EUROPEAN COMMUNITIES – MEASURES AFFECTING THE APPROVAL AND MARKETING OF BIOTECH PRODUCTS
Document: Reports of the Panel Addendum
Date: 29 September 2006
Document codes: WT/DS291/R/Add.9; WT/DS292/R/Add.9; WT/DS293/R/Add.9; WT/DS291/R; WT/DS292/R; WT/DS293/R.
Complainant: Argentina
Respondent: EU
Third parties: Australia, Brazil, Canada, Chile, China, Taiwan, Colombia, El Salvador, Honduras, Mexico, New Zealand, Norway, Paraguay, Peru, Thailand, Uruguay, U.S.
Dispute stage: Mutually Agreed Solution
Agreements cited: Art. 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7, 8, 10.1, Annex B, Annex C  Sanitary and Phytosanitary Measures (SPS)Art. III:4, X:1, X:3(a), XI:1  GATT 1994Art. 2.1, 2.2, 2.8, 2.9, 2.11, 5.1, 5.2, 5.6, 5.8, 12  Technical Barriers to Trade (TBT)Art. 4.2  AgricultureArt. I:1  GATT 1994

EUROPEAN COMMUNITIES – MEASURES AFFECTING
THE APPROVAL AND MARKETING
OF BIOTECH PRODUCTS

Reports of the Panel

Addendum

 This addendum contains Annex K to the Repor ts of the Panel to be found in document
, , The other annexes can be found in the following
addenda:

 – Annex C: Add.1
 – Annex D: Add.2
 – Annex E: Add.3
 – Annex F: Add.4
 – Annex G: Add.5
 – Annex H: Add.6
 – Annex I : Add.7
 – Annex J: Add.8

ANNEX K

LETTER OF THE PANEL TO THE PARTIES OF 8 MAY 2006

 The Panel thanks the Parties for their comments on the interim reports and their comments on
each others' comments. The Panel expects to be able to issue its final reports in accordance with the
applicable timetable, i.e., on 10 May 2006.

 The Panel recalls its letters of 9 February and 2 March 2006 in which it expressed its grave
concern about the leaks which occurred, first of th e interim reports' confiden tial conclusions, then of
the confidential interim reports in their entirety. In a series of letters (EC letters of 13 February and
7 March 2006; US letters of 13 February and 7 March 2006; Canada 's letters of 13 February and
8 March 2006; and Argentina's lette r of 3 March 2006), the Parties all shared the Panel's concern and
deplored the failure to observe the confidentialit y of the Panel's interim reports, but denied any
involvement in, and responsibility for, the leaks.

 The Panel appreciates the Parties' responses and continued cooperation in this matter. Indeed,
as previously noted by the Panel, confidentiality at all stages of the panel process is an inherent part of
the WTO dispute settlement mechanism the purpose of which is to secure a positive solution to a
dispute, and the disclosure of any part of a confidential panel report is, therefore, unacceptable.

 The Panel will issue to the Parties a confidential version of the Panel's final reports (which,
in addition to being confidential as a whole, contai ns and discloses SCI). In order to prevent leaks
from recurring, the Panel will issue to the Parties pa per and electronic versions of the final reports
which would allow it to trace back and attribute any l eaked version of part or all of the confidential
reports to the Party receiving it. Furthermore, the Pane l reserves the right to revert to this issue in the
reports which will be circulated to Members upon comp letion of the translation of the reports into the
official WTO languages, or when it transmits the final reports to the DSB.

 The above-mentioned regrettable situation of a complete disregard of the confidentiality of
the Panel's interim reports has led to these reports of the Panel being discussed and analysed by
groups and members of civil society already at the in terim review stage of the proceedings. In this
context, the Panel notes with concern that, whether inadvertently or on purpose, certain aspects of its
confidential findings have been misconstrued. The Pa nel therefore considers it justified, and indeed
necessary, given the sensitivity of certain matters at issue in this case, to state the following:

(a) The Panel's findings recognize that the notion of "insufficiency of relevant scientific
evidence" as it appears in Article 5.7 of the SPS Agreement includes cases of
qualitative insufficiency of relevant scien tific evidence. Indeed, as the Panel has
noted, the Appellate Body determined that "'relevant scientific evidence' will be
'insufficient' within the meaning of Artic le 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".
1 However, after considering th e evidence before it, the Panel
was ultimately not persuaded that the scientific evidence available at the relevant time
was qualitatively (or quantitatively) insuffici ent, such that a risk assessment as
required under Article 5.1 and as defined in Annex A(4) of the SPS Agreement could
not be performed in relation to the produc ts subject to the member State safeguard
measures challenged in this case. The Panel also recalls the Appellate Body's view

