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   (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 genera l 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 meas ure 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 Eur opean 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 me mber States concerned.    WT/DS291/R 
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  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 orde r 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 outsta nding 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. 
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  Evolution of the EC approval regime for biotech products 
genetically modified organisms a nd 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 th e 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 a nd 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 or ganisms" (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.  WT/DS291/R 
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  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.   WT/DS291/R 
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  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 Europ ean 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 th e 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 peri od, 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 rele vant 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 an d 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. WT/DS291/R 
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  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 speci fied in the written consent.304  
(vi) Transition from Directive 90/220 to Dir ective 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 sa me 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-da y 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 Ar ticle 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.  WT/DS291/R 
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  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. WT/DS291/R 
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  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 i ngredients: 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 nutritiona lly 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 produc t 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.  WT/DS291/R 
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  above for Directives 2001/18 and 90/220.  Our d escription of the procedures laid down in 
Regulation 258/97 has been structured accord ing 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 in gredients and the preparation of initial assessment reports 
under Regulation No 258/97 ". 
318 Ibid. 
319 Article 6(4) of Regulation 258/97. WT/DS291/R 
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  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 assessme nt 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 envisag ed 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 Offi cial 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.  WT/DS291/R 
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  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 enda ngers 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 It aly 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 WT/DS291/R 
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  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:  Regula tion 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 provi de merely a very basic descripti on 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 in clude 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.  WT/DS291/R 
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  (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 requi rements 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. WT/DS291/R 
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  (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 regula tion 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:  WT/DS291/R 
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  "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 w ith 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 consid ered 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 me asure 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 WT/DS291/R 
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  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 Eu ropean 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.  
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  7.165  In our assessment, the better and mo re 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". WT/DS291/R 
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  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-incons istent 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 ]".  WT/DS291/R 
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  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 cas e 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 
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  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 facilitati ng 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.  WT/DS291/R 
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  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 in clude 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.   WT/DS291/R 
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  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 Communiti es 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 ri sks 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 c onsisting 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.  WT/DS291/R 
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  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 biolog ical 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. WT/DS291/R 
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  − effects on the dynamics of populations of species in the receiving environment and 
the genetic diversity of each of these – cha nges 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 facilitati ng 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 d ecomposition 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 dispute366,  
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.  WT/DS291/R 
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  − 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 be lieve 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.   WT/DS291/R 
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  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).  WT/DS291/R 
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  modification of interactions between two organisms, includi ng through trophic interactions
371;  and 
negative effects on the biogeochem ical 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 risk s 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 th ese 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 ar e asking questions about whether the biot ech crop might aff ect 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 cy cled 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. WT/DS291/R 
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  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 S PS 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 diversit y 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.  WT/DS291/R 
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  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 natu re).  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). WT/DS291/R 
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  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 ar ea 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  WT/DS291/R 
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  measure applied to protect "animal or plant life or h ealth".  In considering this argument, it should be 
recalled that the footnote to the de finitions 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 r esidues 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 "f auna", 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 ar ising 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. WT/DS291/R 
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  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 phr asal 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 additio nal 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.  WT/DS291/R 
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  and spread throughout the population.  As more insect populations become resistant, more toxic 
chemical pesticides may need to be appl ied, 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 establis hment 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 th e 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. WT/DS291/R 
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  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 Internati onal 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 plan t, 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, in cluding 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 pestic ides 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 rega rd to environmental risks".  WT/DS291/R 
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  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 pl ants could be considered a "pest"; fo r 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-organi sms, 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 anim als 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.  WT/DS291/R 
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  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 wh ich 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 definiti on 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.)  WT/DS291/R 
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  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 volunteer397 GM 
plants growing in fields of conven tional 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. WT/DS291/R 
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  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 thi nk 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-crossing403).  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.  WT/DS291/R 
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  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 c ould 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 incl uding, 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 transf ers 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. WT/DS291/R 
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  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 herbic ide 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 advant age 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 pesticid e 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 flor a 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.  WT/DS291/R 
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  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 tr ansfer 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 th e 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 WT/DS291/R 
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  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 th at 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.  Furthe rmore, 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.  WT/DS291/R 
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  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 pesticid es.  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 cons ider 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.      WT/DS291/R 
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  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 a nd 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 popu lations (including in targ et 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).  WT/DS291/R 
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  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 studie s 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.  WT/DS291/R 
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  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 w eeds, 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 pa rt of our discussion of Annex A(1)(d) below. 
