Document: WT/DS291/R WT/DS292/R WT/DS293/R Page 343 (iii) various EC member State safeguard  measures prohibiting the import and/or marketing of specific biotech products (h ereafter the "member State safeguard measures"). 7.99 In respect of the first category – the alleged ge neral EC moratorium – we note that it is the only category which consists of one  single alleged measure.  The Co mplaining Parties use slightly different language to describe the specific measure at  issue, but, as we explain in the relevant section below, we consider that the Complaining Parties are in fact challenging one and the same measure.
Document codes: 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

(iii) various EC member State safeguard measures prohibiting the import and/or
marketing of specific biotech products (h ereafter the "member State safeguard
measures").

7.99 In respect of the first category – the alleged ge neral EC moratorium – we note that it is the
only category which consists of one single alleged measure. The Co mplaining Parties use slightly
different language to describe the specific measure at issue, but, as we explain in the relevant section
below, we consider that the Complaining Parties are in fact challenging one and the same measure.
7.100 With regard to the second category – the product-specific EC measures – we note that,
according to the Complaining Parties, the measures falling within this category are distinct from,
albeit related to, the alleged general EC moratorium. As we explain in the relevant section below, the
Complaining Parties have defined the measures at issue differently. However, what characterizes
each of these measures is that it rela tes to one specific biotech product, or to be more accurate, an
approval procedure concerning a specific biotech product. A total of thirty different products are at
issue in this category of measures. In a number of cases, two Complaining Parties are challenging a
(differently defined) measure which concerns the same biotech product. But in no case are all three
Complaining Parties challenging a measure which concerns the same product.
7.101 Concerning the third category – the member State safeguard measures – we note that this
category consists of nine distinct measures taken by six different EC member States, namely, Austria,
France, Germany, Greece, Italy and Luxembourg. The Complaining Parties are each challenging a
different number of safeguard measures. However, each member State safeguard measure is being
challenged by more than one Complaining Party, a nd two of them are being challenged by all three
Complaining Parties. It is important to note that even though the member State safeguard measures
were introduced by the relevant member States and ar e applicable only in the territory of the member
States concerned, the European Communities as a whole is the responding party in respect of the
member State safeguard measures. This is a dire ct consequence of the fact that the Complaining
Parties have directed their complaints against the European Communities, and not individual EC
member States.
275 The European Communities never contested that, for the purposes of this dispute,
the challenged member State measures are attributable to it under international law and hence can be
considered EC measures. Indeed, it was the European Communities – and it alone – that defended the
contested member State safeguard measures before the Panel.276
7.102 We address the three categories of measures at issue in this dispute in separate sections
below. Thus, in Section D, we examine the alle ged general EC moratorium. In Section E, we
examine the various product-specific EC measures. Finally, in Section F, we examine the various
member State safeguard measures.
C. RELEVANT EC APPROVAL PROCEDURES
7.103 This section describes and analyses the relevant EC procedures for the approval of EC-wide
marketing of biotech products. It is useful to do so at the outset, as these procedures are relevant to all

275 A similar situation has previously arisen in the panel proceedings concerning EC – Asbestos, where
the European Communities was the responding party, although the measure at issue was being maintained by
one member State, namely, France. Panel Report, EC – Asbestos, paras. 2.3 and 3.4.
276 It should be pointed out, however, that representa tives of the relevant member States were part of
the EC delegations present at the substantive meetings of th e Panel with the Parties. Furthermore, as part of its
defence of the member State safeguard measures, th e European Communities submitted numerous documents
which it had obtained from the member States concerned.

three categories of measures which are being challe nged by the Complaining Parties. Initially, we
provide a factual description of the specific approval procedures at issue in this dispute. We first
place them in their historical context, by showin g how the EC regime for the approval of biotech
products has evolved over time. Then we explain, by reference to the relevant EC legislation, the
various stages of the approval procedures at issue. Thereafter, we proceed to a legal analysis of these
procedures. It is important to note in this r espect that the Complaining Parties are not challenging
these procedures as such. What the Complaini ng Parties are challenging is the European
Communities' application of these procedures. In order to assess the legal merits of this challenge, we
need to examine, as a threshold matter, whet her the WTO agreement on which the Complaining
Parties are primarily basing their challenge – the SPS Agreement – is applicable to each of these
procedures. The European Commun ities argues that at least in part these procedures fall outside the
scope of the SPS Agreement.
1. Evolution of the EC regime for the approval of biotech products
7.104 The European Communities' legal regime for the approval of the marketing of biotech
products has changed over time, including while thes e Panel proceedings were ongoing. Since this
evolution of the EC approval regime is of some im portance in the present dispute, we set out below,
in the form of a table, relevant dates and legislative milestones.
Evolution of the EC approval regime for biotech products
23 April 1990 Adoption of Council Directive 90/220 "on the deliberate release into the
environment of genetically modified organisms".
23 October 1991 Entry into force of Council Directive 90/220.
27 January 1997 Adoption of Regulation 258/ 97 "concerning novel foods and novel food
ingredients".
15 May 1997 Entry into force of Regulation 258/97.
23 February 1998 Commission proposal for a European Parliament and Council
Directive amending Directive 90/220.
24 and 25 June 1999 2194th Environm ent Council meeting: Common Position, agreed by the
Council on the Commission proposal for a directive amending
Directive 90/220, by which the Council reached a political consensus on a
number of issues which were still outstanding in the draft legislative text.
277
12 March 2001 Adoption of Directive 2001/18 of the European Parliament and of the
Council "on the deliberate release into the environment of genetically
modified organisms and repealing Council Directive 90/220/EEC".
17 April 2001 Entry into force of Directive 2001/18.
25 July 2001 Commission proposal for a Regulation of the European Parliament and of
the Council concerning traceability and labelling of genetically modified
organisms and traceability of food and feed products produced from

277 In response to a question from the Panel, the European Communities has explained that in the EC
legislative process, a common position of the Council is a political decision by the Council which intervenes
after the European Parliament has expressed its opinion on a Commission legislative proposal. It reflects the
Council's position on those elements of the European Parliament's opinion with which the Council disagrees and
which it cannot approve. See the EC reply to Panel question No. 93, Annex D.

Evolution of the EC approval regime for biotech products
genetically modified organisms and amending Directive 2001/18.
17 October 2002 Repeal of Council Directive 90/220.
22 September 2003 Adoption of Regulation 1829/2003 of the European Parliament and of the
Council "on genetically modified food and feed".

Adoption of Regulation 1830/2003 of the European Parliament and of the
Council "concerning the traceability and labelling of genetically modified
organisms and the traceability of food and feed products produced from
genetically modified organisms and amending Directive 2001/18/EC".
7 November 2003 Entry into force of Regulati on 1829/2003, applying as of 18 April 2004.
Entry into force of Regulation 1830/2003.

7.105 In connection with the above table, it is usef ul to recall that it was on 13 May 2003 that the
United States and Canada formally initiated the present dispute settlement proceedings by requesting
consultations with the European Communities. 278 Argentina requested consultations with the
European Communities on 14 May 2003.279 The United States, Canada and Argentina each requested
the establishment of a panel on 7 August 2003. 280 A single panel was established by the DSB on
29 August 2003. 281 The composition of this Panel was determined and announced on
4 March 2004.282
2. Description of the relevant EC approval procedures
7.106 For the purposes of this dispute, the legal inst ruments of primary relevance are those which
were in force on or before the date of establishment of this Panel, i.e., on 29 August 2003. They are:
(a) Directive 90/220/EEC (hereafter "Directive 90/220")283 "on the deliberate release into
the environment of genetically modified organisms" (repealed on 17 October 2002),
(b) Directive 2001/18 (hereafter "Directive 2001/18") 284 "on the deliberate release into
the environment of genetically modi fied organisms and repealing Council
Directive 90/220/EEC",
(c) Regulation 258/97 (hereafter "Regulation 258/97") 285 "concerning novel foods and
novel food ingredients".286

278 WT/DS291/1 and WT/DS292/1, respectively.
279 WT/DS293/1.
280 WT/DS291/23, WT/DS292/17 and WT/DS293/17, respectively.
281 WT/DSB/M/155.
282 WT/DS291/24, WT/DS292/18 and WT/DS293/18.
283 Published in OJ of the EC N° L 117 of 08.05.1990, p. 15.
284 Published in OJ of the EC N° L 106 of 17.04.2001, p. 1.
285 Published in OJ of the EC N° L 43 of 14.02.1997, p. 1.
286 Under EC law, directives are legislative acts th at need to be implemented by EC member States
through national legislation. By contrast, regulations are directly applicable in all EC member States and do not
require any national implementing legislation.

7.107 Below we provide a brief factual descripti on of Directives 90/220 and 2001/18 as well as
Regulation 258/97. We begin with Directives 90/220 and 2001/18.
(a) Deliberate release into the environment of genetically modified organisms: Directives 90/220
and 2001/18
7.108 A fundamental purpose of Directives 90/220 and 2001/18 is to avoid adverse effects on
human health and the environment which might arise from the deliberate release into the environment
of products consisting of, or contai ning, genetically modified organism s (hereafter "GMOs"). In the
present dispute, Directives 90/220 and 2001/18 are rele vant to the extent they regulate the deliberate
release of GMOs for placing on the market as or in products.
287
7.109 Directives 90/220 and 2001/18 lay down administ rative procedures for granting consents for
the placing on the market of GMOs as or in products. In line with the fact that Directive 2001/18 is a
revised version of Directive 90/220, the administ rative procedure laid down by Directive 2001/18 has
been made more efficient. However, there ar e more similarities between the two administrative
procedures than differences, and so in our descriptio n below we deal with them together, while noting
important differences. Since the administrative pr ocedures set out in Directives 90/220 and 2001/18
are multi-stage procedures, we have structured our description according to the main procedural
stages.
7.110 We note that at the request of the Panel, th e European Communities has provided flow charts
which illustrate the administrative procedures as described below. These flow charts are reproduced
in Annexes A-1 and A-2.
(i) Submission of application by applicant
7.111 Before a GMO as or in a product may be placed on the EC market, the manufacturer or
importer of the product (hereafter the "applicant") mu st submit a notification (hereafter "application")
and accompanying dossier to the competent authority of the member State where such a GMO is to be
placed on the market for the firs t time (hereafter the "lead CA"). 288 The application and the dossier
must include specified information, such as informat ion about the applicant, the nature of the GMO,
the commercial names to be used, the intended u ses of the product, proposals for labelling or for
restrictions on use, and an assessment of any risk s for human health and the environment related to
the GMO.289
(ii) Assessment by lead CA
7.112 On receipt and after acknowledgement of the a pplication, the lead CA must examine the
application for compliance with the Directive. To that end, within 90 days after receipt of the
application, the lead CA must prepare an assessment report. 290 For the purposes of calculating the 90-
day period, any periods of time during which the l ead CA is awaiting further information which it
may have requested from the applicant shall not be taken into account. If th e lead CA's assessment

287 The deliberate release for research and developm ent purposes, while covered by the Directives, is
not at issue in this dispute.
288 Articles 5 and 11 of Directive 90/220 and Articles 6 and 13 of Directive 2001/18.
289 Article 11(1) of Directive 90/220 and Article 13(2) and Annexes II, III and IV of Directive 2001/18.
290 Article 12(1) and (2) of Directive 90/220 and Article 14(1) and (2) of Directive 2001/18.

report concludes that a GMO should not be placed on the market, it rejects the application by a
decision that states the reasons, and the procedure is ended.
291
(iii) Circulation of lead CA assessment report to other member States for comments
7.113 In cases where the lead CA's assessment repor t concludes that a GMO may be placed on the
market, the procedure moves on to the Community level. The lead CA submits the application
together with the assessment report to the European Commission (hereafter the "Commission"), which
must forward it to the competent authorities (herea fter the "CAs") of all other EC member States. 292
Within a period of 60 days from the date of circ ulation of the assessment report, a CA of another
member State and, in the case of Directive 2001/18, the Commission, may ask for further information,
make comments or present reasoned objections to the placing on the market of the GMO in question.
7.114 In the absence of any reasoned objection from th e CA of a member State, or in the case of
Directive 2001/18, the Commission, within 60 days following the date of circulation of the
assessment report, the lead CA must give its consent in writing for placing on the market.
293 Under
Directive 2001/18, in cases where the CA of anot her member State or the Commission raises a
reasoned objection, the member States and the Co mmission may take an additional 45-day period to
discuss any outstanding issues with the aim of arri ving at an agreement. If outstanding issues are
resolved within the prescribed period, the lead CA must give its consent for placing on the market.294
(iv) Community-level procedure in case of objections
7.115 In cases where the CA of another member State or, in the case of Directive 2001/18, the
Commission, maintains a reasoned objection, the deci sion on whether to approve the application must
be taken at Community level. 295 To that end, the Commission must prepare a draft measure. The
Commission begins this process by consulting the relevant EC scientific committee with respect to the
objection(s).296 Once the Commission has prepared a draft measure taking into account the opinion of
the relevant EC scientific committee, it must subm it it to the appropriate "Regulatory Committee" for
a vote.

291 Article 12(2)(b) of Directive 90/220 and Articles 14(3)(b) and 15(2) of Directive 2001/18.
292 Article 13(1) of Directive 90/220 (providing that the Commission must forward the assessment
report "immediately") and Article 14(2) of Directive 2001/18, (providing that the Commission must forward the
assessment report within 30 days of its receipt).
293 Article 13(2) of Directive 90/220 and Article 15(3) of Directive 2001/18.
294 Articles 15(1) and (3) of Direc tive 2001/18. We note that in accordance with Article 15(1) any
periods of time during which further information from th e applicant is awaited are no t to be taken into account
for the purpose of calculating the 45-day period.
295 Article 13(3) of Directive 90/220 and Articles 18(1) and 30(2) of Directive 2001/18. Article 18(1)
of Directive 2001/18 specifies that a decision must be adopted and published within 120 days. For the purposes
of calculating the 120-day period, any period of time during which the Commission is awaiting further
information which it may have requested from the applicant or is seeking the opinion of an EC scientific
committee will not be taken into account.
296 Under Directives 2001/18 and 90/220, the relevant scientific committee was the Scientific
Committee for Plants ("SCP"). The SCP has been replaced by the scientific panel on genetically modified
organisms established by the European Food Safety Authority (the "EFSA") which was created pursuant to
Regulation 178/2002. We note that Article 28 of Directive 2001/18 requires that the Commission consult the
scientific committee in case an objection is maintained. According to Article 18(1) of Directive 2001/18, the
period of time the Commission is waiting for the scientific committee opinion is not to exceed 90 days. Under
Directive 90/220, the Commission was not required to do so, but generally chose to do so.

7.116 The Regulatory Committee is composed of repr esentatives of the member States and chaired
by a representative of the Commission.
297 The Regulatory Committee must deliver its opinion on the
draft measure within a time limit which the chairm an may lay down according to the urgency of the
matter.298 The Regulatory Committee delivers opinions by qualified majority vote. The Commission
must adopt the draft measures envisaged if they ar e in accordance with the opinion of the Regulatory
Committee. If the measures envisaged are not in accordance with the opinion of the Regulatory
Committee, or if no opinion is delivered, the Commission must, without delay, submit to the Council
of Ministers (hereafter the "Council") a proposal relating to the measures to be taken.
299
7.117 The Council can either adopt or reject the Commission's draft measure by a qualified
majority.300 In either case, it must act within a time-period which shall in no case exceed three
months from the date of referral to the Council. 301 If the Council has not acted within that time-
period, the Commission must adopt the draft measure it has submitted to the Council.302
(v) Member State consent to placing on the market
7.118 Where a favourable decision has been take n at the Community level, whether by the
Commission on the basis of a favourable opinion by the Regulatory Committee, by the Council after
the submission of a proposal by the Commission, or by the Commission in the event the Council does
not act within three months from the date of referral, the lead CA must give consent in writing to the
placing on the market of the GMO as or in a product concerned. Such consent is transmitted to the
applicant, and the other member States a nd the Commission must be informed thereof. 303 Once the
applicant has received the written consent of the lead CA, it may proceed with the placing on the
market. The approved product may be used wit hout further application throughout the Community,
subject to any conditions specified in the written consent.304
(vi) Transition from Directive 90/220 to Directive 2001/18: Pending applications
7.119 As indicated previously, Directive 90/220 was repealed on 17 October 2002, and EC member
States had to implement Directive 2001/18 by the same date. Directive 2001/18 addresses the issue of
applications submitted under Directive 90/220 bu t still pending on 17 October 2002. Thus,
Directive 2001/18 makes clear that applications r eceived pursuant to Directive 90/220 and in respect
of which the procedures of Directive 90/220 were not completed by 17 October 2002 became subject
to the provisions of Directive 2001/18. Furthe rmore, applicants had until 17 January 2003 to

297 Regulatory Committees have their origin in Article 202 of the EC Treaty and act on the basis of
Article 5 of Council Decision 1999/468/EC. They assist the Commission in the exercise of the powers
delegated to it by the Council for the implementation of its acts.
298 Article 21 of Directive 90/220 and Article 30(2) of Directive 2001/18 (referring to Articles 5 and 7
of Council Decision 1999/468).
299 Ibid.
300 Pursuant to Article 148(2) of the Treaty Establishing the European Community as Amended by
Subsequent Treaties, in force at the time of establishment of this Pa nel, a qualified majority requires at least 62
votes in favour out of a total of 86 votes. For further details, see footnote 580. The Council can also modify the
draft measure, albeit by unanimous vote only. Article 250(1) of the Treaty Establishing the European
Community as Amended by Subsequent Treaties.
301 According to Article 18(1) of Directive 2001/18, the period of time the Council takes to act is not be
taken into account in calculating the 120-day period laid down in Article 18(1).
302 Article 21 of Directive 90/220 and Article 30(2) of Directive 2001/18 (referring to Articles 5 and 7
of Council Decision 1999/468).
303 Article 13(4) of Directive 90/220 and Article 18(2) of Directive 2001/18.
304 Article 13(5) of Directive 90/220 and Article 19(1) and (2) 2001 of Directive 2001/18.

complement their applications in accordance with Directive 2001/18.
305 According to the European
Communities, this means that pending applications only needed to be updated (complemented), not
re-submitted in their entirety. The European Comm unities has further stated that the new information
submitted in relation to the pendi ng applications required a new asse ssment under the provisions of
Directive 2001/18. Thus, irrespective of the proc edural stage reached by an application under
Directive 90/220, the updated application had to go through all procedural stages provided for in
Directive 2001/18, beginning with the initial assessment by the lead CA. However, according to the
European Communities, any results and conclusions reached under the procedures of Directive 90/220
on the basis of the then-existing data and inform ation were in principle still relevant under the
procedures of Directive 2001/18 and hence did not need to be re-examined.
(vii) Safeguard measures by individual member States
7.120 Where a GMO used as or in a product has b een approved for Community-wide marketing
under Directives 90/220 or 2001/18, member States ordinarily may not prohibit or restrict trade in, or
use of, that product on their respective territories, provided the conditions attached to the marketing
approval are being met. Exceptionally, however, member States may provisionally adopt safeguard
measures which prohibit or restrict trade in, or use of, biotech products which have been granted
Community-wide marketing approval.
7.121 Pursuant to Article 16 of Directive 90/220, a member State may provisionally restrict or
prohibit the use and or sale of a product in its territory where it has "justifiable reasons to consider
that a product which has been properly notified and has received written consent [...] constitutes a risk
to human health or the environment". Article 23 of Directive 2001/18 provides that a safeguard
measure may be adopted where, "as a result of new or additional information made available since the
date of the consent and affecting the environmen tal risk assessment or reassessment of existing
information on the basis of new or additional scientific knowledge", a member State has "detailed
grounds for considering that a GMO as or in a produc t [...] constitutes a risk to human health or the
environment [...]".
7.122 The safeguard measures taken pursuant to Dir ectives 90/220 and 2001/18 can be maintained
only on a provisional basis, pending a full assessment at EC level.
306 The member State adopting a
safeguard measure must immediately inform the Commission and other member States of its
measure.
307 Upon notification of the safeguard measure, the Commission must take a decision with
respect to that measure. Such decision will result either in the modification of the Community-wide
marketing approval, or in the termination of the safeguard measure.308
7.123 According to the procedure laid down in the relevant provisions of Directives 90/220 and
2001/18, the Commission, when making a decision on a safeguard measure which has been notified,
is assisted for this purpose by the Regulatory Committee. 309 The Commission must submit a draft of
the measure to be taken to the Regulatory Committ ee, which shall deliver its opinion on the draft. 310
If the draft measure is in accordance with the opini on of the Regulatory Committee or the Standing

305 Article 35 of Directive 2001/18.
306 Article 16(1) of Directive 90/220 and Article 23(1), 3rd paragraph of Directive 2001/18.
307 Article 16(1) of Directive 90/220 and Article 23(1), 3rd paragraph of Directive 2001/18.
308 Article 21 of Directive 90/220. Under Directive 90/220, such a decision by the Commission must
be taken within a period of three months from the time of notification of the measure.
309 Articles 21 of Directive 90/220 and 30(2) of Directive 2001/18.
310 Article 21 of Directive 90/220 and Article 30( 2) of Directive 2001/18. Article 30(2) of
Directive 2001/18 refers to Articles 5, 7 and 8 of Deci sion 1999/468. According to the European Communities
these provisions are similar to Article 21 of Directive 90/220.

Committee on Foodstuffs, the Commission must adopt th e draft measure. However, if the measure is
not in accordance with the opinion of the Committee , or if no opinion is delivered, the Commission
must submit a proposal to the Council on the measure to be taken. The Council must act on the
proposal within a period of three months, failing which the Commission must adopt the proposed
measure.
311
(viii) Availability under EC and member State law of procedures for administrative and judicial
review
7.124 To the extent that an applicant reques ting the approval of a biotech product under
Directives 90/220 and 2001/18 is dissatisfied with any act or failure to act by a national authority of a
member State or of a Community institution, it has the possibility to seek administrative or judicial
review of such acts or omissions at the member State and/or Community level. The law of each
member State provides for administrative and/or judi cial review of acts or omissions relating to the
application at the national level. At Community le vel, Articles 230 and 232 of the EC Treaty provide
that the European Court of Justice has jurisdiction to review the legality of acts, or of the failure to
act, by the European Commission.
7.125 The European Communities has stated before the Panel that, in respect of the biotech products
which are the subject of these proceedings, it is aw are of only one instance where legal proceedings
were brought at member State level. Those pro ceedings concerned a safeguard measure introduced
by Italy pursuant to Regulation 258/97. According to the European Communities, no applications
have been made to the European Court of Justice ch allenging any actions, or an alleged failure to act,
by the Community institutions in respect of any of the relevant biotech products.
(b) Novel foods and novel food ingredients: Regulation 258/97
7.126 We now turn to address Regulation 258/97. Regulation 258/97 concerns the placing on the
market of products to be used as a novel food or a novel food ingredient. These products include
foods and food ingredients contai ning or consisting of GMOs within the meaning of Directives
90/220 and 2001/18. They also include foods and food ingredients produced from, but not containing,
GMOs.
7.127 A fundamental purpose of Regulation 258/97 is to ensure that the covered novel foods and
food ingredients: (1) not present a danger for the c onsumer; (2) not mislead the consumer; and (3) not
differ from foods or food ingredients which they are intended to replace to such an extent that their
normal consumption would be nutritionally disadvantageous to the consumer.
7.128 Applications for the placing on the market of foods and food ingredients containing or
consisting of GMOs are assessed under Regulation 25 8/97 only. However, where an application
concerns a product containing, or consisting of, a GMO and that product is intended for use as food as
well as for feed and for cultivation, the applicati on is assessed under Regulation 258/97 in relation to
its use as food and under Directive 90/220 or Directiv e 2001/18 in relation to its use as feed and in
relation to cultivation.
312
7.129 Regulation 258/97 lays down administrative procedures for granting authorizations for the
placing on the market of the produc ts at issue in this dispute, i.e., foods and food ingredients
containing or consisting of GMOs. These administ rative procedures are similar to those described

311 Article 21 of Directive 90/220 and Article 30 of Directive 2001/18.
312 Article 9(2) of Regulation 258/97.

above for Directives 2001/18 and 90/220. Our d escription of the procedures laid down in
Regulation 258/97 has been structured according to the main procedural stages.
7.130 As with Directives 90/220 and 2001/18, the Eu ropean Communities has provided flow charts
which illustrate the administrative procedures as described below. These flow charts are reproduced
in Annex A-3.
(i) Submission of application by applicant
7.131 Before foods containing or consisting of GM Os may be placed on the EC market, the
applicant must submit a request (hereafter "applica tion") and accompanying dossier to the CA of the
member State where such a product is to be placed on the market for the first time, i.e., the lead CA.
313
The application must contain the necessary informati on, including the studies and materials which are
available to demonstrate that the food complies with the following requirements: (1) that the food not
present a danger for the consumer; (2) that it not mi slead the consumer; and (3) that it not differ from
foods or food ingredients which it is intended to re place to such an extent that its normal consumption
would be nutritionally disadva ntageous to the consumer. 314 In addition, the application must contain
an appropriate proposal for labelling, in accordance with the requirements of Regulation 258/97, of
the relevant food. 315 Where the food contains or consists of a GMO, the application must be
accompanied by the information required under Directive 90/220 and Directive 2001/18, including the
environmental risk assessment.316
(ii) Assessment by lead CA
7.132 Upon receipt of the application, the lead CA is to prepare an initial assessment report within a
period of three months from receipt of the application. The assessment report must determine
whether the application complies with the releva nt requirements and is in accordance with the
Commission's published recommendations.
317 The assessment report must also decide whether or not
an additional assessment is required.318
(iii) Circulation of lead CA assessment report to other member States for comments
7.133 Upon completion of its assessment report, the lead CA must, without delay, forward it to the
Commission, which in turn must forward it to the other member States. Within a period of 60 days
from the date of circulation of the report by the Commission, a member State or the Commission may
make comments or present a reasoned objection to th e marketing of the food concerned. Comments
or objections shall be forwarded to the Commission, which shall circulate them to member States
within the 60-day period.
319

313 Article 4(1) of Regulation 258/97.
314 Articles 6(1) and 3(1) of Regulation 258/97.
315 Article 8 of Regulation 258/97.
316 Article 9 of Regulation 258/97.
317 Article 6(2) and 6(3) of Regulation 258/97. Also Commission Recommendation of 29 July 1997
"concerning the scientific aspects and the presentation of information necessary to support applications for the
placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports
under Regulation No 258/97".
318 Ibid.
319 Article 6(4) of Regulation 258/97.

7.134 If the lead CA's assessment report reaches the conclusion that no additional assessment is
required, and no reasoned objection has been presente d by another member State or the Commission,
the lead CA must inform the applicant, without delay, that the food may be placed on the market.
320
(iv) Community procedure in case an additional assessment is required or an objection is raised
7.135 If the lead CA's assessment report reaches the conclusion that an additional assessment is
required, or a reasoned objection has been raised by another member State or the Commission, an
authorization decision is to be taken at Community level. 321 To that end, the Commission must
prepare a draft measure. The Commission ordinarily begins this process by consulting the relevant
EC scientific committee – the Scientif ic Committee for Food (the "SCF"). 322 Once the Commission
has prepared a draft measure taking into account the opinion of the SCF, it must submit it to the
appropriate Regulatory Committee, the so-calle d Standing Committee for Foodstuffs for a vote.
323
The Standing Committee for Foodstuffs must deliv er its opinion on the Commission's draft measure
within a time limit which the Chairman may lay do wn according to the urgency of the matter. The
Standing Committee for Foodstuffs delivers opinions by qualified majority vote. The Commission
must adopt the draft measure envisaged if it is in accordance with the opinion of the Standing
Committee for Foodstuffs. If the draft measure envisaged is not in accordance with the opinion of the
Standing Committee for Foodstuffs, or if no opin ion is delivered, the Commission must, without
delay, submit to the Council a proposal relating to the measures to be taken.
324
7.136 The Council can either adopt or reject the Commission's draft measure by a qualified
majority.325 In either case, it must act within a time-period which shall in no case exceed three
months from the date of referral to the Council. If the Council has not acted within that time-period,
the Commission must adopt the draft measure it has submitted to the Council.326
7.137 The Commission must without delay inform the applicant of the decision taken at Community
level, which will be published in the Official Journal of the European Communities.327
(v) Simplified Procedure
7.138 It should be noted that for novel foods which ar e "substantially equivalent" to existing foods,
Regulation 258/97 provides for a simplified procedure. 328 This includes food products which are
produced from, but do not contain, GMOs. "Substan tial equivalence" can be demonstrated in two
ways: (1) by relying on scientific evidence available and generally recognized or (2) by relying on an
opinion delivered by one of the competen t food assessment bodies of the member States. 329 In the
case of substantially equivalent novel foods, the applicant must "notify" the Commission of the

320 Article 4(2) of Regulation 258/97.
321 Article 7 of Regulation 258/97.
322Article 11 of Regulation 258/97. Since the entry in to force of Regulation 178/2002, the tasks of the
SCF have been entrusted to the EFSA.
323 Article 13(1) of Regulation 258/97.
324 Articles 13(3) and 13(4) of Regulation 258/97.
325 The Council may also modify the draft measure, although by unanimous vote only. Article 250(1)
of the EC Treaty.
326 Article 13(4) of Regulation 258/97.
327 Article 7(3) of Regulation 258/97.
328 Article 5 of Regulation 258/97.
329 Article 3(4) of Regulation 258/97.

placing on the market when it does so. Then, the Co mmission forwards to the member States, within
60 days, a copy of the application.
330
(vi) Safeguard measures by individual member States
7.139 As with Directives 90/220 or 2001/18, where a biotech product has been approved for
Community-wide marketing under Regulation 258/97, member States ordinarily may not prohibit or
restrict trade in, or use of, that product on their r espective territories, provided the conditions attached
to the marketing approval are being met. However, Article 12 of Regulation 258/97 provides that a
safeguard measure may be adopted where, "as a result of new information or a reassessment of
existing information", a member State has "detailed grounds for considering that the use of a food or a
food ingredient complying with this Regulation endangers human health or the environment [...]".
7.140 The safeguard measures taken pursuant to Regul ation 258/97 can be maintained only on a
provisional basis, pending a full assessment at EC level.
331 The member State adopting a safeguard
measure must immediately inform the Commission and other member States of its measure. 332 Upon
notification of the safeguard measure, the Commissi on must take a decision with respect to that
measure. Such decision will result either in the modification of the Community-wide marketing
approval, or in the termination of the measure.333
7.141 According to Article 13 of Regulation 258/ 97, when making a decision on a safeguard
measure which has been notified, the Commission is assisted by the Standing Committee on
Foodstuffs. The Commission must submit a draft of the measure to be taken to the Standing
Committee on Foodstuffs, which shall deliver its opin ion on the draft. If the draft measure is in
accordance with the opinion of th e Standing Committee on Foodstuffs, the Commission must adopt
the draft measure. However, if the measure is not in accordance with th e opinion of the Committee,
or if no opinion is delivered, the Commission must submit a proposal to the Council on the measure to
be taken. The Council must act on the proposal within a period of three months, failing which the
Commission must adopt the proposed measure.
334
(vii) Availability under EC and member State law of procedures for administrative and judicial
review
7.142 With regard to the availability of procedures for administrative or judicial review under EC
law and member State law, we note that the possib ility to challenge actions or omissions by member
State or Community authorities exists in the same way under Regulation 258/97 as it exists under
Directives 90/220 and 2001/18.
7.143 As we have stated earlier, the European Co mmunities has stated before the Panel that, in
respect of the biotech products which are the s ubject of these proceedings, it is aware of only one
instance where legal proceedings were brought at me mber State level. Those proceedings concerned
a safeguard measure introduced by Italy pursuant to Regulation 258/97.335 According to the European

330 Article 5 of Regulation 258/97.
331 Article 12(1) of Regulation 258/97.
332 Ibid.
333 In contrast with Directive 90/220, we note that Regulation 258/97 does not establish a timeframe
for a decision by the Commission.
334 Article 13(4)(b) of Regulation 258/97.
335 On 13 November 2000 Monsanto Agricoltura Italia SpA and others brought proceedings before the
Italian courts challenging the validity of the Italian Decr ee of 4 August 2000 temporarily suspending trade in

Communities, no applications have been made to the European Court of Justice challenging any
actions, or an alleged failure to act, by the Community institutions in respect of any of the relevant
biotech products.
(c) GM food and feed and traceability and labelli ng of GMOs and traceability of food and feed
products produced from GMOs: Regulation 1829/2003 and Regulation 1830/2003
7.144 Regulation 1829/2003 "on genetically modified food and feed"
336 (hereafter
"Regulation 1829/2003") and Re gulation 1830/2003 "c oncerning the traceability and labelling of
genetically modified organisms and the traceab ility of food and feed products produced from
genetically modified organisms and amending Directive 2001/18/EC" 337 (hereafter
"Regulation 1830/2003") are not directly relevant to this dispute. While there are frequent references
to these Regulations in the Panel record, the Par ties have provided little information on their content
and purpose. Accordingly, we provide merely a very basic description of these most recent legislative
instruments concerning the approval of biotech products.
7.145 Regarding Regulation 1829/2003, we note that it replaced Regulation 258/97, although
Regulation 258/97 remains applicable to novel food s other than GM foods. Regulation 1829/2003
lays down streamlined Community procedures for the approval of GM food and feed as well as new
provisions for the labelling of GM food and feed. Notably, it establishes the "one door-one key"
principle whereby the approval of a biotech prod uct which is for use as food and feed and for
cultivation can be requested in one single applica tion filed exclusively under Regulation 1829/2003.
It appears, however, that the applicant also h as the choice of submitting an application both under
Directive 2001/18, insofar as the application is for th e deliberate release of the relevant product into
the environment, and under Regulation 1829/2003, in sofar as the application is for the use of the
product as or in a food product.
7.146 Regarding Regulation 1830/2003, we note that it applies to all products containing or
consisting of GMOs irrespective of their use ( i.e., food and feed as well as cultivation).
Regulation 1830/2003 provides a Community framework for the traceability of products consisting of
or containing GMOs, and food and feed produced from GMOs with the objectives of facilitating
accurate labelling, monitoring the effects on the envi ronment and, where appropriate, on health, and
the implementation of the appropriate risk management measures including, if necessary, withdrawal
of products. Directive 2001/18 already requires member States to take measures to ensure traceability
of authorized GMOs at all stages of their placing on the market. However, it does not contain a
definition of traceability for GMOs, and it does not include the objectives of traceability or a complete
approach for its implementation. Regulati on 1830/2003 therefore amends Directive 2001/18 in
relevant part. Regulation 1830/200 3 sets up a harmonized Community system for the labelling of all
products consisting of or containing GMOs and imposes additional labelling requirements for these
products.