1 Appellate Body Report, Japan – Apples, para. 178 (emphasis added).

that the concepts of "insufficiency of re levant scientific evidence" as it appears in
Article 5.7 and "scientific uncertainty" ar e not interchangeable and that it would
therefore be inappropriate to interpret Ar ticle 5.7 through the prism of "scientific
uncertainty".
2
(b) In applying the concept of "insufficiency of scientific evidence" as it appears in
Article 5.7 of the SPS Agreement, the Panel has kept in mind the Appellate Body's
statement that "the risk that is to be ev aluated in a risk assessment under Article 5.1
of the SPS Agreement is not only risk ascertainable in a science laboratory operating
under strictly controlled conditions, but also risk in human societies as they actually
exist, in other words, the actual potential for adverse effects on human health in the
real world where people live and work and die". 3 Yet after considering the evidence
before it, which includes the various risk assessments undertaken by lead CAs and by
the relevant EC scientific committees, the Pa nel was ultimately not persuaded that in
relation to the products subject to the member State safeguard measures challenged in
this case, the scientific evidence available at the relevant time did not allow the
performance of an assessment of the risk in human societies, or natural environments,
as they actually exist, in accordance w ith the provisions of Article 5.1 and
Annex A(4) of the SPS Agreement.
(c) The Panel's findings relating to Article 5.1 of the SPS Agreement preserve the
freedom of Members to take prompt prot ective action in the event that new or
additional scientific evidence becomes availa ble which affects their risk assessments.
Particularly if the new or additional scientific evidence provides grounds for
considering that the use or consumption of a product might constitute a risk to human
health and/or the environment, a Member might need expeditiously to re-assess the
risks to human health and/or the environm ent. Initially at least, an expedited re-
assessment of relevant risks might be "appropriate to the circumstances" 4 and might
provide a basis for a different SPS measur e or for an SPS measure where none has
been applied before. 5 However, the same re-assessm ent of relevant risks might no
longer be "appropriate to the circumstances" at some later point in time, e.g., if and
when further and more thorough and elabor ate analysis of the new or additional
scientific evidence, as such and together w ith other available evidence, was possible

2 Ibid., para. 184. We also note in this connection that the Appellate Body in EC – Hormones stated
that "Article 5.1 does not require that the risk assessment must necessarily embody only the view of a majority
of the relevant scientific community. In some cases , the very existence of divergent views presented by
qualified scientists who have investigated the particul ar issue at hand may indicate a state of scientific
uncertainty. Sometimes the divergence may indicate a roughly equal balance of scientific opinion, which may
itself be a form of scientific uncer tainty". Appellate Body Report, EC – Hormones , para. 194. Thus, the
Appellate Body was apparently of the view that this form of scientific uncertainty would not mean, eo ipso, that
relevant scientific evidence is insufficient to perform a risk assessment as required under Article 5.1 and as
defined in Annex A(4) of the SPS Agreement.
3 Appellate Body Report, EC – Hormones, para. 187.
4 We recall that Article 5.1 of the SPS Agreement requires that SPS measures be based on an
assessment, "as appropriate to the circ umstances", of the risks to human, an imal or plant life or health, taking
into account risk assessment techniques developed by the relevant international organizations.
5 It is useful to note in this context that the first type of risk assessment defined in Annex A(4) of the
SPS Agreement, which envisages an evaluation of the likelihood of entry, establishment or spread of a pest or
disease, and of the associated potential biological and economic consequences, "does not require that the
evaluation of the likelihood needs to be done quanti tatively. The likelihood may be expressed either
quantitatively or qualitatively." Appellate Body Report, Australia – Salmon, para. 124.

and indicated, and such analysis would have shown that the conclusions of the initial,
expedited re-assessment of relevant risks is no longer valid.
(d) The Panel's findings leave room for the possibility that even if at a given point in time
relevant scientific evidence is sufficient to perform a risk assessment, a situation
might subsequently arise where the relevant scientific evidence could be considered
insufficient to perform a risk assessment as required under Article 5.1 and as defined
in Annex A(4) of the SPS Agreement. It is conceivable, for instance, that relevant
new scientific evidence would negate the validity of the scientific evidence on which
an existing risk assessment relied, without, however, being sufficient, in quantitative
and qualitative terms, to allow the performance of a new risk assessment.