Document: WT/DS291/R/Add.2 WT/DS292/R/Add.2 WT/DS293/R/Add.2 Page D-88 ANNEX D-4 REPLIES BY THE EUROPEAN COMMUNITIES TO QUESTIONS POSED BY THE PANEL IN THE CONTEXT OF THE FIRST SUBSTANTIVE MEETING For the European Communities
Document codes: WT/DS291/R/Add.2; WT/DS292/R/Add.2; WT/DS293/R/Add.2
Complainant: Argentina
Respondent: EU
Third parties: Australia, Brazil, Canada, Chile, China, Taiwan, Colombia, El Salvador, Honduras, Mexico, New Zealand, Norway, Paraguay, Peru, Thailand, Uruguay, U.S.
Dispute stage: Mutually Agreed Solution
Agreements cited: Art. 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7, 8, 10.1, Annex B, Annex C  Sanitary and Phytosanitary Measures (SPS)Art. III:4, X:1, X:3(a), XI:1  GATT 1994Art. 2.1, 2.2, 2.8, 2.9, 2.11, 5.1, 5.2, 5.6, 5.8, 12  Technical Barriers to Trade (TBT)Art. 4.2  AgricultureArt. I:1  GATT 1994

ANNEX D-4

REPLIES BY THE EUROPEAN COMMUNITIES
TO QUESTIONS POSED BY THE PANEL
IN THE CONTEXT OF THE FIRST SUBSTANTIVE MEETING

For the European Communities

1. Are the parties of the view that the Panel must base its findings and conclusions on the
facts as they existed on the date of establishment of this Panel?

1. By way of a preliminary remark and as stated already at the first hearing, facts occurring after
the establishment of a Panel may be relevant for the resolution of a case in different ways.

2. First of all, they may serve as evidence to underline or corroborate an argument made by a
party with regard to the measure that is being a ttacked. For example, a further specific instance of
application of a measure that is being attacked h as occurred, and it may constitute additional evidence
that the Member in question applies that measure in a specific way. Sp ecifically, the European
Communities has submitted to the Panel abundant info rmation on the implementation of its Directive
2001/18 and its Regulation 258/97 up to the present moment, as evidence inter alia that its approval
procedures were and are running. To cite but one example: since a pproval of GM products in the EU
cannot occur overnight (because of the need to unde rgo a pre-marketing assessment), the fact that a
further use of Bt11 sweet corn h as been recently authorised in th e European Communities proves that
approval procedures were not genera lly stalled in the past, as the complainants contend (i.e. their
claims on the existence of a general "moratorium").

3. Secondly, facts occurring after the establishment of a Panel, may also affect the very subject
matter of the dispute if, for instance, the challenged measure ceases to exist or there is a fundamental
change in its effects. The measure that is be ing challenged may be abolished or, in the case of a
provisional measure, it may expire; or a Member may make a formal statement that it will exercise its
discretion in a given way.

4. In the view of the European Communities, the Panel, generally, must base its findings and
conclusions not only on facts as they existed at the time of the establishment of the Panel, but also on
facts that have occurred after the establishment of the Panel. With regard specifically to the second
aspect mentioned above, therefore, if facts occur that terminate a m easure that has been identified in
the Panel's terms of reference, the Panel has to take th is fact into account. It is in this situation that
the question of mootness arises. The European Communities will comment on that issue below under
question 7.

2. Annex A of the SPS Agreement contains two apparently alternative definitions of risk
assessment. Which of these definitions would be a ppropriate to evaluate the purported risks of
biotech products? Or would both definitions be appropriate?

5. Paragraph 4 of Annex A defines "risk assessment" for the purposes of the SPS Agreement as:

Risk assessment - The evaluation of the likelihood of entry, establishment or spread
of a pest or disease within the territory of an importing Member according to the
sanitary or phytosanitary measures which mi ght be applied, and of the associated
potential biological and economic consequences; or the evaluation of the potential for

adverse effects on human or animal health arising from the presence of additives,
contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs.
6. Although, as the Panel observes, this appears to contain two definitions, possibly applying to
different categories of risk in paragraph 1, in r eality these definitions are not entirely alternative but
complementary. If it were otherwise, it would mean , for example, that when the first definition is
applied the health effects of a disease could not be examined (only the "biological and economic
consequences") and that, when the second is applied, economic effects would have to be ignored.

7. In any event, the European Communities considers that both definitions are relevant to
address risks associated with GMOs which have characteristics and effects coming within both
branches. However, neither individually nor toge ther do they provide for a full coverage of all
potential risks associated with GMOs. The Eur opean Communities refers to its first written
submission in which it identifies ce rtain risks that come under the SPS Agreement and others that do
not.
1

8. The European Communities wi shes to anticipate the answer to Question 103 and draw the
attention of the Panel to another important feature of this definition – that it includes what is
elsewhere considered to be risk management i ssues. It does this because the concept of risk
management is important for a number of other ques tions. With its Question 103 the Panel asked the
European Communities:

Could the European Communities please further explain its comment made during the first
substantive meeting to the effect that the Euro pean Communities considers risk management to
be part of risk assessment for the purposes of the SPS Agreement?

9. The commonly-used definitions of "risk assess ment" and "risk analysis" are those developed
by the Codex Alimentarius. These distinguish between "risk assessment", "risk management" and
"risk communication", which are together referred to as "risk analysis". The precise definitions are:

Risk analysis. A process consisting of three components: ri sk assessment, risk management and risk
communication.

Risk assessment: A scientifically based process consisting of the following steps:

(i) hazard identification,
(ii) hazard characterization,
(iii) exposure assessment, and
(iv) risk characterization.

Risk management: The process of weighing policy alternatives in the light of the results of risk
assessment and, if required, selecting and impl ementing appropriate control options, including
regulatory measures.

Risk communication: The interactive exchange of information and opinions concerning risk among
risk assessors, risk managers, consumers and other interested parties.
2

1 First written submission, paras. 418 et seq.
2 The definitions were adopted by the 22 nd Session of the Codex Alimentarius Commission (1997) and
are published in the tenth edition of the procedural manual of the Codex Alimentarius Commission, in the
section "Definitions for the Purposes of the Codex Alim entarius" [FAO, 1997], see Exhibit EC-117. The same

10. Comparing this definition to that in the SPS Agreement, it is immediately apparent that the
term "risk assessment" as used in the SPS Agreement includes at least both of what the Codex refers
to as "risk assessment" and "risk management". First, the SPS Agreement definition of "risk
assessment" requires an "evaluation" whereas the Codex definition requires primarily an
"identification" and "characterisation" of the hazards. The weighing of the results is a matter for "risk
management" under the Codex definitions. Second, the SPS Agreement definition of risk assessment
includes an "evaluation … according to the sanita ry or phytosanitary measures which might be
applied." It is clear that the SPS definition of risk assessment is equivalent to "weighing policy
alternatives in the light of the results of risk assessmen t" which is part of the Codex definition of "risk
management".