3. Applicability of the SPS Agreement
7.147 The Complaining Parties all allege that th e above-mentioned EC approval procedures
concerning the deliberate release of biotech pr oducts into the environment (Directive 90/220 and
subsequently Directive 2001/18) and concer ning novel foods and novel food ingredients

and use of certain novel foods within Italy (issued purs uant to Article 12 of Regulation 258/97), and seeking
compensation for loss claimed to result from the Decree. These proceedings are still pending.
336 Published in OJ N° L 268, 18/10/2003, p. 1.
337 Published in OJ N° L 268, 18/10/2003, p. 24.

(Regulation 258/97) are SPS measures within the scope of the SPS Agreement. The European
Communities maintains that the EC approval pro cedures fall in part within the scope of the
SPS Agreement, and in part outside of scope of the SPS Agreement. In this section, the Panel will
determine whether the relevant EC approval pr ocedures are SPS measures which fall to be assessed
under the SPS Agreement.
7.148 We note that Annex A(1) of the SPS Agreement provides the following legal definition of the
term "SPS measure":
DEFINITIONS
338
Sanitary or phytosanitary measure - Any measure applied:
 (a) to protect animal or plant life or health within the territory of the
Member from risks arising from the entry, est ablishment or spread of pests, diseases,
disease-carrying organisms or disease-causing organisms;
 (b) to protect human or animal life or health within the territory of the
Member from risks arising from additives, contaminants, toxins or disease-causing
organisms in foods, beverages or feedstuffs;
 (c) to protect human life or health within the territory of the Member
from risks arising from diseases carried by an imals, plants or products thereof, or
from the entry, establishment or spread of pests; or
 (d) to prevent or limit other damage within the territory of the Member
from the entry, establishment or spread of pests.
Sanitary or phytosanitary measures include all relevant laws, decrees, regulations,
requirements and procedures including, inter alia, end product criteria; processes and
production methods; testing, inspection, certification and approval procedures;
quarantine treatments including relevant requirements associated with the transport of
animals or plants, or with the materials n ecessary for their survival during transport;
provisions on relevant statistical methods , sampling procedures and methods of risk
assessment; and packaging and labelling requirements directly related to food safety.
7.149 Annex A(1) indicates that for the purposes of determining whether a particular measure
constitutes an "SPS measure" regard must be had to such elements as the purpose of the measure, its
legal form and its nature. The purpose element is addressed in Annex A(1)(a) through (d) ("any
measure applied to"). The form element is referre d to in the second paragraph of Annex A(1) ("laws,
decrees, regulations"). Finally, the nature of measures qualifying as SPS measures is also addressed
in the second paragraph of Annex A(1) ("requirements and procedures, including, inter alia , end
product criteria; processes and production methods; testing, inspection, certification and approval
procedures; [etc.]").

338 ( original footnote ) For the purpose of these definitions, "animal" includes fish and wild fauna;
"plant" includes forests and wild flora; "pests" incl ude weeds; and "contaminants" include pesticide and
veterinary drug residues and extraneous matter.

(a) Whether a law, or a requirement contained therein, may be deemed to embody an SPS
measure as well as a non-SPS measure
7.150 Before examining in detail whether the rele vant EC approval procedures are SPS measures
which are to be assessed under the provisions of the SPS Agreement, it is necessary to address an issue
put before us by the European Communities. The is sue is whether a law, or a requirement contained
therein, may, if it meets the applicable conditions , be considered to incorporate an SPS measure as
well as a distinct measure which falls to be assessed under a WTO agreement other than the
SPS Agreement, such as the TBT Agreement.
7.151 The European Communities argues that the SPS Agreement has a limited scope of
application and that the scope is defined by refere nce to the objective, or purpose, of the measure at
issue, that is the reasons justifying the measure. The European Communities considers that if a WTO
Member acts for two different reasons, one of which falls within the scope of the SPS Agreement, and
the other of which does not, there are in effect two different measures for WTO purposes. According
to the European Communities, this is so even if the two different objectives are sought to be achieved
by a measure reflected in a single document. Th e measure (or part thereof) taken for any of the
reasons enumerated in the SPS Agreement falls within the scope of that Agreement. The measure (or
part thereof) taken for other reasons falls outside the scope of the SPS Agreement.
7.152 The European Communities argues that there is nothing in the SPS Agreement or in any other
WTO agreement that obliges a WTO Member to refra in from adopting in its domestic jurisdiction a
single act, incorporating two or more measures re gulated by more than one WTO agreement or
provision. The European Communities submits that th is situation is very common in the context of
the WTO, and the issue with which the Panel is confronted is thus a horizontal one.
7.153 The European Communities considers that wh ere a Member's regulation pursues an SPS
objective and also a non-SPS objective, and that regulation is found by a panel to fall within the scope
of the SPS Agreement and to be inconsistent with it (becau se the way in which the SPS objective is
dealt with conflicts with the rules in the Agreement), the most that the panel could properly find is that
the regulation includes an SPS measure and that the SPS measure in the regulation is inconsistent with
the SPS Agreement. The panel's recommendation could only be that the Member take the measures
necessary to bring the SPS measure in the regulation into conformity with the SPS Agreement. The
European Communities submits that the panel coul d not make any recommendation in relation to the
regulation as a whole, unless it also considered and made findings in relation to the measures in the
regulation that fall outside the scope of the SPS Agreement. Consequently, when it would come to
implementation, the Member concerned would be u nder an obligation to bring the SPS measure into
conformity with the SPS Agreement, by removing the SPS objective and the elements of the measure
that derive therefrom, but the Member in questi on would not be under an obligation to remove the
regulation.
7.154 In relation to the present dispute, the Europ ean Communities submits that the environmental
and related objectives of its legislation for the approval of biotech products and of measures taken
thereunder which are not governed by the SPS Agreement may have to be assessed by reference to the
TBT Agreement. The European Communities considers th at the addition of an SPS objective to a
measure does not exclude the application of the TBT Agreement to non-SPS aspects of that measure.
In such a case, the SPS Agreement would apply to the extent that SPS objectives are pursued and the
TBT Agreement would apply to the extent that non-SPS objectives are pursued.
7.155 The European Communities points out that it is aware of Article 1.5 of the TBT Agreement,
which provides that:

"The provisions of this Agreement do not apply to sanitary and phytosanitary
measures as defined in Annex A of the Agre ement on the Application of Sanitary and
Phytosanitary Measures."
7.156 According to the European Communities, Article 1.5 of the TBT Agreement means that a
single measure that, at the same time, falls within the scope of the SPS Agreement and within the
scope of the TBT Agreement falls to be considered only under the SPS Agreement. Article 1.5 does
not mean that an act that contains both an SPS measure and a TBT measure ( i.e., a measure falling
under the TBT Agreement but not under the SPS Agreement) falls to be considered only under the
SPS Agreement and not at all under the TBT Agreement. If that were true, it would allow Members to
camouflage TBT measures behind the SPS Agreement, which is in certain respects less strict than the
TBT Agreement, by simply adding an SPS aspect to the act . Conversely, it would also lead to the
bizarre result that a perfectly lawful TBT measure might suddenly become unlawful, just because it is
in the same act as an SPS measure, and happens not to comply with a provision of the SPS Agreement.
Furthermore, 99 percent of an act might be a TBT measure and 1 percent of the act an SPS measure,
and yet the whole act would fall to be considered only under the SPS Agreement, and the
TBT Agreement would not apply at all. In the European Communities' view, that cannot be right.
7.157 The United States notes that the European Communities has not disputed that both its novel
foods regulation and deliberate release direc tives are covered within the scope of the SPS Agreement.
Furthermore, with regard to the member Stat e measures, the European Communities acknowledges
that each of the member State measures was adopted for "some reasons" that fall within the scope of
the SPS Agreement. The United States considers that the European Communities' agreement that its
measures were adopted for "some reasons" that fall within the scope of the SPS Agreement is more
than sufficient to bring those measures with the scope of that Agreement.
7.158 Article 1.5 of the TBT Agreement is quite clear in stating that the provisions of the
TBT Agreement "do not apply" to SPS measure s as defined in Annex A of the SPS Agreement.
Annex A makes clear that "any measure" applied to protect against one of the enumerated risks falls
within the scope of the SPS Agreement. The Annex does not state that the measure needs to be
exclusively applied to protect against on ly the enumerated risks. Nor does the SPS Agreement
 say
that an SPS measure – meaning a measure addressing a risk enumerated in Annex A – somehow loses
its status as an SPS measure if the adoption of th e measure is also supported by other rationales.
Thus, for example, even if the European Comm unities' deliberate release directives could be
construed to cover some risks outside the scope of the SPS Agreement, these directives would still be
SPS measures, and subject to the disciplines under the SPS Agreement.
7.159 Canada notes that Article 1.5 of the TBT Agreement states that it does not apply to SPS
measures as defined in Annex A of the SPS Agreement. According to Canada, this does not assist in
resolving the more discrete question of whether a single or "indivisible" measure taken for both SPS
and non-SPS reasons can be considered as both an SPS measure and a non-SPS measure, or whether,
as the European Communities contends, it must be considered to be a series of measures. On balance,
Canada is of the view that a hermetic approach to the SPS Agreement and the TBT Agreement,
respectively, is probably neither valid from an interpretive standpoint, nor useful from a practical
perspective. A Member's measure is an SPS measure to the extent that it addresses SPS risks; to the
extent that it addresses other risks or policy object ives, it is another type of measure, including,
possibly, a TBT measure. Whether a measure that addresses both SPS risks and other types of risks
or policy objectives should be considered a single measure or a series of measures is purely semantic.
7.160 Canada notes that, in any event, the Europ ean Communities has conced ed that its measures
are at least in part SPS measures. All Parties agre e that a measure taken for reasons having to do with

the definition of an SPS measure in Annex A(1) must be examined in the light of the requirements of
the SPS Agreement. As a consequence, if that measure does not meet those requirements, it gives rise
to a violation of one or more of the provisions of the SPS Agreement. The fact that the measure might
also have a TBT dimension and may even be TBT- consistent would be entirely beside the point
because consistency with one Agreement cannot ope rate to excuse or remedy a violation under
another Agreement.
7.161 Argentina argues that the European Communities adm its that the measures at issue in this
dispute which affect the approval and marketing of biotech products are partially covered by the
SPS Agreement. According to Argentina, the SPS Agreement is the agreement to be applied, since it
refers to the protection against certain risks a nd not against certain products. Argentina further
submits that in accordance with Article 1.5 of the TBT Agreement the SPS Agreement and the
TBT Agreement are mutually exclusive. Finally, Argen tina contends that, by definition, a measure
cannot be a series of measures.
7.162 The Panel considers that the issue raised by the European Communities is best analysed using
a hypothetical example. Thus, assume that a Memb er imposes two identical requirements with regard
to a particular product, and that each of the two requ irements is laid down in a separate law. The law
containing the first requirement states that that requirement is applied for one of the purposes
enumerated in Annex A(1) of the SPS Agreement. The law containing the second requirement states
that the second requirement is applied exclusively for a different purpose, one which is not covered by
Annex A(1). Clearly, the first requirement woul d qualify as an SPS measure, as it meets the form
(law), nature (requirement) and purpose (one of th e enumerated purposes) elements of the definition
of the term "SPS measure" as provided in Annex A(1). Equally clearly, the second requirement
would not qualify as an SPS measure. While it woul d meet the form (law) and nature (requirement)
elements of the definition of an SPS measure, it wo uld not satisfy the purpose element, as it is not
applied for one of the purposes enumerated in Annex A(1). Needless to say, however, the second
requirement would also constitute a measure for WTO purposes. For simplicity, we refer to it here as
the "non-SPS measure".
7.163 Now assume that the Member concerned decid es to consolidate the two separate laws which
contain the identical requirements into one single law. Since the two requirements in question are
identical, the relevant requirement is included onl y once in the consolidated law. As the two
independent purposes of the requirement in question remain as valid as before, the consolidated law
specifies that the requirement is applied for both purposes. The issue now arises whether the
requirement in the consolidated law (hereafter "the requirement at issue") constitutes an SPS measure
or a non-SPS measure, or both.
7.164 According to the United States' and Argentina's view, the requirement must be considered an
SPS measure, and an SPS measure alone, because it meets all elements of the definition of an SPS
measure. It undoubtedly meets the form and nature elements; and since the requirement is at least in
part applied for one of the purposes enumerated in Annex A(1), the United States' and Argentina's
position is that it also meets the purpose element of the definition of an SPS measure. The European
Communities rejects this view, arguing that the require ment at issue should be considered (i) an SPS
measure to the extent it is applied for one of th e purposes enumerated in Annex A(1) and (ii) a non-
SPS measure to the extent it is applied for a purpose which is not covered by Annex A(1).339

339 Canada has stated that a hermetic approach to the SPS Agreement and the TBT Agreement,
respectively, is probably neither valid from an interpretativ e standpoint, nor useful from a practical perspective.
According to Canada, a requirement is an SPS measure to the extent it addresses SPS risks; to the extent that it

7.165 In our assessment, the better and more appropriate view is that of the European Communities.
Hence, we consider that to the extent the requirement in the consolidated law is applied for one of the
purposes enumerated in Annex A(1), it may be pr operly viewed as a measure which falls to be
assessed under the SPS Agreement; to the extent it is applied for a purpose which is not covered by
Annex A(1), it may be viewed as a separate measure which fa lls to be assessed under a WTO
agreement other than the SPS Agreement. It is important to stress, however, that our view is premised
on the circumstance that the requirement at issue could be split up into two separate requirements
which would be identical to the requirement at issue, and which would ha ve an autonomous raison
d'être, i.e., a different purpose which would provide an independent basis for imposing the
requirement.
7.166 We recognize that, formally, the requirement at issue constitutes one single requirement.
However, neither the WTO Agreement nor WTO jurisprudence establishes that a requirement meeting
the condition referred to in the previous paragraph may not be deemed to embody two, if not more,
distinct measures which fall to be assessed unde r different WTO agreements. We note that
Annex A(1) of the SPS Agreement, which defines the term "SPS measur e", refers to "[a]ny measure"
and to "requirements". But these references do not imply that a requirement cannot be considered to
embody an SPS measure as well as a non-SPS measure.
7.167 We note the United States' and Argentina's argument that Article 1.5 of the TBT Agreement
supports a different conclusion. To recall, Ar ticle 1.5 states that the provisions of the TBT Agreement
"do not apply" to SPS measures as defined in Annex A(1) of the SPS Agreement. The operation of
Article 1.5 is best illustrated by reference to th e specific case of our hy pothetical requirement
contained in the consolidated law. To that end, we assume that the consolidated law qualifies as a
technical regulation within the meaning of Annex 1(1) of the TBT Agreement.
340 We have stated
above that to the extent the requirement in the c onsolidated law is applied for one of the purposes
enumerated in Annex A(1) of the SPS Agreement, it can be viewed as an SPS measure. As such, it
falls to be assessed under the SPS Agreement, provided the measure may affect international trade. 341
Article 1.5 makes clear that to the extent the re quirement at issue qualifies as an SPS measure, the
provisions of the TBT Agreement would "not apply", even though the requirement at issue is
contained in a law which meets the definition of a tec hnical regulation. We have also said that to the
extent the requirement at issue is applied for a purpose not covered by Annex A(1) of the
SPS Agreement, it can be viewed as embodying a non-SPS measur e. By its terms, Article 1.5 is not
applicable to non-SPS measures. However, given that the requirement is assumed to be part of a
technical regulation, it falls to be assessed under the TBT Agreement, to the extent it embodies a non-
SPS measure. 342 As the foregoing considera tions demonstrate, our view that a requirement may in

addresses other risks or policy objectives, it is another type of measure, including, possibly, one to be assessed
under the TBT Agreement. Canada considers that the issue of wh ether a requirement that addresses both SPS
risks and other types of risks or policy objectives should be considered a single measure or a series of measures
is purely semantic.
340 Annex 1(1) defines a technical regulation as a "[d]ocument which lays down product characteristics
or their related processes and production methods, including the applicable administrative provisions, with
which compliance is necessary". Annex 1(1) further speci fies that a technical regula tion "may also include or
deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a
product, process or production method".
341 Articles 1.1 and 1.2 of the SPS Agreement make clear that the SPS Agreement applies to all
measures which (i) meet the definition of an SPS measure provided in Annex A(1) and (ii) may affect
international trade.
342 We note that according to Article 1.4 of the SPS Agreement, "[n]othing in this Agreement shall
affect the rights of Members under the [ TBT Agreement] with respect to measures not within the scope of this
Agreement".

certain cases incorporate more than one measure is consistent with, and gives meaning and effect to,
the provisions of Article 1.5. Therefore, we do not agree that Article 1.5 compels a different view.
7.168 In addition to the foregoing considerations, th ere is another consideration which we think
militates against treating the requirement at issue as constituting only an SPS measure. To see this, it
should first of all be recalled that, as a general matter, Members impose requirements because they
consider it necessary to do so.
343 If they do deem it necessary to impose a particular requirement, it is
only logical that they also seek to minimize the risk of a successful legal challenge, whether before a
domestic court or at the WTO. In the case of our hypothetical example, the Member concerned would
face the risk – for instance, due to uncertainties as to the correct interpretation or application of
relevant WTO provisions – that a WTO panel woul d find the requirement at issue to be WTO-
inconsistent as an SPS measure but WTO-consistent as a non-SPS measure, or vice versa, or that a
panel would find the requirement to be WTO-inconsistent either as an SPS or as a non-SPS measure.
7.169 If the view were taken that the requirement at issue would constitute an SPS measure only,
the Member concerned would have to defend that requirement as an SPS measure. In view of the
possibility that the requirement at issue might withstand scrutiny by a WTO panel as a non-SPS
measure, but not as an SPS measure, it is reasonable to assume, however, that, ex abundanti cautela,
the Member concerned would not want to forgo th e opportunity of defending the requirement at issue
also as a non-SPS measure. The Member concerned coul d prevent this by enacting the requirement at
issue twice, either in different laws with a statem ent of the appropriate purpose or in the same law as
separate provisions with a statement of their different purpose. However, a Member might face
substantial difficulties in convincing its legislator s of the need for enacting the same requirement
twice, whether it be in different laws or as separa te provisions in the same law. Moreover, pursuing
this option might run counter to many Members' ba sic legislative objectives and requirements. It is
axiomatic that the primary objective of legislation is to communicate directives to those affected by it
in a manner that is clear, easily understandable and reduces uncertainties. By enacting the same
requirement twice, in different laws or as separ ate provisions in the same law, a Member would
arguably reduce clarity and create a potential for c onfusion and uncertainty among those affected by
the law. Also, if the same requirement were enact ed twice in different laws, the result would be a
more fragmented domestic legal order.
7.170 Thus, if we were to embrace the view that the requirement in the consolidated law must be
considered to constitute an SPS measure only, we would effectively impose an unwanted choice on
the Member concerned. The Member could either choose to enact the requirement at issue twice and
thus possibly act inconsistently with sound legisla tive objectives. Or it could choose not to enact the
requirement twice and thus expose itself to potential legal risks. We think it would be ill-advised to
put Members in a situation where they effectively have to make this kind of choice, particularly when
it is not imposed by WTO rules. As we have said, we are unaware of a directive in the WTO
Agreement which says that a requirement can never be deemed to embody two or more distinct
measures which fall to be assessed under different WTO agreements.
7.171 To be clear, we are not saying that Members cannot, or should not, enact the same
requirement twice if they see fit to do so. Plainly, Members may do so. Our concern is with those
Members, and the European Communi ties appears to be among them, that see fit not to do so. We
consider that we should not interpret the WTO Agreement in a manner which would effectively
require Members to choose between enacting a requir ement twice, which may be inconsistent with

343 Article 2.1 of the SPS Agreement provides that "Members have the right to take "[SPS] measures
necessary for the protection of human, animal or plant life or health, provided that such measures are not
inconsistent with the provisions of [the SPS Agreement]".

their internal laws or their le gitimate preference, and exposing themselves to potential legal risks,
which may be imprudent.
7.172 Turning now to the specific case before us, we note the European Communities' assertion that
the EC approval legislation which sets out the releva nt approval procedures is applied in part for
purposes which are identified in Annex A(1) of the SPS Agreement and in part for other purposes.
The European Communities submits that to the extent the relevant EC approval legislation is applied
for purposes which are identified in Annex A(1), it is governed by the SPS Agreement; to the extent
the legislation is applied for other purposes, it fa lls within the scope of another WTO agreement,
possibly the TBT Agreement. Since, as we will see, the a pproval procedures are conducted for a
number of purposes (namely, to avoid various adver se effects), our analysis above suggests that it
may conceivably be warranted to view each of th e relevant EC approval procedures as incorporating
an SPS measure as well as a non-SPS measure.
7.173 Given this, it is pertinent to recall that, acco rding to the European Communities, the question
of whether the measures at issue in this disput e are SPS measures or non-SPS measures, or both, may
have implications for the implementation of a possibl e adverse DSB ruling in this dispute, and that, in
the European Communities' view, it is therefore impo rtant for the Panel appropriately to circumscribe
the focus and scope of its findings. We also not e that two Complaining Parties, Argentina and
Canada, have presented claims under the TBT Agreement. Argentina has indicated that its claims
under the TBT Agreement are made in the alternative, in case we reject its claims under the
SPS Agreement. Canada, however, has stated that if the Panel were to determine that parts of the
measures at issue are covered by the TBT Agreement in addition to the SPS Agreement, Canada's
claims under the TBT Agreement are to be considered cumulative rather than alternative vis-à-vis its
claims under the SPS Agreement. In the light of these elements, and in the interests of effective
dispute resolution, we find it appropriate to analy se for each of the relevant EC approval procedures
whether it is an SPS measure, and if so, whether it is an SPS measure only, or whether it may be
considered to embody an SPS measure as well as a non-SPS measure. This analysis will also
facilitate a similar inquiry to be carried out by us in Section F below, where we examine the
Complaining Parties' complaints in respect of the member State safeguard measures.
7.174 Accordingly, we now proceed to examine whether the EC approval procedures are SPS
measures within the meaning of Annex A(1) of the SPS Agreement. To that end, we will consider one
by one the definitional elements of the term "SPS measure" and then will draw appropriate
conclusions on whether the EC a pproval procedures are SPS measures, and if so, on whether they are
SPS measures only.
(b) Whether the EC approval procedures are SPS measures in terms of their purpose
7.175 We first analyse whether the EC approval procedures are SPS measures in terms of the
purpose element of the Annex A(1) definition of the term "SPS measure". As we set out to determine
whether the European Communities is correct in arguing that each of the EC approval procedures can
be viewed as embodying both an SPS measure a nd a non-SPS measure, we consider all relevant
purposes for which the EC approval procedures are applie d. As always, we begin our analysis with a
summary of the Parties' arguments.
7.176 The United States argues that the approval regime is unquestionably an SPS measure. It
notes that Directive 90/220 states that one of its objectives is "to protect human health and the
environment" from, among other things, the "pla cing on the market [of] genetically modified

organisms as or in products within the Community".
344 The same objective is stated in
Directive 2001/18.345 Regulation 258/97 states that "foods and food ingredients falling within the
scope of the Regulation must not present a da nger for the consumer" or be "nutritionally
disadvantageous".346
7.177 According to the United States, the EC approval regime requires consideration of specific
risks that fall within the definition of an SPS measure as set out in Annex A(1) to the SPS Agreement.
Thus, concerns that a biotech product might lead to an allergic or toxic reaction on the part of certain
animals or concerns that some biotech plant varieties could harm beneficial organisms as well as
target organisms, fall within the definition of Anne x A(1)(a). Concerns that a biotech product might
lead to an allergic or toxic reaction on the part of consumers or regarding unacceptable levels of
pesticide residue in pesticide-producing plant varieti es, fall within the definition of Annex A(1)(b).
Similarly, concerns that widespread consumption of varieties containing antibiotic resistance marker
genes might lead to the development of antibiotic resistant strains of bacteria also fall under the
definition of Annex A(1)(b). Such concerns have been characterized as food safety issues. Thus,
according to the United States, a measure based on these concerns is a measure designed to protect
"human or animal life or health" from "disea se-causing organisms" in "foods, beverages or
feedstuffs."
7.178 The United States further argues that concerns re garding the cross-contamination (or transfer)
of biotech products to non-target organisms, e.g., concerns that herbicide tolerance could be
transferred from a biotech variety to a wild variet y, fall within the scope of Annex A(1)(d). The
United States points out in this regard that Annex A defines "pests" to incl ude weeds, and weeds are
defined as "plant[s] that grow[]… where [they are] not wanted." 347
7.179 Canada argues that the central purpose of Directive 2001/18 is to protect against the kinds of
risks identified in paragraph 1 of Annex A of the SPS Agreement. Directive 2001/18 requires that an
environmental risk assessment be conducted and list s the following "potential adverse effects" of
biotech products that should be addressed:348
− diseases to humans including allergenic or toxic effects;
− diseases to animals and plants including t oxic, and where appropriate allergenic
effects;
− effects on the dynamics of populations of species in the receiving environment and on
genetic diversity of each of these populations;
− altered susceptibility to pathogens facilitating the dissemination of infectious diseases
and/or creating new reservoirs or vectors.

Canada argues that Annex A(1) defines the purpose of an SPS measure as being to address, inter alia,
these potential adverse effects.

7.180 Canada further notes that the Directiv e identifies as a potential concern the " spread of
GMO(s) in the environment."
349 In this context, according to Canada the Directive requires, where

344 Article 1 of Directive 90/220.
345 Article 1 of Directive 2001/18.
346 Article 3(1) of Regulation 258/97.
347 The New Shorter Oxford English Dictionary, L. Brown (ed.) (Clarendon Press, 2002), Vol. 2,
p. 2171.
348 Annex II C.2.1. of Directive 2001/18.
349 Ibid, emphasis added by Canada.

appropriate, the submission of information in the application for approval relating to the "likelihood
of the GMO [becoming] persistent and invasive in natural habitats…"; "any selective advantage or
disadvantage conferred to the GMO and the like lihood of this becoming realised…"; and the
"potential … environmental impact of the direct a nd indirect interactions between the GMO with non-
target organisms, including impact on population levels of competitors, prey, hosts, symbionts,
predators, parasites and pathogens".
7.181 Canada also maintains that the requirement in Directive 2001/18 for information regarding
"possible…effects on animal health and conse quences for the feed/food chain resulting from the
consumption of the GMO and any product derived from it, if it is intended to be used as animal feed"
is further evidence that Directive 2001/18 is an SPS measure with the objective of addressing
concerns identified in Annex A(1) of the SPS Agreement.
350
7.182 Concerning Directive 90/220, Canada notes that si milar to its successor Directive, the central
objective of Directive 90/220 was "to protect human health and the environment…when placing on
the market products containing, or consisting of , genetically modified organisms intended for
subsequent deliberate release into the environment." 351 Moreover, information similar to that
identified under Directive 2001/18 was also to be included in notifications under Directive 90/220. 352
Therefore, according to Canada, Directive 90/220 was also an SPS measure as defined in Annex A(1)
of the SPS Agreement.
7.183 Regarding Regulation 258/97, Canada argues that the central purpose of Regulation 258/97 is
to protect against risks identified in paragraph 1(b) of Annex A of the SPS Agreement. Furthermore,
Commission Recommendation 97/618 sets out the type of scientific information necessary to support
applications for the placing on the market of novel foods and novel food ingredients under
Regulation 258/97.353 Canada notes that, pursuant to Commission Recommendation 97/618, safety
assessments conducted under Regulation 258/97 should include an assessment of contaminants, toxins
and disease-causing organisms resulting from the novel elements of the novel food or food ingredient
in question. These are among the risks explicitly identified in Annex A(1)(b). The Commission
Recommendation states that the safety assessment should address only "[c]hemical or microbiological
contaminants of novel foods…specifically related to th e novelty…" and "the presence of microbial
toxins and microbial or viral infective agents …[when] this is a consequence of the novelty."
354
Canada also points out that Part XIII of th e Commission Recommendation sets out the type of
toxicological information that should be included in an assessment for novel foods under
Regulation 258/97, including toxicity, mutagenicity and allergenicity studies.355
7.184 Argentina maintains that the European Communities' approval procedures are SPS measures,
because their stated purpose is to determine, by means of case-by-case assessment, the presence or
absence of "additives", "contaminants" or "toxins" in foods, beverages or feedstuffs and the risks to
human life and health resulting from their presence. The risks to which the EC legislation refers, and the
risks which have been evaluated by the respective EC scientific committees, fall within the scope of
Annex A(1) of the SPS Agreement because they refer to or deal with, inter alia, risks such as toxic or

350 Annex II D.1. of Directive 2001/18.
351 Article 1 of Directive 90/220.
352 Annex II, Part IV of Directive 90/220.
353 Commission Recommendation of 29 July 1997 concerning the scientific aspects of the presentation
of information necessary to support applications for the placing on the market of novel foods and novel food
ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97, Commission
Recommendation 97/618, (Exhibit CDA-24).
354 Ibid, Art. 5 (emphasis added by Canada).
355 Ibid, p. 14, Part XIII.

allergic effects in humans and animals, the gr owth of antibiotic-resista nt bacteria and cross-
contamination.
7.185 The European Communities argues that the SPS Agreement applies to measures taken to
prevent an exhaustive list of narrowly defined risks and that the provisions of the SPS Agreement are
specifically designed to regulate such measures. Ho wever, the issues arising out of the existence of
GMOs and the issues addressed by Directives 90/22 0 and 2001/18 as well as by Regulation 258/97,
go beyond the risks envisaged and regulated by the SPS Agreement. Thus, according to the European
Communities, the SPS Agreement does not provide a sufficient lega l framework for the examination
of the EC measures at issue.
7.186 The European Communities maintains that the SPS Agreement is relevant only to some of the
issues examined by EC authorities in the course of GMO approval procedures, but does not cover all
of the issues of concern. Thus, while Annex A(1)(b) of the SPS Agreement concerns certain things
"in foods, beverages or feedstuffs", according to the European Communities, a GMO seed destined to
be planted in the ground, not eaten by humans or fe d to animals cannot be considered to be a "food,
beverage or feedstuff". Similarly, a GM crop or plant is not in itself necessarily a food, although it
may be processed into something that becomes a food. Furthermore, a crop or plant is not necessarily
a "feedstuff" for animals – that depends on whether or not it is destined for such use, and whether or
not the crop will first be processed.
7.187 The European Communities furt her argues that while the te rm "disease" appears in both
Annex A of the SPS Agreement and the EC legislation, a GMO is not infected or an infection and is
not, in itself, a "disease" within the meaning of Annex A(1).
356 Nor is a GMO a "disease-carrying
organism" or generally considered a "disease-causi ng organism" within the meaning of Annex A.
Furthermore, with regard to the term "pest" as us ed in the definition in Annex A(1), the European
Communities maintains that, in light of the definition of a pest in the 1997 International Plant
Protection Convention (hereafter the "IPPC") 357, in order for a GMO to be a pest within the meaning
of the SPS Agreement, the relevant GMO would have to be "p athogenic" or "injurious" – that is, it
would have to do more than merely interact in some way with humans, animals or plants.
7.188 The Panel will determine below whether the specific risks or concerns identified in Directives
90/220 and 2001/18 and in Regulation 258/97 are risks that fall within the scope of the definition of
an SPS measure in Annex A(1). For this purpose, the Panel will consider separately the approval
legislation concerning the deliberate release of bi otech products, established by Directive 90/220 and
subsequently by Directive 2001/18, and that concerning novel foods established by
Regulation 258/97.
(i) Directives 90/220 and 2001/18
7.189 Directive 90/220 indicates that a central purpose of the Directive is "to protect human health
and the environment [...] when placing on the market products containing, or consisting of, genetically
modified organisms intended for subsequent deliberate release into the environment". 358

356 The European Communities makes reference to the OIE definition of a disease by the World
Organization for Animal Health (OIE) as "the clinical and/or pathological manifestation of infection",
International Animal Health Code, 2002.
357 The European Communities refers to the International Plant Protection Convention (IPPC) 1997,
which defines the term "pest" as "[a]ny species, strain or biotype of plant, animal or pathogenic agent injurious
to plants and plant products", International Plant Protection Convention, FAO, Rome 1997.
358 Article 1.1, second tiret, of Directive 90/220.

