. The European Communities notes that there is a fundamental disagreement between the
parties as to the burden of proof which arises once the European Communities has put forward the
evidence which it considers justifies actions whic h may have led to delays in authorization
procedures. In such circumstances it must be for the Complainants to respond by rebutting that
evidence. It cannot be enough to argue, as the Unite d States does for example, that there existed an
"across-the-board general moratorium" which obviates the need to rebut the evidence put forward by
the European Communities (See US reply to Question 145). First, the Complainants have not proven
the existence of an alleged "moratorium" or its application to any of the authorizations which form the
subject of these proceedings. Second, the independent scientific experts appointed by the Panel have
confirmed that the evidence put forward by the Eu ropean Communities confirms that the scientific
concerns raised by the EC Competent Authorities a nd the resulting delays were justified. In such
circumstances the European Communities fails to unde rstand how it can be said that it has failed to
justify its actions, or how in such circumstances the relevant action could be said to arise from the
application of an alleged "moratorium".

42. The European Communities would further not e that the United States considers that it " does
not have the burden of establishing that particular delays were justified or unjustified " (Reply to
Question 145). The European Communities would si mply point out the fact that, when a WTO
Member alleges a violation of Annex C(1)(a) of the SPS Agreement (or, for that matter, of Article
5.2.1 of the TBT Agreement), that Member bears the burden of proving that there are "delays" and that

9 First Written Submission of the European Communities, para. 640.

such delays are "undue". Canada, on the other hand, seems to agree that the Complainants bear the
burden of proving "undue delays" (see Canada's reply to Question 145
10).

43. Finally, Argentina's position is striking, as it seems to be based on a general, unsubstantiated
dismissal of all the evidence submitted by the Eu ropean Communities as not being "evidence" (see
Reply to Question 145: " We do not agree with this statement, because it assumes that the EC has
submitted evidence… "). Apparently, Argentina considers that any scientific paper, any technical
element or any established fact that does not s upport its case is not "evidence", but second-class
information that should not be taken into account. Such approach is obviously biased and untenable,
as exemplified in Argentina's reply to Question 146. The European Communities fails to understand
how Argentina can assert that the studies and analysis undertaken by the Commission du Génie
Biomoléculaire and the French AFSSA cannot be said to be "scientific evidence". Both are well-
renowned and reputable institutions which purported to take their d ecisions on the basis of scientific
elements (or lack thereof) which were placed before them in the relevant dossiers. The fact that
Argentina does not agree with the outcome cannot of itself determine the characterisation of the
process by which the relevant decisions were taken.

VII. RELEVANT INTERNATIONAL STANDARDS: COMMENTS ON QUESTIONS 121
AND 140
44. The European Communities notes the plain di sagreement between the United States, on the
one hand, and Canada and Argentina, on the ot her hand, as regards the issue of the relevant
international standards that the European Communities had to take into account prior to August 2003.
Argentina and Canada believe that no relevant risk assessment techniques had been developed by
relevant international organisati ons in the period October 1998 to August 2003 (see their replies to
Question 121). By contrast, the United States believe s that such techniques had been established, and
identifies no less than six Codex and IPPC standards which it considers to be relevant (see US reply to
Question 121). The European Communities submits th at these standards – as well as those identified
by the Communities in its answer to Question 121 – are properly to be taken into account in assessing
the compatibility of the Communities' actions with the relevant rules of WTO law. However, the
European Communities would recall two fundamental points:

45. First, Codex and IPPC standa rds do not exhaust the range of issues ariring from the products
of biotechnology, in particular as regards environmental risks.

46. Second, the IPPC and Codex standards we re developed precisely during the period 1998-
2003, and they were not adopted until July 2003 (in the case of the Codex principles on risk
assessment of food derived from modern biotechnol ogy) and April 2004 (in the case of ISPM 11).
However, they incorporate many of the issues and c oncerns that were being raised at the time by the
EC Competent Authorites in connection with th e assessment of specific GMO products. This fact
provides further confirmation that the behaviour of the EC Competent Authorities was perfectly
justified.

47. Otherwise, there appears to be broad agreem ent amongst the parties that the Codex standards
and ISPM 11 are not "rules of international law" w ithin the meaning of Article 31(3)(c) of the Vienna
Convention, in the sense that they are not binding international law instruments as such (See replies to

10 However, Canada fails once again to clarify what is the nature of its claims and of the challenged
measures, as in its Reply to Questi on 145 it refers to "delays" as the result of an alleged "moratorium", or as
confirmation of the alleged "moratorium". On this issue, see the Comments in Section VIII.

Question 140; the United States does not express a view on this point, considering the matter to be
theoretical).