11. It also appears that, since labelling requirements are part of the SPS Agreement definition of
an SPS measure in annex A.1, and the SPS Agreement definition of risk assessment requires an
"evaluation … according to the sanitary or phytosan itary measures which might be applied" that the
SPS Agreement definition of "risk assessment" includes also elements of risk communication ( e.g.
labelling). The term "risk assessment" as used in the SPS Agreement can therefore be considered to
correspond broadly to the concept of "risk analysis" as defined by the Codex Alimentarius.

12. The term "risk assessment" in the EC GMO or food legislation
3 is used more in the Codex
sense in that the risk management decisions are left to regulatory bodies whilst the risk assessment
strictu sensu belongs mainly to technical bodies. This explains part of the misconceptions about the
EC system that prevails on the part of the Complainants.

13. The European Communities would add that this feature of use of the term "risk assessment"
in the SPS Agreement has already been noted by the Appella te Body when it chided the panel in EC –
Hormones for having assumed that the SPS Agreement did not allow for taking into consideration of
what are usually termed "risk management" issues. It stated that:

The second preliminary consideration relates to the Panel's effort to distinguish
between "risk assessment" and "risk management". The Panel observed that an
assessment of risk is, at least with resp ect to risks to human life and health, a
"scientific" examination of data and factual studies; it is not, in the view of the Panel,
a "policy" exercise involving social value judgments made by political bodies. The
Panel describes the latter as "non-scientific" and as pertaining to "risk management"
rather than to "risk assessment". We must stress, in this connection, that Article 5 and
Annex A of the SPS Agreement speak of "risk assessment" only and that the term
"risk management" is not to be found either in Article 5 or in any other provision of
the SPS Agreement . Thus, the Panel's distinction, which it apparently employs to
achieve or support what appears to be a r estrictive notion of risk assessment, has no
textual basis. …
4

document also contains definition of the components of risk characteri zation being the qualitative and/or
quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known
or potential adverse health effects in a given populati on based on hazard identificatio n, hazard characterization
and exposure assessment..
3 See for instance article 6 "risk analysis", which differentiates between risk assessment and risk
management, of Regulation (EC) 178/2002, laying down the general principles and requirements of food law,
establishing the European Food Safety Authority and laying down procedures in matters of food safety.
4 Appellate Body report, EC – Hormones, para. 86.

14. The European Communities trusts that the Panel will not be similarly misled and will
understand that the term "risk assessment" as used in the SPS Agreement comports more than simply a
scientific identification, characterisation and assessment of hazards but also permits and indeed
requires a broader evaluation of the risks, thei r consequences and of the measures that may be
employed to control and manage them.

3. Do the parties consider that food allergens can be considered to be "toxins" or "disease-
causing organisms" in a food, beverage or feedstuff?

15. A toxin is "a poisonous substance produced during the metabolism and growth of certain
microorganisms and some higher plant and animal species."
5 An allergen is defined as "pertaining to
antigens6 that induce an allergic response in an organi sm or any substance that can cause an allergy." 7
Allergenic responses are only provoke d in certain individuals that e xhibit sensitivity to the allergen
and are not of a general nature. Hence a food allergen cannot be considered as a toxin.

16. A food allergen is also not a disease-causi ng organism. Neither is a food allergen an
organism (i.e. a biological entity capable of rep lication). Nor is an allergy a disease, but rather a
medical condition. A "disease" is a clinical or pathological manifestation of infection (see also reply
to question 78). A "medical condition" is an i ndividual-based response to different environmental
factors such as allergies to food, pollen, insects (see also reply to question 78).

4. Which (if any) are the other binding international law instruments which are relevant to
this case? Could the parties please identify the specific provisions which they believe to be of
relevance, and explain specifically how these provisions could be applied in this case?

17. In its First Written Submission the European Communities set out its support for the approach
taken by the Appellate Body in US-Shrimp.
8 It follows from that decision that the Panel is required to
interpret the relevant rules of WTO law consistently with other rules of international law that may be
relevant to these proceedings. In this regard it is important to note that the Appellate Body has
interpreted WTO rules by reference to treaties whic h are not binding on all parties to the proceedings.
In US-Shrimp, it invoked – in support of arguments made by the United States – treaties which that
country had not signed or had si gned but not ratified. One such treaty was the 1992 Convention on
Biological Diversity.

18. As regards "binding interna tional law instruments", the European Communities considers that
the 1992 Convention on Biological Diversity and its 2000 Biosafety Protocol "are relevant to this
case". The 1992 Convention is binding on the Europe an Communities, Argentina and Canada and has
been signed by the United States. The 2000 Protocol is binding on the European Communities (which
has obligations under the Protocol vis-à-vis third parties: see Article 24), and has been signed by
Argentina and Canada. The European Communities is not inviting the panel to "apply" these
instruments as such, but rather to ensure that the WTO rules are interpreted consistently with them.

19. Under Article 18 of the 1969 Vienna Conven tion on the Law of Treaties (which reflects
customary international law) a state which has si gned a treaty is thus bound to "refrain from acts
which would defeat [its] object and purpose". Furt her, as noted in the response to Question 11 from

5 See http://www.biology-online.org/dictionary.asp [last visited on 15 June 2004]
6 Antigens are defined as substances that are reco gnized by the immune system and induce an immune
reaction.
7 Ibidem.
8 See first written submission of the European Communties, paras. 453 et seq.

Argentina, the United States is participating in the Protocol's Clearing-House Mechanisms (under
Articles 11 and 20) and must therefore be taken to have no objection to the approach required by the
Protocol.

20. With regard to the specific provisions that th e European Communities considers to be relevant
to this case,
9 the following is a non-exhaustive set of ex amples (the European Communities reserves
its right to identify further provisions of these instruments and of other conventions as these
proceedings develop):

 (a) the Preamble to the 1992 Convention and Articles 1, 10(6) and 11(8) of the 2000
Protocol are relevant to the application of the precautionary principle;

 (b) Article 8(g) of the 1992 Convention and the whole of the 2000 Protocol are relevant
to demonstrate that biotech products and their non-biotech equivalents are not to be
treated as "like products";

 (c) Articles 8, 10, 15 and 11 and Annex III of the 2000 Protocol are relevant to the
determination of the nature of a risk a ssessment that the international community
considers to be relevant in decision-ma king for biotech products, and they confirm
that the approach taken by the SPS Agreement is not considered to be sufficient in and
of itself to address all the risks posed by biotech products;

 (d) Article 26 of the 2000 Protocol is rele vant for establishing that the international
community has determined that socio-econom ic considerations may be taken into
account in taking import decisions in respect of biotech products;

 (e) Article 23 of the 2000 Protocol is rele vant in confirming that the international
community has determined that public opinion is a relevant public policy
consideration in relation to biotech products; and

 (f) Paragraph 8(f) of Annex III of the 2000 Prot ocol is relevant in confirming the view of
the international community that "risk management" is to be treated as part of the risk
assessment process, and that "risk manage ment" includes monitoring the living
modified organism in the receiving environment.

21. Finally, the European Communiti es considers that the provisions of inter alia the Codex
Alimentarius Commission and other equivalent st andards are highly relevant to these proceedings.
However, these are to be treated as inter alia "international standards, guidelines and
recommendations" within the meaning of Articles 3 and 5, Annex A point 3, of the SPS Agreement
and Article 2 of the TBT Agreement. For the purposes of the response to this Question the European
Communities proceeds on the basis that the Panel do es not consider these instruments to be "binding
international law instruments" within the meaning of the question.