Directive 90/220 also states that "Member States shal l ensure that all appropriate measures are taken
to avoid adverse effects on human health and the environment which might arise from the deliberate
release or placing on the market of GMOs."
359 Although Directive 90/220 does not explicitly identify
what potential risks for human health and the e nvironment must be assessed prior to a release of
GMOs into the environment, it does identify the info rmation required in an application for marketing
approval. Thus, information to be provided by a pplicants relating to the characteristics of the final
GMO includes, inter alia, toxic or allergenic effects, inform ation on pathogenicity, communicability,
host range, and antibiotic resistance patterns. 360 Information to be provided by applicants relating to
the potential environmental impact of the GMOs includes information on:361
− potential for excessive population increase in the environment;
− competitive advantage of the GMOs in re lation to the unmodified recipient or
parental organism(s);
− anticipated mechanism and result of inter action between the released GMOs and the
target organism;
− identification and description of non-target organisms which may be affected
unwittingly;
− likelihood of post-release shifts in biological interactions or in host range;
− known or predicted effects on non-target or ganisms in the environment, impact on
population levels of competitors: preys, hosts, symbionts, predators, parasites and
pathogens;
− known or predicted involvement in biogeochemical processes;
− other potentially significant interactions with the environment.

7.190 Turning to Directive 2001/18, we note that as with Directive 90/220, a central purpose of the
Directive is to protect human health and the e nvironment when placing on the market genetically
modified organisms as or in products.
362 Article 4 further clarifies that the purpose of
Directive 2001/18 is to "avoid adverse effects on human health and the environment which might
arise from the deliberate release or the placing on the market of GMOs." 363 Like Directive 90/220,
Directive 2001/18 does not explicitly identify what potential risks for human health and the
environment must be assessed prior to a release of GMOs into the environment, but identifies the
information to be provided by applicants in th eir applications for marketing approval. The
information which we have said was to be provided by applicants under Directive 90/220 is also to be
provided under Directive 2001/18.
364 Unlike Directive 90/220, however, Directive 2001/18 also
addresses the methodology to be followed to perform an environmental risk assessment. In this
context, Annex II.C.2.1 of the Directive mentions that potential adverse effects of GMOs vary from
case to case and may include:
− disease to humans including allergenic or toxic effects;
− disease to animals and plants including t oxic, and where appropriate, allergenic
effects;

359 Article 4(1) of Directive 90/220.
360 Annex II.II.C.2(i). The chapeau to the Annex states, inter alia, that "[n]ot all the points included
will apply to every case. It is to be expected, theref ore, that individual notifica tions will address only the
particular subset of considerations that are appropriate to individual situations."
361 Annex II.IV.C of Directive 90/220.
362 Article 1, second tiret, of Directive 2001/18.
363 Article 4(1) of Directive 2001/18.
364 Annexes IIIA and IIIB.

− effects on the dynamics of populations of species in the receiving environment and
the genetic diversity of each of these – changes in populations and in genetic diversity
brought about by effects on life/health wh ich may have more de leterious effects on
one species than another, hence changing population dynamics;
− altered susceptibility to pathogens facilitating the dissemination of infectious diseases
and/or creating new reservoirs or vectors;
− 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;
− effects on biogeochemistry (biogeochemical cycles), particularly carbon and nitrogen
recycling through changes in soil decomposition of organic material.

7.191 The Directive states that adverse effects may occu r directly or indirectly through mechanisms
which may include the spread of the GMO(s) in the environment; the transfer of the inserted genetic
material to other organisms or the same organism; phenotypic and genetic instability; interactions
with other organisms; and changes in manageme nt, including, where applicable, in agricultural
practices.
365
7.192 Furthermore, and again in addition to the pr ovisions of Directive 90/220, Annex II.D.1 of
Directive 2001/18 identifies concerns that are to be considered in the case of GMOs other than higher
plants, while Annex II.D.2 identifies concerns to be considered in the case of genetically modified
higher plants (hereafter "GMHP"). With respect to GMHP, the products at issue in this dispute 366,
the following issues are to be considered:
− likelihood of the GMHP becoming more pers istent than the recipient or parental
plants in agricultural habitats or more invasive in natural habitats;
− any selective advantage or disadvantage conferred to the GMHP;
− potential for gene transfer to the same or other sexually compatible plant species
under conditions of planting the GMHP and any selective advantage or disadvantage
conferred to those plant species;
− potential immediate and/or delayed envir onmental impact resulting from direct and
indirect interactions between the GMHP and target organisms, such as predators,
parasitoids, and pathogens (if applicable);
− possible immediate and/or delayed environmental impact resulting from direct and
indirect interactions of the GMHP with non-target organisms, (also taking into
account organisms which interact with ta rget organisms), including impact on
population levels of competitors, herbivores, symbionts (where applicable), parasites
and pathogens;
− possible immediate and/or delayed effects on human health resulting from potential
direct and indirect interactions of the GM HP and persons working with, coming into
contact with or in the vicinity of the GMHP release(s);
− 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;

365 Annex II.C.2 of Directive 2001/18.
366 Annex III of Directive 2001/18 indicates that "higher plants" means plants which belong to the
taxonomic group Spermatophytae (Gymnospermae and Angiospermae). The products at issue in this dispute are
all Angiospermae.

− possible immediate and/or delayed effects on biogeochemical processes resulting
from potential direct and indirect interacti ons of the GMO and target and non-target
organisms in the vicinity of the GMO release(s);
− possible immediate and/or delayed, direct and indirect environm ental impacts of the
specific cultivation, management and ha rvesting techniques used for the GMHP
where these are different from those used for non-GMHPs.

7.193 The Panel notes that in replacing Directive 90/220, Directive 2001/18 was presented as an
improvement over the previous Directive, providing, inter alia , clarification of the scope of
Directive 90/220.
367 Indeed, as we have indicated, Directive 2001/18 specifies or amplifies in its
annexes some of the potential risks from GMOs from which protection of human health and the
environment is to be provided. In view of the fact that Directive 2001/18 clarifies rather than expands
the scope of Directive 90/220, we believe that we can presume that any potential adverse effect within
the scope of Directive 2001/18 was also covered by Directive 90/220.
7.194 We note that, according to the European Communities, the EC approval legislation has the
objective of addressing concerns relating to:
− herbicide tolerance in GM plants (agricultu ral persistence of the GM plant and cross-
breeds; natural persistence resulting in damage to the ecological balance or
biodiversity; effects on human or farm animal health from the modified gene in
foodstuffs, from allergens or from increased herbicide use; impact on wild flora and
fauna from herbicide use; effects of cross-breeding on wild flora);
− insecticidal properties of GM plants (agricu ltural insect resistance; spread of insect
resistance trait into wild flora; effects on human or farm animal health, including
allergies; effects on human or farm animal health from increased insecticide use;
effects on wild fauna of the toxin in the GM plant; effect on wild fauna from
increased insecticide use); and
− antibiotic resistance.

We consider that these are not concerns in addition to those identified in the Directives themselves
(see paragraphs 7.189-7.192 above), but rather a di fferent way of describing the concerns contained
therein.

7.195 As a result, and given the greater degree of specificity of the relevant provisions of
Directive 2001/18 compared to those of Directive 90/220, for the purposes of our analysis, we will
focus on the potential adverse effects identified in Directive 2001/18. We are aware that Annex II.C.2
to Directive 2001/18 by stating that "adverse effects may include" (emphasis added) is not intended to
be a closed list of the possible adverse effects of GMOs on human health and the environment.
Therefore, we will also consider the additional possi ble adverse effects which have been identified by
the European Communities in the case at hand. The fact that we address the potential adverse effects
of GMOs mentioned in Directive 2001/18, or ment ioned separately by the European Communities,
should not be construed to mean that we necessar ily agree that all GMOs, or even specific GMOs,
actually or potentially give rise to such effects.
7.196 Having determined that the purpose of Directives 90/220 and 2001/18 is to protect human
health and the environment from adverse effects on human health and the environment which might

367 1st and 2nd preambular paragraphs of Directive 2001/18.

result from the deliberate release of GMOs into the environment, we now proceed to examine whether
that purpose is covered by the various sub-paragraphs of Annex A(1) to the SPS Agreement.
Protection of the environment

7.197 The Panel will first consider the general purpose of protection of the environment as stated in
Directives 90/220 and 2001/18.
7.198 The European Communities observes that Directives 90/220 and 2001/18 repeatedly state
that one of the purposes of these pieces of legislati on is to protect the environment. The European
Communities contrasts this with Annex A of the SPS Agreement which it claims does not address
environmental protection, unlike Article 2.2 of the TBT Agreement, for example, which expressly
refers to "the environment". According to the Eur opean Communities, it is clear that when the drafter
of an international agreement uses a term in one inst rument but not in another, the drafter intended to
exclude that term from the latter instrument. The European Communities concludes from this that the
SPS Agreement was not intended to address the prevention of risks to the environment.
7.199 The European Communities contends that this is also clear from the negotiating history of the
SPS Agreement. In this context, the European Communities refers to a 1993 Uruguay Round GATT
Secretariat background paper on the proposed SPS Agreement, wherein it is stated that " [m]easures
for environmental protection, per se, [… ] are not covered by the proposed [SPS] Agreement".368 The
European Communities also refers to the "Cover not e to the SPS Decision circulated on 20 December
1990 (also known as the 'Dunkel text')" 369. However, the European Communities is mistaken in
referring to the Dunkel text. The European Comm unities meant to refer to the cover note to the Draft
Text on Sanitary and Phytosanitary Measures circulated on 20 November 1990 (not 20 December
1990, as the European Communities contends) by the Chairman of the Working Group on Sanitary
and Phytosanitary Measures. The European Comm unities points out that the cover note at issue
addressed certain bracketed elements in the dr aft text which included a reference to "the
environment". The European Communities notes th at, according to the cover note, the relevant
brackets are "linked to the question of whether or not this agreement should apply to measures taken
for the protection of animal welfare and the environment […]". 370 The European Communities further
notes that this bracketed text was not retained in the final text of the SPS Agreement. The European
Communities deduces from this that environmental damage per se does not fall within the scope of
the SPS Agreement.
7.200 The European Communities contends that the ordi nary meaning of the word "environment" is
broad and includes the protection of biodiversity; it does not focus on a short-term risk to the life or
health of a particular animal or plant. Furthermore, according to the European Communities, negative
effects on biodiversity may occur without negatively a ffecting the wild flora and fauna or an area. In
the European Communities' view, such effects coul d result from positive effects on wild fauna and/or
flora that disrupt the ecological equilibrium; negative effects on soil or water micro-organisms;

368 Quoted in EC second written submission, footnote 35.
369 EC reply to Panel question No. 120(c).
370 Uruguay Round document MTN.GNG/NG5/WGSP/7, p. 1 (reference identified by Panel).

modification of interactions between two organisms, includi ng through trophic interactions
371; and
negative effects on the biogeochemical processes of an ecosystem.372
7.201 The United States argues, in contrast, that a biotech plant can only damage biodiversity or
the ecological balance through its ability to adversely affect, directly or indirectly, the wild flora or
fauna of the area. Any damage would occur due to alterations in the invasiveness or persistence of
certain plant species, causing changes in the abun dance of different plant species and secondary
negative impacts on animal life.
7.202 The United States considers that the Europ ean Communities' citation to the negotiating
history is incomplete and misleading, and in no way supports the European Communities' contention.
The United States notes that the "bracketed text" refe rred to by the European Communities is actually
two different bracketed phrases.. Both of these phrases are contained in the co ncluding paragraph of
the Annex A(1) definition of "SPS measure" (that is , in the paragraph followi ng lettered paragraphs a
to d) – a paragraph which (in its final form) describes types of measures – such as labelling and
quarantines – as opposed to describing particular typ es of risks. One of the bracketed phrases would
have expressly included animal welfare, environm ent, and consumer inter ests and concerns. The
second bracketed phrase would have expressly excluded those issues.
7.203 The United States points out that the final text of the SPS Agreement drops both the proposal
for an explicit inclusion and the proposal for an explicit exclusion of environmental and animal
welfare concerns. Thus, contrary to the European Communities' assertions, this change is not the least
bit instructive on whether the drafters of the agr eement intended to include or exclude environmental
issues. On the other hand, this change could supp ort an interpretation that the drafters decided to
leave the last paragraph of Annex A(1) to describe types of measures (such as labelling and
quarantine) and to place the types of covered risks within the lettered paragraphs a to d.
7.204 The United States argues, moreover, that the European Communities does not make note of a
more relevant and significant change betw een the late 1990 draft text and the final SPS Agreement.
The late 1990 draft text did not include footnote 4, which defines "animal" to include "wild fauna"
and "plant" to include "wild flora". The fact that these clarifications were added to the text means that
the issue of environmental damage was in fact c onsidered by the drafters, and that the drafters
purposely and specifically decided to include damage to wild flora and fauna within the scope of the
SPS Agreement. Thus, contrary to the European Commun ities' assertions, the negotiating history of
the SPS Agreement provides no support for the European Communities' contention that the
SPS Agreement was not intended to cover damage to the environment.
7.205 Canada argues that the SPS Agreement explicitly covers wild flora and fauna. Canada
maintains that the term "fauna" encompasses both macrofauna and microfauna, whereas the term
"flora" includes also microflora. The types of risk related to the environment that are addressed in
Directives 90/220 and 2001/18 are those that ultimatel y pertain to animal or plant life or health.
Nothing in the SPS Agreement limits SPS measures to short-term risks. "Biological diversity" is

371 The New Shorter Oxford English Dictionary defines "trophic" as "of or pertaining to nutrition"
L. Brown (ed.) (Clarendon Press, 2002), Vol. 2, p. 3403.
372 In response to a question by the Panel, Dr. Snow, one of the experts consulted by the Panel,
indicated that: "The biogeochemical cycle refers to the cycling of nutrients and carbon in any type of ecosystem
including a farmer's field. People are asking questions about whether the biotech crop might affect nutrients that
come out of the dead materials from the crop and are r ecycled into the soil so it could affect soil fertility and
things like that and just the rate at which nutrients are cycled locally. So biogeochemical, if that is clear enough,
nutrients and carbon cycling in the form of organic matter and then back to their original components in an
ecosystem. ", Annex J, para. 305.

defined in the Convention on Biological Diversity as "the variability among living organisms from all
sources…".
373 In the context of this case, any harm to biodiversity or the ecological balance of an
area arising from biotech products is through harm to plants and animals, as defined by the
SPS Agreement. Canada considers that the materials from the negotiating history to which the
European Communities refers do not indicate wh ether WTO Members intended for all types of
environmental measures to be excluded; indeed, the mo re plausible reading of those materials is that
the WTO Members intended for more general types of environmental measures, such as those relating
to air and water quality, waste management, and th e like, to be excluded from the coverage of the
SPS Agreement, but that environmental effects related to SPS-type risks would remain within the
scope of that agreement.
7.206 Argentina argues that since humans, animals and plants comprise the universe of living
things, and since biodiversity is concerned with the diversity of living things, biodiversity is
necessarily related to human, animal or plant life or health. In Argentina’s view, the most likely way
in which biotech products could da mage biodiversity or the ecological balance of an area is through
negatively affecting wild flora and/or fauna. A me asure taken to protect biodiversity would therefore
be covered by the definition of an SPS measure contained in Annex A(1).
7.207 The Panel recalls that Directives 90/220 and 2001/18 serve to protect human health and the
"environment". It is clear from the Directives that as part of the purpose of protecting the
"environment" they address the protection of the health of animals or plants. Indeed, Article 2(8) of
Directive 90/220 states that the term "environmental ri sk assessment" as used in the Directive "means
the evaluation of the risk to human health and the environment ( which includes plants and animals )
…" (emphasis added). Among the information require d with the submission of an application under
Directive 90/220, in the context of "Information on the environment", is information on flora and
fauna, including crops, livestock and migratory species. 374. Directive 2001/18 refers to assessing the
accumulated effects of consents for placing on the market on "human health and the environment,
including inter alia flora and fauna, ... animal health...". 375 We note that in accordance with
Annex A(1)(a) and (b) of the SPS Agreement, the SPS Agreement covers measures applied to protect
animal and plant life or health from certain risks. Thus, to the extent Directives 90/220 and 2001/18
are applied to protect animals and plants as part of their purpose of protecting the environment, they
are not a priori excluded from the scope of application of the SPS Agreement.
7.208 The European Communities argues, however, th at negative effects on the environment may
occur without there being negative effects on wild flora and fauna. The European Communities
refers to adverse effects on biodiversity as a rele vant example. The European Communities implies
that to the extent Directive 90/220 and 2001/18 are applied to protect the environment from such
adverse effects, the Directives fall outside the scope of the SPS Agreement. We will address this
argument below in the context of our analysis of Directives 90/220 and 2001/18 under Annex A(1)(d)
of the SPS Agreement. Annex A(1)(d) refers to measures app lied to prevent or limit "other damage
within the territory" from risks associated with "pests". As we will explain, we consider
that Annex A(1)(d) covers measures applied to pr event or limit certain forms of damage to the
environment. At this point, we need only observe that neither the TBT Agreement nor the GATT
Secretariat background paper referred to by the European Communities, nor the Working Group

373 The Convention on Biological Diversity defines "biological diversity" in Article 2 as "the variability
among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems
and the ecological complexes of which they are part; this includes diversity within species, between species and
of ecosystems." Convention on Biological Diversity (CBD) done in Rio de Janeiro, 5 June 2002.
374 Annex II.III.B.9 of Directive 90/220.
375 Chapeau to Annex II of Directive 2001/18.

Chairman's Draft Text on Sanitary and Phytosanitary Measures supports the view that all measures
applied to protect from risks to the environment othe r than risks to the life or health of animals or
plants fall outside the scope of application of the SPS Agreement.
7.209 Regarding the European Communities' reliance on the TBT Agreement, we do not consider
that the fact that the TBT Agreement refers to "the environment" , and that Annex A(1) does not,
precludes us from interpreting the term "other dama ge" in Annex A(1)(d) to encompass also certain
damage to the environment other than damage to the lif e or health of animals or plants. The fact that
the term "other damage" is broad and unqualified suggests to us that it is intended to ensure coverage
of a residual category of damage, which, as we will see, is not limited to environmental damage.
Therefore, we do not find it surprising that the draf ters omitted a reference to "the environment" in
Annex A(1)(d).
7.210 As far as the the 1993 GATT Secretariat backgrou nd paper is concerned, we consider that it
merely intended to clarify that the purpose of environmental protection, per se, is not sufficient to
bring a measure within the scope of application of the SPS Agreement, even if the measure otherwise
meets the definition of an SPS measure (e.g., in terms of its form and nature). To provide an example,
a measure to reduce air pollution may be applied to pr otect the life or health of plants (to the extent
that high levels of air pollution could result in cer tain plant species lacking sufficient sunlight for
them to exist and survive), and hence to protect the environment, but it would nonetheless not be a
measure applied for one of the purposes enumerated in Annex A(1) of the SPS Agreement (in that the
measure would not be applied to protect plant lif e or health from risks arising from the entry,
establishment or spread of pests, diseases, disease-carrying organisms or disease-causing organisms,
or to prevent other damage from the entry, establishment or spread of pests).
7.211 Finally, we turn to the 1990 Draft Text on Sanitary and Phytosanitary Measures circulated by
the Chairman of the Working Group on Sanitary and Phytosanitary Measures. We note that the draft
text contained bracketed text the acceptance of which would have meant that "measures for the
protection of animal welfare and of the environmen t, as well as of consumer interests and concerns"
are "SPS measures" within the meaning of the Annex A(1) definition.
376 However, the Annex A(1)
definition in the Chairman's draft text also containe d bracketed text which stated that "[r]equirements
concerning quality, composition, grading, [consumer pr eferences, [...], the environment or ethical and
moral considerations] are not included in the definition of sanitary or phytosanitary measures". 377
Neither of the two bracketed texts was included in the final text of the SPS Agreement. Since
according to one of the two bracketed texts measu res taken for the protection of the environment
would have been covered by the SPS Agreement, while according to the other bracketed text such
measures would not have been covered, and since ne ither text was included in the final text of the
SPS Agreement, we cannot draw the inference that the Eur opean Communities asks us to draw – that
the removal of the bracketed text which would have meant that measures taken for the protection of
the environment are SPS measures implied a decision that such measures should not be covered by
the SPS Agreement. In view of the fact that neither of the two bracketed texts was included in the
final text of the SPS Agreement, we consider that the Working Group Chairman's draft text does not
assist us in determining whether all measures applie d to protect from risks to the environment other
than risks to the life or health of animals or pl ants fall outside the scope of application of the
SPS Agreement.

376 Uruguay Round document MTN.GNG/NG5/WGSP/7, p. 8.
377 Ibid. (emphasis added).

Annex A(1)(a) to the SPS Agreement: Protection of 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
7.212 As indicated, we will now analyse whether Di rectives 90/220 and 2001/18 can be considered
as measures applied for one of the purposes identif ied in sub-paragraphs (a) through (d) of
Annex A(1) of the SPS Agreement. We begin this analysis with Annex A(1)(a). Annex A(1)(a)
makes clear that the SPS Agreement is applicable to measures applied "to protect animal or plant life
or health within the territory of the Member from risks arising from the entry, establishment or spread
of pests, diseases, disease-carrying organisms or disease-causing organisms".
7.213 In order for us to determine whether Direc tives 90/220 and 2001/18 fall within the scope of
Annex A(1)(a), we need to consider the meaning and scope of some of the terms and phrases used in
Annex A(1)(a) and address whether certain potential effects of GMOs identified in the Directives
meet the definition of these terms and phrases. Accord ingly, we have structured our analysis below
according to certain terms and phrases used in Anne x A(1)(a), including "animal or plant life or
health", "risks arising from", "entry, establishmen t or spread", "pests" and "diseases, disease-carrying
organisms or disease-causing organisms." We note that one specific concern which has been
identified in Directives 90/220 and 2001/18 relates to potential adverse effects of GMOs resulting
from the use of antibiotic resistance marker gen es. A separate subsection addresses whether this
concern can be considered to relate to the risks covered in Annex A(1)(a).
"animal or plant life or health"
7.214 The United States argues that the EC approval re gime requires consideration of, inter alia,
concerns that a biotech product might harm benefi cial organisms as well as target organisms.
According to the United States, these are concerns rela ting to potential risks to animal or plant life or
health.
7.215 Canada observes that Annex A of the SPS Agreement defines plants and animals to include
wild flora and wild fauna, which are integral parts of what is commonly understood as "the
environment". Furthermore, Canada mainta ins that the term "fauna" as used in the SPS Agreement
encompasses both macrofauna and microfauna, whereas the term "flora" includes also microflora.

Contrary to the arguments of the European Co mmunities, according to Canada nothing in the
SPS Agreement limits measures to those that address short-term risks to plant or animal life or health.
7.216 Argentina argues that the most likely way in which biotech products could damage biodiversity
or the ecological balance of an area is through negatively affecting wild flora and/or fauna. Annex A of
the SPS Agreement explicitly states that the term "animals" includes wild fauna and the term "plants"
includes wild flora.
7.217 The European Communities argues that GMOs could affect micro-organisms that are
specialized in biophysical or biochemical processes in the soil, or aquatic micro-organisms, and thus
affect ecosystems without affecting plant or animal health.
7.218 The Panel understands the European Communities to argue that a measure taken to address
any adverse effects biotech products might have on soil or aquatic micro-organisms would not be a

measure applied to protect "animal or plant life or h ealth". In considering this argument, it should be
recalled that the footnote to the definitions provided in Annex A of the SPS Agreement states that:
378
"For the purpose of these definitions, 'animal' includes fish and wild fauna; 'plant'
includes forests and wild flora; 'pests' include weeds; and 'contaminants' include
pesticide and veterinary drug residues and extraneous matter."
7.219 The term "fauna" is commonly defined as "the anim als or animal life of a given area, habitat,
or epoch"379, whereas the term "flora" is commonly defined as "plants or plant life of a given area,
habitat, or epoch". 380 The clarification provided in the footnote to Annex A that the terms "animal"
and "plant" include "wild fauna" and "wild flora" in dicates to us that the scope of the phrase "animal
or plant life or health" is meant to be comprehensiv e in coverage. Moreover, we note that, textually,
the unqualified terms "animal" and "fauna", on the one hand, and "plant" and "flora", on the other, can
encompass macro- and micro-fauna, on the one hand, and macro- and micro-flora, on the other. We
also consider that the terms "animal" and "plant" can encompass both target and non-target fauna and
flora. By "non-target" fauna and flora, we mean plants and animals (including insects) which are not
themselves the organisms farmers seek to control or eliminate through the cultivation of GM crops,
but which are affected by the cultivation of the GM crop, including through consumption of
components of the GM plants ( e.g., pollen). In the light of this, we consider that non-target micro-
organisms, such as soil or aquatic micro-organisms, are "animals" or plants" within the meaning of
Annex A(1).
381
7.220 We note that Directive 2001/18 specifies that in order to allow competent authorities to draw
conclusions on the potential environmental impact fr om the release of GM plants, applicants should
provide information on the "effects on biogeochemist ry (biogeochemical cycles), particularly carbon
and nitrogen recycling through changes in soil decomposition of organic material". 382 We understand
that this concern relates to the potential introduction of transgenes into the soil via the roots of GM
plants (e.g., in the case of Bt-producing plants) or through the decomposition of GM plants. This may
potentially pose a threat to non-target soil micr o-organisms. Presumably the same products of
decomposition could be introduced to bodies of water through run-off, and hence pose potential
threats to non-target water micro-organisms. We consider that to the extent Directives 90/220 and
2001/18 could be used to protect the life or health of non-target micro-organisms from risks covered
by Annex A(1)(a), the Directives would fall within the scope of this Annex.
"risks arising from"
7.221 The United States considers that the phrase "arising from" does not require a demonstration
that the risk be direct or immedi ate. Although there may be intermed iate effects that occur before the
effect of concern appears, the risks nonetheless "arise from" the organism in that it is the presence of
the organism that triggers the necessary sequen ce of events. The United States maintains, for
example, that adverse effects on plant and animal he alth due to the use of mo re powerful pesticides to
control insects or weeds which have developed he rbicide resistance as a result of the planting of
herbicide-resistant biotech crops would be "risks arising from" the establishment or spread of a pest.

378 Emphasis added.
379 The Shorter Oxford English Dictionary, L. Brown (ed.) (Oxford University Press, 2002), Vol. 1,
p. 931.
380 Ibid., p. 979.
381 We note that the common definition of an "organism" is: "an organized living body; esp. (the
material structure) of an individual animal, plant, bacterium, etc.". The Shorter Oxford English Dictionary,
L. Brown (ed.) (Oxford University Press, 2002), Vol. 2, p. 2019.
382 Tiret 6 of Annex II C.2 of Directive 2001/18.