48. As regards the IPPC, there appears to be agreement that the 1979 version is a rule of
international law within the meaning of Article 31(3 )(c). Insofar as the 1997 IPPC is concerned, this
had been accepted by Argentina, Canada and the United States by the time the Panel was constituted,
but had not yet entered into force. The European Communities had not accepted the instrument. In the
case of the 2000 Biosafety Protocol this too had not entered into forced by the time the panel was
constituted, but it had been signed by Argentina, Canada and the European Communities.

49. As the European Communities has previously mentioned, in previous disputes the WTO
Appellate Body has referred to instruments which were not binding on all the parties to a WTO
dispute in interpreting WTO rules. In particular, in United States – Shrimps (1998) the Appellate
Body relied on: UNCLOS (which had not been signed by US, but which arguably reflects for the most
part international customary law), the Convention on Biological Diversity (which had been signed but
not ratified by Thailand and the US), Agenda 21 (whi ch is a "programme" or a "plan of action" to be
developed through several means, including the further development of international law on
sustainable development), the Convention on the Con servation of Migratory Species of Wild Animals
(to which Malaysia, Thailand and the US were no t parties). In this connection, the European
Communities notes that under Article 18 of the Vienna Convention a state, which has signed a treaty
is bound not to take any steps to defeat its object and purpose. These considerations indicate that it is
appropriate to take account the international instru ments referred to in the reply of the European
Communities to Question 121 in construing and interpreting WTO rules, such as the SPS Agreement,
although it does not provide a basis for reading into the SPS Agreement matters which the drafters
plainly intended to exclude (such as biodiversity and the protection of the environment in general).

50. Finally, the United States appears to be isolat ed in its view that the Codex standards, then
IPPC and ISPM 11 can be used as "additional factua l evidence" of the ordinary meaning of terms
contained in Annex A of the SPS Agreement. The European Communities and Canada consider that
they are aids to interpretation and do not have evidentiary status as such (see replies to Question 140).

VIII. THE CHALLENGED MEASURES: COMMENTS ON QUESTIONS 179, 185, 193, 194,
195, 197
51. The European Communities would like to provide the following comments on the
Complainants' replies to Questions 179, 185, 193, 194, 195 and 197. Those questions are useful to
demonstrate the identity and nature of the "cha llenged measures", and to demonstrate that the
approach that the Complainants have pursued since the very beginning of this dispute is
misconceived.

52. First of all
, the Complainants' replies constitute further evidence of the insufficient
characterisation of the "challenged measures" and th e sweeping approach to law, facts and evidence
adopted by the Complainants. This is nicely illustra ted by the Complainants' inability to distinguish
between their claims on the alleged ‘de facto' moratorium and the alleged product-specific moratoria
(or marketing bans, in Canada's parlance) and the circularity of many of their arguments:

53. The United States, in its reply to Question 197, bluntly states that "[s]ince the general
moratorium applied to all products, a necessary corollary
 is that the EC also adopted product-
specific moratoria on each of the product applications covered in the US panel request."

54. Canada contends that it " has provided ample evidence of the existence of the moratorium and
the product-specific marketing bans, being the manifestation
 of the moratorium in the context of the
approval procedures of the four specific products of concern to Canada." (Reply to Question 179)

55. Canada further argues that "[t]he product-specific marketing bans are a direct consequence of
the moratorium as applied to individual product appl ications. They are also proof of the moratorium
and, for Canada, the most injurious manifestation of the moratorium. They are however distinct
measures from the moratorium and give rise to distinct violati ons of the WTO Agreement. The
arguments in relation to the pr oduct-specific bans are intended to focus on the direct and detrimental
impact of the moratorium on specific product applications ". According to Canada, "[i]n principle, the
adoption of the moratorium led to the adoption of the product-specific marketing bans. "(Reply to
Question 185)

56. Argentina dismisses the importance of looking at individual product applications because, in
its view, " the number of the selected product applications should not be relevant because this does
not change the fact that there is a "de facto" moratorium." (Reply to Question 179).

57. It is clear from the Complainants' repli es that there is no distinction between the " general"
claims and the " product-specific" claims. Instead of characterising the alleged product specific
moratoria as distinct measures, the Complainants describe them as the " corollary", the
"manifestation", the "direct consequence" or the "impact" of the alleged general moratorium.

58. The Panel should not be misled by this ki nd of circular reasoning whose only purpose is to
prevent an examination of the reasons that expl ain and justify the behaviour of the European
Communities during the relevant time period.