9 The European Communities reserves the right to argue that the standards established by these two
conventions may be treated as "international standards, guidelines and recommendations" within the meaning of
the SPS Agreement and/or the TBT Agreement.

For all complaining parties

5. With reference to paras. 285 to 297 of the EC first written submission, how do the
complaining parties account for the fact th at the companies withdrawing notifications
apparently did not cite undue delays in the pr ocessing of notifications as reasons for the
withdrawal (except in the case of the notifi cation concerning Monsanto Roundup Ready oilseed
rape (GT73))?

6. With reference to pp. 27-36 of the EC first written submission, could the complaining
parties please indicate whether the European Communities' description of their own regulatory
systems is accurate?

7. In the light of the European Communities' answer to Question 1 above in which it
touched upon the concept of "mootness", do the co mplaining parties consider that this concept
is of relevance in the present case?

22. As stated above, the European Communities takes the view that the concept of mootness
arises where facts occur after the establishment of the Panel that affect the very existence of a
"measure" identified in the Panel's terms of referen ce. Thus, if a measure is terminated after the
establishment of the Panel, the case has become moot in respect of this measure and the Panel is in
principle not to rule on it any longer. No moot ness exists, on the other hand, where a challenged
measure did not exist already at the time of the panel establishment. In this case, the dispute is simply
inadmissible as it lacks any material object.

23. The distinction is of some importance in th e present case as it covers a variety of different
situations which need to be distinguished one from the other.

24. To begin with, the European Communities does not consider that the concept of mootness
applies to claims regarding products withdrawn alre ady before the establishment of the Panel, or to
the alleged "general suspension" or "moratorium". With respect to either, there cannot have been any
measure in existence already at the time of the establishment of the Panel. The approval procedures
have never been suspended or stalle d as alleged by the Complainants. In any event, even if certain
delays that occurred in the application of Di rective 90/220 were to be seen to constitute a
"moratorium," these must have ended with the ap plication of Directive 2001/18. The European
Communities would like to recall the US statement at the DSB meeting of 18 August DSB, where the
panel requests were being considered: " EC legislation sets out such procedures [for the approval of
crops and food products], and those procedures, as written, are not th e focus of the US complaint.
The United States only asks that those procedu res be permitted to proceed to their normal
conclusion." The European Communities wonders how one could seriously question the plain fact
that, in August 2003, the EC procedures were proceeding to their normal conclusion

25. Therefore, the European Comm unities respectfully requests the Panel to find that, with regard
to applications withdrawn before the panel establishment and the alleged "moratorium", the
Complainants' case is without object and, hence, inadmissible ab initio.

26. Mootness can apply to claims regarding a ll those product applications that have been
withdrawn after the establishment of the Panel. The European Communities' position is that the Panel
should not rule on these products.

27. The concept of mootness is well established in the jurisdictional systems of national and
international law. To name but two examples: U nder Article III of the US Constitution federal courts

may adjudicate only actual ongoing cases or controversies. The US Supreme Court has interpreted
this provision to require that parties must conti nue to have a personal stake in the outcome of the
lawsuit.
10 The International Court of Justice on several occasions held that applications had become
moot following events subsequent to the filing of an application and that, therefore, there was no
ground for proceeding to judgment on the merits any longer.11

28. The European Communities believes that the c oncept of mootness applies in the WTO dispute
settlement system as in any other dispute settleme nt system, and therefore panels are entitled to
consider case by case whether events subsequent to the establishment of their terms of reference affect
their capacity to adjudicate a given dispute. This position is confirmed by the provisions of the DSU.
The DSU, and in particular its Article 3, defines generally the purpose of the dispute settlement.
Article 3.3 refers to "the prompt settlement of situations in which a Member considers that any
benefits accruing to it directly or in directly under the covered agreements are being impaired by
measures taken by another Member" [emphasis added] . As is clear from this provision, the purpose
of the dispute settlement is to address and redress situ ations that are in actual existence. Similarly,
Article 3.4 of the DSU stipulates that "recommendations or rulings made by the DSB shall be aimed at
achieving a satisfactory settlement of the matter…" so mething that cannot be achieved if there is no
matter to settle any longer. Finally, Article 3.7 of the DSU requires a Member to "exercise [before
bringing a case] its judgment as to whether acti on under these procedures would be fruitful." Clearly,

10 "'Under Article III of the Constitution, federal co urts may adjudicate only actual, ongoing cases or
controversies ... . Article III denies federal courts the powe r 'to decide questions that cannot affect the rights of
litigants in the case before them, ... and confines them to resolving 'real and substantial controvers[ies] admitting
of specific relief through a decree of a conclusive character , as distinguished from an opinion advising what the
law would be upon a hypothetical st ate of facts.' This case-or-controver sy requirement subsists through all
stages of federal judicial proceedings, trial and appellate. To sustain our jurisdiction in the present case, it is not
enough that a dispute was very much alive when suit was filed, or when review was obtained in the Court of
Appeals ... . The parties must continue to have a 'personal stake in the outcome' of the lawsuit.'' Lewis v.
Continental Bank Corp., 494 U.S. 472, 477-478 (1990) (internal citations omitted). The Court's emphasis upon
mootness as a constitutional rule mandated by Article III is long stated in the cases. E.g., Liner v. Jafco, 375
U.S. 301, 306 n. 3 (1964); DeFunis v. Odegaard, 416 U. S. 312, 316 (1974); Sibron v. New York, 392 U.S. 40,
57 (1968). See Honig v. Doe, 484 U.S. 305, 317 (1988), and id., 332 (Justice Scalia dissenting).
11 Questions of Interpretation and Application of the 1971 Montreal Convention raising from the Aerial
Incident at Lockerbie (Libyan Arab Jamahiriya v Unite d States of America), Judgment, ICJ Reports 1998, at
"The Court has already acknowledged, on several occas ions in the past, that events subsequent to the
filing of an application may "render an application without object" (Border and Transborder Armed
Actions (Nicaragua v. Honduras), Jurisdiction and Admissibility, Judgment, I.C.J. Reports 1988, p. 95,
para. 66) and "therefore the Court is not called upon to give a decision thereon" (Nuclear Tests
(Australia v. France), Judgment, I.C.J. Reports 1974, p. 272, para. 62) (cf. Northern Cameroons,
Judgment, I.C.J. Reports 1963, p. 38).
Thus formulated, the Respondent's objection is that th ere is no ground for proceeding to judgment on
the merits, which objection must be examined within the framework of this jurisprudence.
In the view of the Court, this last submission of Libya must be upheld. The date, 3 March 1992, on
which Libya filed its Application , is in fact the only relevant date for determining the admissibility of
the Application. Security Council resolutions 748 (1992) and 883 (1993) cannot be taken into
consideration in this regard, since they were ad opted at a later date. As to Security Council
resolution 731 (1992), adopted before the filing of the Application, it could not form a legal
impediment to the admissibility of the latter b ecause it was a mere reco mmendation without binding
effect, as was recognized moreover by the United St ates. Consequently, Libya's Application cannot be
held inadmissible on these grounds."
See also Nuclear Tests, Australia v France , Judgment, ICJ Reports 1974, p.272, para 62 and Border
and Transborder Armed Actions (Nicaragua v. Hondur as), Jurisdiction and Admissibility, Judgment, I.C.J
Reports 1998, p.95, para. 66.

a case on a measure that is not in existence any l onger would be devoid of any practical purpose and,
therefore, not fruitful.