7.222 Canada also argues that the phrase "arising from" does not require that the risk be immediate
or direct. If, for example, a biotech product qualif ies as a "pest" that needs to be controlled with
herbicides, any resulting risks to wild flora and/or fauna "arise from" the pest. This includes a
situation where a pest management strategy is no longer effective becau se the target pest has
developed resistance, resulting in health risks to wild fauna from increased or altered use of
pesticides.
7.223 The European Communities argues that the use of the phrase "arising from" indicates a
requirement of causality; that is, the measure must be applied with the objective of preventing certain
risks "arising from" a certain situation.
7.224 The Panel notes that the dictionary defines the phrasal verb "to arise from" as meaning "occur
as a result of".
383 Thus, the phrase "risks arising from" indicates that the relevant risks to animal or
plant life or health must occur as a result of some event, substance, condition, etc. In the specific
context of Annex A(1)(a), the phrase "risks arising from" implies that the risks to animal or plant life
or health must occur as a result of a pest, di sease, disease-carrying organism or disease-causing
organism.
7.225 Article 4 of Directives 90/220 and 2001/18 makes clear that these Directives are measures
applied to protect human health and the environm ent from adverse effects "which might arise from"
the deliberate release of GMOs into the environmen t. Thus, like Annex A(1)(a), the Directives use
the phrasal verb "to arise from". We recognize that Annex A(1) uses the phrase "arising from", not
"which might arise from". However, the phrase "arising from" is broad and unqualified. We
therefore think that Annex A(1) brings within the scope of the SPS Agreement, not just measures
which are applied to protect against risks which invariably and inevitably arise from, e.g., the spread
of a pest, but also measures applied to protect against risks which might arise from, e.g., the spread of
a pest.
7.226 We note that Annex II of Directive 2001/18 indicates that direct, indirect, immediate and
delayed adverse effects are to be considered in the assessment of GMOs. Here again, we note that the
phrase "arising from" in Annex A(1) is broad and unqualified. There is nothing in Annex A(1)(a)
which indicates that potential risks to animal or plan t life or health must necessarily be the direct or
immediate result of, e.g., the spread of a pest. Notably, A nnex A(1) does not say that only risks
"arising directly and immediately from", e.g., the spread of a pest, are covered. We therefore do not
consider that measures taken to protect animal or plan t life or health from risks that arise indirectly or
in the longer term from pests, diseases, disease-carrying organisms or disease-causing organisms fall
outside the scope of Annex A(1)(a). Accordingly, the reference in Annex II of Directive 2001/18 to
indirect and delayed adverse effects does not, by itself, remove that Directive from the scope of
Annex A(1)(a).
"entry, establishment or spread"
7.227 The European Communities argues that concerns regarding the potential development of
resistance in target pests are not a question of "est ablishment or spread" of a pest. The pest, that is,
the insect of concern, already exists and will not spr ead to other areas. Rather the problem relates to
the treatment of the pest, and the need to use additional insecticides in order to get rid of the pest.
7.228 The United States disagrees, arguing that the concern about the potential development of
resistant target insects is that those individuals carrying the r esistance trait could become established

383 The Concise Oxford Dictionary, 10th edn, J. Pearsall (ed.) (Oxford University Press, 1999), p. 71.

and spread throughout the population. As more insect populations become resistant, more toxic
chemical pesticides may need to be applied, causing greater environmental damage.
7.229 Canada observes that if a pest management strate gy is no longer effective because the target
pest has developed resistance, an alternative pest management strategy would still have the objective
of addressing risks "arising from" the establishment or spread of the resistant pest.
7.230 Argentina notes that if a pest management strategy is no longer effective because the target
pest has developed resistance, the "risks arising fro m the entry, establishment or spread" of that pest
have not disappeared. The concern remains that the target pest may become established or spread.
7.231 Before addressing the European Communities' spec ific argument on resistance in target pests,
it is useful to consider more generally whether Directives 90/220 and 2001/18 are concerned with the
"entry, establishment or spread" of pests, diseases, etc. The Panel recalls in this regard that the
purpose of Directive 2001/18 is to avoid adverse effect s arising from the "deliberate release into the
environment" of GMOs.
384 The term "deliberate release" is defined as "any intentional introduction
into the environment of a GMO". 385 Annex II.C.2.1 to Directive 2001/18 specifies that potential
adverse effects of GMOs may include disease to animals and plants. It is clear to us that the purpose
of avoiding disease in general includes the purpose of avoiding, more specifically, the "entry,
establishment or spread" of "diseases". Furthermor e, Annex C.2.1 specifies that effects on the
dynamics of populations of species and genetic diversity of populations are relevant adverse effects.
These effects relate to potential "pest effects" of GMOs which could occur, inter alia , through the
spread of pollen from genetically modified plants to other plants ("out-crossing") 386, or through the
development of persistence or "invasiveness" of the GMO or GM plant due to a selective
advantage.
387 We think that the purpose of avoiding "p est effects" of GMOs includes the purpose of
avoiding the "entry, establishment or spread" of GM Os as "pests". We also note that Annex II.C.2.1
of Directive 2001/18 specifically states that adverse effects may occur through the "spread of GMO(s)
in the environment". In the light of this, we are satisfied that Directives 90/220 and 2001/18 can be
considered to constitute measures applied to protect against risks arising from the "entry,
establishment or spread" of, inter alia, disease and "pest effects" which may be caused by GMOs.
7.232 We now turn to the European Communities' ar gument that possible concerns regarding the
potential development of resistance in target pests ( e.g., insects) are not concerns regarding the
"establishment or spread" of a pest. It appears th at the effect of the development of resistance in
target pests may be a potential adverse effect of GMOs which Directives 90/220 and 2001/18 seek to
avoid.388 We are not persuaded, however, that in terms of Annex A(1) risks associated with the
development of resistance would not be risks arisi ng from the "establishment or spread" of the target
pest. Even if, as the European Communities argues, th e target pest may have existed in a particular
area before, if the pest develops resistance, it may be that thanks to the resistance trait the pest can not
only exist in the area in question, but also become established and thus beco me more of a problem.

384 Article 4 of the Directives.
385 Article 2(3) of Directive 2001/18 (emphasis added).
386 The Panel understands the term "out-crossing" or "cross-breeding" to refer to the unintentional
breeding of a cultivated plant, in this case a GM plant, with another cultivated or wild plant, in this case a
"conventional" or non-GM, plant.
387 The Panel understands selective advantage to refer to the enhanced ability of a particular trait to
survive in a population, thus leading to a change in the co mposition of traits within the population. In this case,
the spread of herbicide resistance may allow plants with that trait to out-compete other plants for water,
nutrients, space, etc.
388 See, e.g., Annex II.iv.C.4 of Directive 90/220 and Annex IIIA.iv.B.11 and Annex II.D.1.4 of
Directive 2001/18.

Similarly, the resistance trait may allow the pest to spread to areas it has not entered before, e.g.,
because of a pest management strategy which was eff ective prior to the development of resistance in
the relevant pest.
"pests"
7.233 The United States notes that the ordinary meaning of the term "pest" is "any thing or person
that is noxious, destructive or troublesome".
389 The United States further argues that the IPPC
definition of a pest, as contained in the International Standard for Phytosanitary Measures Number 11,
Pest Risk Analysis for Quarantine Pests, including Analysis of Environmental Effects and Living
Modified Organisms (hereafter ISPM No. 11) supports the view that the scope of IPPC also extends to
organisms which may directly affect uncultivated and/or unmanaged plants, indirectly affect plants, or
indirectly affect plants through effects on other organisms. 390 While the United States does not
contend that this is dispositive of the term "pest" under the SPS Agreement, the specific inclusion of
such damage in ISPM No. 11, by the body explicitly recognized by the SPS Agreement as responsible
for international standards for plant health, is a dditional evidence that the ordinary meaning of the
term "pest" includes a biotech plant that cross-breed s with existing flora, and consequently, adversely
affects biological diversity.
7.234 Canada argues that the use of the term "pest" in Annex A(1)(a), (c) and (d) suggests that in
the context of the SPS Agreement, "pest" should be defined as "any species, strain or biotype of plant,
animal or pathogenic agent injurious to plants, plan t products, animals or humans." In Canada's view,
the biotech products at issue in this dispute can be viewed as a potential "pest" to plants, including
"wild flora", or a potential "pest" to animals, including "wild fauna".
7.235 Argentina recalls that the International Plant Protection Convention of 1997 has defined a
"pest" to be "[a]ny species, strain or biotype of plant, animal or pathogenic agent injurious to plants or
plant products." Argentina argues that the phrase "injurious to plants and plant products" should be

389 The Shorter Oxford English Dictionary, L. Brown (ed.) (Oxford University Press, 2002), Vol. 2,
p. 2171.
390 The United States notes that the FAO's International Plant Protection Convention of 1997 defines
the term "pest" as "[a]ny speci es, strain or biotype of plant, animal or pa thogenic agent injurious to plants or
plant products". The IPPC's 2004 revisions to ISPM No. 11, which modified the existing standard specifically
to address risks from a particular category of GM crops ("living modified organisms", or "LMOs"), identifies
among the potential phytosanitary risks for LMOs:

c. Adverse effects on non-target organisms including, for example:

- changes in host range of the LMO, including the cases where it is intended for
use as a biological control agent or organism otherwise claimed to be beneficial
- effects on other organisms, such as biological control agents, beneficial

organisms, or soil fauna and microflora, nitrogen-fixing bacteria, that result in a
phytosanitary impact (indirect effects)
- capacity to vector other pests
- negative direct or indirect effects of plant-produced pesticides on non-target
organisms beneficial to plants." (emphasis added by the United States)

International Standard for Phytosanitary Measure No. 11, Pest Risk Analysis for Quarantine Pests
Including Analysis of Environmental Risks , FAO, Rome, 2004 (adopted April 2004), Annex 1 "Comments on
the scope of the IPPC in regard to environmental risks".

interpreted broadly, as is evidenced by the broad interpretation given in the context of ISPM No. 11
391
and that the term "pests" in the SPS Agreement should be given a similarl y broad interpretation. An
organism is a "pest" for the purposes of the SPS Agreement and ISPM No. 11 if it is "injurious to plants
or plant products" in the sense of causing damage to plant life or hea lth. According to Argentina, any
undesirable cross-breed of plants could be considered a "pest"; for instance when a herbicide-tolerance
gene is transferred to a crop’s weeds. Argentina argues that the SPS Agreement covers risks arising
from a biotech product that becomes a weed, that is, a persistent and invasive plant that grows in
environments where it is not wanted and overtakes other plant species, ra ising broader ecological
concerns.
7.236 The European Communities argues that the IPPC definiti on may provide relevant context
for the purposes of interpreting the term "pest" in Annex A(1) of the SPS Agreement. In particular,
the European Communities insists that (1) a pest must be a living organism, and so isolated strands of
modified DNA cannot be, in and of themselves, injurious to human, animal or plant life or health;
and (2) the organism must cause injury to a pl ant. The mere presence of a transgene may be
undesirable but it need not present any phytosanitary risk. The European Communities contends that
a cross-breed that harms biodiversity, micro-organisms, animals or the environment is not a pest.
7.237 The European Communities maintains that a crop that is resistant to a herbicide is not a pest if
it is growing in the right place at the right time. However, in the wrong place (such as a neighbouring
field) or at the wrong time (such as the following ye ar in the same field sown with a different crop)
the plant may be unwanted. The unwanted plant may compete with other crops, and its herbicide
resistant trait could give it a selective advantage. It might choke or stunt other crop plants. It could
thus adversely affect or injure other crops. It c ould therefore become a pest, and a measure taken to
control it could be within the scope of the SPS Agreement.
7.238 The Panel notes at the outset that three of the sub-paragraphs of Annex A(1) to the
SPS Agreement, namely, Annex A(1)(a), A(1)(c) and A(1)(d), identify "pests" as a possible source of
risks. The word "pest" ordinarily means "a troublesome, annoying or destructive person, animal, or
thing".
392 In applying this definition to Annex A(1), we find two contextual elements in particular to
be noteworthy. The first is the previously menti oned footnote to the definitions provided in Annex A
of the SPS Agreement. It specifies that, for the purposes of the SPS Agreement, the term "pest"
includes weeds. Weeds are plants. Therefore, we consider that the term "pest" in Annex A(1) must
be understood to cover plants in addition to animals.
7.239 The other element which we find instructive are the references in Annex A(1)(a) and A(1)(c)
to "animal or plant life or health" and "human life or health" as well as the reference in Annex A(1)(d)
to "other damage". It is apparent from these references that the SPS Agreement is intended to be
applicable, not just to measures taken to protect agai nst risks which pose a threat to the life, and thus
the very existence, of animals, plants or humans, but also to measures taken to protect against risks to
the "health" of animals, plants or humans, and to measures taken to prevent other "damage" within the
territory of a Member. In the light of this, we c onsider that the term "pest" should be interpreted to
cover "destructive" animals or plants – that is animals or plants which destroy the life and threaten the
very existence of other animals, plants or humans. Equally, however, we think that, for the purposes
of the SPS Agreement, the term "pest" should be interpreted to cover animals and plants which cause

391 International Standard for Phytosanitary Measure No. 11, Pest Risk Analysis for Quarantine Pests
Including Analysis of Environmental Risks, FAO, Rome, 2004 (adopted April 2004), Annex 1, p. 34.
392 The New Shorter Oxford English Dictionary , L. Brown (ed.) (Clarendon Press, 1993), Vol. 2
p. 2174.

other, less serious, deleterious effects, namely, anim als and plants which cause harm to the health of
animals, plants or humans or which cause other harm.
7.240 Consistent with the foregoing considerations, it may thus be said that in the context of the
SPS Agreement the term "pest" should be understood as refe rring to an animal or plant which is
destructive, or causes harm to the health of othe r animals, plants or humans, or other harm, or a
troublesome or annoying animal or plant.
7.241 We note that the 1997 IPPC defines the term "pest" as "[a]ny species, strain or biotype of
plant, animal or pathogenic agent injurious to plants or plant products".
393 We agree that plants, or
animals, which are "injurious" to other plants or plant products constitute "pests" within the meaning
of Annex A(1). Indeed, we have said that, in our view, the term "pest" in Annex A(1) encompasses
destructive animals or plants, or animals or plants which cause harm to the health of animals or plants.
However, we have determined that the term "pest" in Annex A(1) also encompasses animals or plants
which cause other harm, and troublesome or annoying animals or plants. The IPPC definition of the
term "pest" does not specifically bear out the second part of our interpretation. We recognize that the
definition of the term "pest" in the IPPC may in so me respects be informative to, and hence aid, an
interpreter of the SPS Agreement. But the negotiated IPPC definition is not dispositive of the meaning
and scope of the term "pest" as it appears in Annex A(1). 394 Therefore, we do not consider that the
IPPC definition of "pest" detracts from our view that pl ants may be considered as "pests" even if they
are not injurious to other plants.
7.242 The Parties have presented various arguments which suggest that GM plants could be
considered "pests" within the meaning of Annex A(1) in each of the following three situations: (a)
situations where GM plants grow where they are undesired, e.g., as a result of seed spillage or
persistence or invasiveness; (b) situations of un intentional gene flow or transfer from a GMO plant
("out-crossing"), leading to cross-breeds between GM plants and other plants, whether conventional
crops or wild flora, which have undesired introduced traits (such as herbicide or insect resistance) and
may establish or spread; and (c) s ituations where pesticide-producing ( e.g., insecticide-producing)
GM plants increase the potential fo r the development of pesticide-r esistance in target organisms,
notably insects.395 We will address these three situations be low, as necessary. In addition, in sub-
section (d), we will address concerns that GM pl ants might act as "pests" in other situations,
specifically concerns regarding potential adverse effects of GMOs on non-target organisms and on
biogeochemical cycles.
GM plants growing where they are undesired
7.243 We first turn to examine whether GM plants which grow where they are undesired can be
considered as "pests". The Eur opean Communities argues that they can. The United States also
argues that a GM plant that might potentially establis h or spread into new ar eas and out-compete and

393 FAO International Plant Protection Convention, 1997, Article II, No. 1 (emphasis added). We note
that the 1997 Convention was not in force on the date of establishment of this Panel. However, Article II.2 of
the FAO's 1979 International Plant Protection Convention defined the term "pest" in very similar terms, stating
that the term "pest" includes "any form of plant or animal life, or pathogenic agent, injurious or potentially
injurious to plants or plant products".
394 It is important to note in this context that unlike the SPS Agreement, the IPPC is concerned only
with plant pests, not animal pests.
395 The Panel will use the term "pesticide" to encompass both insecticides and herbicides. One of the
experts advising the Panel, Dr. Snow, indicated that herbicide resistance can develop from selection of naturally
occurring herbicide tolerant plants, but this has only been shown to occur in a few instances. It is much more
likely for this trait to be passed due to out-crossing. (Annex H, para. 153.)

displace wild flora thereby potentially altering the availability of resources such as food and shelter
used by wild fauna would be considered to be a "w eed". Canada and Argentina as well argue that if a
GM plant becomes a persistent and invasive plant that grows in environments where it is not wanted and
overtakes other plant species, it becomes a weed or a "pest" in the context of the SPS Agreement.
7.244 We recall our view that the term "pest" in Anne x A(1) refers to a plant which is destructive,
or causes harm to the health of other animals, plan ts or humans, or other ha rm, or a plant which is
troublesome or annoying. It is clear to us that a plant which grows where it is not wanted may, for
that reason, be destructive, cause harm to the health of other organism s or other harm, or be
troublesome or annoying. For instance, an unwan ted plant in a cultivated field may necessitate
control or eradication efforts by a farmer ( e.g., in the case of weeds) or diminish the economic value
of the crop the farmer is seeking to grow ( e.g., because his/her market is non-GMO with low or little
tolerance for impurities). We also recall that th e footnote to Annex A specifically indicates that
"pests" include weeds. A weed is defined as a "wild plant growing where it is not wanted and in
competition with wild plants".
396 Thus, the footnote supports the view that plants growing where they
are undesired can be considered as "pests".
7.245 An important implication of the view that plants growing where they are undesired may be
considered as "pests" is that even a cultivated pl ant or crop may in some situations be or become a
"pest". Whether that is so would depend on the relevant circumstances, and notably where it grows
and the perspective of the user of the land where th e plant grows. The Panel therefore agrees with the
observation of the European Communities that plants which in one situation may be desirable and
hence cultivated (i.e., cultivated sunflowers growing in a field of sunflowers), in another context may
be considered "pests" (i.e., sunflowers accidentally growing in a soybean field). Similarly, a GM
plant cultivated expressly in a particular fiel d would not qualify as a "pest", whereas volunteer 397 GM
plants growing in fields of conventional plants might be considered to be undesirable plants and hence
"pests", or "weeds", from the perspective of the farmer seeking to grow a crop other than the
unwanted GM crop.398
7.246 Turning to Directives 90/220 and 2001/18, we not e that the Directives seek to avoid adverse
effects on the environment which might arise from the deliberate release of GMOs. More
specifically, Directive 2001/18 specifies that adve rse effects of GMOs include "effects on the
dynamics of populations of species in the receiving environment and the genetic diversity of each of
these"
399, which in turn include the potential of the GM plant for excessive population increase in the
environment and any competitive advantage of the GM Os in relation to the unmodified recipient or
parental organisms. 400 Along similar lines, Directive 2001/18 specifies that in order to allow
competent authorities to draw conclusions on the po tential environmental impa ct from the release of
GM plants, applicants should provide information on the "[l]ikelihood of [GM plants] becoming more

396 The Concise Oxford Dictionary, 10th edn, J. Pearsall (ed.) (Oxford University Press, 1999), p. 1623.
397 Volunteer GM plants are GM plants growing unexpectedly from seeds sown through natural
processes, e.g., by wind, animals or birds, or from seeds which were accidentally droppe d as they were
transported between locations.
398 This view is also supported by the experts advising the Panel. Dr. Squire, for example, defines
volunteer plants as "plants that originate from seed or vegetative material shed or left by a crop, and that inhabit
fields, usually emerging as a weed within a crop" (emphasis added). Although Dr. Squire uses the term "feral"
to describe plants that originate from seed or vegetative material left by crops and th at exist outside fields, in
waysides and the margins of agriculture, he observes that some authors use the term feral for plants descended
from a crop whether they are found inside or outside fields. (Annex H, para. 45.)
399 Annex II.C.2.1 of Directive 2001/18.
400 Annex IIIA.IV.B.8 and 9 of Directive 2001/18.

persistent than the recipient or parental plants in agricultural habitats or more invasive in natural
habitats" and "[a]ny selective advantage or disadvantage conferred to the [GM plant]".
401
7.247 We consider that these potential effects of GM plants relate to situations where GM plants
grow where they are undesired. In such situ ations, due to a potential competitive advantage,
persistence and invasiveness, GM plants may cr owd out or eliminate other plants. Competitive
pressure from GM plants may also affect the genetic diversity of remaining plant populations, putting
at risk the survival of certain pl ant species. As these potential effect s of GM plants impact negatively
on the ability of other plants to exist and survive in the affected area, we think they can be considered
to cause harm to the "life or health" of other plants . In other words, we think that by causing harm in
the aforementioned ways, GM plants would act as "pests" within the meaning of Annex A(1)(a). 402
Therefore, to the extent Directives 90/220 and 2 001/18 are applied to avoid the adverse effects
identified in the previous paragraph, they can, in our view, be considered as measures applied "to
protect [...] plant life or health [… ] from risks arising from the entry, establishment or spread" of GM
plants qua "pests".
unintentional gene flow or transfer from a GM plant to other plants
7.248 We next consider the situation where a GM plant cross-breeds with other plants, whether
conventional crops or wild flora (out-crossing 403). The issue is whether in such a situation the GM
plant could be considered a "pest" within the me aning of Annex A(1). We first recall the main
arguments.
7.249 The United States argues that any undesirable cross-breeding of a plant would render the
plant a "pest". The United States considers that th is view is supported by the Annex to ISPM No. 11
which extends the IPPC definition of a pest to organisms which may directly affect uncultivated
and/or unmanaged plants, indirectly affect plants, or indirectly affect plants through effects on other
organisms.404
7.250 Canada notes that the focus of inquiry in terms of pest characteristics in the context of
Directive 2001/18 is the plant containing the transg ene, not the modified DNA itself. Canada
considers that an undesirable cross-breed of a plant would be considered a "pest" under the
SPS Agreement to the extent that the undesirable cross-br eed of the plant harms "animal or plant life
or health" (Annex A(1)(a)) or "human life or he alth" (Annex A(1)(c)) or causes "other damage"
(Annex A(1)(d)). According to Canada, the risks associated with insecticid al crops, such as those
producing Bt, arise from their potential impact on insect populations, whether target insects or

401 Annex II.D.2.1 and D.2.2.of Directive 2001/18.
402 If it were considered, contrary to our view, that the adverse effects in question do not cause harm to
the "life or health" of other plants, we think they would need to be considered to cause "other damage" within
the meaning of Annex A(1)(d).
403 As previously noted, we use the term "out-crossing" or "cross-breeding" to refer to the unintentional
breeding of a cultivated plant, in this case a GM plant, with another cultivated or wild plant, in this case a
"conventional" or non-GM, plant. Out-crossing could result in the transfer of characteristics of GM plants, such
as herbicide resistance or the production of Bt toxin, into conventional or wild plant populations. The experts
advising the Panel indicated that the likelihood of out-crossing depends on the species of plant. Dr. Squire, for
example, indicates that in Europe o ilseed rape plants are more likely to out-cross with susceptible wild species
than cotton or corn plants. He stat es, however, that the fact that a pl ant is a GM plant should not markedly
affect the likelihood of out-crossing, unless the genetic modification changes the male fertility of the plant. (See
Annex H, paras. 145-148.)
404 International Standard for Phytosanitary Measure No. 11, Pest Risk Analysis for Quarantine Pests
Including Analysis of Environmental Risks, FAO, Rome, 2004 (adopted April 2004), Annex 1, p. 34.

otherwise. To the extent that insecticidal crops ha rm insects, they can be c onsidered "pests" to wild
fauna. If insecticidal crops increase the potential fo r the development of resistance to other biological
control agents, such as Bt, this may have a correspondi ng indirect effect on plants. Canada also refers
to the statement in ISPM No. 11 that the scope of the IPPC also extends to organisms which are pests
because they indirectly affect plants through effects on other organisms.
7.251 Argentina considers that any undesirable cross-breed could be considered a "pest"; for instance
when a herbicide-tolerance gene is transferred to a crop’s weeds.
7.252 The European Communities argues that (1) a pest must be a living organism, i.e. isolated
strands of modified DNA cannot be, in and of themsel ves, injurious to human, animal or plant life or
health; and (2) the organism must cause injury to a plant. The mere presence of a transgene may be
undesirable but not present any phytosanitary risk; pl ants do not injure flora by cross-breeding with
them, and for that reason cannot be considered "pests". Furthermore, the European Communities
argues that the transfer of herbicide resistance from genetically modified plants into wild flora could
result in the development of a herbicide-resistant wild population which could become invasive and
could result in damage to biodiversity, however the European Communities considers that the novel
herbicide-resistant wild plant would not be a pest as defined by the IPPC, since it would primarily
affect insects and other organisms of the trophic chain.
405
7.253 The Panel notes that according to Annex 3 of FA O's ISPM No. 11, a living modified
organism (hereafter an "LMO") may be deemed to be a "pest" if the LMO is associated with
"[a]dverse effects of gene flow or gene transfer including, for example [...] transfer of pesticide or pest
resistance genes to compatible species".406 Annex 3 of ISPM No. 11 further states in this regard that:
"In cases of phytosanitary risks related to gene flow, the LMO is acting more as a
potential vector or pathway for introducti on of a genetic construct of phytosanitary
concern rather than as a pest in and of it self. Therefore, the term "pest" should be
understood to include the potential of an LMO to act as a vector or pathway for
introduction of a gene presenting a potential phytosanitary risk."407
7.254 Annex 3 of ISPM No. 11 suggests that contrary to what the European Communities contends
in paragraph 7.236 above, an unwanted transgene in a cross-breed between a GM plant and other
plants may be considered to present a potential phyt osanitary risk. As none of the Parties has argued
that a transgene presenting a potential phytosanitary risk should be considered as a "pest" within the
meaning of Annex A(1), we see no need to address this issue. We merely note that Annex 3 of ISPM
No. 11 does not suggest that the transgene should or could be viewed as a "pest" in its own right.
Rather, it states that the LMO which potentially transfers the transgene should be viewed as a "pest".
7.255 Along the lines of the above-quoted statement in Annex 3 of ISPM No. 11, it could be argued
that the term "pest" as it appears in Annex A(1) of the SPS Agreement should be understood to
include GMOs which could act as vectors or pathwa ys for the introduction into the same or another

405 See supra, footnote 371.
406 International Standard for Phytosanitary Measure No. 11, Pest Risk Analysis for Quarantine Pests
Including Analysis of Environmental Risks , FAO, Rome, 2004 (adopted April 2004), Annex 3, p. 36. The
European Communities has pointed out that the 1997 IPPC on the basis of which ISPM No. 11 was published
had not been ratified by the European Communities on the date of establishment of this Panel. We note in this
regard that we are neither applying ISPM No. 11 as su ch nor treating it as dispositive of the meaning of terms
used in Annex A(1) of the SPS Agreement. However, we think we may refer to it if we find that it is
informative and aids us in establishing the meaning and scope of the terms used in Annex A(1).
407 Ibid, Annex 3, p. 37.

plant of a gene presenting a risk for the life or health of other plants or for animals. However, for the
purposes of the present dispute, we need not ta ke a position on whether a GM plant which cross-
breeds with other plants could be viewed as a "p est" within the meaning of Annex A(1). We are
satisfied that even if a GM plant which cross-bree ds with other plants were not itself viewed as a
"pest", the cross-breeds could be regarded as "pests" for the purposes of Annex A(1), to the extent
they have undesired introduced traits (such as herbicide or insect resistance) and harm animal, plant or
human life or health or result in other damage. Fo r instance, the herbicide resistant trait might be
conferred to a cross-breed plant, which could give it a selective advantage when the relevant herbicide
is used. In other words, the cross-breed could beco me persistent or invasive and thus pose a risk to
the life or health of wild flora or fauna.
7.256 Another concern arising from cross-breeds that ha ve acquired herbicide resistance is that they
may lead to the need for an incr eased use of the same herbicides, or for the use of more toxic
herbicides, to control the resistant weeds.
408 We recall that the United States points out that
section 2.3.1.2 of ISPM No. 11 mentions as an indi rect effect of a "pest" "environmental and other
undesired effects of control measures". 409 The United States appears to argue on this basis that if a
cross-breed plant has acquired herbicide resistance a nd this necessitates the use of more or different
herbicides, any undesired effect of this pesticide use on non-target flora and fauna would qualify as an
indirect and undesired effect of the herbicide r esistant GMO or cross-breed on non-target flora and
fauna. On the other hand, the European Communities argues that potential risks to animal or plant life
or health would be the result, not of the spread of resistant cross-breeds, but of steps taken to prevent
the spread of resistant crossbreeds, i.e., of the change in the use of pesticides. We accept that any
injury to animals or plants would be a direct resu lt of the pesticide use. Nonetheless, any injury to
animals or plants would be an indirect result of th e entry, establishment or spread of resistant cross-
breeds. The harmful pesticide use would not be necessary if the herbicide resistance trait had not
been conferred on these cross-breeds by the GM plant. We therefore consider that risks to animal or
plant life or health resulting from a change in pes ticide use may be viewed as arising indirectly from
the entry, establishment or spread of cross-breeds qua relevant pest. We note that this view is also

408 Dr. Andow, for example, has indi cated that "[t]here is abundant evidence that repeated use of a
given biotech herbicide tolerant crop would likely result in the evolution of resistance in weeds to the herbicide.
[...] Adverse effects on non-target flora and fauna could arise directly from transgene products, directly from the
herbicide compounds, or indirectly through the effects of the transgen ic crop or the herbicide on the
environment. [...] Gene flow from a GMHT crop to a weedy relative can create weeds that are more difficult to
control with herbicides." (excerpts from Annex H, paras. 170-172.) Dr. Snow has indicated that "[f]requencies
of specific crop genes in free-living plant populations depend on their rates of introduction and also their effects
on plant fitness (i.e, relative survival and reproduction). Unlike some types of nontransgenic herbicide
tolerance, the transgenes that confer tolerance to gl yphosate and glufosinate are not expected to have any
negative effects on crop yields or the fitness of crop relatives [...] In the absence of exposure to the herbicide in
question, herbicide-tolerant plants will not have any selective advantage over their non-transgenic counterparts.
But when the herbicide is used repeatedly, it will select very quickly for plants that are resistant to the herbicide.
The scientific literature in weed science is full of exam ples of rapid evolution and spread of herbicide resistant
weeds [...] In principal, the potential for the establishm ent and spread of herbicide-tolerant plants is similar for
nontransgenic vs. transgenic crops that have genes for th ese traits. [...] The more the herbicide is used, the
stronger the selection pressure favoring herbicide-resistant weeds. [...] Another method for suppressing
populations of herbicide-resistant weeds is to use several types of herbicides in tank-mixes each year, before or
after a crop is grown, to kill off resistant plants. Management options become more challenging and more
complicated when the pest population has genes for several types of herbicide resistance. In some cases, it may
be necessary to revert to the use of herbicides that have greater toxicity and longer persistence in the
environment (e.g., 2,4-D)." (excerpts from Annex H, paras. 150-155)
409 International Standard for Phytosanitary Measure No. 11, Pest Risk Analysis for Quarantine Pests
Including Analysis of Environmental Risks, FAO, Rome, 2004 (adopted April 2004), Section 2.3.1.2.

consistent with the aforementioned section 2.3.1.2 of ISPM No. 11, which specifically states that
indirect pest effects include environmental and other undesired effects of pest control measures.
7.257 Having regard to Directives 90/220 and 2001/18, we recall, first of all, that they seek to avoid
adverse effects on the environment which might aris e from the deliberate release of GMOs. We also
note that Directive 2001/18 specifies that in order to allow competent authorities to draw conclusions
on the potential environmental impact from the re lease of GM plants, applicants should provide
information on the "potential for gene transfer to the same or other sexually compatible plant species
[… ] and any selective advantage or disadvantage conferred to those species"
410, and "possible
immediate and/or delayed environmental impact resu lting from direct and indirect interactions of the
GMHP with non-target organisms [...]." 411 In the light of this, we think Directives 90/220 and
2001/18 can be considered as measures applied to prot ect animal or plant life or health from risks
arising directly ( e.g., through changes in selective advantage) or indirectly ( e.g., through changes in
the use of pesticides) from the entry, establishment or spread of cross-breeds with undesired traits
(such as herbicide or insect resistance) resulting from transfer of genetic material from a GM plant.
7.258 We recognize that Directives 90/220 and 2001/18 are measures applied in respect of, and
primarily concerned with, GMOs rather than their cr oss-breeds. Nonetheless, we think the Directives
can be viewed as measures protecting from risks ar ising from cross-breeds of GM plants, given that
the relevant cross-breeds would be an effect of the deliberate release of GM plants into the
environment. As noted, Directives 90/220 and 2001/18 seek to avoid adverse effects of the release of
GMOs into the environment, including those resulti ng from gene transfer. Hence, there is a rational
relationship between controlling the release into th e environment of GM plants which might cross-
breed with other plants and the purpose of protecting animal or plant life or health from risks arising
from the entry, spread or establishment of cross-brea ds with undesired traits. Also, there is nothing in
the text of Annex A(1) to suggest that the prod uct subject to an SPS measure – in this case, a GM
plant to be released into the environment – need it self be the pest which gi ves rise to the risks from
which the measure seeks to protect.
development of pesticide-resistance in target and non-target organisms
7.259 We address next the situation where pesticide-producing ( e.g., insecticide-producing) GM
plants increase the potential for the development of pesticide-resistance in target and non-target
organisms, notably insect populations, and where this leads to negative environmental effects. As in
the gene flow situation, the issue is whether in th e situation where resistance develops in target and
non-target organisms, the GM plant could be considered a "pest" within the meaning of Annex A(1).
7.260 The Panel understands from the evidence provided by the Parties and from the expert advice
that resistance in insect popula tions to pesticides may develop due to frequent exposure to
pesticides.412 This is the case whether the insect is the target of a GM insecticide-producing plant or a

410 Annex II.D.2.3 of Directive 2001/18.
411 Annex II.D.2.5 of Directive 2001/18.
412 One of the experts advising the Panel, Dr. Andow, states that " [t]here is strong evidence that
resistance will develop in the field to any insecticide applied uniformly over wide areas for a long enough period
of time. This has been a scientific consensus since the 1980s", and further expressed the view that "[...]of all of
the potential environmental risks of transgenic Bt crops, it can be said that resistance in the target pests is a real,
tangible risk, while risks associated with gene flow and risks to non-target organisms are mostly only potential
risks" (Annex H, paras. 92 and 96, respectively). Another expert, Dr. Squire, states that "[t]he emergence of
resistance by pest insects to pesticides differs widely from context to context depending on factors such as the
exposure to and strength of the toxin, the movement of insect populations from areas where the pesticide is not
applied, and the genetics and mating system of the insect. Resistance to Bt crops has o ccurred and is influenced

non-target insect. We further understand that if high levels of resistance were to develop in insect
populations, it is possible that pesticides might be needed where none were applied before, or that
increased volumes of the same pesticides or more toxic chemical pesticides might be needed, to
control the resistant insects, which might potentially cause greater environmental damage. It is also
possible that the resistant insect population w ould gain a selective advantage with negative
consequences for other flora and fauna, or that the development of resistance in the insect population
could have deleterious effects on predators of the r esistant insects, including on other predator insects,
birds or mammals. The Panel further understands th at potential impacts of the development of insect
resistance include ecosystem effects. Ecosystem effects include negative effects on animal or plant
life or health.
7.261 The European Communities argues that the concerns in this situation are not with the GMO as
a pest, but with changes in the characteristics or the genetic make-up of the target organisms.
According to the European Communities, the potential risks to animal or plant life or health do not
arise from the "establishment" or "spread" of the targ et organisms, since the target organisms already
existed before the introduction of the GMO. Furthermore, the European Communities argues that it is
the use of the additional pesticides used to cont rol the target organism which may cause adverse
environmental effects, not the pest itself. Th e European Communities does not in this context
explicitly address the issue of development of resistance in non-target insect populations.
7.262 The United States argues that the language used in ISPM No. 11 regarding pests, such as
"indirectly affect plants […] by other processes such as competition" and "significant reduction,
displacement, or elimination of other plant species"
413 clearly includes all reasonably foreseeable
injuries that an organism might cause to plant life or health. Annex I of ISPM No. 11 explicitly
provides that the scope also extends to those injuri es caused by organisms that indirectly affect plant
species or health, through effects on other organisms in the ecosystem. The Un ited States appears to
argue on this basis that if an insect population deve lops resistance to a pesticide produced by a GM
plant, and this necessitates the use of more or di fferent pesticides, any undesired effect of this
pesticide use on non-target flora or fauna would qu alify as an indirect and undesired effect of the
plant-produced pesticide on non-target flora or fauna . Consequently, in the United States' view, the
"pest" would be the pesticide-producing GM plant.
7.263 For the purposes of the present dispute, it is not necessary for us to take a position on whether
a GM plant to which target or non-target organisms ( i.e., insect populations) develop resistance, with
the result that more or different pesticides need to be used to control the resistant organisms and that
other non-target organisms are negatively affected by the pesticide use, could be viewed as a "pest"
within the meaning of Annex A(1). Even if a GM plant to which insect populations develop
resistance were not viewed as a "pest", we think the resistant target or non-target organisms ( i.e., the
resistant insects) could be regarded as "pests" w ithin the meaning of Annex A(1), inasmuch as they
present a risk to animal, plant or human life or health or result in other damage. In fact, pesticide-
producing or pesticide-resistant GM plants are cu ltivated precisely because the target organisms are
considered "pests".

by the "dose" of toxin delivered to the pest and the ge netic nature of the pest, among other factors. [...] The
processes involved in Bt resistance and its management are generally appreciated by scientists, and mitigation
strategies that have a strong scientific basis have been considered." (Annex H, para. 105.)
413 International Standard for Phytosanitary Measure No. 11, Pest Risk Analysis for Quarantine Pests
Including Analysis of Environmental Risks , FAO, Rome, 2004 (adopted April 2004), Article 2.3.1.1 and
Annex 1, p.34.

