EUROPEAN COMMUNITIES – MEASURES AFFECTING
THE APPROVAL AND MARKETING
OF BIOTECH PRODUCTS
Reports of the Panel
WT/DS291/R
WT/DS292/R
WT/DS293/R
(29 September 2006)
http://www.wto.org/english/tratop_e/dispu_e/291r_8_e.doc
8.1
Before concluding, the Panel wishes to make clear the
issues on which it made a decision, and those which it did not address.
8.419 The issues
before the Panel concerned the alleged failure of the European Communities to
reach final decisions regarding the approval of biotech products from October
1998 to the time of establishment of the Panel on 29 August 2003, and the
WTO-consistency of prohibitions imposed by certain EC member States with regard
to specific biotech products after these products had been approved by the
European Communities for Community-wide marketing.
8.420 In light of
this, the Panel did not examine:
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whether biotech products in general are safe or not.
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whether the biotech products at issue in this dispute are "like"
their conventional counterparts.
Although this claim was made by the Complaining Parties (i.e., the
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whether the European Communities has a right to require the pre-marketing
approval of biotech products. This was
not raised by the Complaining Parties.
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whether the European Communities' approval procedures as established by
Directive 90/220, Directive 2001/18 and Regulation 258/97, which
provide for a product-by-product assessment requiring scientific consideration
of various potential risks, are consistent with the European Communities'
obligations under the WTO agreements.
This was not raised by the Complaining Parties.
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the conclusions of the relevant EC
scientific committees regarding the safety evaluation of specific biotech
products. These were not challenged by
the Complaining Parties, although they did challenge the scientific basis for
some of the questions and objections made by various EC member States. In light of this, the Panel, in consultation
with the Parties, sought advice from a number of scientific experts.
8.421 Turning to
the issues the Panel did examine, the
Panel first considered whether the EC approval legislation under which the
European Communities allegedly did not reach final decisions is properly assessed under the SPS Agreement. The Panel has found that the European
Communities' procedures for the approval of GMOs set out in Directives 90/220
and 2001/18 are SPS measures within the meaning of the SPS Agreement. The
potential risks to be examined in the context of these directives, particularly
as described in the annexes to Directive 2001/18, are the types of risk
covered by the SPS Agreement. Regarding the European Communities'
procedures for the approval of novel foods and food ingredients set out in
Regulation 258/97, the Panel has found that these are, in part, SPS
measures within the scope of the SPS Agreement.
8.422 The Panel notes,
however, that both the evidence provided by the European Communities and the
advice provided to the Panel by the experts advising it indicate that many of
the identified concerns are highly unlikely to occur in practice (e.g., the transfer of antibiotic
resistance from marker genes used in the production of some biotech plants to
bacteria in the human gut). On the other
hand, other identified concerns, such as those relating to the development of
pesticide-resistance in target insects through exposure to pesticides
(including those incorporated into biotech plants) have indeed been documented
to occur, including with respect to non-biotech crops. We reiterate, however, that the right of the
European Communities to consider these possible risks prior to giving approval
for the consumption or planting of biotech plants has not been questioned by
any of the Complaining Parties.
8.423 The
Complaining Parties asserted that a moratorium on approvals was in effect in
the European Communities between October 1998 and August 2003. Based on the evidence before it, the Panel
has found that the European Communities applied a general de facto moratorium on approvals of biotech products between June
1999 and 29 August 2003, the date of establishment of this Panel. The Panel determined that the moratorium was
not itself an SPS measure within the meaning of the SPS Agreement, but rather affected the operation and
application of the EC approval procedures, which are set out in the relevant EC
approval legislation and which we had found to be SPS measures. With respect to Directives 90/220 and
2001/18, the Panel has concluded that the general de facto moratorium resulted in a failure to complete individual
approval procedures without undue delay, and hence gave rise to an inconsistency
with Article 8 and Annex C of the SPS Agreement. With respect to Regulation 258/97, the
Panel found that, to the extent the approval procedure addressed safety aspects
within the scope of the SPS Agreement,
the general de facto moratorium resulted
in a failure to complete individual approval procedures without undue delay,
and hence also gave rise to an inconsistency with Article 8 and Annex C of
the SPS Agreement.
8.419 The
Complaining Parties also claimed that, contrary to its WTO obligations, the
European Communities failed to consider for final approval applications
concerning certain specified biotech products for which the European
Communities had commenced approval procedures.
We examined the record of consideration of 27 applications identified by
the Complaining Parties. We have found
that there was undue delay in the completion of the approval procedure with
respect to 24 of the 27 relevant products.
We therefore concluded that, in relation to the approval procedures
concerning these 24 products, the European Communities has breached its
obligations under Article 8 and Annex C of the SPS Agreement.
8.420 The
Complaining Parties furthermore brought complaints against nine safeguard
measures taken by certain EC member States.
These safeguard measures are in the form of prohibitions imposed by an
individual EC member State on a particular biotech product that has been
formally approved for use within the European Communities. The safeguard measures challenged by the
Complaining Parties have been taken by
8.421 We
determined that the objectives identified by each member State for its
safeguard measure(s) fall within the scope of the SPS Agreement. For each
of the products at issue, the European Communities' relevant scientific
committee had evaluated the potential risks to human health and/or the
environment prior to the granting of Community-wide approval, and had provided
a positive opinion. The relevant EC
scientific committee subsequently also reviewed the arguments and the evidence
submitted by the member State to justify the prohibition, and did not consider
that such information called into question its earlier conclusions. The Panel thus considered that sufficient
scientific evidence was available to permit a risk assessment as required by
the SPS Agreement. Hence, in no case was the situation one in
which the Panel had been persuaded that the relevant scientific evidence was
insufficient to perform a risk assessment, such that the member State might
have had recourse to a provisional measure under Article 5.7 of the SPS Agreement.