29. Consistent with these principles and as pointed out by the panel in Japan - Film, "it is not the
practice of GATT/WTO panels to rule on measures wh ich have expired or which have been repealed
or withdrawn."
12 Where there have nevertheless been ru lings on such measures, usually there was
either an agreement of the parties to do so 13 or the measure had been terminated so shortly before the
panel's ruling that the panel could not take that fact into account any longer. 14 Neither case applies in
the present situation.

For the European Communities:

11. With regard to the diagrams concerning the relevant EC approval procedures (Exhibits
CDA-21, CDA-22 and CDA-23), could the European Communities indicate whether these
diagrams correctly summarize the relevant EC approval procedures? If not, why not?

30. The diagrams contained in Exhibits CDA-21, CDA-22 and CDA-23 do not accurately
describe the notification or application procedur es contained, respectively, in Directive 2001/18,
Directive 90/220 and Regulation 258/97.

31. The European Communities has provided summar ies of this legislation in its First Written
Submission (section II.C). However, in order to fu rther ease the work of the Panel, it now attaches
flowcharts of the main notification and application pr ocedures contained in this legislation in Exhibits
EC-118, EC-119 and EC-120.

12. With the entry into force of EC Direct ive 2001/18, were all pending applications
required to be re-filed and re-examined as if new applications, irrespective of what step in the
procedure they had previously reached under EC Directive 90/220?

32. No. The relevant provision governing the tran sition between the two legislative acts is as far
as ongoing notifications were concerned is Article 35 of Directive 2001/18 according to which

1. Notifications concerning placing on the market of GMOs as or in products
received pursuant to Directive 90/220/EEC, and in respect of which the procedures of
that Directive have not been completed by 17 October 2002 shall be subject to the
provisions of this Directive.
2. By 17 January 2003 notifiers shall have complemented their notification in
accordance with this Directive. [emphasis added]
33. As can be seen from this provision the pending ap plications were only required to be up-dated
("complemented"), not to be re-submitted as a whole. Hence all results and conclusions reached on
the existing data were still relevant and would in principle not be re -examined again. However, with
regard to the up-dated information a new assessme nt was required and that assessment was to follow
the normal stages of procedure.

13 See e.g. EEC – Restrictions on Imports of Apples from Chile (BISD 27S/98) and United States –
Prohibitions on Imports of Tuna and Tuna Products from Canada, (BISD 29S/91)
14 See e.g. US – Wool Shirts and Blouses

13. With reference to para. 559 of the EC first written submission, please explain further (i)
what is the "interim approach", (ii) when it was adopted, (iii) whether it was still being followed
when this Panel was established, and (iv) how it is relevant to this dispute. In answering this
question, please also address whether a similar approach was followed with respect to biotech
products which were approved for marketing in the European Communities prior to October
1998. If not, why not?

34. The "interim approach" consisted in anticipa ting certain stricter requirements which were to
be put in Directive 2001/18 as identified in the Council Common Position of June 1999 (see also reply
to question 92 on this point) in line with the precautionary principle. With regard, in particular, to
requirements on monitoring, labelling and traceability, it was clear that the existing legislation, i.e.
Directive 90/220, did not provide a legal basis to impose these requirements on pending applications.
The notifiers, therefore, were approached to see whether they would be willing to implement such
requirements on a voluntary basis. Most agreed to do so and entered in a dialogue with the competent
authorities to work out the details, in particular of monitoring plans and codes of practice. With the
entry into force of Directive 2001/18 the "inter im approach" ended as applications could now be
assessed under the new legal basis.
15 The interim approach has not resulted in a decision on these
applications before the entry into force of Dir ective 2001/18, because the relevant issues – most often
monitoring plans – could not be solved in time.16 Dialogue on such issues continued and is continuing
under Directive 2001/18. Even if it has not resulted in a decision, the "interim approach" proves that
there has at no time been a suspension of the approval process.

35. The "interim approach", thus, is not an act that was "adopted" in any form, it is merely a
practice that was followed on the basis of a political intent to try and achieve results in the approval
procedures despite the transitional period of legislative changes.

36. Applying stricter requirements to products already authorised would have meant withdrawing
the market authorisation for these products and ob liging the applicants to re-apply under the new
Directive. Under Directive 90/220, this would have been legally impossible or at least questionable
given that the legal basis to terminate an author isation under Directive 90/220 was framed to apply to
risk issues addressed under the Directive. Approach ing the holder of the authorisation to inquire,
whether on a voluntary basis, they would withdraw their products was not an option (what would the
incentive have been for them?).

37. At the moment of the adoption of Directive 2001/18 the legislator opted for the solution to
require the authorisation holders to apply for re newal of their authorisation before October 2006.
17
The decision was based on considerations of legitima te expectations. The market authorisations had
been granted without any time limit applying. To impose a requirement of renewal by 2006
approximately corresponded to a period of ten years of market authorisation (most products
authorised were authorised around 1996) which is the maximum period possible under Directive
2001/18.18

14. During the period from October 1998 to the present, has the European Communities
rejected any applications for the placing on the market of biotech products under the legislation
at issue (EC Directives 90/220 and 2001/18 and Regulation 258/97)?

15 See Article 35 of Directive 2001/18.
16 See chronologies for notifications under Directive 2001/18, Exhibits EC 62 to 110.
17 See Article 17(1)(b) of Directive 2001/18.
18 See Article 13(2)(d) of Directive 2001/18.

38. No. There was one product that was wit hdrawn after it had received a negative assessment
(GM potato from Avebe).

15. With reference to para. 549 of the EC first written submission, is the simplified
procedure under EC Regulation 258/97 a procedu re whereby the relevant food products – i.e.,
products which are produced from but do not co ntain genetically modified organisms – require
prior approval before they may be placed on the market? If so, please explain, including by
identifying relevant legislative provisions, the competent body authorised to grant approval, etc.
If not, is the fact that thirteen such food pr oducts have been placed on the market since 1998
relevant to assessing the correctness of the compla ining parties' assertion that the European
Communities has failed to "approve" any new biotech products since October 1998?

39. GM products that are produced from but do not contain GMOs, which are placed on the
market under the simplified procedure laid down in Articles 3(4) and 5 of Regulation 258/97 require
prior recognition of "substantial e quivalence" through a national competent authority and, therefore,
do effectively require prior approval.

40. Under the simplified procedur e products cannot be placed on the market without having been
notified. Notification in turn is only possible if it has been demonstrated that the product in question
is 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
(see Article 3(4)).