7.264 Turning to Directives 90/220 and 2001/18, we again recall that the Directives seek to avoid
adverse effects on the environment which might aris e from the deliberate release of GMOs. We also
note that Directive 2001/18 specifies that in order to allow competent authorities to draw conclusions
on the potential environmental impact from the re lease of GM plants, applicants should provide
information on the "potential immediate and/or de layed environmental impact resulting from direct
and indirect interactions between the [GM plant ] and target organisms".
414 S i m i l a r l y ,
Directive 2001/18 specifies that in order to allow competent authorities to draw conclusions on the
potential environmental impact from the release of GM plants, applicants should provide information
on the "potential immediate and/or delayed environm ental impact resulting from direct and indirect
interactions between the [GM plant ] and non-target organisms. 415 In the light of this, we think
Directives 90/220 and 2001/18 can be considered as measures applied to protect animal or plant life
or health from risks arising, directly or indirectly, from the entry, establishment or spread of target or
non-target organisms which have deve loped, or might develop, resistance to a pesticide as a result of
interactions with GM plants producing that pesticide.
7.265 We have noted earlier that Directives 90/220 and 2001/18 are measures applied in respect of,
and primarily concerned with, GMOs. We have also pointed out, however, that Directives 90/220 and
2001/18 seek to avoid adverse effects of the release of GMOs into the environment, including those
resulting from the interactions between pesticide-pr oducing GM plants and target organisms. We
have explained that the kind of adverse effects on anim al or plant life or health which are at issue in
the situation we are considering would be indir ect effects of the GMO-induced development of
resistance in target and non-target organisms. Hence, there is a rational relationship between
controlling the release into the environment of pesticide-producing GM plants and the purpose of
protecting animal or plant life or health from risk s arising indirectly from the entry, spread or
establishment of resistant target or non-target organisms. 416 Also, as we have previously stated, there
is nothing in the text of Annex A(1) to suggest th at the product subject to an SPS measure – in this
case, a pesticide-producing GMO to be released into the environment – need itself be the pest which
gives rise to the risks from which the measure seeks to protect.
7.266 The European Communities argues th at potential risks to animal or plant life or health would
be the result, not of the spread of resistant target or ganisms, but of steps taken to prevent the spread of
resistant target organisms, i.e., of the change in the use of pesticides. We accept that injury to animals
or plants could be a direct result of the pesticide use. Nonetheless, as we ha ve said, any injury to
animals or plants would be an indirect result of the entry, establishment or spread of resistant insects.
Without the development of resistance in the ta rget (or non-target) organisms, the more harmful
pesticide use would not be necessary. We therefore consider that risks to animal or plant life or health
resulting from a change in pesticide use may be viewed as arising indirectly from the entry,
establishment or spread of resistant target (or non-target) organisms qua relevant pest. We note that
this view is also consistent with the afor ementioned section 2.3.1.2 of ISPM No. 11, which
specifically states that indirect pest effects include environmental and other undesired effects of pest
control measures.
7.267 The European Communities further argues that poten tial risks to animal or plant life or health
would in any event not arise from the "establishment" or "spread" of the target organisms, given that
the target organisms already existed, but from a cha nge in the characteristics, or the genetic make-up,

414 Annex II.D.2.4 of Directive 2001/18.
415 Ibid.
416 We note that in addressing the issue of resistance in target or non-target organisms all Parties have
been assuming that the resistant organisms would be controlled through the use of more or different pesticides
and that this could adversely affect wild flora and/or fauna.

of the target organisms. We are not persuaded by this argument. In our view, there could be a
legitimate concern that the target (or non-target) or ganisms would establish or spread. Indeed, were it
otherwise, there would be no need to proceed to any change in the control of the resistant insect
populations. Moreover, if, as the European Commun ities asserts, the resistant target (or non-target)
insects had characteristics or a genetic make-up different from previous generations of these insects, it
would seem that this might be the difference that would allow the resistant insect populations to
become established or spread.
effects on non-target organisms and biogeochemical cycles
7.268 Before leaving the issue of "pests", we need to address whether other potential adverse effects
than the ones we have already considered could also be viewed as effects of GMOs qua "pests" on
animal or plant life or health. We note in this respect that Directive 2001/18 specifies that adverse
effects of GMOs include "effects on the dynamics of populations of species in the receiving
environment and the genetic diversity of each of these"
417, which in turn include adverse effects of the
release of GMOs on non-target organisms. 418 Similarly, Directive 2001/18 specifies that in order to
allow competent authorities to draw conclusions on the potential environmental impact from the
release of GM plants, applicants should provide information on the "[p]ossible immediate and/or
delayed environmental impact resulting from direct and indirect interactions of [GM plants] with non-
target organisms (also taking into account organisms which interact with target organisms) [...]". 419
Furthermore, Directive 2001/18 refers to possible adverse "effects on biogeochemistry
(biogeochemical cycles), particularly carbon an d nitrogen recycling through changes in soil
decomposition of organic material" 420, and "[p]ossible immediate and/or delayed effects on
biogeochemical processes resulting from potential dir ect and indirect interactions of the GMO and
target and non-target organisms in the vicinity of GMO release(s)".421
7.269 Having regard to effects on non-target organisms, we consider that to the extent that GM
plants may result in changes in animal or plant populations (including in target organism populations),
this may increase or decrease the food available for particular non-target animal populations and thus
enhance, or detract from, the fitness and health of these animal populations, which in turn may have a
deleterious effect on the life or health of plants, e.g., by affecting their ability to reproduce, etc. These
effects would thus impact on the genetic divers ity of an ecosystem, including populations of
species.422 In our view, by causing harm to the life or health. 423 In our view, by causing harm to the
health of animals or other plants in this way, GM plants would act as "pests" within the meaning of

417 Annex II.C.2.1 of Directive 2001/18.
418 Annex IIIA.IV.B.12 of Directive 2001/18.
419 Annex II.D.2.5 of Directive 2001/18.
420 Annex II.C.2.1 of Directive 2001/18.
421 Annex II.D.2.8 of Directive 2001/18.
422 We recall the comment of one of the experts advisi ng the Panel, Dr. Andow, that "[...]of all of the
potential environmental risks of transgenic Bt crops, it can be said that resistance in the target pests is a real,
tangible risk, while risks associated with gene flow and risks to non-target organisms are mostly only potential
risks" (Annex H, para. 96). Dr. Andow further indicated that "[to] my knowledge there are no reports of adverse
effects on soil micro- or macro-flora or fauna separate from those in the UK-FSE trials. Nor are there any
reports of adverse effects on soil dwe lling bacteria, algae, or protozoa. Ho wever, to my knowledge there have
not been any studies of any of these possible effects. Th e Panel should not infer that the absence of information
implies an absence of effect." (Annex H, para. 174)
423 Even if it were considered that adverse effect s on genetic diversity of ecosystems, including
populations of species, would not be damage to the life or health of these populations and hence would fall
outside the scope of Annex A(1)(a), these effects could in our view be considered to constitute "other damage"
within the territory of a Member and hence would fall within the scope of Annex A(1)(d).

Annex A(1).
424 We note that in relation to potential adver se impacts on plant life or health, this view
is consistent with Annex 3 of I SPM No. 11. Annex 3 states that LMOs may be considered as "pests"
if they are associated with adverse effects on non-target organisms, including "effects on other
organisms, such as biological control agents, bene ficial organisms, or soil fauna and microflora,
nitrogen-fixing bacteria, that result in a phytosanitary impact (indirect effects)". In the light of these
elements, we think Directives 90/220 and 2001/18 can be considered as measures applied to protect
the life or health of non-target organisms, whether animals or plants, from risks arising from the entry,
establishment or spread of GM plants qua "pests".
7.270 Regarding effects on biogeochemistry, it is useful to distinguish between direct and indirect
potential effects of GMOs. To the extent that GMOs might affect th e life or health of non-target soil
microfauna or –flora, Directives 90/220 and 2001/ 18 could, as we have indicated earlier, be
considered as measures applied to protect the life or health of soil microfauna or –flora from risks
arising from the entry, establishment or spread of GM plants qua "pests".425 To the extent that GMOs
might adversely affect soil microfauna or –flora, or nitrogen-fixing bacteria, and this would have an
adverse effect on the life or health of other plan ts or animals, we think Directives 90/220 and 2001/18
could be considered as measures applied to protect th e life or health of animals or plants from risks
arising indirectly from the entry, establishment or spread of GM plants qua "pests".426
7.271 We note that Directive 2001/18 also specifies that in order to allow competent authorities to
draw conclusions on the potentia l environmental impact from the release of GM plants, applicants
should provide information on the "[p]ossible imme diate and/or delayed, direct and indirect
environmental impacts of the specific cultivation, management and harvesting techniques used for the
GMHP where these are different from those used for non-GMHPs". 427 The European Communities
has argued that the use of GM crops as opposed to conventional crops may have adverse effects on
the agro-ecological environment and on biodiversity. In this context, the European Communities has
referred to research on the effect, if any, that the management practices associated with genetically
modified herbicide tolerant crops might have on fa rmland wildlife, when compared with weed control
used with non-GM crops.
428
7.272 The concern referred to by the European Communi ties pertains to changes in weed control
practices – specifically, changes in herbicide use – that may be associated with the introduction of
herbicide tolerant GM crops. 429 In relation to this scenario, ther e is no doubt in our minds that the

424 International Standard for Phytosanitary Measure No. 11, Pest Risk Analysis for Quarantine Pests
Including Analysis of Environmental Risks, FAO, Rome, 2004 (adopted April 2004), Annex 3, p. 36.
425 We understand that such direct risks may arise, for example, through the exposure of soil
microfauna to Bt toxins in the roots of Bt-producing GM plants, or through the decomposition and absorption
into the soil of other transgenes.
426 We note that in relation to potential adverse impacts on plant life or health, this view is consistent
with Annex 3 of ISPM No. 11, which refers to effects on soil fauna and microflora, and nitrogen-fixing bacteria,
which might result in a phytosanitary impact. International Standard for Phytosanitary Measure No. 11, Pest
Risk Analysis for Quarantine Pests Incl uding Analysis of Environmental Risks , FAO, Rome, 2004 (adopted
April 2004), Annex 3, p. 36.
427 Paragraph 9 of Annex II.D.2. of Directive 2001/18.
428 UK Department for Environment Food and Rural Affairs, "GM crops: Effects on farmland
wildlife", October 2003 (Exhibit EC-38). These studies are referred to as the "Farm Scale Evaluation".
429 The European Communities addresses specifically changes in herbicide use, and has not provided
any information about other potential changes in weed control practices related to the introduction of GM crops
as compared to non-GM crops.

weeds against which the herbicide is used qualif y as "pests" within the meaning of Annex A(1).
430
The herbicide use, for its part, constitutes a pest control measure. In the scenario posited by the
European Communities, potential risks to the enviro nment, including to non-target organisms such as
farmland wildlife, would be the result of a change in weed control practices, i.e., the application of a
herbicide, the increased application of a herbicide, or the application of a different, more harmful
herbicide. Indirectly, however, any environm ental risks would be the result of the entry,
establishment or spread of the relevant weeds. Give n this, we consider that risks to the environment
resulting from the use of a herbicide, or of a differe nt herbicide, may be viewed as arising indirectly
from the entry, establishment or spread of weeds qua relevant pests. We note that this view is
consistent with the previously mentioned section 2. 3.1.2 of ISPM No. 11, which specifically states
that indirect pest effects include environmental and other undesired effects of pest control measures.
7.273 Regarding the link to GM plants, we note th at Directives 90/220 and 2001/18 seek to avoid
adverse effects of the release of GMOs into the environment, including those resulting from a change
in management practices in the wake of the introduc tion of herbicide tolerant GM plants. Based on
the evidence before us, we understand that herbicide to lerant GM plants are linked to the herbicide to
which they are tolerant. Indeed, the herbicide-to lerance trait of these GM plants is the reason why
these plants have been genetically modified in the first place. In other words, these GM plants have
been developed so that farmers can use the relevant herbicide to protect the plants against competition
from particular weeds. Moreover, the herbicide to which GM plants are tolerant has been developed
to help control and/or eradicate the re levant weeds. Thus, it is clear that, via the relevant herbicide,
the GM plants in question are also linked to the weeds, and hence the pests, to be controlled.
7.274 As the GM plants, the herbicide and the weeds are interlinked in the aforementioned ways, we
consider that there is a rational relationship betw een controlling the release into the environment of
herbicide tolerant GM plants and the purpose of protecting the environment from risks arising
indirectly from the entry, spread or establishment of weeds. Also, we recall our earlier statement that
there is nothing in the text of Annex A(1) to sugg est that the product subject to an SPS measure – in
this case, a herbicide tolerant GM plant to be rel eased into the environment – need itself be the pest
which gives rise, directly or indirectly, to the risks from which the measure seeks to protect.
7.275 In the light of the foregoing, to the extent that Directives 90/220 and 2001/18 seek to avoid
adverse effects on the environment which involve a dverse effects on the life or health of non-target
organisms (animals and plants) and which arise from the management techniques associated with
GMOs, we consider that the Directives can be viewed as measures applied to protect the life or health
of animals or plants from risks arising indirectly from the entry, establishment or spread of weeds qua
"pests".431
"diseases, disease carrying organisms or disease-causing organisms"
7.276 The European Communities notes that the World Organization for Animal Health (OIE)
defines a disease as: "the clinical and/or pathological manifestation of infection". 432 A GMO is not
infected or an infection, and is not, in itself, a disease, a disease-carrying organism, nor generally
considered a disease-causing organism.

430 We note that a particular herbicide may target a specific weed or a broad spectrum of weeds. For
simplicity, we hereafter refer to "weeds" in the plural.
431 We will consider this scenario further as part of our discussion of Annex A(1)(d) below.
432 International Animal Health Code, 2002.

7.277 The Panel observes that the common definition of the term "disease" as it appears in
Annex A(1)(a) is "a disorder of structure or func tion in an animal or plant of such a degree as to
produce or threaten to produce detectable illness or disorder".
433 The World Health Organization
(hereafter the "WHO") defines disease as "[a] pathological condition of the body that presents a group
of clinical signs, symptoms, and laboratory findings peculiar to it and setting the condition apart as an
abnormal entity differing from other norma l or pathological conditions (CMD 1997)". 434 Regarding
the term "disease-carrying organisms" and "disease- causing organisms" in Annex A(1)(a), we note
that the WHO defines a disease-carrying organism as a "vector" and a disease-causing organism as a
"pathogen".435
7.278 The European Communities contends that GMOs per se are neither infected nor infections,
nor diseases, nor disease-carrying or disease-causing organisms. We note that we do not need to
determine in the abstract whether GMOs are diseas es, disease-carrying organisms, etc. Rather, we
need to determine whether the adverse effects whic h might arise from the deliberate release of GMOs
into the environment and which Directives 90/ 220 and 2001/18 seek to avoid are covered by
Annex A(1). In this regard, we note that Direc tive 2001/18 specifies that potential adverse effects of
GMOs include disease to animals and plants, and altered susceptibility to pathogens facilitating the
dissemination of infectious diseases and/or creating new reservoirs or vectors.
436 Directives 90/220
and 2001/18 thus seek to prevent GM plants from introducing or spreading diseases, and from altering
the susceptibility of animals or plants to pathogens , which might facilitate the introduction or spread
of disease-causing organisms (that is, pathogens) or create new disease-carrying organisms (vectors).
In the light of this, we think that Directiv es 90/220 and 2001/18 can be considered as measures
applied to protect animal or plant life or health from risks arising from the entry, establishment or
spread of diseases, disease-carrying organisms ( e.g., vectors) and disease-causing organisms ( e.g,
pathogens).
antibiotic resistance marker genes
7.279 The European Communities observes that the risks of concern regarding antibiotic
resistance marker genes (hereafter "ARMG") are th at the ARMG could be transferred from the plant
to bacteria in the digestive tract of humans or an imals, and that this might negatively impact on the
use of antibiotics in clinical or veterinary medical treatments. The European Communities argues that
it is not the plant DNA, but a separate pathogen, that causes the disease; the plant DNA merely
contributes to the development of antibiotic resistan ce, and therefore such effects fall outside of the
scope of the SPS Agreement. Another concern, according to the European Communities, relates to the
risk that persistence of plant-derived DNA in so il residues could transfer antibiotic resistance to
microbial pathogens which would otherwise be treata ble by the antibiotic at issue if the pathogens
should infect and cause disease in humans or animals.
7.280 The United States argues that it is not necessary for plant DNA to be an organism for
measures taken to protect against any increased risk of antibiotic resistance to fall within the scope of
the SPS Agreement. Concerns relating to effects of plant DNA are essentially concerns about the
potential effects of the altered plant, which is an organism within the scope of Annex A(1)(a). The
text of this provision requires only that the measure be adopted to protect against the risks …arising
from the establishment or spread of diseases …or disease-causing organisms. The United States notes

433 The Shorter Oxford English Dictionary , L. Brown (ed.) (Oxford University Press, 2002), Vol. 1,
p. 698.
434 See http://www.who.int/docstore/peh/Vegetation_fires/Health_Guidelines_final_AnnC.pdf.
435 Ibid.
436 Annex II.C.2.1 of Directive 2001/18.

that for an animal infected with the pathogen that would ordinarily be treated with the antibiotic to
which the pathogen had become resistant, the transfer of the resistance gene would contribute to the
establishment and spread of disease--the disease caused by the now resistant pathogen—a risk that
clearly falls within Annex A(1)(a). If an altere d plant contributes to the spread of the disease, a
measure taken for the purposes of controlling such a plant is a measure taken to protect against the
‘risks arising from the spread of...disease-causing organisms." The fact that the altered plant is not the
sole cause of the disease does not change this conclusion.
7.281 The Panel considers that the concern raised by the European Communities relates to the
potential transfer to pathogens of ARMG present in certain GMOs. If pathogens were to become
resistant to certain antibiotics in this manner, this might lessen the effectiveness of medical treatments
involving these antibiotics and hence might pose a risk to the life or health of animals infected with
the resistant pathogen.
437
7.282 The European Communities argues that neith er the GM plant nor the ARMG can be
considered a disease-causing organism. We find it unnecessary to take a position on whether the GM
plant or the ARMG could be viewed as a disease-causing organism within the meaning of
Annex A(1). We are satisfied that even if the GM plant or the ARMG were not viewed as a "disease-
causing organisms" in and of themselves, the pathoge n which develops resistance to the antibiotic in
question could be regarded as a "disease-causing organism" for the purposes of Annex A(1).
7.283 Having regard to Directives 90/220 and 2001/18, we recall that the Directives seek to avoid
adverse effects on the environment which might aris e from the deliberate release of GMOs. We also
note that Directive 2001/18 specifies that potential adverse effects of GMOs include "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".
438 In the light of
this, we think that Directives 90/220 and 2001/18 can be considered as measures applied to protect
animal life or health from risks arising from th e entry, establishment or spread of disease-causing
organisms which have or might become resistant to antibiotics due to the transfer of ARMG from a
GM plant. Similarly, the Directives can, in our view, be considered as measures applied to protect
animal life or health from risks arising from the en try, establishment or spread of diseases due to the
reduced effectiveness of antibiotics u sed to treat the pathogens which have become resistant to these
antibiotics through gene transfer.
7.284 We recognize, as we have done earlier, th at Directives 90/220 and 2001/18 are measures
applied in respect of, and primarily concerned w ith, GMOs. We have also pointed out earlier,
however, that Directives 90/220 and 2001/18 seek to avoid adverse effects of the release of GMOs
into the environment, including those resulting from the transfer to pathogens of genes conferring
antibiotic resistance. The potential ri sks to animal life or health whic h are at issue in the situation we
are considering would be the direct or indirect result of pathogens which have or might become
resistant to antibiotics due to the transfer of gene tic material from a GM plant containing an ARMG.

437 We note, however, that according to the experts advising the Panel, the risk of transferral of the
antibiotic resistance marker gene is negligible. Dr. Nutti, for example, described the steps that would be
necessary for such a transfer to occur, and stated th at "[t]here have been numerous experiments aimed at
evaluating the possibility of transfer of plant DNA to microbes and mammalian cells. To date, there are no
reports that marker genes in plant DNA transfer to thes e cells." (Annex H, para. 1123) Dr. Andow stated that
"[t]o my knowledge, all reports have not found adverse effects on flora or fauna from antibiotic resistance genes
or gene products. Extensive studies on nptII did not find any adverse effects, and found that any undetected
adverse effects would likely be several orders of magnitude smaller than naturally occurring phenomena."
(Annex H, para. 175)
438 Annex II.C.2.1 of Directive 2001/18.

Hence, there is a rational relationship between c ontrolling the release into the environment of GM
plants containing an ARMG and the purpose of prot ecting animal life or health from risks arising
from the entry, spread or establishment of disease- causing organisms and diseases. Also, we recall
that there is nothing in the text of Annex A(1) to suggest that the product subject to an SPS measure –
in this case, a GM plant containing an ARMG to be released into the environment – need itself be the
disease-causing organism, or the disease, which giv es rise to the risks from which the measure seeks
to protect.
Preliminary conclusions concerning Annex A(1)(a)to the SPS Agreement
7.285 In light of the above considerations, we are of the view that, of the potential adverse effects of
GMOs identified in Annex II.C.2.1 of Directiv e 2001/18, the following fall within the scope of
Annex A(1)(a) of the SPS Agreement:
− disease to animals and plants including toxic, and where appropriate, allergenic effects
439;
− effects on the dynamics of populations of species in the receiving environment and the
genetic diversity of each of these;
− altered susceptibility to pathogens facilitating the dissemination of infectious diseases and/or
creating new reservoirs or vectors;
− 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;
− effects on biogeochemistry (biogeochemica l cycles), particularly carbon and nitrogen
recycling through changes in soil decomposition of organic material.

This does not exclude, however, that, depending on the circumstances, some of these potential
adverse effects may also fall within the scope of other sub-paragraphs of Annex A(1).

7.286 Similarly, with respect to the concerns identified in Annex D.2 of Directive 2001/18 with
respect to genetically modified higher plants (GMH P), we consider that the following fall within the
scope of Annex A(1)(a), while recognizing that, de pending on the circumstances, some may also fall
within the scope of other sub-paragraphs of Annex A(1):
− likelihood of the GMHP becoming more persistent than the recipient or parental plants in
agricultural habitats or more invasive in natural habitats;
− any selective advantage or disadvantage conferred to the GMHP;
− potential for gene transfer to the same or other sexually compatible plant species under
conditions of planting the GMHP and any selec tive advantage or disadvantage conferred to
those plant species;
− potential immediate and/or delayed environmenta l impact resulting from direct and indirect
interactions between the GMHP and target orga nisms, such as predators, parasitoids, and
pathogens (if applicable);
− possible immediate and/or delayed environmenta l 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), includi ng impact on population levels of competitors,
herbivores, symbionts (where applicable), parasites and pathogens;

439 We address potential allergenic effects below, in the context of our analysis of Annex A(1)(b) and in
footnote 495.

− possible immediate and/or delayed effects on biogeochemical processes resulting from
potential direct and indirect interactions of the GMO and target and non-target organisms in
the vicinity of the GMO release(s);
− possible immediate and/or delayed, direct and indirect environmental impacts of the specific
cultivation, management and harvesting tec hniques used for the GM HP where these are
different from those used for non-GMHPs.

Annex A(1)(b) to the SPS Agreement: Protection of human or animal life or health from risks
arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages
or feedstuffs
7.287 We now turn to analyse whether Directiv es 90/220 and 2001/18 fall within the scope of
Annex A(1)(b) of the SPS Agreement. As we have done above with re gard to Annex A(1)(a), we will
structure our analysis below according to certain terms and phrases used in Annex A(1)(b), including
"foods, beverages or feedstuffs", "additives", "cont aminants" and "toxins". The Parties have also
addressed concerns relating to potential effects of allergens on human and animal health in the context
of Annex A(1)(b), hence we will also consider these concerns below.
"foods, beverages or feedstuffs"
7.288 The European Communities notes that a food is something that is intentionally ingested by a
human for nutritional purposes; a beverage is someth ing that is drunk; and a feedstuff is something
that farmed animals are intentionally permitted to ingest for nutritional purposes. Annex A(1)(b) does
not encompass products that are not "foods, beverag es or feedstuffs". A GM seed to be used in
agriculture is not a "food, beverage or feedstuff". It is destined to be planted in the ground, not eaten
by humans or fed to animals. Therefore, accord ing to the European Communities, a GM sowing seed
cannot fall within Annex A(1)(b). Similarly, a crop or plant is not in itself necessarily a food. It may
be processed into something that becomes a food, but that does not make the crop or plant itself a
food. A GM crop or plant does not therefore necessar ily fall within sub-paragraph (b). However, the
European Communities notes that Annex A(1)(b) may cover the risk of a modified gene in food,
beverages or feedstuffs causing disease in humans or animals.
7.289 The European Communities further argues that a crop or plant is not necessarily a "feedstuff"
for animals – that depends on whether or not it is d estined for such use, and whether or not the crop
will first be processed. Finally, the impact of a GMO on wild flora and fauna does not fall within sub-
paragraph (b), because it does not relate to foods, beverages or feedstuffs. The GM crop is not a
"feedstuff" vis-à-vis the pest. The same is true in respect of non-target organisms, since the crop is
not a "feedstuff" vis-à-vis such organisms.
7.290 The Complaining Parties argue that "foods, beverages or feedstuffs" encompass genetically
modified plants intended for use in foods, incl uding processed foods. The gene or DNA which is
inserted into a GM plant can be considered to be an additive or a disease-causing organism. Proteins
which are expressed due to the changes generated during genetic modification can be considered to be
contaminants or toxins depending upon their food safety effects.
7.291 The Panel notes that the common definition of a "food" is a substance taken into the body to
maintain life and growth. 440 Thus, we consider that a substan ce which a human being or an animal
consumes for nutritional reasons may be classified as a "food". A "feedstuff" on the other hand is

440 The Shorter Oxford English Dictionary , L. Brown (ed.) (Oxford University Press, 2002), Vol. 1,
p. 1001.

defined as fodder
441, and "fodder" is defined as "food for cattle , horses, etc., and more specifically as
dried food, as hay, straw, etc., for stall-feeding".442
7.292 Applying these definitions in the context of this dispute, we consider that a GM crop grown
for the explicit purpose of providing food to animals, and in particular to farmed animals, would
qualify as a "feedstuff". A GM crop that has been grown for a different purpose, but is eaten by
animals, including wild fauna 443, can be considered to be a "food " for that animal. This would
include, for example, pollen of the GM crop which is consumed by insects and GM plants consumed
by non-target insects, deer, rabbits or other wild fauna. Contrary to the European Communities, we
think GM seeds used for sowing purposes could also be considered animal "food", for instance if
these seeds are spilled next to a field or on a farm and are subsequently eaten by birds, etc.
"additives"
7.293 The United States claims that certain types of gen es, such as the ARMG, fall within the
definition of an additive under the SPS Agreement. According to the United States, this is further
supported by the Codex definition of an additive, wh ich does not exclude genetic inserts or constructs
added to food crops.444 Thus, consistent with the Codex defi nition, the ARMG is a component of the
food from the biotech plant; is not normally consumed as a food by itself; is not normally used as a
typical ingredient of the food; and is intentiona lly added to the plant (and thus the food from the
plant), for a technological purpose in the manufacture of the food. Protection against any associated
human or animal health risks, such as either the development of antibiotic resistance or the
development of the disease the antibiotics would be used to treat, falls within Annex A(1)(b). For the
same reason, products that contain ARMG are also covered by the SPS Agreement.
7.294 Canada considers that an ARMG is a "substance" in the basic sense of that term, and nothing
in the Codex definition would exclude the possibility that an ARMG could be considered an additive.
7.295 The European Communities notes that the Codex provides a relevant definition for the
purposes of determining the meaning of "additive" in Annex A(1)(b). Codex defines an additive as a
substance which is added to "food", not a substance which is added to plants and which may find its
way into food. The European Communities argues that the GMO products relevant in this dispute are
not "additives" within the Codex definition. No r is a gene an additive – whether introduced by
recombinant DNA technology or by conventional breed ing. Genes are not substances, but rather
instructions for the creation of substances.
7.296 According to the European Communities, the de finition of "additive" proposed by the United
States would encompass any gene, whether introd uced by recombinant DNA technology or by
conventional breeding. Furthermore, the Europ ean Communities argues that the risks of concern
regarding ARMG fall outside of the scope of the SPS Agreement. In particular, ARMG or food
produced with GM plants which contain ARMG do not cause disease.