59. In the circumstances, the European Communities can only conclude that the Complainants
have failed to identify with any degree of precision what is the measure or measures that they are
challenging, and what would be the nature of such m easures (an act? a delay? both things at the same
time?).

60. Secondly
, as regards the alleged general moratorium, the Complainants contest the European
Communities' view that, for the purposes of proving a ‘moratorium' that applies across the board, it
does not suffice to address only a limited selection of product applications. In their views, they have
proved that there were no approvals between Oct ober 1998 and August 2003 (see United States' reply
to Question 179), or between October 1998 and Ma y 2004 (see Canada's reply to Question 179).
Argentina argues that "[t]he EC assertion is flawed because, as a result of the moratorium, there have
been neither approvals nor rejections" (see reply to Question 179).

61. However, if the Complainants argue that the European Communities has adopted a ‘de facto
moratorium' on approvals of all GM products, they should prove that such measure applies beyond the
specific product applications at stake in these proc eedings. Conversely, if the European Communities
establishes, as it has done, that there is no such thing as a general suspension of approval procedures
(and, for that purpose, it is enough to put forward one specific example), then the claims of the
Complainants against a general abstract measure should be dismissed.

62. The European Communities would point out that , contrary to the United States' and Canada's
assertions, the absence of any approval
11 between October 1998 and August 2003, or between October

11 The European Communities would however recall that several products have been authorised since
1998 under the simplified procedure of Regulation 258/97.

1998 and May 2004, is by no means evidence of the existence of a general suspension of approvals.
At this stage, the European Communities would lim it itself to recalling that Directive 2001/18 entered
into force in October 2002; that applicants were given the opportunity to resubmit their dossiers by
the end of January 2003; and that the European Communities started the assessment of those dossiers
forthwith, in accordance with the provisions of the Directive. Needless to say that, before approvals
could be granted, the European Communities needed to complete the required risk assessment. But
that does not mean that the procedure was suspende d in 2003: to the contrary, the proof that the
procedure was running is that the European Communities approved Maize Roundup Ready NK 603
on 19 July 2004. The European Communities would recall that the Complainants have not challenged
Directive 2001/18 and, therefore, they cannot comp lain that the European Communities follows the
provisions of the Directive for the purposes of making decisions on specific GM products. The
Complainants can simply not
 argue that the European Communitie s was supposed to suddenly make
final decisions on all pending applications on the date of the request for consultations, or on the date
of Panel establishment, or on any other relevant date.

63. Similarly, the approvals of Maize Bt 11 a nd Maize NK 603 for food use on 19 May 2004 and
26 October 2004 respectively, together with the chronologies submitted by the European
Communities, also show that the procedures we re not suspended in 2003, contrary to the
Complainants' allegations.

64. Finally
, the European Communities takes note of th e United States' replies to Questions 193,
194 and 195 that the "examples" of statements referring to a supposed ‘de facto moratorium' show that
countries that were arguably not in favour of any such thing as a moratorium nevertheless " allowed
the moratorium to continue ". The European Communities consid ers that the Complainants, and
specifically the United States, have failed to establish that a measure was adopted, or that a course of
action which was considered binding by all authorities was decided and consistently implemented12.
Sweeping and imprecise statements such as the replies to Questions 193, 194, and 195 can hardly be a
substitute for a complete and rigorous examination of each product applica tion. Tellingly, when it
comes to analysing specific products like Maize GA 21 (UK application), the United States refrains
from discussing the science and the current state of play and it simply makes unqualified statements
about an alleged seven-month delay back in 1999. The European Communiti es wonders what is the
usefulness of such arguments for the purposes of finding a positive solution to the dispute today.

IX. FACTUAL AND SCIENTIFIC ISSUES: COMM ENTS ON QUESTIONS 127, 143, 144,
148, 150, 165, 166, 167, 168, 169, 196
65. The European Communities would like to provide the following comments on the
Complainants' replies to Questions 127, 143, 144, 148, 150, 165, 166, 167, 168, 169 and 196. Those
questions usefully address a number of factual issues of timeframes and approval procedures for some
individual product applications, and re lated scientific and technical evidence. They are very useful to
clarify the nature and the extent of delays in th ese specific chronologies, and why they were justified
in the actual context of these applications, at the time of the "challenged measures". They illustrate the
disagreements, misunderstandings and misleading asser tions on the part of the Complainants, with
regard to the facts and the EC approval procedur es and institutions. These individual procedures and
facts were addressed only at a late stage in the Complainants' submissions.

66. On factual and technical issues also, the Complainants are wrongfully and artificially trying to
widen as much as possible the scope of the issues at st ake, or to bring them into conformity with their
claims, and to maintain their confusion between apples and pears.