41. Substantial equivalence, acco rding to Article 3(4), in principle can be demonstrated in two
ways: (1) by relying on scientific evidence availa ble and generally recognized and (2) by relying on
an opinion delivered by one of the competent food assessment bodies of the EU Member States (see
Article 4(3)). Only the latter option, however, is de facto applicable to GM products as there exists no
generally recognised scientific evidence on the substantial equivalence of these products.
Accordingly, no applicant for GM products under th e simplified procedure has ever even tried to
demonstrate substantial equivalence under this first option.

42. In order to obtain an opinion from a competen t food assessment body in an EU Member State,
an applicant has to submit a dossier on, and the competent body proceeds to a full assessment of, the
product in question.

43. Once the competent body has reached a positive opinion, th e applicant may proceed to
notifying the product on the basis of that opinion. The notification is made to the Commission.
Neither the Commission nor another Member States, at this stage, can prevent the notification on the
basis that it would not agree with the opinion. Note, however, that under Article 3(4) second
subparagraph, the Regulatory Committee establishe d at Community level has the possibility to
determine whether a type of food or food ingred ient can claim substantial equivalence. The
Regulatory Committee, thus, established in January 1998, that only GM products that do not contain
any more traces of novel proteins or foreign DNA would be admitted for a substantial equivalence
assessment under the simplified procedure.

44. Upon notification, the prod uct may be placed on the market in the European Union.
19

16. Please describe the nature and type of assessment the relevant Regulatory Committees
undertake of draft "measures"/"decisions" submitted to them by the Commission.

19 See also Exhibit EC-120.

45. 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 (so-ca lled "Comitology" Decision) and of their rules of
procedures. They assist the Commission in the exer cise of the powers delegated to it by the Council
for the implementation of its acts.
20 They are composed of representatives of the Member States and
are presided over by a Commission representative. As their name suggests, they are regulatory
bodies, involved in a decision-making process.
21

46. As any regulatory body that has to deliver an opinion on an act which involves consideration
of complex facts, including facts of a technical and scientific nature, the assessment undertaken by the
Regulatory Committees of the draft Commission measures is a complete one and covers all its
aspects. The Regulatory Committees fulfils risk mana gement functions and, as such, they have to
take into account all relevant factors, the first of which is of course risk assessment strictu sensu
(seeabove reply to question 2).

47. In practice, the Regulatory Committees receive the texts of the draft Commission's measures
at least 14 days before their meeting. Each draf t measure is supported by scientific assessments and
addresses relevant appropriate risk management is sues. In addition, draft measures may take account
also of other justifications and considerations, such as the degree of social acceptance of an existing
risk (that is, the desired level of protection), the possibility of fraud or misuse, the need to provide
accurate information to consumers etc.. Furtherm ore, as the Regulatory Committees are composed of
representatives of the Member States, they also di spose of the Member States' scientific assessments
and other justifications and cons iderations. On top of this, Regulatory Committees can base their
decision on any other available scientific or other information, such as publications and studies of
scientists or research centres, or reports produced by international, Community and national bodies,
which are available on the matter (on this point see also reply on question 17, para. 52).

48. Finally, it is important to note that each Regulatory Committee fulfils its tasks within the
framework of a specific legislation. As regards GM products, the relevant legislation is currently
contained in Directive 2001/18 and Regulation 1829/2003 . Those texts determine the elements that
are relevant for the assessment and authorisation (or rejection) of GM products.

17. On what basis does the European Communities proceed when it decides to take a
measure that does not follow the advice/opinion of the relevant scientific committee?

49. The European Communities understands this question not to be referring to the situation that
a measure is adopted for reasons that lie outside the scope of the scientific advice/opinion provided by
a scientific committee. It is clear, for example, th at the choice of the acceptable level of protection is
made by the risk regulator and not by a scientific committee. Equally, in taking its decision, a risk
regulator has to take into account a number of management considerations (e.g. other legitimate
factors) which go well beyond scientific considerati ons and are thus not addressed (and much less,
decided upon) by a scientific committee (see also replies to questions 2, 18 and 86).

50. Rather, the European Communities understands this question to be referring to the specific
situation that it would adopt a measure based on scientific grounds that do not follow the
advice/opinion given by its own scientific committee on that issue. In particular, the scientific

20 See case T-188/97, Rothmans v. Commission, [1999] ECR II-2463, para. 57-60.
21 See case T-70/99 Alpharma Inc. Against Council, [2002] ECR II-03495, para. 283.

advice would have concluded that there is no clear evidence of harm of a given product, but a measure
would be adopted based on the grounds that there may be a risk of possible harm.
22

51. At the outset, it should be stated that in the EU legal system, like in so many other legal
systems, including that of the USA, the opinions of scientific committees are only of an advisory, not
binding, nature. EU law, in principle, has defined a priori the areas where a regulatory measure
should take into account a scientific assessment. In su ch situations, the relevant provisions in the EC
legislation allow or require the relevant instituti ons to "consult" the competent scientific committee. 23
The advisory nature of scientific opinions has also been confirmed in numerous decisions of the
European Court of Justice.24

52. In forming a view on the scientific issues of risk regulation, the EC institutions are required to
take into account the opinion of the relevant sci entific committee, where one is provided, and the
latest scientific information available from any ot her reliable national, Comm unity or international
source.
25 This is a universally recognised principle of the way to conduct a proper risk assessment.
On the basis of such scientific information they may decide not to follow, partly or totally, the views
of a specific scientific committee wh en the balance of all the scien tific evidence available suggests
that the chosen level of protection is not likely to be achieved by following the opinion of the specific
scientific committee, or when other legitimate fa ctors so require. Since the late 1980s, the EC
institutions are required to provide an explanation of the reasons for not following the opinion of the
specific scientific committee relevant to the matter under consideration.

53. These principles are well illustrated in a case that involved a measure taken in the field of risk
regulation on additives in feedingstuffs. The C ouncil had adopted a regulation which effectively
withdrew a marketing authorisation for a number of antibiotics used as additive in feedingstuff.
26 The
Council based its decision on the grounds that th ere was a possible risk for human health

22 Generally speaking, it is not uncommon, in the EU as in many other regulatory systems, for opinions
of scientific committees to provide incomplete or inco nclusive guidance to risk managers because they are
termed with phrases like: "there seems to be no reasonable ground to believe, on the basis of the information
available, that a significant risk to health or the environment is likely to arise", etc. In particular, scientific
committees frequently have a hard time to evaluate scientific uncertainty and its implications to risk.
23 See also for example the relevant provisions in Regulation 1829/2003 on genetically modified food
and feed. Article 6 lays down the rules for obtaining an opinion from the "Authority » (i.e. EFSA). Article 7(1)
then states that the Commissi on is to take a decision " taking into account" the opinion of the Authority, any
relevant provisions of Community law and other legitimate factors relevant to the matter under consideration. »
[emphasis added].
24 See, e.g., Case C-120/97, Upjohn, [1999] ECR I-223, at paragraph 47, and Case C-405/92, Armand
Mondiet [1993] ECR I-6133, at paragraphs 31-32 and 36 (both judgments holding that the opinion of the
scientific committee is not of mandatory but of advisory nature only); see also Case T-13/99, Pfizer [2002] ECR
II-3305, at paragraphs 196 and 201 (holding that the Commission is not obliged to follow the opinion of the
scientific committee because its opinion is of advisory nature only. On Pfizer more generally, see also below).
25 See, e.g., third recital of preamble to Council Regulation (EEC) 2377/90 establishing a procedure for
the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin,
(OJ No L 224, 18.08.1990, p.1-8), which provides: "Whereas in order to protect public health, maximum
residue limits must be established in accordance with generally recognized principles of safety assessment,
taking into account any other scientific assessment of the safety of the s ubstances concerned which may have
been undertaken by international organizations, in particular the Codex Alimentarius or, where such substances
are used for other purposes, by other scientific committees established within the Community".
26 Council Regulation (EC) N° 2821/98 of 17 Decembe r 1998 amending, as regards withdrawal of the
authorisation of certain antibiotics, Directive 70/524/EEC concerning additives in feedingstuffs (OJ 1998 L 351,
p.4)