441 Ibid., p. 937.
442 Ibid., p. 997.
443 The Panel recalls its view that the SPS Agreement explicitly covers risks to wild fauna and
distinguishes neither among categories of animals (such as insects, birds, and mammals) nor between "target"
and "non-target" species.
444 Art. 2a, Codex Procedural Manual 14th edition (Reference A), p. 43.

7.297 The Panel notes that the New Shorter Oxford English Dictionary defines "additives" as "a
substance added to another so as to give it specific qualities".
445 Given that Annex A(1)(b) is
concerned with additives in foods, we also find informative that Codex defines a "food additive" as:
"Food additive means any substance not normally consumed as a food by itself and
not normally used as a typical ingredient of the food, whether or not it has nutritive
value, the intentional addition of which to food for a technological (including
organoleptic) purpose in the manufacture, processing, preparation, treatment,
packing, packaging, transport or holding of such food results, or may be reasonably
expected to result, (directly or indirectly) in it or its by-products becoming a
component of or otherwise affecting the ch aracteristics of such foods. The term does
not include 'contaminants' or substances adde d to food for maintaining or improving
nutritional qualities."
446
7.298 The Panel is not convinced by the European Communities' categorical assertion that genes
cannot be considered substances. A "substance" is defined as the "real physical matter of which a
person or thing consists". 447 It is our understanding that genes may be considered as "real physical
matter". We do not dispute that genes contain and encode instructions for the creation of various
substances. However, this does not exclude that genes may themselves constitute substances.
7.299 We note that the Codex definition of "food addi tives" refers to additions made "in the
manufacture" of the food in question or at subseque nt stages of food production. In the present
dispute, the Panel considers that "food" encompasses GM plants that are eaten as such or processed
into products that are eaten. We note that the c oncept of "manufacture" does not fit well with the first
situation where plants are grown for food purposes ( e.g., sweet maize for fresh consumption). As we
see it, the farmer cannot add substances to a plant for a technological purpose in the same way that a
manufacturer can add substances to a food product for a technological purpose ( e.g., colouring to
match the flavour of a yoghurt). If farmers wish to add a substance of the relevant type, we think they
effectively have to do so at the stage of developing and producing the seeds of the plant. Therefore,
we think that in the special case of "plant producti on", substances intentionally added at the stage of
seed development and production could be reasonabl y considered to be substances added in the
manufacture of the food plant, if the substances ar e present in the harvested plant as a component or
affect the characteristics of the harvested plant.
7.300 In any event, the Codex definition is not dis positive of the meaning of the term "additives" as
it appears in Annex A(1)(b). We are awar e that pursuant to Article 3(1) of the SPS Agreement
Members are to base their SPS measures on "international standards, guidelines and
recommendations", where they exist, and that in accordance with Annex A(3)(a) of the
SPS Agreement, Codex standards relating to food additives are relevant "international standards"
within the meaning of Annex A(3)(a). 448 However, unlike Article 3(1) and Annex A(3), Annex A(1)
makes no reference to "international standards, guidelines and recommendations". Had the drafters of

445 The Shorter Oxford English Dictionary , L. Brown (ed.) (Oxford University Press, 2002), Vol. 1,
p. 25.
446 Codex Procedural Manual 14 th edition (Reference A), p. 43. The same definition of an additive is
contained in Section 2(a), Codex General Standard for Food Additives (Codex Stan 192-1995) (Rev.6-2005).
447 Concise Oxford Dictionary, Judy Pearsall (ed.) (Oxford University Press, 1999), p. 1429.
448 It is useful to recall that the Appellate Body ha s established that for an SPS measure to be "based
on" an international standard the meas ure need not necessarily "conform to", or comply with, that standard.
Appellate Body Report, EC – Hormones , para. 163. Therefore, even if the meaning and scope of the term
"additives" as it appears in the SPS Agreement and in the Codex standard did not correspond exactly, it would
still be possible for Members to "base" their SPS measure on the Codex standard.

the SPS Agreement intended for terms like "additives" to have the meaning given to them by
definitions contained in relevant international sta ndards, etc., we think Anne x A(1) would have made
this clear.
449 Looking at the text of Annex A(1)(b), we note that it broadly, and simply, refers to
"additives" "in foods". The ordinary meaning of the term "additives" read in the context of
Annex A(1)(b) does not suggest that for an added s ubstance to qualify as an "additive" in a food, the
substance needs to have been added at a particular stage prior to the consumption of the food in
question.
7.301 In the light of the foregoing, the Panel is of the view that genes, intentionally added for a
technological purpose to GM plants that are eaten or being used as an input into processed foods, can
be considered "additives in foods" within the meaning of Annex A(1)(b). This should not be
construed to mean, however, that all genes of a plant that is eaten or being used as input into
processed foods could be classified as "additives".
7.302 We note that Directive 2001/18 specifies that potential adverse effects of GMOs include
"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".
450 The Parties disagree whether ARMG shoul d be considered as "additives" within the
meaning of Annex A(1)(b).
7.303 Based on the explanations given by the Parties, we understand that ARMG are genes used in
genetic engineering to detect whether cells into wh ich another foreign gene is inserted have actually
taken up that gene. 451 While the ARMG are needed only in the genetic engineering process, the
marker genes remain in the GM plant. We recogni ze that ARMG may not be the kinds of substances
that are normally considered to be "additives", e.g., they do not enhance the flavour, appearance or
preservation of a product. However, the ARMG is deliberately added in the production of a GM
product that is consumed as food, for a specific technological purpose ( e.g., to permit the tracing of
successful gene transfers), is a component of the GM plants which are processed into food products
and remains in the product that is finally consumed. In the light of this, we are of the view that in the
context of an approval procedure assessing the sa fety of specific food products ARMG may be
considered to constitute food "additives" within the meaning of Annex A(1)(b).
7.304 We note that the potential adverse effect re ferred to in Directive 2001/18 is primarily
associated with the transmission of antibiotic resi stance from the marker genes present in GM plants
to the digestive gut of animals or humans. The con cern is that this might result in humans or animals
developing antibiotic resistance.452 The development of antibiotic resi stance can be considered a risk
to human or animal life or health, in that it may compromise the effectiveness of medical or veterinary
treatments for diseases. Any potential increase in th e population of antibiotic resistant bacteria could
also facilitate the dissemination of infectious di seases, as antibiotic treatment would not be effective
in stopping the spread of such diseases. Another potential risk is that new reservoirs of diseases could

449 We find instructive in this regard the provisions of Article 1.1 of the TBT Agreement. Article 1.1
provides that " [g]eneral terms for standardizati on and procedures for assessment of conformity shall normally
have the meaning given to them by definitions adopted within the United Nations system and by international
standardizing bodies taking into account their context and in the light of the object and purpose of this
Agreement".
450 Annex II.C.2.1 of Directive 2001/18.
451 For example, we understand that scientists attach these ARMG to the gene which they are seeking to
introduce into plant cells. After these linked genes have b een inserted into plants, the plant cells are grown in a
substance which has been treated with the antibiotic. Only cells which contain the antibiotic resistance, and thus
the gene of interest, will survive.
452 See supra, para. 7.303.

be created in humans or animals where resistant bact eria have failed to be eliminated by antibiotic
treatments. In the light of this, Directives 90/ 220 and 2001/18 can, in our view, be considered as
measures applied to protect human or animal life or health from risks arising indirectly, namely via
the potential transfer to humans or animals of marker genes conferring resistance to antibiotics used in
human or veterinary medicine, from additives in foods or feedstuffs.
"contaminants"
7.305 The European Communities argues that concerns related to higher levels of toxins or
contaminants in food, beverages or feedstuffs as a result of incre ased use of herbicides due to the
introduction of herbicide-resistant crops may fall within Annex A(1)(b) of the SPS Agreement.
However, the European Communities argues that a foreign gene intentionally introduced into a plant
through genetic modification techniques is not a contaminant within the meaning of either
Annex A(1)(b) of the SPS Agreement or the Codex General Standard for Contaminants and Toxins in
Food (hereafter, Codex Standard 193). The Codex defines a contaminant as:
"any substance not intentionally added to food, which is present in such food as a
result of the production (including operations carried out in crop husbandry, animal
husbandry and veterinary medi cine), manufacture, processing preparation, treatment,
packing, packaging, transport or holding of such food or as a result of environmental
contamination."
453
7.306 The European Communities maintains that both the GMOs and the proteins produced by the
GMOs with which this case is concerned will be inte ntionally present in food. Thus they cannot fall
within the Codex definition of contaminant.
7.307 Finally, the European Communities argues that the phr ase in Codex Standard 193 "as a result
of the production … of such food" refers to the process of food production, not to the more
fundamental process of genetic engineering or desi gn. Similarly, the common and ordinary meaning
of the words "crop husbandry" refers to what happens on the farm, not what happens in the laboratory.
Furthermore, if the Codex definition of contamin ant covered any substance unintentionally present as
a result of the production of the plant, and included the modification created by gene transfers, or the
resulting protein, then most genes and proteins in conventional plants would be "contaminants".
7.308 Canada considers that the modification or reaction created by gene transfer, or the expressed
protein, could be considered a "contaminant" as that term is defined in C odex Standard 193. While
the insertion of the transgene is intentional, that insertion may have unintended effects, one of which
could be the creation or expression of an unintended substance. This uninten ded substance could be
considered a contaminant, rather than the transgene itself.
7.309 Furthermore, Canada argues that Codex Standard 193 sets out guidelines for the
establishment of the maximum level and guideline leve ls for contaminants in food or feed, a process
that requires an assessment of the "effects" of a contaminant on human and animal health. Codex
Standard 193 recognizes that there may be substa nces that fall within the Codex definition of
"contaminant" but are nonetheless excluded from the scope of the Codex Standard because they have
"no public health significance".
454 Accordingly, whether a substance falls within Codex Standard 193

453 Art. 1.2.3, Codex General Standard for Contaminants and Toxins in Food (Codex Stan 193-1995)
(Rev.1-1997) (emphasis added).
454 Ibid., p. 1, Art. 1.2.2. Moreover, Standard 193 provides on p. 3:

is closely tied to the risks to public health associat ed with that substance, or in other words, the
"effects" of the substance.
7.310 Canada notes that the Codex definition requires th at the substance must be "present in food as
a result of production". One of the examples of production cited is "operations carried out in crop
husbandry." Crop husbandry includes the development of seeds. Much of modern crop husbandry is
carried out both on the farm and in the laboratory, as an interactive, iterative process between scientist
and farmer. Regardless of where selective breedi ng activities take place, these activities are part of
crop husbandry. According to Canada, it therefore logically follows that an unintended substance
arising from the genetic modification or reaction by gene transfers is "present in food as a result of
production". This type of unintended substance could be considered a "contaminant" for the purposes
of Codex Standard 193.
7.311 Argentina argues that the gene transfers used in the development of agricultural
biotechnology products could generate effects similar to "contaminants".
7.312 The Panel notes that the common meaning of a cont aminant is "a substance which pollutes,
corrupts or infects".
455 We also note that the footnote to Annex A to the SPS Agreement states in
relevant part that "[f]or purposes of these defin itions […] 'contaminants' include pesticide and
veterinary drug residues and extraneous matter". Th ese definitions have in common the fact that they
refer to substances which are not intentionally added to food. This view is consistent with the above-
mentioned Codex definition of "con taminant", which refers to any substance not intentionally added
to food, and which is present in such food as a result of the production, processing, packaging, etc, or
as a result of environmental contamination.456
7.313 Based on the above elements, and noting that the term "contaminants" must be interpreted so
as to have a meaning that differs from the meani ng of the term "additive" which also refers to
substances, we consider that a critical element for determining whether a substance can be considered
to be a "contaminant" is that the presence of the su bstance which is said to "infect or pollute" be
unintentional. For this reason, we consider that ge nes intentionally added to GM plants that are eaten
or used as inputs into processed foods would not be "contaminants" in and of themselves.
Furthermore, we think that substances such as pr oteins which are produced by GM plants, and which
are intended, should not be considered to be "contaminants ". However, we agree with Canada that
proteins produced through the unintended expression of modified genes in agricultural crops may be
considered "contaminants" within the meaning of A nnex A(1)(b), if these proteins "infect or pollute"
the food product.
7.314 The European Communities argues, based on the Codex definition of the term "contaminant",
that a protein unintentionally expressed as a result of a genetic modification of a plant should not be
considered a "contaminant". Th e European Communities considers that for the unwanted substance

When there are indications that health hazards may be involved with consumption of foods
that are contaminated, it is necessary th at a risk assessment is made. When health concerns
can be substantiated, a risk management policy must be applied, based on a thorough
evaluation of the situation. Depending on the assessment of the problems and the possible
solutions, it may be necessary to establish maximum levels or other measures governing the
contamination of foods. In special cases, it ma y also have to be considered to give dietary
recommendations, when other measures are not sufficiently adequa te to exclude the
possibility of hazards to health. (emphasis added)
455 The New Shorter Oxford English Dictionary , L. Brown (ed.) (Oxford University Press, 2002),
Vol. 1, p. 499.
456 Codex Procedural Manual, 14th Edition, (Reference A), Rome, 2004, pg. 43.

to qualify as a "contaminant", it would need to be present as a result of the production of the food, and
not as a result of the genetic engineering, or the desi gn, of the plant which is used as an input into the
processed food. It is correct that the Codex defi nition of "contaminants" refers to substances which
are present in food as a result of the production (inc luding operations carried out in crop husbandry)
of the food in question. We recall, however, that we are concerned here with GM plants that are eaten
or used as inputs into processed foods. It seems to us that in circumstances where a substance would
be created or expressed unintentionally in the process of cultivation of GM plants, i.e., in the process
of the production of the plants, it can be reasonably sai d that the relevant subs tance is present in the
food "as a result of the production" of that food. In any event, the Codex definition is not dispositive
of the meaning of the term "contaminant" as it appears in Annex A(1)(b).
457 Annex A(1)(b) broadly,
and simply, refers to "contaminants" "in foods". It does not suggest that for a substance present in
food to qualify as a "contaminant", the substance needs to have been added at a particular stage prior
to the consumption of the food in question.
7.315 We note that Directive 2001/18 specifies that potential adverse effects of GMOs include
"disease to humans including allergenic or toxic effe cts" and "disease to animals [...] including toxic,
and where appropriate, allergenic, effects". 458 Furthermore, Directive 2001/18 specifies that in order
to allow competent authorities to draw conclusions on the potential environmental impact from the
release of GM plants, applicants should provide information on the "[p]ossible 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 fro m it, if it is intended to be used as animal
feed".459 The Parties have not addressed how contaminants in food or feedstuffs could give rise to
disease and hence health problems in humans or animals. To the extent that such risks exist, we think
that Directives 90/220 and 2001/18 could be consid ered as measures applied to protect human or
animal life or health from risks arising from cont aminants in foods or feedstuffs, namely from
proteins unintentionally produced in GM plants whic h are eaten or used in the production of food or
feedstuffs.
7.316 We note the European Communities' argument that the introduction of herbicide-resistant GM
crops might lead to a higher level of contaminan ts, specifically herbicide residues, in foods or
feedstuffs, inasmuch as the herbicide-resistance of GM crops might allow for and entail an increased
use of herbicides in the field. 460 We would agree that the term "contaminants" in Annex A(1)(b)
could encompass herbicide residues present in foods or feedstuffs, and that they may pose risks to
human or animal life or health. 461 It is not clear to us from reading Directives 90/220 and 2001/18
whether they are applied, inter alia, to avoid disease to humans or animals resulting from herbicide
residues in GM plants used as food or feedstuff. To the extent they could be so applied, however, we
would agree that the Directives can be seen as meas ures applied to protect human or animal life or
health from risks arising from pesticide residues, and hence contaminants, in GM plants used as or in
foods or feedstuffs.

457 We have addressed earlier, in the context of our di scussion of the term "additives", the fact that the
SPS Agreement in provisions other than Annex A(1) refers to "international standards".
458 Annex II.C.2.1 of Directive 2001/18.
459 Annex II.D.2.7 of Directive 2001/18.
460 We recall that one of the experts advising the Pa nel, Dr. Snow, noted that "[a]pplication rates of
glufosinate and glyphosate are expected to increase greatly if these herbicide-tolerant crops are adopted by
farmers". (Annex H, para. 1115)
461 The United States has pointed out, for instance, that pesticide residues in biotech crops might
conceivably have allergenic effects and thus present dietary risks.

"toxins"
7.317 The European Communities notes that a toxin can be de fined as "a poisonous substance
produced during the metabolism and growth of certa in micro-organisms and some higher plant and
animal species."
462 The European Communities considers that the unintentional production of a
poisonous substance during the me tabolism and growth of either GM or non-GM plants may be
considered as a toxin in the context of Annex A of the SPS Agreement. However, the toxic
characteristics of seeds or crops, or their effects on non-target organisms, do not fall within SPS
Annex A(1)(b) unless the GMO is a "food, beverage or feedstuff."
7.318 The European Communities maintains, furthermor e, that the potential toxins created as a
result of the intentionally introduced specific genetic modificati on would not be c overed by Annex A
of the SPS Agreement. For example, the toxic effect of an insecticidal crop on the target pest itself
cannot fall under Annex A(1)(b), since it is not possibl e to seek to kill target pests and at the same
time seek to protect the life and health of those very same pests.
7.319 The United States argues that one food safety-relate d concern regarding all new plant
varieties, developed through mode rn biotechnology or otherwise, is the unintentional production of a
toxin in the food. Toxins introduced into foods by way of biotech or conventional breeding are
encompassed by the term "toxins" in the context of Annex A(1)(b). There is nothing in the
SPS Agreement to indicate that "risks arising from … toxins … in foods, beverages or feedstuffs"
should not apply to risks arising from toxins that are in food as a result of breeding changes
introduced into the food plant.
7.320 Canada agrees that the genetic modification of a plant might unintentionally result in the
production of a toxin. The same is true of pro ducts from traditionally-bred plants. Canada argues
that, apart from potential effects on non-target organi sms, the "toxic characteristics of seeds or crops"
are only assessed if these products are used for human or animal consumption, not, for example, when
these products are for industrial purposes (e.g. the oil from oilseed rape used in lubrication or as crude
oil).
7.321 The Panel notes that common definitions of a "toxin" are "a poison produced by a micro-
organism or other organism and acting as an antigen in the body"
463 or "any poisonous antigenic
substance produced by or derived from micro-orga nisms, which causes disease when present at low
concentration in the body" 464. Codex Standard 193 defines two types of toxins in the context of
describing the general standard for contaminants an d toxins in foods. One is a mycotoxin defined as
"a toxicant that is produced as a toxic metabolite of certain microfungi that are not intentionally added
to food."465 The other is a microbial toxin defined as "toxicants that are produced by algae and that
may be accumulated in edible aquatic organisms such as shellfish." 466 FAO defines a toxin as "a
compound produced by one organism, which is deleteri ous to the growth and/or survival of another
organism of the same or different species".467 We note that these definitions do not suggest that toxins

462 See http://www.biology-online.org/dictionary.asp as of 15 June 2004.
463 Concise Oxford Dictionary , 10 th Edition, Judy Pearsall (ed.) (O xford University Press, 1999),
p. 1517.
464 The Shorter Oxford English Dictionary , L. Brown (ed.) (Oxford University Press, 2002), Vol. 2,
p. 3312.
465 Codex Standard 193 – 1995, General Standard for Contaminants and Toxins in Foods, (Rev.1-
1997), p. 1.
466 Ibid, p. 1.
467 FAO Glossary of Biotechnology for Food and Agriculture, A. Zaid, H.G. Hughes, E. Porceddu and
F. Nichols (eds.) (FAO, Rome, 2001), p. 285.

in foods are inherently substances which have been unintentionally added to foods.
468 T o b e s u r e ,
every effort is ordinarily made to avoid the presen ce of toxins in foods. Nonetheless, a toxin specific
to a particular pest is sometimes deliberately added to a food for the purpose of controlling or
eradicating that target pest.
7.322 The European Communities argues that the toxins produced by insecticidal GM plants to kill
the target insect are not "covered" by Annex A( 1)(b) since the production by the GM plant of the
toxins is intentional and since it is not possible to kill the target insect and at the same time seek to
protect the life and health of those very insects. In our view, the mere fact that the toxin is
intentionally produced in the GM plant would not necessarily remove any concerns relating to the
toxic effect on the target insect from the scope of Annex A(1)(b). For it could be argued, not
implausibly, that the insecticide-producing GM plan t constitutes a "toxin" in the food of the target
insect which poses a risk to the life and health of the target insect. However, the target insect in the
European Communities' example is assumed to be a recognized pest. Accordingly, the release of
insecticide-producing GM plants into the environment would nor mally be controlled, not to protect
the life or health of the target insect from risks aris ing from the release of the GM plant, but to protect
the life or health of non-target organisms, etc., from any risks arising from the release of the GM
plant.469 We note that in the present case, the Europ ean Communities does not argue that Directives
90/220 and 2001/18 are measures applied to protect target pests, such as in sects, from risks arising
from the release into the environment of pesticide-producing GM plants.
7.323 We agree with the Parties that a poisonous substance which is produced during the
metabolism or growth of a GM crop could qualify as a "toxin" within the meaning of Annex A(1)(b).
We also agree with the European Communities that for an SPS measure to be covered by
Annex A(1)(b), the toxin which gives rise to risks for human or animal life or health would have to be
present in "foods, beverages or feedstuffs". However, we recall that a GM plant which is grown in a
field may be eaten as food by wild fauna.470
7.324 We note that Directive 2001/18 specifies that potential adverse effects of GMOs include
"disease to humans including allergenic or toxic effe cts" and "disease to animals [...] including toxic,
and where appropriate, allergenic, effects". 471 Furthermore, Directive 2001/18 specifies that in order
to allow competent authorities to draw conclusions on the potential environmental impact from the
release of GM plants, applicants should provide information on the "[p]ossible 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 fro m it, if it is intended to be used as animal
feed".472 In the light of this, Directives 90/220 and 2001/18 can, in our view, be considered as
measures applied to protect the life or health of humans or animals (not including target organisms)
from risks arising from toxins produced in GM plants which are foods or feedstuffs.

468 We note that the Codex definition of "mycotoxins" refers to the unintentional presence in food of
the microfungi, not the unintentional presence of the toxins they may produce.
469 We refer in this context to our previous discussion of potential risks to animal or plant health arising
from the development of resistance in target insects to the insecticide produced by GM plants.
470 If a GM plant produces a poisonous substance which could adversely affect the health of non-target
organisms even if the non-target organisms do not eat the GM plant, or parts thereof, e.g., through exposure
other than through ingestion as food, we think the GM plant might qualify as a "pest" within the meaning of
Annex A(1)(a).
471 Annex II.C.2.1 of Directive 2001/18.
472 Annex II.D.2.7 of Directive 2001/18.

allergens
7.325 The European Communities notes that genetic modification may lead to the production of
novel proteins or to the increased production of known proteins which may induce an allergic
reaction. According to the European Communities, an allergen is defined as "pertaining to antigens
that induce an allergic response in an organism or any substance that can cause an allergy."
473
Allergenic responses are only provoked in certain individuals that exhi bit sensitivity to the allergen.
On the other hand, a toxin is "a poisonous subs tance produced during the metabolism and growth of
certain micro-organisms and some higher plant and animal species." 474 Hence, according to the
European Communities, a food allergen cannot be considered to be a toxin. The European
Communities argues that it is questionable to describ e allergies as diseases; th ey are better described
as medical conditions. In addition, the risk is not so much that the GMO will cause an allergy (which
would already be present in the subject), but that it would provoke the allergic reaction.
7.326 The European Communities further notes that pot ential allergenic effects arising from GM
plants may occur as a result of exposure other than through food. Consequently, the issue of
allergenicity is not confined to food safety. Rather, the potential presence of allergens in the
environment as a result of the release of GM plants may be considered a broader environmental issue,
not included in the scope of Annex A(1) of the SPS Agreement.
7.327 The United States argues that the concern that a biotech product might lead to an allergic
reaction on the part of consumers, e.g., concerns regarding allergic reactions based on consumption of
a biotech variety that incorporates a genetic trait th at can lead to such reactions, falls within the
definition of Annex A(1)(b). An allergen would ge nerally fall within the definition of a toxin. A
"toxin" is generally defined as "a poison." 475 A "poison" is in turn defined as "any substance which,
when introduced into or abso rbed by a living organism, destroys life or injures health ….".476 Food
allergens clearly fall within the description of a substance that "destroys life or injures health".
According to the United States, the allergenicity c oncern relating to the products at issue in this
dispute is that a protein produced in the plant could be allergenic. Or in other words, it is a substance
that "destroys life or injures health," or a "poi sonous substance," produced during the metabolism and
growth of a plant.
7.328 The United States maintains that one exception to this general rule is that when the allergen is
itself a pesticide residue, or is a component of a p esticide residue, it would fall within the definition
of a contaminant, pursuant to footnote 4 of Annex A(1). Any dietary risks that pesticide residues of
GM crops might present would be "risks arising from ... contaminants in foods," including the risk of
an allergic reaction from consuming the food.
7.329 The United States argues, in addition, that Annex A( 1)(b) is not restricted to dietary risks, but
includes any measure taken to protect human or an imal life or health from "risks arising from ...
toxins ... in foods ... or feedst uffs." Measures taken to protect against occupational exposures from
the Bt toxin in the GM plants would fall within this description.
7.330 Canada claims that in the context of biochemistry , a "toxin" is defined as "any of the various
poisonous substances produced by certain plant and animal cells, including bacterial toxins,

473 The European Communities notes that antigens are defined as substances that are recognized by the
immune system and induce an immune reaction.
474 See http://www.biology-online.org/dictionary.asp [last visited on 15 June 2004].
475 The Compact Oxford English Dictionary, Oxford University Press, 1971, 24th Printing, p. 2224.
476 Ibid., p. 3367.

phytotoxins and zootoxins."
477 "Toxic" means "relating to a harm ful effect by a poisonous substance
on the human body by physical contact, ingestion, or inhalation". 478 A "poison" can be defined as "a
substance that in relatively small doses has an action that either destroys life or impairs seriously the
functions of organs or tissues". 479 Hence, Canada argues that for the purposes of the SPS Agreement,
allergens in food and feedstuffs can be considered toxins because allergens, in some circumstances,
can destroy life or impair seriously the functions of organs or tissues for people with immunological
sensitivities to that allergen.
7.331 Argentina also argues that the risks arising from a food allergen are comparable to the risks
arising from "toxins" or "disease-causing organi sms". Allergens, toxins and disease-causing
organisms all pose risks to health, even if allergens may affect just a sub-set of the population, instead
of the population as a whole. Argentina agrees that 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 since Annex A(1)(b) does not specify or restrict the mode of exposure.
7.332 The Panel observes that the Complaining Parties address the concern regarding potential
allergic responses to GMOs in the context of An nex A(1)(b). It is our understanding from the
evidence provided by the Parties that allergic res ponses are primarily associated with the ingestion of
products consisting of or containing GMOs, rath er than through contact with the GM plant per se.
However, the European Communities has also argued th at an allergic reaction could potentially result
from exposure to an allergen produced by a GM plant other than through the ingestion of that plant as
or in a food. We will address this concern in the context of our discussion of Annex A(1)(c).
7.333 Turning to allergenicity as a food safety concern, we note that Annex A(1)(b) is silent on
whether risks arising from allergens produced in GM plants which are used as or in foods or
feedstuffs are covered. Food allergenicity concerns were certainly widely known by Members at the
time the SPS Agreement was drafted. While the absence of a re ference to allergens in Annex A(1)(b)
might conceivably reflect a deliber ate choice to exempt food allergen icity risks from the scope of the
SPS Agreement, equally, the absence of a reference to allergens could mean that allergens were
considered to be covered by the text of Annex A(1 )(b). The Complaining Parties in fact argue that
allergens could be subsumed within the category of "toxins" or "disease-causing organisms". Below,
we will examine whether allergens in foods or feedstuffs could be considered to fall within the
category of "toxins".
7.334 The term "allergen" is commonly defined as "a substance that causes an allergic reaction". 480
The term "allergic" is defined as "of, caused by, or relating to an allergy" 481, and the term "allergy" is
defined in turn as "a damaging immune response by the body to a substance to which it has become
hypersensitive"482. It may be inferred from these definitions that an "allergen" is a substance which
causes a damaging immune response by the body in humans or animals which have become
hypersensitive to that substance. This is consiste nt with the definition of "allergen" provided in the

477 McGraw-Hill Dictionary of Scientific and Technical Terms , 6 th ed. (New York : McGraw-Hill),
p. 2168. Canada notes that this definition of toxin applies only in the context of biochemistry. In other
contexts, "toxin" might be interpreted differently, e.g., mercury may be a considered a toxin although it is not
produced by a living organism.
478 Ibid, p. 2168.
479 Ibid, p. 1626.
480 The Concise Oxford Dictionary , 10th Edition, Judy Pearsall (ed.) (Oxford University Press, 1999),
p. 35.
481 Ibid.
482 Ibid.

FAO Glossary of Biotechnology for Food and Agricu lture, which describes an allergen as "an antigen
that provokes an immune response".
483
7.335 With specific reference to the products at i ssue in this dispute, we add that, in our
understanding, allergens would be proteins generated through the expression of genes. 484 Thus, the
concern about potential allergenicity of GMOs relat es to the effect of modified genes on protein
composition in GM plants and the subsequent expo sure of humans or animals to these proteins
through the consumption of food or feedstuffs produced using the GM plants.
7.336 As noted, the Complaining Parties argue that "a llergens" would generally meet the definition
of the term "toxins" as it is used in Annex A(1)(b). We have stated earlier that the term "toxin" in
Annex A(1)(b) can be understood to refer to a pois onous substance produced by a micro-organism or
other organism and acting as an antigen in the body. A "poison" is commonly defined as "a substance
that causes death or harm when introduced into or absorbed by a living organism" 485, or as "a
substance that through its chemical action is able to kill, injure, or impair an organism"486.
7.337 We have said that allergens may be understood as substances which act as antigens and cause
a damaging immune response by the body in humans or animals. From the information submitted to
us, we understand that such immune responses can be very damaging to health, and in some cases
may even be fatal, e.g., in the event of an anaphylactic shock. 487 In the light of this, it seems to us to
be correct to characterize food alle rgens as substances which can "cau se death or harm" to health, or
as substances which through their chemical action are able to "kill, injure or impair an organism".
Thus understood, the kind of food allergens which might be produced by GMOs can be appropriately
viewed as poisonous substances produced by an or ganism and acting as an antigen in the body.
Consequently, we think that for the specific pur poses of Annex A(1) the term "toxins" encompasses,
inter alia, food allergens which might be produced by GM Os. We observe in this connection that we
have seen no evidence establishing that the drafters of the SPS Agreement intended to exclude food
allergens from the scope of the SPS Agreement in general, and the term "toxins" in particular.
7.338 We have pointed out earlier that in the specific context of this dispute, allergens would be
proteins generated through the expression of genes in GM Os. It is useful to clarify, therefore, that we
do not purport to suggest that "toxins" within the meaning of Annex A(1)(b) necessarily need to be
proteins. Poisonous substances other than poisonous proteins may qualify as "toxins".
7.339 We have stated above that allergens are substances which cause a damaging immune response
by the body in humans or animals which have become hypersensitive to that substance. The fact that

483 FAO Glossary of Biotechnology for Food and Agriculture, A. Zaid, H.G. Hughes, E. Porceddu and
F. Nichols (eds.) (FAO, Rome, 2001),p. 8.
484 In the context of GM foods, one of the experts ad vising the Panel, Dr. Nutti, indicated that "in this
case [allergens] are a sub-categ ory [of toxins] because they are proteins . The allergens are always protein."
(Annex J, para. 1172) Dr. Nutti further noted that: "If you go to the Codex [Guideline for the Conduct of Food
Safety Assessment of Foods Derived from Recombinant-DNA Plants], when you go to the annex "Assessment
of possible allergenicity", you see all newly expressed proteins produced by GMOs. As far as GMOs are
concerned when you go to look for allergens you are looking for the proteins." (Annex J, para. 1188)
485 The Concise Oxford Dictionary , 10th Edition, Judy Pearsall (ed.) (Oxford University Press, 1999),
p. 1105.
486 Webster's New Encyclopedic Dictionary (Könemann, 1993), p. 777.
487 We note that the United States, with referen ce to H.A. Sampson, "Food allergy Part 1:
Immunopathogenesis and Clinical Diso rders", Journal of Allergy and C linical Immunology, Vol. 103:00. 717-
728, May 1999, has defined an aphylaxis as a sudden and severe reacti on characterized by a sudden drop in
blood pressure and breathing difficulties that may be fatal.

a food allergen does not present a risk to all human be ings or animals does not, in our view, mean that
it cannot qualify as a "toxin" in foods or feedstuff within the meaning of Annex A(1)(b). We see
nothing in Annex A(1) or in the ordinary meaning of the term "toxin" which indicates that for a
substance to qualify as a "toxin" in a food or in a feedstuff, the substance needs to be poisonous for
each and every human being or animal which is exposed to it through the consumption of the food or
feedstuff. Indeed, we find it difficult to believe th at the term "toxins" was intended to have such a
narrow meaning.
488 If that were the case, a measure applied by a Member to protect human health
from risks arising from substances present in food wh ich are poisonous for only a small fraction of its
population would not be subject to the disciplines of the SPS Agreement. Conversely, a measure
applied to protect from risks arising from subs tances present in food which are poisonous for the
entire population would be subject to the SPS Agreement. In our view, it would be incongruous if
Members were subject to stricter disciplines when it comes to controlling risks affecting the entire
population than they would be when they seek to control risks affecting only a small segment of their
population. Also, the measures taken in either case might have equivalent effects on trade.489
7.340 We note that Directive 2001/18 specifies that potential adverse effects of GMOs include
"disease to humans including allergenic or toxic effe cts" and "disease to animals [...] including toxic,
and where appropriate, allergenic, effects". 490 Furthermore, Directive 2001/18 specifies that in order
to allow competent authorities to draw conclusions on the potential environmental impact from the
release of GM plants, applicants should provide information on the "[p]ossible 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 fro m it, if it is intended to be used as animal
feed".491 In the light of this, to the extent that Directives 90/220 and 2001/18 seek to protect humans
and animals from allergenic effects of GM plants u sed as or in foods, the Di rectives can, in our view,
be considered as measures applied to protect human or animal life or health from risks arising from
toxins produced in GM plants which are foods or feedstuffs.
"disease-causing organisms"
7.341 Canada and Argentina argue that the kind of food allergens which might be produced by
GMOs could also be viewed as "disease-causing orga nisms" within the meaning of Annex A(1)(b).
Argentina also argues that the risk arising from th e mass consumption of products containing
ARMG, which may lead to the development of bacter ia resistant to antibiotics, falls within the
definition given in Annex A(1)(b). According to Argentina, therefore, a measure based on such
concerns is a measure aimed at protecting human and animal health from the risks arising from
diseases and disease-causing organisms in foods, beverages and feedstuffs.