67. For example, in their replies to Ques tion 127, they mistakenly assert that breeding
encompasses the genetic engineering steps to produce a GM plant in the laboratory. Rather, the core
of breeding, as stated by Dr. Andow (referred to in Canada's answer), is the natural cross between
different parent lines holding different genomic characteristics, and carrying different intrinsic genetic
properties/traits (including, where appropriate, t hose obtained earlier through genetic engineering), in
order to introgress and combine the desired properties/tr aits in the offspring. This in turn enables the
selection of the desired agronomic or other phenotypic traits in the field (as well as multiplying the
relevant offspring).

68. Because breeding is perfo rmed through a process of crosses, reproduction and selection
occurring naturally, it is itself explicitly excluded as such from the scope of the EC legislation on
GMOs. New breeding opportunities may indeed arise from genetic engineering, but breeding does not
include per se the introduction in a parent line in vitro, through genetic engineering, of a particular
transgene which may be of non plant origin. This is done for the sake of introducing a particular
desired property, which may not occur naturally and may not be available for natural selection
through breeding, and is therefore related, but distinct from the breeding itself.

69. As another example, in their replies to Questions 143 and 144, besides the striking
disagreements among the Complainants as regards th e possibility to use the risk assessment of one
product for one specific use, in the process of asses sing another product, or for another use (see for
instance the first paragraph of the answers of Ca nada, the United States and Argentina for Question
143), they again try to swiftly eliminate all the issues that need to be considered in this context, as is
well recognised now by international consensus on these issues.

70. First the European Communiti es notes that the Complainants all avoid addressing the issue of
the stacked products referred to in the Questions of the Panel, as their arguments would not hold in
this case for reasons explained extensively by the European Communities in its comments on the
scientific advice.

71. They fail in particular to recognise what they themselves implement, namely that the basis of
any sound and thorough risk assessment of a particular product is the unique transformation event ,
NOT
 the trait introduced or the generic nature of a protein expressed.

72. Consequently, they fail to address the issue of transformation specific unintended effects, as
well as one of the critical criteria of the assessment of risks, which is, besides hazard identification,
the exposure to that hazard, which is fundament ally different for each individual product and each
individual use. This is because one protein ("tra it") expressed in different plants may be – even
slightly, as pointed out by Argentina in res ponse to Question 144 – different, expressed at
significantly different levels, and often in completely different plant organs.

73. These case by case situations will both affect dram atically the particular exposure data to any
potential hazard, for human health, and for target a nd non target organisms. In turn, this critically
needs to be informed by the sp ecific end use which will affect any exposure assessment, and by the
organisms associated with the plant species which ma y be target or non target of the expressed trait,
and which are of course fundamentally different between different plant product species . Maize is not
be compared with oilseed rape, as suggested by Ar gentina and Canada in reply to Question 144; and
non target organisms are different for each plant species, which may result in possible different modes
of action of any expressed new protein, contrarily to what the US is stating in its reply to Question
144.

74. Moreover, the European Communities notes th at the Complainants make some misleading
statements when they seek to eliminate any cons ideration of scientific uncertainties, such as the
statement made by Canada in its reply to Question 144 that : " these transgenic modifications, and
their associated potential risks, are well understood" – that being a statement that is in absolute
contradiction with the overwhelming evidence fo r scientific uncertainties and for the striking
evolution of scientific knowledge in the relevant pe riod, which was provided by the Panel's experts in
their advice.

75. Yet another artificial simplification in the Co mplainants' responses is the answer provided by
Canada to Question 148 on the concerns about bioge ochemical cycles, where Canada claims that the
only instance where that concern was raised was in two documents issued by one Member State, for
two similar oilseed rape applications. Not only does Ca nada fail to mention that this issue was also
extensively discussed in the context of Bt maize applications
13, but more importantly that it was a
concern identified by the EC legislator, which required that all pending applications would be updated
at the latest in January 2003 to address that particular concern.

76. Indeed, as early as the end of the year 2000, the final text of Annex II of Directive
2001/18/EC
14 had been agreed, and it included in its sec tion C2 (steps of the environmental risk
assessment), as one particular characteristic which may cause adverse effects and needs to be
identified, "the effects on biogeochemistry (bioge ochemical cycles), particularly carbon and nitrogen
recycling through changes in soil decomposition of or ganic material (see for example items II.A.11(f)
and IV.B.15 in Annex III A, and D 11 in Annex III B)".