(development of antibiotic resistance) and that in the light of scientific uncertainty based on a number
of scientific reports and studies from several sources it was necessary to take preventive action.

54. The relevant scientific committee which had b een consulted by the European Commission in
preparation of the decision (and had dealt specifica lly with the question of risk of development of
antibiotic resistance) had concluded that the use of a specific antibiotic did not seem to constitute an
immediate and significant risk to public health. The Community institutions, however, while relying
in parts on that opinion, disagreed with its conclu sions on the basis of a broader set of scientific
evidence coming from several other sources. They did so on the basis of other scientific information,
namely of conclusions and recommendations in a numb er of reports produced by other international,
Community and national bodies, published in the years preceding the adoption of the contested
measure. In particular, they took account of sever al studies presented by scientific bodies of the EU
Member States.

55. The Council's decision was challenged before th e Court (of First Instan ce) of the European
Communities.
27 The applicant alleged, amongst other clai ms, an error of risk assessment and risk
management and a misapplication of the precautionary principle. The applicant challenged, inter alia,
the fact that the Community institutions had not fo llowed the opinion of its own specific scientific
committee.

56. The Court first recalled that the scientific co mmittee was merely an advisory body, that its
opinions, therefore, were not binding on the Community institutions, and that its role, in a procedure
designed to culminate in a decision or a legislative measure, is restricted, as regards the answer to
questions which the competent institution has asked it, to providing a reasoned analysis of the relevant
facts of the case in the light of the current know ledge about the subject, in order to provide the
institution with the factual knowledge which will enable it to take an informed decision.28

57. The Court pointing to the competent institu tion's obligation to assess the probative value of
the opinion delivered by the committee went on to state:

To the extent to which the Community institution opts to disregard the opinion, it
must provide specific reasons for its findings by comparison with those made in the
opinion and its statement of reasons must explain why it is disregarding the latter. The
statement of reasons must be of a scientific level at least commensurate with that of
the opinion in question. In such a case, th e institution may take as its basis either a
supplementary opinion from the same committ ee of experts or other evidence, whose
probative value is at least commensurat e with that of the opinion concerned. In the
event that the Community institution disregards only part of the opinion, it may also
avail itself of those parts of the scientific reasoning which it does not dispute.
29
[emphasis added]
58. On the basis of these principles, the Court found that the Community institutions were entitled
in that specific case to disregard the conclusions drawn by the relevant scientific committee.

59. The Court recalled in this context that a sc ientific opinion is a necessary but not sufficient
condition for risk regulation. It stated:

27 Case T-13/99, Pfizer [2002] ECR II-330.
28 Ibidem at paras. 196 and 197.
29 Ibidem at para. 199.

That finding can also be justified on grounds of principle relating to the political
responsibilities and democratic legitimacy of the Commission. Whilst the
Commission's exercise of public authority is rendered legitimate, pursuant to Article
155 of the EC Treaty (now Article 211 EC), by the European Parliament's political
control, the members of SCAN [i.e. the scientific committee in question], although
they have scientific legitimacy, have neith er democratic legitimacy nor political
responsibilities. Scientific legitimacy is not a sufficient basis for the exercise of public
authority.
30 [emphasis added]
60. On the basis of the above principles the C ourt examined whether the Community institutions,
in relying on the other relevant scientific information, had erred in concluding that the use as a growth
promoter of the antibiotic in question constituted a risk to human health. The Court heard experts on
the question of whether there is a risk of developm ent of antibiotic resistance and drew from that
discussion the following conclusion:

It is not for the Court to assess the merits of either of the scientific points of view
argued before it and to substitute its assessment for that of the Community
institutions, on which the Treaty confers sole responsibility in that regard. In the light
of the foregoing, the Court nevertheless finds that the parties' arguments, supported in
each case by the opinions of eminent scientists, show that there was great uncertainty,
at the time of adoption of the contested re gulation, about the link between the use of
virginiamycin as an additive in feedingstu ffs and the development of streptogramin
resistance in humans. Since the Community institutions could reasonably take the
view that they had a proper scientific basis fo r a possible link, the mere fact that there
were scientific indications to the contra ry does not establish that they exceeded the
bounds of their discretion in finding that there was a risk to human health.31
61. On the basis of that conclusion the Court found that the applicant had not established that the
Community institutions had erred when disregarding the opinion of the relevant scientific committee
and concluding, on the basis of all scientific knowledge available at the time of the adoption of the
contested regulation, the use as additive in feedingstu ffs of the antibiotic in question entailed a risk to
human health.32

62. In providing the above reply the European Communities hopes to have addressed also, in
parts at least, the additional questions raised at the first hearing by Mr. Kumar. Mr. Kumar had
inquired whether there are multiple committees invol ved in a risk assessment process. The answer
generally speaking and as regards GMOs and GM products is "yes", as EU Member States usually
have independent scientific bodies or in house experts (i.e. within the competent authority) that advise
the competent authorities on scientific issues in risk regulation. 33 This is for example the case of

30 Ibidem at para. 201.
31 Ibidem at para. 393.
32 See Ibidem para. 40. Note that on the same day the C ourt decided on another case that dealt with
similar facts, i.e. the withdrawal of a market authorisation for another antibiotic used as additive in
feedingstuffs. In this case, the Community instituti ons had taken the decision without specifically consulting
their own scientific committee. Instead they had relied on the scientific committee's opinion in the above case
and on the relevant reports and conclusions of other na tional and international bodies mentioned above. The
Court found that the Community institutions were entitle d to rely on that information, see Case T-70/99
Alpharma Inc. v. Council, [2002] ECR II-03495, in particular at para. 240.
33 The only exception to this statement would s eem to arise when exclusive competence has been
granted to the EU and a unique risk assessment agency at EU level has been established, e.g. in the area of
providing marketing authorisation and supervision of medicinal products for human health (see Council

France (Commission de Génie Biomoléculaire - CGB), Belgium (Biosafety Advisory
Council/Bioveiligheidsraad/Conseil consultative de Biosécurité), the Netherlands, (Committee on
Genetic Modification - COGEM), Spain (Comisi ón de Bioseguridad), Germany (Robert-Koch-
Institut), Italy (Istituto Superiore di Sanità), the UK (Advisory Committee on Release to the
Environment – ACRE) and Sweden (Swedish Board of Agriculture.