488 It is useful to point out in this context that food safety regulations establishing maximum residue
levels for pesticides or veterinary drugs, or regarding the approval of the use of certain food additives, are
frequently established to ensure the protection of the health of those segments of the population considered to be
most vulnerable to the potential health risk, for example, infants, pregnant women or the elderly. The Codex
Standard for Food Additives, for example, provides that: "Where the food additive is to be used in foods eaten
by special groups of consumers, account shall be taken of the probable daily intake of the food additive by
consumers in those groups." (Codex Stan 192-1995, Rev.5-2004.) Furthermore, specific standards have been
developed with respect to special groups of consumers, such as the Codex Standard for Processed Cereal-based
Foods for Infants and Children, Codex Stan. 74-1981 (amended 1985, 1987, 1989, 1991), FAO, Rome.
489 Regarding effects on trade, we note that our view that protection of vulnerable sub-populations from
food allergens falls within the scope of the SPS Agreement does not imply that products containing such
allergens should be prohibited. Adequate protection might be achieved through a requirement that food
products containing known allergens be labelled so that the susceptible population is informed of their content.
490 Annex II.C.2.1 of Directive 2001/18.
491 Annex II.D.2.7 of Directive 2001/18.

7.342 The Panel recalls that it has already found that the f ood allergens at issue in this dispute can
be considered as "toxins" within the meaning of A nnex A(1)(b), and therefore it is not necessary to
address whether they could, in addition, be cons idered as "disease-causing organisms" within the
meaning of Annex A(1)(b). Similarly, we have al ready found that ARMG could, in the case at hand,
be considered to be "additives" within the meani ng of Annex A(1)(b). Therefore, we do not find it
necessary to address whether they could also be considered as "disease-causing organisms".
Preliminary conclusions concerning Annex A(1)(b)to the SPS Agreement
7.343 In light of the above considerations, we are of the view that, of the potential adverse effects of
GMOs identified in Annex II of Directive 2001/ 18, the following fall within the scope of
Annex A(1)(b) of the SPS Agreement:
− "disease to humans including allergenic or toxic effects"
− "altered susceptibility to pathogens facilitating the dissemination of infectious diseases and/or
creating new reservoirs or vectors"
− "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".

This does not exclude, however, that, depending on the circumstances, some of these potential
adverse effects may also fall within the scope of other sub-paragraphs of Annex A(1).

7.344 Similarly, with respect to the concerns identified in Annex D.2 of Directive 2001/18 with
respect to genetically modified higher plants (GMHP) , we consider that the following falls within the
scope of Annex A(1)(a), while recognizing that , depending on the circumstances, it may also fall
within the scope of other sub-paragraphs of Annex A(1):
− 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.

Annex A(1)(c) to the SPS Agreement: protection of human life or health from risks arising
from diseases carried by animals, plants or pr oducts thereof, or from the entry, establishment
or spread or pests
7.345 We now turn to analyse whether Directiv es 90/220 and 2001/18 fall within the scope of
Annex A(1)(c) of the SPS Agreement. The Parties have addressed A nnex A(1)(c) in connection with
the issue of the potential allergenicity of GMOs and GMO-induced increased use of pesticides, hence
we analyse these issues under corresponding headings.
allergenic effects of GMOs unrelated to consumption as food
7.346 We first turn to analyse the issue of the poten tial allergenic effects of GMOs which are not
used as or in foods.
7.347 The European Communities notes that potential allergenic effects arising from GM plants
may occur as a result of exposure other than through f ood. Consequently, the issue of allergenicity is
not confined to food safety. Rather, the potential presence of allergens in the environment as a result
of the release of GM plants may be considered a broader environmental issue, not included in the
scope of Annex A(1) of the SPS Agreement.

7.348 The United States argues that measures taken to address risks from occupational or
residential exposure to biotech plants, such as possi ble allergic reactions in farmers applying Bt
microbial pesticides, would generally fall within paragraph 1(c), as measures "to protect human life or
health [...] from risks arising from [...] the establishment or spread of pests."
7.349 The Panel recalls that it has addressed the issue of the risks arsing from the potential of
GMOs to produce food allergens above in the context of its analysis under Annex A(1)(b). What is at
issue here is the potential of GMOs to produce alle rgenic effects in persons working, or otherwise
coming into contact, with GMOs.
7.350 We consider that if interaction with, and exposure to, GMOs other than as or in a food
produced allergenic effects in persons, the GMOs in question could be viewed as "pests" within the
meaning of Annex A(1). We recall our view that th e term "pests" in Annex A(1) encompasses plants
which are destructive, or which cause harm to the hea lth of other animals, plants or humans. We also
recall our view that allergens may be understood as substances which cause a damaging immune
response by the body in humans, and that such immune responses can be very damaging to health, and
in some cases may even be fatal, e.g., in the event of an an aphylactic shock. In the light of this, we
consider that to the extent a GM plant produces alle rgenic effects other than as a food, it would be a
plant which causes harm to the health of humans and, as such, would qualify as a "pest". We
recognize that a GM crop producing this type of allergenic effects would often be cultivated
intentionally. From the perspective of the farm er cultivating the GM crop, the GM crop would not,
therefore, constitute a "pest". However, from the pe rspective of the farm worker who is in contact
with the crop in the field, or a person walking p ast the field, the GM crop may constitute a "pest" if
the person is hypersensitive to the allergen.
492
7.351 The European Communities has argued that a p est must be a living organism. We have
previously noted that the term "pest" in Annex A( 1) encompasses plants which are destructive, or
which cause harm to the health of other animals, pl ants or humans. While it may be true that many
organisms will lose their ability to act as pests if th ey are no longer alive, we are not persuaded that
this is necessarily always the case. In particular, we are not convinced that all plants which are pests
as living organisms cease to be destructive or harmful to health immediately after being harvested. As
a result, we do not believe that GM plants which ha ve been harvested could not be considered to be
"pests" if they cause harm to the health of hum ans who may be handling them during harvesting,
transport or processing.
7.352 We note that Directive 2001/18 specifies that potential adverse effects of GMOs include
"disease to humans including allergenic or toxic effects". 493 Furthermore, Directive 2001/18 specifies
that in order to allow competent authorities to draw conclusions on the potential environmental impact
from the release of GM plants, applicants should provide information on the "[p]ossible immediate
and/or delayed effects on human health resulting from potential direct and indirect interactions of the
[GM plant] and persons working with, coming into cont act with or in the vicinity of the [GM plant]
release(s)".494 We think that by controlling the release of GMOs into the environment to avoid effects
of this kind, Directives 90/220 and 2001/18 serve to avoid the entry, spread or establishment of
allergenic GMOs. In the light of this, we c onsider that Directives 90/220 and 2001/18 can be

492 In our view, the ordinary meaning of the term "pest" as it is used in the context of Annex A(1)(c)
does not suggest that for a plant to qua lify as a "pest", it necessa rily needs to cause harm to the health of each
and every person coming in contact with it. This view is consistent with our interpretation of the term "toxin" in
Annex A(1)(b).
493 Annex II.C.2.1 of Directive 2001/18.
494 Annex II.D.2.6 of Directive 2001/18.

appropriately viewed as measures applied to protect human life or health from risks arising from the
entry, establishment or spread of GM plants qua "pests".
495
possible health effects from increased herbicide use associated with GMOs
7.353 The European Communities argues that negative effects of the use of herbicides on human
health do not fall within Annex A(1)(c) because the herbicide is not a "disease carried by animals,
plants or products thereof" and because the risk ar ises even if the GM plant is not a pest. Negative
effects on human health from the consumption of pesticide residues might, however, fall within the
scope of Annex A(1)(b).
7.354 The Panel understands the European Communities to argue that the introduction of herbicide-
resistant GM plants might entail use of herbicides in the field when no herbicides were previously
used, increased use of herbicides or use of different herbicides, and that this might in turn cause harm
to human health. We further understand the EC argume nt to be that the relevant harm would not be
the result of herbicide residues in the GM plant, but of exposure to the herbicide other than through
the consumption of the GM plant. 496 Thus, according to the Europ ean Communities, a change in
weed control practices – specifically, changes in he rbicide use – which may be associated with the
introduction of herbicide tolerant GM crops might have adverse effects on human health, e.g., for
workers applying them in the field.
7.355 As an initial matter, we note that the Eur opean Communities has not explained why such
potential health effects might arise. As noted by us earlier, it is our understanding that before a plant
protection product can be used on any crop cultivated within the European Communities, the use of
the product on the relevant crop is subjected to an assessment for safety. Therefore, it would seem
that if herbicides used in conjunction with herbicid e tolerant GM crops have been approved for use,
and if they are applied in accordance with any co nditions that may have been attached to their
approval, such application should not normally be harmful to human health. Having said this, it may
be that the European Communities' concern about po ssible negative health effects relates to improper
use, or unanticipated effects, of approved herb icides. We therefore proceed with our analysis,
assuming that there may be situations where the us e of approved herbicides could cause harm to the
health of persons applying the herbicide in the field or otherwise coming into contact with it.
7.356 We note that the scenario posited by the Eur opean Communities – that a change in weed
control practices associated with the introduction of herbicide tolerant GM crops might have adverse
effects on human health – is very similar to anothe r scenario we have already considered, namely the
scenario in which a change in we ed control practices associated w ith the introduction of herbicide
tolerant GM crops might have adverse effects on the environment. Accordingly, our analysis parallels
that of the latter scenario.

495 We recall that Directive 2001/1 8 also specifies that potential adverse effects of GMOs include
"disease to animals including allergenic or toxic effects". It would appear, therefore, that Directives 90/220 and
2001/18 could also be applied to prevent GMOs from producing allergenic effects resulting from exposure of
animals to GMOs other than as or in a food. For completeness, we note that in this situation the GMOs could be
viewed as "pests" in relation to susceptible animals. Accordingly, we think that if applied to prevent such
effects, Directives 90/220 and 2001/18 may be appropriat ely viewed as measures app lied to protect animal life
or health from risks arising from the entr y, establishment or spread of GM plants qua "pests". As such, they
would be covered by Annex A(1)(a).
496 We recall that in the context of our analysis under Annex A(1)(b) we have addressed a similar
argument relating to the possibility of the increased use of herbicides leading to a higher level of contaminants,
specifically herbicide residues, in GM plants used as or in foods or feedstuffs.

7.357 Thus, also in relation to the scenario involving adverse effects on human health, it is clear to
us that the weeds against which a particular herbicid e is used qualify as "pests" within the meaning of
Annex A(1), and that the herbicide use constitutes a p est control measure. We likewise consider that
risks to human health resulting from the use of a herb icide, or of a different herbicide, may be viewed
as arising indirectly from the entry, establishment or spread of weeds qua relevant pests.
7.358 Regarding the link to GM plants, we note th at Directives 90/220 and 2001/18 seek to avoid
adverse effects of the release of GMOs into the environment, including indirect effects on human
health, such as effects occurring through a change in management practices in the wake of the
introduction of herbicide tolerant GM plants.
497 As we have observed earlier, herbicide tolerant GM
plants are linked to the herbicide to which they ar e tolerant. Moreover, the herbicide to which GM
plants are tolerant has been developed to help contro l and/or eradicate the relevant weeds. Thus, it is
clear that, via the relevant herbicide, the GM plants in question are also linked to the weeds, and
hence the pests, to be controlled.
7.359 The GM plants, the herbicide and the weeds being interlinked in this way, we consider that
there is a rational relationship be tween controlling the release into the environment of herbicide
tolerant GM plants and the purpose of protecting hu man health from risks arising indirectly from the
entry, spread or establishment of weeds. We recall in this context that there is nothing in the text of
Annex A(1) to suggest that the product subject to an SPS measure – in this case, a herbicide tolerant
GM plant to be released into the environment – need itself be the pest which gives rise, directly or
indirectly, to the risks from which the measure seeks to protect.
7.360 In the light of the foregoing, to the extent that Directives 90/220 and 2001/18 seek to avoid
adverse effects on human health which arise from ch anges in management practices associated with
the introduction into the environment of GMOs, we consider that the Directives can be viewed as
measures applied to protect human life or health from risks arising indirectly from the entry,
establishment or spread of weeds qua "pests".498
Preliminary conclusions concerning Annex A(1)(c) to the SPS Agreement
7.361 In light of the above considerations, we are of the view that, of the potential adverse effects of
GMOs identified in Annex II of Directive 2001/ 18, the following falls within the scope of
Annex A(1)(c) of the SPS Agreement:
− "disease to humans including allergenic or toxic effects".

This does not exclude, however, that, depending on the circumstances, this potential adverse effect
may also fall within the scope of other sub-paragraphs of Annex A(1).

7.362 Similarly, with respect to the concerns identified in Annex D.2 of Directive 2001/18 with
respect to genetically modified higher plants (GMHP) , we consider that the following falls within the
scope of Annex A(1)(c):

497 See the introductory paragraph of Annex II of Directive 2001/18, which defines "indirect effects" as
"effects on human health or the environment occurring th rough a causal chain of ev ents, through mechanisms
such as interactions with other organisms, transfer of genetic material, or changes in use or management".
498 We made a similar point above in relation to the situation where target organisms, notably insects,
develop resistance to a pesticide. We said there that risks to animal or plant life or health resulting from a
change in pesticide use may be viewed as arising indirec tly from the entry, establishment or spread of resistant
target organisms.

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

Annex A(1)(d) to the SPS Agreement: Prevent or limit other damage within the territory of a
Member from the entry, establishment or spread of pests
7.363 We turn, finally, to analyse whether Direc tives 90/220 and 2001/18 fall within the scope of
Annex A(1)(d) of the SPS Agreement. In order for us to determine whether Directives 90/220 and
2001/18 fall within the scope of Annex A(1)(d), we n eed to consider in particular the meaning and
scope of the term "other damage" used in Annex A(1)(d) and address whether certain potential effects
of GMOs could be said to give rise to "other damage".
"other damage"
7.364 The United States maintains that the term "other damage" means damage other than damage
to animal or plant life or health, or to human life or health. This could include, for example, property
damage by pests. However, nothing in the SPS Agreement excludes other non-life or non-health
damage to plants, animals or humans caused by pests.
7.365 Canada observes that the ordinary meaning of the term "damage" is "harm done to a thing
[…]; esp. physical injury impairing value or usefulness." 499 The context of the term "damage"
suggests that "damage" means the injurious or harmful potential biological and economic
consequences that result from the occurrence of an event. The use of the term "other" suggests that
the type of damage contemplated in Annex A(1)(d) is distinct from the damage to animal or plant life
or health and human life or health arising from the en try, establishment and spread of pests that fall
within the scope of Annex A(1)(a ) and (c), respectively. Canada recalls its argument that the terms
"animal" and "plant" are defined broadly in the SPS Agreement.500 According to Canada, many of the
risks to biodiversity or the environment cited by the European Communities fa ll within the risks to
animal and plant life or health contemplated by Anne x A(1)(a). Canada does not consider that plants,
animals, or humans can be "damaged" unless there is damage to their "life or health"; it would be
inconsistent with the object and purpose of the SPS Agreement to extend the definition of damage to
plants, animals or humans to include so-called damage that is not based on injury or harm to their life
or health. In this particular context, reduced yield of a crop, as a result of competition from a pest
such as a weed, would be considered impairment to the health of the crop plant.
7.366 According to Canada, "other damage" is not limited to damage sustained by plants, animals or
humans but includes damage from the entry, establishmen t or spread of pests to the functioning of the
environment or the ecosystem taken as a whole, i ndependent of damage to the life or health of
specific plants or animals. This would include, for example, damage resulting from ecosystem
destabilization and from control, eradication or mana gement programs that would be needed if a pest
were introduced, and impacts of such programs ( e.g. pesticides…) on biological diversity. Other
examples include environmental and other undesired effects of control measures; the capacity of a
pest to act as a vector for other pests; signifi cant effects on designated environmentally sensitive or
protected areas; significant changes in ecological processes and the structure, stability or processes of
an ecosystem (including further effects on plant spec ies, erosion, water table changes, increased fire
hazard, nutrient cycling etc.); effects on human u se (water quality, recreational uses, tourism, animal

499 The New Shorter Oxford English Dictionary , L. Brown (ed.) (Clarendon Press, 1993), Vol. 1,
p. 588.
500 See paras. 7.205 and 7.215.

grazing, hunting, fishing); and costs of environmenta l restoration. Canada argues that this view is
supported by the relevant international standard for analysing the risks a ssociated with pests,
including LMOs.
501
7.367 Argentina maintains that the concept of "other da mage" in Annex A(1)(d) refers to the
prevention of situations not listed in paragraphs (a), (b) and (c) and related to pests. Examples of such
"other damage" include concerns related to the fi tness of plants, animals or humans. Argentina
considers that the broader ecological consequences of a GM plant that grows where it is not wanted also
constitute "other damage" caused by the "entry, establishment or spread of pests". Concerns regarding
cross-contamination of other organisms by biot ech products likewise fall under Annex A(1)(d).
Measures to prevent or minimize adverse effects related to excessive population increase of a GM plant
in the environment or to competitive advantage of the GMOs in relation to unmodified organisms also
fall within the scope of Annex A(1)(d) of the SPS Agreement. While in Argentina's view, the most
likely way in which biotech products could damage biodiversity or the ecological balance of an area is
by negatively affecting wild flora and/or fauna, Argentina considers that the scope of Annex A(1)(d) is
sufficiently broad to encompass any possible other damage to biodiversity or the ecological balance.
7.368 The European Communities considers that the term "other damage" covers damages arising
from the entry, establishment or spread of a pest othe r than damage to the "life or health" of humans,
animals and plants. The European Communities ma intains that it is commonly accepted that the
words "other damage" refer to economic damage. This includes, for example, a reduction in the value
of a crop whose quality is reduced because of damage by a pest that does not threaten the life or
health of the plant. However, the European Communities observes that "other damage" is expressly
linked only to the risks arising from the entry, establishment or spread of a "pest". Since the
European Communities argues that a GMO is not a pest unless it is growing in the wrong place and/or
at the wrong time, this provision cannot be used to bring all measures applied to protect against
damage to ecology or the environment arising fro m the introduction of a GMO under the scope of the
SPS Agreement. In particular, according to the Europ ean Communities the effects of GMOs on non-
living components in the environment, such as bi ogeochemistry, particularly carbon and nitrogen
recycling through changes in soil decomposition of organic material, are among the concerns
identified in the EC legislation which clearly fall outside the scope of the SPS Agreement.
502
7.369 The Panel considers that it may be inferred from the reference in Annex A(1)(d) to " other
damage" (emphasis added) that like Annex A(1)(d), sub-paragraphs (a) thro ugh (c) of Annex A(1)
refer to measures which are applied to protect from a certain kind of potential "damage". The
"damage" at issue in sub-paragra phs (a) through (c) of Annex A(1) is damage to plant, animal or
human life or health. It follows, therefore, th at the category of "other damage" covered by
Annex A(1)(d) must comprise damage other than dama ge to the life or health of plants, animals or
humans. This is indeed the view expressed by all of the Parties.
7.370 The residual category of "other damage" is potentially very broad. 503 In our view, "other
damage" could include damage to property, includi ng infrastructure (such as water intake systems,

501 International Standard for Phytosanitary Measure No. 11, Pest Risk Analysis for Quarantine Pests,
Including Analysis of Environmental Risks", FAO, Rome, 2004 (adopted April 2004), pp. 23-24.
502 The European Communities notes, for example, Section C2.1, sixth indent in Annex II, and
items II.A.11(f) and IV.B.15 in Annex IIIA, and D11 in Annex IIIB, of Directive 2001/18.
503 We note that the text of Annex A(1)(d) refers to "other damage within the territory", and not to
"other damage to humans, animals or plants". We therefore see no basis in the text of Annex A(1)(d) for
construing the term "other damage" so as to encompass only other damage to humans, animals or plants. It is
clear, however, that only damage from the entry, establishment or spread of "pests" can qualify as "other
damage" within the meaning of Annex A(1)(d).

electrical power lines, etc.). In addition, we think "other damage" could include economic damage
(such as damage in terms of sales lost by farmers) . The dictionary defines the term "damage" as
"physical harm impairing the value, usefulness, or normal function of something" and "unwelcome
and detrimental effects"
504, or "a loss or harm resulting from injury to person, property, or
reputation"505. These definitions cover harm resulting in a reduction of economic value, adverse
economic effects, or economic loss. Also, interpreting "other damage" to include economic damage is
consistent with the context of A nnex A(1)(d). Article 5.3 of the SPS Agreement states that relevant
"economic factors" to be taken into account in a risk assessment include "the potential damage in
terms of loss of production or sales in the event of the entry, establishment or spread of a pest or a
disease". Thus, Article 5.3 shows that the SPS Agreement elsewhere uses the term "damage" in an
economic sense, and it does so in connection w ith damage from "pests". Thus, Article 5.3
contemplates a similar situation to that contemplated in Annex A(1)(d).
7.371 We note that damage to plant, animal or human life or health may entail consequential
economic damage. Governmental measures protective of the life or health of plants and animals are
sometimes taken precisely to avoid such adverse ec onomic consequences. We therefore agree with
Canada that measures taken, e.g., to protect cultivated crops against weeds which might enter a field
and out-compete and crowd out the cultivated crops, thus reducing crop yield, might be appropriately
regarded as measures falling within the scope of A nnex A(1)(a) rather than as measures falling within
the scope of Annex A(1)(d). This view is consiste nt with the fact that Annex A(1)(d) omits reference
to "diseases". Obviously, the entry, esta blishment or spread of diseases may, inter alia , lead to
economic damage in the territory of a Member. 506 However, in the case of a disease, economic
damage would be the result of the damage the disease causes to plant, animal or human life or health.
The same is not necessarily true for a pest. We re call in this respect that the term "pest", as we
interpret it, refers, not just to an animal or plant wh ich is destructive of animals, plants or humans, or
which causes harm to the health of other animals, pl ants or humans, but also to an animal or plant
which causes other harm. It is therefore unde rstandable that Annex A(1)(d) specifically and
separately addresses measures applied to control damage other than damage to plant, animal or human
life or health.507
7.372 In addition to physical damage to property or economic damage, we consider that the concept
of "other damage" is also susceptible of encompassi ng damage to the environment other than damage
to the life or health of living organisms ( i.e., animals or plants). We note in this regard Argentina's
argument that the concept of "other damage" might encompass damage to "biodiversity". Dictionaries
define "biodiversity" as "the variety of plant and an imal life in the world or in a particular habitat" 508

504 The Concise Oxford Dictionary , 10th Edition, Judy Pearsall (ed.) (Oxford University Press, 1999),
p. 361.
505 Webster's New Encyclopedic Dictionary (Könemann, 1993), p. 252.
506 This is recognized in the aforementioned Article 5.3, which, to recall, re fers to "the potential
damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or a
disease".
507 We note in passing that there may be situations where a pest gives rise to damage to the life or
health of other animals or plants without this necessar ily being considered a reason for applying a measure to
protect the life or health of these other animals or plan ts. For instance, the affected other animals or plants
might themselves be pests. However, the pest in question may, in addition and at the same time, give rise to
economic damage which is different and separate from the damage it causes to the life or health of other animals
or plants. That economic damage may be considered a reason for applying a measure to limit the pest. Thus, as
this example shows, the mere fact that a pest gives rise, inter alia, to potential damage to the life or health of
other animals or plants does not mean that any measur e applied to combat that pest is automatically or
exclusively covered by Annex A(1)(a).
508 The Concise Oxford Dictionary, 10th edn., J. Pearsall (ed.) (Oxford University Press, 1999), p. 135.

or "biological diversity in an environment as indicated by number of different species of plants and
animals"
509. The Glossary of Biotechnology for food and agriculture defines "biodiversity" as "[t]he
variability among living organisms from all sources, including, inter alia, terrestrial, marine and other
ecosystems and the ecological complexes of which they are part; this includes diversity within
species, between species and of ecosystems". 510 We deduce from the aforementioned definitions that
damage to "biodiversity" implies damage to living organisms. Accordingly, we are not persuaded that
the term "other damage" in Annex A(1)(d) includes damage to "biodiversity" as such. However, as
we have noted earlier, a measure applied to pr event damage to "biodiversity" may qualify as a
measure applied to protect animal or plant life or health from the kind of risks referred to in
Annex A(1)(a) and (b).
7.373 Turning now to consider Directives 90/220 and 2001/18, we note that Directive 2001/18
specifies that potential adverse effects of GMOs in clude "effects on biogeochemistry (biogeochemical
cycles), particularly carbon and nitrogen recycling through changes in soil decomposition or organic
material".511 Furthermore, Directive 2001/18 specifies that in order to allow competent authorities to
draw conclusions on the potential e nvironmental impact from the release of GMO plants, applicants
should provide information on the "[p]ossible imme diate and/or delayed effects on biogeochemical
processes resulting from potential direct and indirect interactions of the GMO and target and non-
target organisms in the vicinity of the GMO release(s)". 512 We have already indicated that to the
extent GMOs might affect the life or health of soil microfauna or -flora, the concern would be that
GMOs might act as pests and, as such, give rise to ri sks to animal or plant life or health. In other
words, this would be a concern falling within the sc ope of Annex A(1)(a). Likewise, if GMOs were
to have effects on soil micro-organisms and this were to pose risks to the life or health of other
animals or plants, we think this would be a con cern that GMOs might act as pests which indirectly
give rise to risks to animal or plant life or health.
7.374 The European Communities argues that concerns regarding effects of GMOs on
biogeochemistry also include concerns about eff ects on non-living components in the environment,
such as the recycling of carbon and nitrogen th rough changes in soil decomposition of organic
material. In the European Communities' view, such concerns are outside the scope of the
SPS Agreement. We are not persuaded by this argument. To the extent that GMOs might cause
damage to (as opposed to mere changes in) geochemi cal cycles, such that there would be damage to
the environment other than damage to living organi sms, we think such environmental damage could
be considered as "other damage" from the entry, establishment or spread of GMOs qua "pests" within
the meaning of Annex A(1)(d). In the light of th is, to the extent that Directives 90/220 and 2001/18
seek to avoid adverse effects of GMOs on "non- living components" in the environment, including
those which are part of geochemical processes, the Directives can, in our view, be considered as
measures applied to prevent or limit "other damage" from the entry, establishment or spread of GMOs
qua "pests".
7.375 We note that Directive 2001/18 also specifies that potential adverse effects of GMOs include
"effects on the dynamics of populations of species in the receiving environment" 513, which include the
"potential for excessive population increase" and "competitive advantage of the GMOs" 514.

509 Webster's New Encyclopedic Dictionary (Könemann, 1993), p. 98.
510 FAO Glossary of Biotechnology for food and agriculture, A. Zaid, H.G. Hughes, E. Porceddu and F.
Nichols (eds.) Rome, 2001, p. 30.
511 Annex II.C.2.1 of Directive 2001/18.
512 Annex II.D.2.7 of Directive 2001/18.
513 Annex II.C.2.1 of Directive 2001/18.
514 Annex IIIA.iv.B.7 and 8 of Directive 2001/18.

Furthermore, Directive 2001/18 specifies that in order to allow competent authorities to draw
conclusions on the potential environmental impact from the release of GMO plants, applicants should
provide information on the "[l]ikelihood of the [G MO plant] becoming more persistent than the
recipient or parental plants in agricultural habita ts or more invasive in natural habitats"; "[a]ny
selective advantage or disadvantage conferred to the [G MO plant]"; "[p]otential for gene transfer to
the same or other sexually compatible plant species under conditions of planting the [GMO plant] and
any selective advantage or disadvantage conferred to those plant species"; "[p]otential immediate
and/or delayed environmen tal impact resulting from direct and indirect interactions between the
[GMO plant] and target organisms, such as predat ors, parasitoids, and pathogens (if applicable)";
"[p]ossible immediate and/or delayed environmen tal impact resulting from direct and indirect
interactions of the [GMO plant] with non-target organisms, (also taking into account organisms which
interact with target organisms), including impact on population levels of competitors, herbivores,
symbionts (where applicable), parasites and pathogens".
515
7.376 We have addressed these various adverse effects earlier. All of them relate to potential
effects of "pests". In these situations, the GMOs themselves or cross-breeds might act as pests, or
target organisms or non-target organisms might become pests, as a result of the release of GMOs into
the environment. The Parties have not addressed wh ether any of the aforementioned types of "pests"
could cause damage to the "non-living components" in the environment. We have no basis on which
to determine whether this would or would not be po ssible. Therefore, we simply note that to the
extent Directives 90/220 and 2001/18 seek to avoid adverse effects of GMOs on the environment
other than adverse effects on animal or plant life or health or on geochemical processes, the Directives
can, in our view, be considered as measures applied to prevent or limit "other damage" from the entry,
establishment or spread of "pests".
7.377 We note, furthermore, that Directive 2001/18 also specifies that in order to allow competent
authorities to draw conclusions on the potential envi ronmental impact from the release of GM plants,
applicants should provide information on the "[p]ossible immediate and/or delayed, direct and indirect
environmental impacts of the specific cultivation, management and harvesting techniques used for the
GMHP where these are different from those used for non-GMHPs". 516 The European Communities
has argued that the use of GM crops as opposed to conventional crops may have adverse effects on
the agro-ecological environment and on biodiversity. In this context, the European Communities has
referred to research on the effect, if any, that the management practices associated with genetically
modified herbicide tolerant crops might have on fa rmland wildlife, when compared with weed control
used with non-GM crops.
517
7.378 We have addressed the issue of the potentia l adverse effects on non-target organisms,
including farmland wildlife, arising from changes in weed control practices (including changes in
herbicide use) that may be associ ated with the introduction of GM crops in the context of our
discussion of Annex A(1)(a). We determined th at to the extent Directives 90/220 and 2001/18 are
applied to avoid such effects, they can be viewed as measures applied to protect the life or health of
animals or plants from risks arising indirectly from the entry, establishment or spread of weeds qua
"pests". To the extent that changes in weed cont rol practices might cause damage to the environment
other than damage to the life or health of non-ta rget organisms, we think such damage could be
considered as "other damage" resulting indirectly ( i.e., via such changes), from the entry,
establishment or spread of weeds qua "pests" within the meaning of Annex A(1)(d). In the light of

515 Annex II.D.2.1-5 of Directive 2001/18.
516 Paragraph 9 of Annex II.D.2. of Directive 2001/18.
517 UK Department for Environment Food and Rural Affairs, "GM crops: Effects on farmland
wildlife", October 2003. These studies are referred to as the "Farm Scale Evaluation".

this, to the extent that Directives 90/220 and 2 001/18 seek to avoid adverse effects arising from
management techniques associated with GMOs other than damage to the life or health of non-target
organisms, the Directives can, in our view, be considered as measures applied to prevent or limit
"other damage" resulting indirectly from the entry, establishment or spread of weeds qua "pests".
Preliminary conclusions concerning Annex A(1)(d) to the SPS Agreement
7.379 In light of these considerations, we are of the view that, of the potential adverse effects of
GMOs identified in Annex II of Directive 2001/ 18, the following fall within the scope of
Annex A(1)(d) of the SPS Agreement, e.g., to the extent they relate to the protection of "non-living
components" in the environment:
− effects on the dynamics of populations of species in the receiving environment;
− effects on biogeochemistry (biogeochemica l cycles), particularly carbon and nitrogen
recycling through changes in soil decomposition of organic material.