77. Another instance where the Complainants misl ead the Panel on the facts and the timing of the
EC procedures for GMO applications is to be fou nd in the answer of the United States to Question
150. The premise of the reply (no more than one year is contemplated for a procedure under Directive
90/220) is the hypothetical situation of a product application where no single scientific or technical
concern would be raised, where the data provi ded by the applicant w ould not necessitate any
clarification or amendment, and where no single request for further information would be issued. This
was of course never the case for the products at stak e, given all the scientific uncertainties and issues
raised, as also witnessed by the advice of the Panel's experts.

78. This situation is well known by the United States, where such product applications in the
relevant period also usually took several years under their own framework, for the same reasons.
There is simply no legal basis to assume that ther e was a time frame to reach a decision in roughly
one year – on the contrary the United States seem s to demonstrate factually that one should not
normally expect a decision earlier than the minimum timeframe for reviewing applications that the
United States presents (when no scientific/technical difficulties are raised).

79. And of course, the clarification to be made that the Directive provides for the clock to stop
each time a request for clarification or further information is made, pendi ng additional information
from the applicant, would extend that minimal timefram e to several years, even before the entry into
force of Directive 2001/18/EC, which required further updates of the applications. This is exemplified
by most of the chronologies provided by the European Communities.

13 This discussion refers to the effect on biogeochem ical cycles of the biodegradability of the Bt toxin
in the soil, or of the effect of alleged higher lignin content of Bt maize on its own biodegradability in the soil.
14 The purpose of the Annex is, as defined in its title, to set the "Principles for the Environmental risk
assessment" to be conducted under Directive 2001/18.

80. As the EC experience has developed with th e assessment of dossiers, it appears that the
deadlines, when set in Directive 90/220/EEC, could not be met because time was so frequently frozen
pending replies from the notifier to questions from regulatory authorities. Therefore, the timeframes to
be considered have in reality to take into acc ount these delays due to outstanding replies from the
notifier and the time necessary for the authorities an d independent scientific bodies to properly review
and assess the updated data or pending concerns in th e light of the complexity and evolution of the
science at stake.

81. Incidentally, the European Communities notes in the United States' reply to Question 166 that
it was able to identify and access all the informatio n submitted by the applicant, in one application
procedure (EC-74), where in particular Dr. Nutti said she was unable to find the necessary
documentation in preparing her responses.

82. On the contrary, when the United States claims that the applicant provided all the information
requested in 1999 and in 2001 by the authorities in another application procedure (EC-93, reply to
Question 167), it again misleads th e Panel, as the information was not provided in a satisfactory
manner by the applicant, as witnessed by the content of attachments 23, 25 and 26 of the relevant
chronology, where it is clearly stat ed what information requested in 1999 and later was still missing.
When the United States claims that its understanding is that : " the applicant provided the information
requested", and that "the applicant responde d to the 31 August 2001 letter" (attachment 23),
"explaining that the information requested had al ready been provided or could be addressed with
information that the BCS had already provided", it bl untly fails to submit any evidence to support this
misleading allegation, nor does it address the fact that even if it were true that information proved was
not satisfactory for the lead competent authority, as witnessed by the ev idence presented in that
chronology and cited above.

83. Finally, the Complainants also mislead the Pa nel in their interpretation of the EC arguments
on facts and science. In its reply to Question 196, the United States confuses the notion of using the
parent line as a comparator in the (limited) substan tial equivalence analysis of a GM plant, with the
notion of the requirement to complete a thorough ri sk assessment of any of both GM parent lines,
when they are used as the two parents in a GM stacked product, before one can complete the
assessment of the risks of the stacked GM offspring itself.

84. The European Communities would refer the Panel to its comments on expert advice as
regards the issue of assessing stacked genes in GM pl ants, and in particular to its comment on the
advice provided by the Panel experts in reply to Qu estion 111 in paragraphs 887ff of its submission.
But it would like to also correct here the misleadi ng alleged inconsistency presented in footnote 25 to
the United States reply to this question. As is recognised by all expert advice today (see the references
provided by the European Communities in the comm ents on expert advice cited above) GM products
made of stacked genes need to have a thorough a nd completed assessment of the risks of each of the
parent transformation events that constitute the stack, and, in addition , an assessment of any
interaction, or of any positive or nega tive synergistic effect, that may occur between the individual
insertions present in the stacked hybrid.

85. These two requirements are cumulative, not excl usive or contradictory, as is also evidenced
by the advice provided to the United States by its own independent expert advisory opinions (see
again the quoted recommendations cited in paragr aphs 887ff of the EC submission on comments on
expert advice, addressing this very issue) and which it fails to implement.

86. This is simply one example of the necessary case by case approach, which is applied in all
instances and requires that each GM product is assessed on its own merits, and which the
Complainants seem to fail to implement.