63. Mr. Kumar also inquired whether the opinions of the EC scientific committees had an
overriding effect over the opinions issued by such b odies at the Member State level. This is not the
case. In light of the above principles it is clear that the EC scientific committee's opinion is merely of
an advisory nature and that the EC institutions ma y disagree with its conclusions on the basis of other
relevant scientific information, including that of scientific bodies in the Member States.

64. Furthermore, Mr. Kumar inquired whether the relevant scientific committees were
specifically set up to provide advice on GMOs only or whether they would also provide advice on
non-GMO issues. At the EC level, up to the establishment of the European Food Safety Authority
(EFSA) in 2003, three scientific committees were consulted on GMOs, namely the Scientific
Committee on Plants, the Scientific Committee on Foods and the Scientific Committee on Animal
Nutrition. Neither was specifically established fo r issues concerning GMOs only, but had a broader
mandate.
34 With the establishment of EFSA, a scientific Panel specifically for GMO issues has been
established. This Panel deals both with release into the environment and with food use questions. As
for scientific bodies in the Member States, a co nsiderable number of th em were established
specifically to provide advice on GMOs only. This is, for example the case of the Biosafety Advisory
Council in Belgium or the COGEM in the Netherlands.

65. Mr. Kumar's last question, finally, namely whether the Commission had ever disregarded the
advice of EC scientific committees, has been answered in the affirmative by the above examples.

18. In the consideration of notifications s ubmitted since October 1998, what aspects of
potential risks have not been specifically or su fficiently addressed by the relevant scientific
committees?

66. In light of its reply to question 17, it is clear that the "relevant scientific committees" in the
risk assessment of GMOs and GM products were and are not only the EC scientific committees but
also Member State scientific committees as well as other international scientific bodies. The
European Communities, however, understands this question to specifically mean the committees at
the Community level, namely the Scientific Co mmittee on Plants and the Scientific Committee on
Foods, both of which are now united as one specifi c panel on GMOs under the European Food Safety
Authority (EFSA).

Regulation (EEC) 2309/93 of 22 July 1993), although even in such a situation the derogations laid down in
Article 95 of the EC Treaty may still apply.
34 The SCPs mandate was : "Scientific and technical questions relating to plants intended for human or
animal consumption, production or processing of non-food products as regards characteristics liable to affect
human or animal health or the environment, including the use of pesticides."
The SCFs mandate was: "Scientific and technical ques tions concerning consumer health and food safety
associated with the consumption of food products and in particular questions relating to toxicology and hygiene
in the entire food production chain, nutrition, and applications of agrifood technologies, as well as those relating
to materials coming into contact with foodstuffs, such as packaging."
The Animal Nutrition's Committee's mandate was:
"Scientific and technical questions concerning animal
nutrition, its effect on animal health, on the quality and health of products of animal origin, and concerning the
technologies applied to animal nutrition."

67. In general terms, the following can be said: First, the role of these scientific committees was
(and is) to provide advice on scientific issues only. These committees' role was (and is) not to decide
on the granting of a market authorisation as that decision has to be taken not only on the basis of the
scientific considerations referred to the Committee but also in taking into account other legitimate
factors and, in particular, risk management c onsiderations (see also reply on question 16) The
Committees' role and mandate was (and is) not to address such risk management considerations,
which include a number of other issues among wh ich traceability, post-market monitoring and codes
of good agricultural practice. It should be pointed out, however, that the committees, in the relevant
period would sometimes address such issues, and in particular issues of post-market monitoring and
codes of good agricultural practices. Indeed, as has been shown in the first submission, in four cases,
the SCP recommended the development of such m onitoring plans and/or codes of good agricultural
practices.
35

68. Second, the committees' mandate to address scientific issues was limited in that it was based
on Directive 90/220 and, thus, did not take into account new standards as they were to be
implemented through the new legislation. In particular, standards for a comprehensive risk
assessment were only developed through Directive 2001/18. Certain risk considerations were only
added through the new legislation, such as, fo r example, the impact on the environment and on
biodiversity of changed agricultural practices.

69. Third, on some of the scientific issues that the opinions of the committees would address,
other scientific committees in the Member States w ould sometimes have divergent opinions. In its
first submission the European Communities has descr ibed for each individual application, which
Member States raised (and maintained) objections or requested additional information, including
where an opinion of the relevant EC scientific co mmittee had already been issued. These cases will
be further documented through the additional documents which the Pa nel has requested the European
Communities to provide.

70. Finally, the opinions of the scientific comm ittees would sometimes become "outdated" by
virtue of new research data. As has been explained, many of the scientific issues surrounding the risk
assessment of GMOs are in constant evolution. To take one example: the scientific requirements on
molecular characterisation have developed rapidly in the past years. Thus, on the basis of new
methods of molecular characterisation it was found in 2001, that the molecular characterisation, on
the basis of which the product Roundup Ready So ybean (C/UK/94/M3/1) had been authorised in
1996, did not correspond to the molecular description of the actual product on the market: i.e. extra
DNA fragments were found to be inserted in the plan t genome contrary to what had been indicated
and notified in the application for the market authori sation. This is one exam ple of a new scientific
issue that has arisen in the course of examinati on of GMO products and which has motivated greater
emphasis on molecular characterisation in recent years.

19. Please comment on Canada's remarks at pa ra. 101 of Canada's first oral statement,
specifically with respect to Austria's different treatment of maize and oilseed rape.

71. The European Communities recalls that Article 5.7, rather than Article 5.5 SPS Agreement is
the relevant provision to assess the national safeguard measures (see also reply to question 110). The
European Communities further recalls that Article 5.5 SPS Agreement is concerned with, if anything,

35 See products Ms8Rf3 oilseed rape, Liberator oilseed rape, Falcon GS40/90 oilseed rape and A5/15
fodder beet.

the consistency of definitive behaviour of the European Communities rather than with provisional
steps in the application process taken at regional level (see the answer to question 38).

72. Contrary to what Canada asserts at para. 101 of its oral statement, namely that it is not clear to
what the European Communities re fers, the relevant matters are summarised in annex CDA-77, at
page 3. For the avoidance of doubt, the public doc ument there referred to is attached to this
response.
36

73. Similarly, Canada's asser tion that "Austria's concerns had no basis in the scientific
information provided to the committee" is not an acc urate summary of the opinion of the Scientific
Committee on Plants (Exhibit CDA-77). In that opini on, the scientific committee first pointed out to
the Commission that the Austrian document did not c ontain any new science. It thus signalled to the
Commission that the outstanding issues were issues for the regulator, rather than issues for the
scientists.

74. As regards Austria's "different treatment " of maize and oilseed rape, the European
Communities has pointed out that no two risk assessmen ts are the same, and that is certainly the case
when the crops concerned are different. Furthermore, the primary issue in the case of oilseed rape
concerns herbicide resistance; whereas in th e case of Maize (Bt-176 and MON 810) the concerns
rather centre on questions of insecticidal propert ies and antibiotic resistance. Nor should it be
forgotten that the oilseed rape Community authorisations were adopted in 1996 and 1998, whereas the
Austrian measures with regard to Maize T-25 were adopted in 2000, at a time when both scientists
and legislators were in the process of re-assessing both the scientific issues on the one hand, and the
appropriate legislation on the other hand.