7.380 Similarly, with respect to the concerns identified in Annex D.2 of Directive 2001/18 with
respect to genetically modified higher plants (GMH P), we consider that the following fall within the
scope of Annex A(1)(d) of the SPS Agreement, e.g., to the extent they relate to the protection of "non-
living components" in the environment:
− likelihood of the GMHP becoming more persistent than the recipient or parental plants in
agricultural habitats or more invasive in natural habitats;
− any selective advantage or disadvantage conferred to the GMHP;
− potential for gene transfer to the same or other sexually compatible plant species under
conditions of planting the GMHP and any selec tive advantage or disadvantage conferred to
those plant species;
− potential immediate and/or delayed environmenta l impact resulting from direct and indirect
interactions between the GMHP and target orga nisms, such as predators, parasitoids, and
pathogens (if applicable);
− possible immediate and/or delayed environmenta l 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), includi ng impact on population levels of competitors,
herbivores, symbionts (where applicable), parasites and pathogens;
− possible immediate and/or delayed effects on biogeochemical processes resulting from
potential direct and indirect interactions of the GMO and target and non-target organisms in
the vicinity of the GMO release(s);
− possible immediate and/or delayed, direct and indirect environmental impacts of the specific
cultivation, management and harvesting tec hniques used for the GM HP where these are
different from those used for non-GMHPs.

Labelling to indicate presence of GMOs

7.381 Before concluding our examination of Direc tives 90/220 and 2001/18 under Annex A(1), it is
necessary to address the labelling requirements imposed by Directive 2001/18. The Parties did not
raise and discuss this issue as part of their ar guments on whether Directive 2001/18 falls within the
scope of Annex A(1). However, since the issue of labelling requirements is of some significance to
our examination below of whether Regulation 2 58/97 falls within the scope of Annex A(1),
consistency requires that we broach the issue as part of our examination of Directives 90/220 and
2001/18.

7.382 Directive 2001/18 provides that the applicant must submit a proposal for labelling. The
proposal must include the commercial name of the relevant product containing a GMO, the name of
the GMO, and a clear statement that a GMO is present, either on a label or in a document
accompanying the product. The competent member State authorities must examine applications for
compliance with the requirements of Directive 2001/18, including the labelling requirements. The
applicant must not place a GMO on the market unless it has received the written consent of the
competent authority and unless it has complied with any conditions required in the consent. The
written consent must specify the labelling requirement s. In all cases, the statement that a GMO is
present must appear on a label or in an accompanying document.
518
7.383 Furthermore, with regard to GMOs which ha ve been approved for placing on the market,
Directive 2001/18 requires member States to take all necessary measures to ensure that at all stages of
the placing on the market, the labelling of the releva nt GMOs comply with the requirements specified
in the written consent. 519 The Directive does not specify the measures which need to be taken by
member States in fulfilment of this requirement.
7.384 As we understand it, Directive 2001/18 requires labelling or documentation to indicate the
presence of a GMO in cases where the competent authorities have determined, based on available
scientific evidence, that the release of the relevant GMO into the environment is safe for both human
health and the environment. A requirement to i ndicate the presence of a GMO in such cases may not
at first glance appear to be a measure that would fall within the scope of the SPS Agreement.
Therefore, we think we should examine whether the labelling requirement in Directive 2001/18 is
linked to the purpose of protecting human health an d the environment and hence is a measure applied
for one of the purposes identified in Annex A(1).
7.385 We recall in this regard that the only stated purpose of Directive 2001/18, besides the
approximation of member State laws, is to protect human health and the environment from risks
arising from the deliberate release of GMOs into the environment. 520 This is in contrast to
Regulation 258/97 (which we will consider below) that makes reference to other purposes, such as not
misleading the consumer. In the light of this, we think that if the labelling requirement in
Directive 2001/18 is rationally related to the stated purpose of Directive 2001/18, and in the absence
of sufficient indications of a different or add itional purpose, we may and should presume that the
labelling requirement is intended to serve the purpose articulated in the Directive.
521
7.386 In considering the issue whether the labelling requirement in Directive 2001/18 is rationally
related to the stated purpose of Directive 2001/18, we find instructive, among other provisions, those
of Article 20 of the Directive. Article 20 addresses situations where after the consent to the placing
on the market of a product containing or consis ting of a GMO has been given, new information
becomes available to competent authorities, from the users of the product or other sources, which
could have consequences for the risks of the GMO to human health or the environment. Article 20

518 Articles 4(4), 13(2)(f) and 19(3)(e) as well as Annex IV of Directive 2001/18. While
Directive 90/220 also imposed certain labelling requirements, it did not require a statement to the effect that a
GMO is present. Article 11(1) and Annex III of Directive 90/220.
519 Article 21(1) of Directive 2001/18.
520 Article 1 of Directive 2001/18.
521 We note that the 40 th preambular paragraph of the Directiv e states that the presence of a GMO
should be indicated on a label or in a document "[i]n order to ensure that the presence of GMOs in products
containing, or consisting of, genetically modified organisms is appropriately identified". The phrase
"appropriately identified" does not indicate that the labelling requirement is applied for the purpose of protecting
human health and the environement. But this phrase likewise does not indicate that the labelling requirement is
applied for a purpose other than, or additional to, the protection of human health or the environment.

provides that in such situations the consent to the placing on the market may be amended or
terminated, depending on the results of a review pr ocedure which is to be conducted when relevant
new information becomes available.
522 While the Directive does not specify the precise consequences
flowing from a decision to terminate the consent, it is reasonable to assume that the relevant product
could no longer be lawfully made available by selle rs to third parties, and that measures might be
taken to inform the public of the newly discovered risks and to require or encourage users of the
product to return it to the seller or to discontinue using it.
7.387 The requirement that the presence of a GMO in a product be explicitly identified on a label or
in an accompanying document fits the situation contemplated in Article 20. As pointed out,
Article 20 refers, inter alia, to situations where new information becomes available, from the users of
a product, with regard to the risks of a GMO to hu man health or the environment after the consent to
the placing on the market has been given. Explicit identification of the presence of a GMO alerts and
sensitizes operators and users of a product containi ng or consisting of a GMO to the possibility that
any observed adverse effects of the product on human health or the environment might be attributable
to the presence of a GMO as opposed to other factors. Increased awareness of operators and users of
the presence of GMOs may be presumed to lead to a situation where more observations which could
be indicative of risks associated with a GMO are reported to consent holders and competent
authorities, or where relevant observations are repor ted more promptly. Explicit identification of the
presence in a product of a GMO may thus be presume d to result in consent holders and competent
authorities being better informed, or informed more promptly, than they otherwise would be of
unanticipated risks of a GMO to human health a nd the environment, allowing them to determine
whether additional measures are necessary to protect human health and the environment.
523
7.388 Additionally, we observe that explicit identif ication of the presence in a product of a GMO
serves the purpose of health and/or environmental pr otection in situations of unexpected, accidental
release of a GMO – e.g., in connection with its storage or transport – into an environment in which the
GMO is not be used or in which the potential for adverse effects has not speci fically been considered
in the risk assessment. 524 In such situations, it can, in our view, be presumed that explicit
identification of the presence in a product of a GMO will result in consent holders and competent
authorities being more promptly and more effectivel y informed of any relevant incidents than would
be the case if the product being stored or transported did not explicitly identify the presence of a
GMO. To use again the example of storage or transport, we note that persons storing or transporting
GMOs ( e.g., the driver of a transportation vehicle) need not necessarily be persons under the
supervision of the producer or user of GMOs or persons otherwise familiar with the specific
characteristics of the product they are handling. Fo r such persons in particular, explicit identification

522 We also note that Article 23(1) of Directive 2001/1 8 requires member States to ensure that in the
event of a severe risk, emergency measures, such as susp ension or termination of the placing on the market, are
applied, including information to the public.
523 We are mindful of the fact that Directive 2001/18 contains monitoring requirements, inter alia to
identify the occurr ence of unanticipated adverse effects of GMOs on human health or the environment.
However, information and data may in some cases be collected and reported through general surveillance
practices already implemented for agricultural cultivars other than the GM crop in question. Therefore, users of
GM crops may not necessarily associat e monitoring with the presence of a GMO. Furthermore, monitoring
plans may not always be implemented by those responsi ble for doing so. We consider that in such cases,
by alerting users to the presence of GMOs, labelling to indicate their presence can be presumed to result in
consent holders and competent authorities being better informed, or informed more promptly, than they
otherwise would be of observations of unanticipated adverse effects of GMOs on human health or the
environment.
524 Accidental dissemination of GM seeds might occur, for instance, as a result of an accident involving
a vehicle transporting GM seed bags from the seller to the farmer.

of the presence of a GMO renders more likely, and facilitates, an adequate and prompt response in
situations of unexpected, accidental release of a GMO into the environment.
525
7.389 In the light of the foregoing considerations, we are of the view that there is a rational
relationship between, on the one hand, the purpose st ated in Directive 2001/18 of protecting human
health and the environment and, on the other hand, the particular labelling requirement contained in
Directive 2001/18, which applies in cases where a product containing or consisting of a GMO has
been found to be safe for human health and the environment. Furthermore, neither in
Directive 2001/18 nor in any other piece of evidence before us do we see sufficient indications that
the labelling requirement in Directive 2001/18 is intended to serve a purpose different from, or
additional to, the purpose Directiv e 2001/18 says it seeks to achieve, i.e., the protection of human
health and the environment.
526
7.390 We note that Annex A(1) to the SPS Agreement specifies that SPS measures include, " inter
alia", "packaging and labelling requirements directly re lated to food safety". As is indicated by the
term "inter alia" in Annex A(1), the requirements specifi cally mentioned are not necessarily intended
to exclude similar requirements. Hence, while recognizing that labelling requirements imposed on
food safety grounds may be more common, we consider that labelling requirements imposed for the
purpose of protecting plant, animal or human health from the risks covered in Annex A(1)(a) and (c),
or for the purpose of preventing or limiting other damage from the risk covered in Annex A(1)(d),
would likewise be subject to the disciplines of the SPS Agreement.
527
7.391 We have determined above that the labelling requirement in Directive 2001/18 is rationally
related to the purpose of protecting human health a nd the environment. We have also observed that
the Panel record does not contain sufficient indications of a purpose different from, or additional to,
the protection of human health and the environment. In these circumstances, we think we may and
should presume that the labelling requirement is app lied to protect human health and the environment
from possible unanticipated effects of GMOs. To the extent it is applied to protect the environment, it
would fall within the scope of Annex A(1)(a), (b) or (d), depending on what the adverse effects would
be. To the extent it is applied to protect human health, it would fall within the scope of Annex A(1)(b)
or (c).
528 Thus, we consider that the labelling requirement in question does not remove
Directive 2001/18 from the scope of the SPS Agreement.
7.392 We stress that our finding that the labelling re quirement in Directive 2001/18 falls within the
scope of the SPS Agreement does not necessarily imply that the requirement is consistent with the
provisions of that Agreement. The consistency of the relevant requirement with the SPS Agreement is
an issue that is not before us, and so we refrain from expressing a view on it.

525 We note that in the case of unexpected, accidental release there could be a need for a rapid response
to prevent or limit adverse effects on human health or the environment.
526 Further elaboration of this point is provided supra, at paras. 6.60 et seq., in response to a comment
made by the European Communities at the interim review stage.
527 The reference to "labelling requirements directly related to food safety " (emphasis added) in the
second sub-paragraph of Annex A(1) is in our view intended to provide an example of a labelling requirement
which clearly and unambiguously serves one of the purposes identified in Annex A(1). It may be inferred from
this reference that some food-related labelling requirements would not be subject to the SPS Agreement, e.g.,
food labelling required to provide quality assurance, volum e of contents, or to reflect consumer preferences or
moral considerations.
528 We have addressed earlier how GMOs might give rise to risks falling within the scope of the various
sub-paragraphs of Annex A(1), and so we refer to our earlier analysis in this regard.

Conclusions with respect to the purpose of Directives 90/220 and 2001/18

7.393 In our analysis above, we have identified and considered the risks or adverse effects
Directives 90/220 and 2001/18 seek to avoid, eith er by their express terms or according to the
European Communities. In relation to all of these ri sks, we have determined that, in terms of the
origin of these risks and their possi ble consequences, they are risks covered by one or more of the
sub-paragraphs of Annex A(1). In the light of th is, and since the stated purpose of Directives 90/220
and 2001/18 is to avoid these risks, we are of the view that Directives 90/220 and 2001/18 can be
considered as measures which are applied for the purposes identified in Annex A(1)(a) through (d).
In other words, we consider that they meet the purpose element of the definition of the term "SPS
measure". To that extent, Directives 90/220 and 2001/18 constitute SPS measures.529
(ii) Regulation 258/97
7.394 The Panel now turns to examine whether the specific risks or concerns identified in
Regulation 258/97 are risks that fall within the scope of the definition of an SPS measure provided in
Annex A(1) of the SPS Agreement. The Panel recalls that Regulation 258/97 concerns novel foods
and food ingredients, including foods and food in gredients containing or consisting of genetically
modified organisms within the meaning of Directive 90/220, and foods and food ingredients produced
from, but not containing, genetically modified organisms.
7.395 Regarding the purposes for which Regulation 258/97 is applied, we note Article 3(1) of the
Regulation, which states that foods and food ingredients falling within the scope of the
Regulation must not:
− present a danger for the consumer,
− mislead the consumer,
− differ from foods or food ingredients which they are intended to replace to such an extent that
their normal consumption would be nutritionally disadvantageous for the consumer.

7.396 It is important to note that marketing approva l is granted only if the novel food or food
ingredient for which marketing approval is sought complies with the criteria of Article 3(1) of
Regulation 258/97.
530
7.397 We will determine below for each of the thr ee purposes for which Regulation 258/97 is
applied whether that purpose falls within the scope of Annex A(1). The Part ies have addressed only
some of the purposes of Regulation 258/97 and then only in relatively general terms. We therefore
begin our task by setting out the Parties' main arguments on the purposes of Regulation 258/97.
7.398 The United States argues that European Communities' biotech approval regime for novel
foods is unquestionably an SPS m easure. Regulation 258/97 states that "[f]oods and food ingredients
falling within the scope of the Regulation must not present a danger for the consumer" or be
"nutritionally disadvantageous."531 According to the United States, the specific risks articulated in the
Regulation fall within the definition of an SPS measure under the SPS Agreement. For example,
concerns that a biotech product might lead to an a llergic or toxic reaction on the part of consumers,

529 We note that we have yet to analyze whethe r Directives 90/220 and 2001/18 meet the other
definitional elements of the term "SPS measure". We will do so once we have considered the purposes of
Regulation 258/97.
530 Articles 6(1) and 6(3) of Regulation 258/97.
531 Article 3(1) of Regulation 258/97.

e.g., concerns regarding unacceptable levels of pesticide residue in pesticide-producing plant varieties,
allergic reactions based on consumption of a biotech variety that incorporates a genetic trait that can
lead to such reactions, or the presence of toxins or other contaminants in foods containing biotech
products, fall within the definition of Annex A(1 )(b), which covers measures applied to protect
"human or animal life or health" from risks aris ing from "contaminants" or "toxins" in "foods,
beverages or feedstuffs."
7.399 The United States further argues that concerns that widespread consumption of varieties
containing ARMG might lead to the development of antibiotic resistant strains of bacteria also fall
under the definition of Annex A(1)(b). Such concerns have been characterized as food safety issues.
Thus, a measure based on these concerns is a measur e designed to protect "human or animal life or
health" from "disease-causing organisms" in "foods, beverages or feedstuffs."
7.400 Canada argues that the central purpose of Regula tion 258/97 is to protect against risks
identified in sub-paragraph (b) of Annex A(1) of the SPS Agreement, namely, to "protect human or
animal life or health […] from risks arising from […] contaminants, toxins or disease-causing
organisms in food, beverages or feedstuffs". Regul ation 258/97 identifies the "protect[ion] of public
health" as a justification for adoption of a single safety assessment throughout the European
Community.
532 The Regulation further states that "[f]oods and food ingredients falling with the scope
of this Regulation must not: present a dange r for the consumer" or be "nutritionally
disadvantageous."533
7.401 Canada observes that Commission Recommendati on 97/618 sets out the type of scientific
information necessary to support applications for the placing on the market of novel foods and novel
food ingredients under Regulation 258/97. 534 Safety assessments conducted under Regulation 258/97
should include an assessment of contaminants, toxins and disease-causing organisms resulting from
the novel elements of the novel food or food ingr edient in question. The safety assessment should
address only "[c]hemical or microbiological contamin ants of novel foods […] specifically related to
the novelty […]" and "the presence of microbial toxins and microbial or viral infective agents […]
[when] this is a consequence of the novelty."
535 Part XIII of the Commission Recommendation sets
out the type of toxicological information that sh ould be included in an assessment for novel foods
under Regulation 258/97, including toxicity, mutagenicity and allergenicity studies.536
7.402 Argentina maintains that the EC approval proce dures, including those for novel food under
Regulation 258/97, are SPS measures. Argentina recalls that the definition of SPS measures in
Annex A(1) explicitly includes "inter alia [...] approval procedures [..]". In particular, Argentina notes

532 2nd preambular paragraph of Regulation 258/97.
533 Article 3(1) of Regulation 258/97.
534 Commission Recommendation 97/618.
535 Ibid., Article 5.
536 Ibid, p. 14, Part XIII, which states:
 "This scheme covers the set of toxicological information needed to assess the [novel
foods]. The range of scenarios can extend from foods for which substantial equivalence can be
established to foods for which substantial equivalence cannot be established and which,
therefore, require an appropriate nutritional-toxicological testing program.
 If substantial equivalence to a traditional coun terpart cannot be established, the safety
assessment based on a case-by-case evaluati on must consider the following elements:-
consideration of the possible toxicity of the analytically identified individual chemical
components; toxicity studies in vitro and in vivo including mutagenicity studies, reproduction
and teratogenicity studies as well as long term feeding studies, following a tiered approach on
a case-by-case basis; studies on potential allergenicity."

that the purpose of the EC regulations for the approval of biotech products is to determine, by means of
case-by-case assessment, the presence or absence of "additives", "contaminants" or "toxins" in foods,
beverages or feedstuffs and the risks to human life and health resulting from their presence. Argentina
considers that the risks to which the EC legisla tion refers, and which have been evaluated by the
respective EC scientific committees, are covered by Annex A(1) because both the legislation and the
scientific opinions refer to or deal with, inter alia, risks such as toxic or allergic effects in humans and
animals, the growth of antibiotic-resistant bacteria and cross-contamination.
7.403 The European Communities argues that some of the matters addressed by
Regulation 258/97 go beyond the risks envisaged and regulated by the SPS Agreement. The scope of
the SPS Agreement depends on the objectives of a measure. Some aspects of Regulation 258/97 fall
within the scope of the SPS Agreement, but other aspects do not. In particular, the European
Communities argues that the GMOs with which this case is concerned are not additives according to
the Codex definition for additives.
537 Furthermore, since both the GMOs and the proteins produced
by the GMOs are intentionally present in food, they cannot be c onsidered to be "contaminants" or
"toxins" within the meaning of Annex A(1)(b).
"present a danger for the consumer"
7.404 The Panel begins its examination with the first purpose articulated in Regulation 258/97,
which is to prevent GMOs used as or in foods from "present[ing] a danger for the consumer".
Regulation 258/97 does not elaborate on how it is to be determined whether a product within the
scope of the Regulation presents "a danger" for th e consumer. Nonetheless, it is clear from the
Regulation's preamble that a fundamental objective of the Regulation is to "protect public health" 538
and to ensure that GMOs present in foods are "safe for human health" 539. We therefore think that the
phrase "danger for the consumer" s hould be understood as referring to a danger for the life or health
of the consumer.
7.405 This view is consistent with Commission Recommendation 97/618, which was referred to by
Canada. Commission Recommendation 97/618 sets out the type of scientific information necessary to
support applications for the placing on the market of novel foods and novel food ingredients under
Regulation 258/97. This Recommendation indicates that, inter alia, the following must be assessed:
− critical nutrients, any critical toxicants and anti-nutritional factors;
− potential for toxigenicity and/or pathogenicity of any novel microorganisms;
− potential occurrence of allergic reactions to novel proteins or othe r constituents of novel
foods; and
− potential toxicological effects related to the f unctions of marker genes (including antibiotic
resistance marker genes).
540

537 According to the Codex Procedural Manual, a "[f]ood additive means any substance not normally
consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has
nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in
the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food
results, or may be reasonably expected to result, (directly or indirectly) in it or its by-products becoming a
component of or otherwise affecting the characteristics of such foods. The term does not include
"contaminantsError! Bookmark not defined. " or substances added to food for maintaining or improving
nutritional qualities." Codex Procedural Manual, 14
th Edition, Reference A, p. 43.
538 2nd and 6th preambular paragraph of Regulation 258/97.
539 8th preambular paragraph of Regulation 258/97.
540 Commission Recommendation 97/618, p. 5 et seq.

7.406 We note that potential toxic, pathogenic and allerg ic effects of foods containing or consisting
of GMOs all present dangers for the life or health of the consumer. We further note that Article 3(4)
of Regulation 258/97 provides a derogation from the regular approval procedure for foods or food
ingredients which have been found to be substantially equivalent to existing foods or food ingredients
as regards their "composition, nutritional value, metabolism, intended use and the level of undesirable
substances contained therein " (emphasis added). This makes clear that potential risks to the life or
health of consumers could arise from "undesirable substances contained" in foods containing or
consisting of GMOs.
7.407 We recall that Annex A(1)(b) brings within the scope of the SPS Agreement measures applied
"to protect human or animal life or health [...] from risks arising from additives, contaminants, toxins
or disease-causing organisms in foods, beverages or f eedstuffs". We have addressed the meaning and
scope of Annex A(1)(b) when we analysed Directives 90/220 and 2001/18. Based on the above
considerations, to the extent that Regulation 258/97 seeks to protect consumers from dangerous foods,
it may, in our view, be considered as a measure app lied to protect the life or health of consumers from
risks arising from additives (including antibiotic resistance marker genes), contaminants ( e.g.,
pesticide residues in pesticide-produc ing or resistant GM plants) or toxins (including allergens) in
foods. In other words, we are of the view that the first purpose of Regulation 258/97 is covered by
Annex A(1)(b).
"mislead the consumer"

7.408 The second purpose identified in Regulation 258/ 97 is to avoid that foods containing or
consisting of GMOs "mislead the consumer". We note in this regard that Article 8.1 of
Regulation 258/97 requires the labelling of food to ensure that the final consumer is informed of:
− any characteristic or food property such as composition, nutritional value or nutritional
effects, or the intended use of the food, wh ich renders a novel food or food ingredient no
longer equivalent to an existing food or food ingredient;
− the presence in the novel food or food ingredie nt of material which is not present in an
existing equivalent foodstuff and which may have implications for the health of certain
sections of the population;
− the presence in the novel food or food ingredie nt of material which is not present in an
existing equivalent foodstuff and which gives rise to ethical concerns; and
− the presence of an organism genetically modified by techniques of genetic modification.

7.409 We note that marketing approval is granted only if the relevant novel food or food ingredient
complies with Article 3(1) of Regulation 258/97, which includes the requirement that the food or food
ingredient not mislead the consumer, and if it is labelled in accordance with the above-mentioned
requirements of Article 8(1) of the Regulation.
541
7.410 The Panel recalls that pursuant to Annex A(1) of the SPS Agreement, SPS measures include,
inter alia, "labelling requirements directly related to food safety". The term "food safety" as it is used in
the SPS Agreement encompasses the safety of such subs tances as food additives, contaminants
(including pesticide residues), etc.542 Potential health risks arising from such substances are addressed
in Annex A(1)(b). Therefore, we consider that labelling requirements related to food safety are labelling

541 Articles 6(1) and 6(3) of Regulation 258/97.
542 Annex A(3) specifies the relevant international standards for "food safety", which include Codex
standards relating to food additives, pesticide residues and contaminants.

requirements which are applied to protect human health from risks arising from additives, contaminants,
toxins or disease-causing organisms in foods.
7.411 Of the four above-mentioned issues on which Article 8(1) requires information to be
provided, the second appears to be directly rela ted to food safety (materials which may have
implications for the health of certain sections of the population). The first and third issues seem
unrelated to food safety (nutritional value or nutritional effects, or the intended use of the food, and on
materials which give rise to ethical concerns). Th e fourth issue relates to information on the presence
in a food of a GMO. This information parallels the above-noted labelling requirement in
Directive 2001/18. The requirement in Regulation 258/97 is imposed irrespective of whether there is a
food safety concern, that is to say, an actual or potential health risk associated with the presence of that
GMO in the food in question. Since Regulation 258/97 seeks to ensure that novel foods not mislead the
consumer in addition to ensuring that they not pres ent a danger for the consumer, it is reasonable to
assume that the requirement that the consumer be informed of the presence of a GMO irrespective of
whether there is an associated health risk is at least in part imposed to prevent consumers from being
misled. In other words, we consider that, at least in part, Regulation 258/97 requires the identification of
the presence of a GMO in a food product in order to ensure that those consumers who have a preference
for food not containing or consisting of GMOs ar e not misled into purchasing food containing or
consisting of GMOs.
543
7.412 We are of the view that to the extent Regulation 258/97 is applied to ensure that novel foods
not mislead the consumer, it does not constitute a measure applied to protect the life or health of
consumers from risks arising from, e.g., additives or contaminants in foods. Accordingly, we
consider that the second purpose of Regulation 258/97 falls outside the scope of Annex A(1).
"nutritionally disadvantageous"
7.413 The third purpose of Regulation 258/97 is to ensure that novel foods, including foods
containing or consisting of GMOs, not differ from foods which they are intended to replace to such an
extent that their normal consumption would be "nut ritionally disadvantageous" for the consumer. We
recall that the first purpose of Regulation 258/97 is to prevent novel foods from presenting a "danger"
for the consumer. We have to assume, therefore, that the concept of "danger for the consumer",
which we have said is linked to the protection of th e life or health of the consumer, is distinct and
separate from the concept of "nutritional disadvantag e for the consumer". Indeed, conceptually, it
makes sense to distinguish the two situations. The normal consumption of a novel food may be
nutritionally disadvantageous for the consumer if it does not provide the body with nutrients in the
right quantity or of the right quality. This fact alone would not mean, however, that the relevant novel
food would present a danger for the consumer. To cons ider a hypothetical example, if oranges were
to be genetically modified in such a way that th ey contained greatly reduced levels of Vitamin C,
presumably juice produced from these oranges woul d likewise be a poor source of Vitamin C.
Consumers who normally drank orange juice as an im portant source of Vitamin C in their diet might
be nutritionally disadvantaged if they consumed ju ice from the genetically modified, low Vitamin C,
oranges. However, this nutritional disadvantage could be rectified through the consumption of
another source of Vitamin C. Based on these c onsiderations, we are not convinced that the
requirement that novel foods not be nutritionally di sadvantageous for consumers is intended, as such,
to protect the life or health of consumers.

543 We do not mean to suggest th at the absence of information ab out the presence of a GMO would
necessarily lead to consumers being misled. Rather, our statement concerns the reas ons for which we consider
the European Communities is applying the identification requirement contained in Regulation 258/97.

7.414 The Panel recalls that, Annex A(1)(b) brings within the scope of the SPS Agreement measures
applied "to protect human [...] life or health [...] from risks arising from additives, contaminants, toxins
or disease-causing organisms in foods [...]". We ha ve indicated that, in our view, the requirement in
Regulation 258/97 that novel foods not be nutritionally disadvantageous for the consumer is not applied,
as such, to protect "human life or health". Therefore, to the extent that Regulation 258/97 is applied to
ensure that novel foods are not nutritionally disadva ntageous for the consumer, we think it cannot be
considered a measure applied to protect the life or health of consumers from risks arising from, e.g.,
additives or contaminants. In other words, we cons ider that the third purpose of Regulation 258/97 is
not covered by Annex A(1).
Conclusions with respect to the purpose of Regulation 258/97

7.415 In our analysis above, we have identified and considered each of the three separate and
independent purposes for which Regulati on 258/97 is applied. We have determined that to the extent
the Regulation seeks to achieve the first of the three purposes – i.e., ensuring that novel foods not
present a danger for the consumer – it may be cons idered as a measure which is applied for the
purpose identified in Annex A(1)(b). In other words, we consider that the first purpose of
Regulation 258/97 meets the purpose element of the definition of the term "SPS measure".544
7.416 On the other hand, to the extent Regulation 2 58/97 is applied to achieve the second and third
purposes – i.e., ensuring that novel foods not mislead the consumer, and that they not be nutritionally
disadvantageous for the consumer – it is not a me asure applied for one of the purposes mentioned in
Annex A(1). To that extent, the Regulation does not meet the purpose element of the definition of the
term "SPS measure". Since the Regulation does no t meet one of the constitutive elements of the
definition of the term "SPS measure", it follows th at Regulation 258/97 is not an SPS measure within
the meaning of Annex A(1) to the extent it is applie d to ensure either that novel foods not mislead the
consumer or that they not be nutritionally disadvantageous for the consumer.
(c) Whether the EC approval procedures are SPS meas ures in terms of their form and by their
nature
7.417 We now turn to analyse whether Directives 90/220 and 2001/18 as well as Regulation 258/97
are "SPS measures" in terms of their form and by their nature.
7.418 The United States argues that Directives 90/220 and 2001/18, as well as Regulation 258/97,
are "approval procedures" under the SPS Agreement. Annex C to the SPS Agreement defines
"approval procedures", as including, inter alia, "procedures for sampling, testing and certification".
Because biotech products must be approved before they can be placed on the market, 545 the
procedures are analogous to the types of proced ures specifically articulated in Annex C, e.g.,
procedures for certification. As such, the pr ocedures fall within the definition of "approval
procedures" provided for under the Annex. Second, these procedures are imposed to "ensure" that the
requirements of the European Communities' approva l legislation for biotech products are met. Third,
the European Communities' approval legislation is a "sanitary or phytosanitary measure" as defined in
Annex A(1) of the SPS Agreement because it is applied for the purpose of protecting human, animal,
or plant life or health or preventing or limiting othe r damage within the territory of the Member from
certain enumerated risks in Annex A.

544 We note that we have yet to analyze whether Regulation 258/97 meets the other definitional
elements of the term "SPS measure".
545 See Articles 6(8) and 19(2) of Directive 2001/18; Articles 6(4) and 11(5) of Directive 90/220;
Article 4(2) of Regulation 258/97.