8.422 The Panel
also considered whether any risk assessment had been provided by the relevant
member States which would reasonably support the prohibition of the biotech
products at issue. Although some of the
member States did provide scientific studies, in no case did they provide an
assessment of the risks to human health and/or the environment meeting the
requirements of the SPS Agreement. The Panel likewise examined whether the risk
assessments undertaken by the EC scientific committees could provide reasonable
support for a prohibition of the biotech products at issue, but considered that
this was not the case. In the light of
this, the Panel has concluded that each of the safeguard measures taken by the
relevant member States fails to meet the obligations of the European
Communities under the SPS Agreement.
8.423 As we have
indicated at the beginning of the Findings section, consistent with the fact
that we examined three legally distinct complaints, we have particularized for
each of the three Complaining Parties (i.e.,
the United States, Canada and Argentina) the conclusions we have reached and
the recommendations we make, if any, in respect of their respective
complaints. Accordingly, we provide
three separate sets of conclusions and recommendations.
8.424 We further
recall that the Complaining Parties are each challenging three identical
categories of EC measures. The
categories in question are:
(a)
the alleged general EC moratorium on
approvals of biotech products (hereafter the "general EC
moratorium");
(b)
various product-specific EC measures
affecting the approval of specific biotech products (hereafter the
"product-specific EC measures"); and
(c)
various EC
8.425
For the reasons set forth in this Report, the Panel
concludes, as a factual matter, that:
(a)
The European Communities
applied a general de facto moratorium
on the approval of biotech products between June 1999 and August 2003,
which is when this Panel was established.
8.426
For the reasons set forth in this Report, the Panel
further concludes, as a legal matter, that:
(a)
The European Communities has
acted inconsistently with its obligations under Annex C(1)(a),
first clause, of the SPS Agreement
and, consequently, with its obligations under Article 8 of the SPS Agreement by applying a general
de facto moratorium on approvals
between June 1999 and August 2003.
(b)
The United States has not
established that the European Communities has acted inconsistently with
its obligations under Annex C(1)(b) of the SPS Agreement by applying a general de facto moratorium on approvals between June 1999 and
August 2003.
(c)
The European Communities has not
acted inconsistently with its obligations under Annex B(1) and
Article 7 of the SPS Agreement
in respect of the general de facto
moratorium on approvals.
(d)
The European Communities has not
acted inconsistently with its obligations under Article 5.1 of the SPS Agreement by applying a general
de facto moratorium on approvals
between June 1999 and August 2003.
(e)
The European Communities has not
acted inconsistently with its obligations under Article 5.5 of the SPS Agreement by applying a general
de facto moratorium on approvals
between June 1999 and August 2003.
(f)
The United States has not
established that the European Communities has acted inconsistently with its
obligations under Article 2.2 of the SPS Agreement
by applying a general de facto
moratorium on approvals between June 1999 and August 2003.
(g)
The United States has not
established that the European Communities has acted inconsistently with its
obligations under Article 2.3 of the SPS Agreement
by applying a general de facto
moratorium on approvals between June 1999 and August 2003.
8.427 Article 3.8
of the DSU provides that "[i]n cases where there is an infringement of the
obligations assumed under a covered agreement, the action is considered prima
facie to constitute a case of nullification or impairment". The European Communities failed to rebut this
presumption. Therefore, to the extent
the European Communities has acted inconsistently with its obligations under
the SPS Agreement, it must be
presumed to have nullified or impaired benefits accruing to the United States
under that Agreement.
8.428 In the light
of these conclusions, the Panel recommends that the Dispute Settlement Body
request the European Communities to bring the general de facto moratorium on approvals into conformity with its
obligations under the SPS Agreement,
if, and to the extent that, that measure has not already ceased to exist.
8.429 The Panel
made findings in relation to twenty-five product-specific EC measures challenged
by the
8.430 For the
reasons set forth in this Report, the Panel concludes that:
(a)
The European Communities has breached
its obligations under Annex C(1)(a), first clause, of the SPS Agreement and, consequently,
its obligations under Article 8 of the SPS Agreement
in respect of the approval procedures concerning:
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Falcon oilseed rape;
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MS8/RF3 oilseed
rape;
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RR fodder beet;
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Bt-531 cotton;
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RR-1445 cotton;
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Liberator oilseed rape;
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Bt-11 maize (EC-69);
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RR oilseed rape (EC-70);
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BXN cotton;
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Bt-1507 maize (EC-74);
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Bt-1507 maize (EC-75);
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NK603 maize;
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GA21 maize (EC-78);
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MON810 x GA21 maize;
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RR sugar beet;
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GA21 maize (food);
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Bt-11 sweet maize (food);
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MON810 x GA21 maize (food);
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Bt-1507 maize (food);
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NK603 maize (food); and
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RR sugar beet (food).
(b)
The
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the
Transgenic potato;
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LL soybeans (EC-71);
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LL oilseed rape; and
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LL soybeans (food).
(c)
The
(d)
The European Communities has not
acted inconsistently with its obligations under Annex B(1) and
Article 7 of the SPS Agreement
in respect of any of the relevant product-specific measures.
(e)
The European Communities has not
acted inconsistently with its obligations under Article 5.1 of the SPS Agreement in respect of any
of the relevant product-specific measures.
(f)
The European Communities has not
acted inconsistently with its obligations under Article 5.5 of the SPS Agreement in respect of any
of the relevant product-specific measures.
(g)
The
8.431 Article 3.8 of the DSU provides that "[i]n cases where there is an infringement of the obligations assumed under a covered agreement, the action is considered prima facie to constitute a case of n