432 International Animal Health Code , 2002.  WT/DS291/R 
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  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 in troducing 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. WT/DS291/R 
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  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 organism s."  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-causi ng 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 pl ant 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 e ffects 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.  WT/DS291/R 
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  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 considerati ons, 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 d ecomposition 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-paragr aphs 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 th e context of our analysis of Annex A(1)(b) and in 
footnote 495. WT/DS291/R 
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  − 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 a llergens on human and animal health in the context 
of Annex A(1)(b), hence we will al so 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-paragr aph (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 duri ng 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.  WT/DS291/R 
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  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 fauna443, 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 fa rm 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. WT/DS291/R 
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  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 info rmative 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 rele vant 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, gui delines 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 14th 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.  WT/DS291/R 
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  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 co mpromise 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 poten tial 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, th e plant cells are grown in a 
substance which has been treated with the antibiotic.  Only  cells which contain the antib iotic resistance, and thus 
the gene of interest, will survive. 
452 See supra , para. 7.303. WT/DS291/R 
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  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, rath er 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:  WT/DS291/R 
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  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 uninte nded 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 e ffects 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. WT/DS291/R 
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  to qualify as a "contaminant", it would need to be pr esent 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.  WT/DS291/R 
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  "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 hea lth 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 ar e 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 t oxic 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 , 10th 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. WT/DS291/R 
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  in foods are inherently substances which have been unintentionally added to foods.
468  T o b e  s ur 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 presen ce 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 in sects 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.   WT/DS291/R 
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  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 th at 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 r eactions 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. WT/DS291/R 
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  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 th e 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 , 6th 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.  WT/DS291/R 
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  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 ab le 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 poi sonous proteins may qualify as "toxins".  
7.339  We have stated above that allergens are s ubstances 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.  WT/DS291/R 
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  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.   WT/DS291/R 
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  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 considerati ons, 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 pathoge ns facilitating the dissemination of infectious diseases and/or 
creating new reservoirs or vectors"  
− "compromising prophylactic or therapeutic medi cal, 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-paragr aphs 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 s ub-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 .  WT/DS291/R 
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  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 pa ragraph 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 imm une 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 harmfu l 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.   WT/DS291/R 
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  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 intr oduction 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.    WT/DS291/R 
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  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 considerati ons, 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 ot her 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.  WT/DS291/R 
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  − possible immediate and/or delayed effects on hum an 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 impair ment to the health of the crop plant. 
7.366  According to Canada, "other damage" is not limite d 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. WT/DS291/R 
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  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, establ ishment 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 th e GMOs in relation to  un modified 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 biodi versity or the ecological balance of an area is 
by negatively affecting wild flora a nd/or fauna, Argentina considers that the scope of Annex A(1)(d) is 
sufficiently broad to encompass any possible other da mage 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.  Th is 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 p est 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).  WT/DS291/R 
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  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, interpre ting "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 reas on 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. WT/DS291/R 
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  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.  WT/DS291/R 
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  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]ossibl e 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 re ferred to as the "Farm Scale Evaluation". WT/DS291/R 
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  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 d ecomposition 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.    WT/DS291/R 
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  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 c onsider 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 40th 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 labe lling 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.   WT/DS291/R 
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  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 trans port – 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 othe r 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.    WT/DS291/R 
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  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 he alth, 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 consiste ncy 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 unex pected, accidental release there coul d 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 ri se 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.  WT/DS291/R 
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  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 Directiv e 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 nutriti onally 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, th e 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.   WT/DS291/R 
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  e.g., concerns regarding unacceptable le vels of pesticide residue in p esticide-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 nutr itional-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." WT/DS291/R 
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  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 commi ttees, 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-resista nt bacteria and cr oss-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 pathoge nicity 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 "contaminants Error! 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 .  WT/DS291/R 
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  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 en sure 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, wh ich 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 safe ty".  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 labe lling 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. WT/DS291/R 
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  requirements which are applied to protect human hea lth from risks arising from additives, contaminants, 
toxins or disease-causi ng 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 a ssociated with the presence of that 
GMO in the food in question.  Sinc e 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 consid er that, at least in pa rt, Regulation 258/97 require s 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 al one 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.  WT/DS291/R 
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  7.414  The Panel  recalls that, Annex A(1)(b) bri ngs 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 nutritiona lly 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.