20. Please explain to what extent and how the European Communities took into
consideration the provisions of Annex C of the SPS Agreement in the preparation of EC
Directive 2001/18.

75. The European Communities always drafts its legislation in light of its international
obligations including its WTO obligations. Accordingly, recital 13 of Directive 2001/18 states that

The content of this Directive duly takes in to account international experience in this
field and international trade commitments and should respect the requirements of the
Cartagena Protocol on Biosafety to the Convention on Biological Diversity. As soon
as possible, and in any case before July 2001 , the Commission should, in the context
of the ratification of the Protocol, submit the appropriate proposals for its
implementation. [emphasis added]
76. As the European Communities has stated in its submission, to the extent that it addresses risks
coming under point 1 of Annex A of the SPS Agreement, the European Communities accepts that the
approval system set up under Directive 2001/18 (as well as under Directive 90/220) is a "procedure to
check and ensure the fulfilment of sanitary and phy tosanitary measures" within the meaning of Point
1 of Annex C.
37 The system is designed to be applied in a way that is compatible with the obligations
set out in Annex C. This fact has not been put into question by the Complainants who have not
challenged the system as such.

36 Exhibit EC-121.
37 First written submission of the European Communities, para. 474.

21. At para. 34 of its oral statement, the European Communities notes that it "cannot
believe that the Panel would rule on this case without taking [scientific and technical] advice".
To date, the European Communities has not, ho wever, identified any specific scientific or
technical issues. In order to allow the Panel to continue reflecting on this issue, the Panel would
appreciate it if the EC could identify, during today's session, specific scientific or technical
issues which it considers would justify the Panel in seeking expert advice.

77. The European Communities would first of all wa nt to refer the Panel to all the issues it has
highlighted with regard to each specific product notification in this case in the chronologies and
attached documents contained in its First Written Submission.
38 Furthermore, the European
Communities would also refer to its answers to th e three questions of the Panel on scientific and
technical advice, issued on the 3 June, which speci fically address the issue of the need for scientific
and technical advice.

78. In short, as regards the identification of an y specific or technical issue which would justify
seeking expert advice, and on the basis of the first he aring, where the complainants admitted to be in
agreement with the favourable, positive scientific opi nions of the scientific committees at community
level, but only with these opinions, the Eur opean Communities considers that all scientific and
technical issues that it had submitted to justify the ti me necessary for the full consideration of all the
applications referred to in the complainants cl aims, and which are not in agreement with these
positive opinions, or which were not considered in the issuance of these positive opinion, or which
cover new scientific information available afte r the positive opinion, or which cover different,
unresolved issues at the time, warrants seeking tec hnical and scientific advice, as the complainants
would be in disagreement with them being a sound basis for the necessity to have further considered
these applications.

79. The Communities are therefore confirmed in th eir view of the need for such advice, and
repeat their request for a meeting with scientific an d technical experts, covering at least these issues
found in dispute between the parties.

80. Some of the Panel's questions, either to all pa rties or to some of them, for example questions
23 to 34, or question 78, are of a scientific and technical nature, or have a strong scientific and
technical background. These are all questions that are also the subject of ongoing scientific and
technical debate. Hence, as it may be anticipated th at different views will be expressed by the Parties
on these questions, the European Co mmunities considers that they wo uld also justify the Panel in
seeking expert advice.

For all parties

22. How many products have been approved under the simplified procedure for foods
produced from but not containing GMOs since October 1998?

81. Seven GM products have b een approved under the simplified procedure since October 1998
(including one, MON 809 - approved during that same month). Altogether, thirteen such products
have been approved since the entry into force of Regulation 258/97 on the 15 May 1997.

23. The European Communities states at paras. 26-28 of its first written submission that
none of the current biotech gene transfer me thods are able to precisely control where the
foreign gene will insert into the recipient cell's genome, or whether that insertion will be stable,

38 Exhibits EC-62 to 110.

and further describes the screening for the desire d traits. How do the points described here
compare with the results of conventional selective breeding techniques?

82. The Panel question only addr esses the introduction of foreign DNA into plants, as referred to
in these paragraphs of our first written submission.

83. There are several fundamental differences betw een the methods of introduction of a genetic
modification through genetic engineering, as referre d to in paragraphs 21 to 25 of the first written
submission by the European Communities, and conventional selective breeding techniques.

84. First, as regards conventional selective breedi ng techniques, whether the organism is obtained
through the selection of single or multiple mutati ons, or through the inbreeding of characters from
related or heterologous parents, all the desired tr aits are generally expressed from genes (mutated or
not) which are located in their natural chromosoma l context, because the genes have either been
mutated on site or have undergone homologous recombination.

85. Indeed, when an organism is expressing a new character due to a mutation, whether in one or
in several genes, these genes reside in their norma l genomic context. Furthermore, the inbreeding of
several character from different parents leads to a ne w combination of genes, for example by virtue of
natural recombination at meiosis, or by virtue of polyploidy, but again only with the genes being
generally located in their natural chromosomal context.

86. In these conventional selective breeding techniqu es, only accidental and rare events may lead
to the change of chromosomal location of the genes responsible for the new desired traits.

87. On the contrary, the techniques of plant gene tic modification through genetic engineering lead
systematically to the "accidental" introduction of th e new genes, conferring the new desired traits, at
random location in the plant chromosomes. In fact th ere is scarce scientific evidence of the biological
basis for any possible preference of the chromosomal context or location that may be consequential to
using one or the other of the transformation techniques.

88. This has very significant consequences as rega rds the differences with conventional selective
breeding techniques.

89. Firstly, the chromosomal context is known to have a critical importance on the level, the
stability, and the regulation of the expression of gen es. Genes that have a particular chromosomal
location maintained through evolutionary time have acquired, with the selection of their mutual
interaction with other genes and their particular natural chromosomal context, a fine tuned expression,
including the level, the stability and the regulation of their expression.

90. On the contrary, the very rudimentary techni ques available today for the genetic engineering
of plants lead to the introduction of the new genes in a chromosomal context, unknown to the scientist
performing that introduction, and also "unknown" to the genes introduced.

91. This chromosomal context may be one whic h is highly expressed, or generally silent, or
composed of redundant non expressed DNA, etc… It may contain in the close or more distant vicinity
of the insertion, critical important regulatory se quences and elements which will affect the expression
or the stability of the newly inserted gene.

92. Some of this may be assessed in the process of the risk assessment of the GMO and in the
collection of relevant data on the new genetically mo dified plant, while much of it will remain cryptic

and will only manifest itself in particular circumst ances, for example in very specific environmental
or pedo-climatic conditions.

93. This may eventually lead to specific un certainties as regards the risk assessment of a
particular GMO.

94. There is, on that first aspect, both a signi ficant qualitative and quantitative difference with
conventional selective breeding techniques, with regard to the scale of time that has been available for
the presence in their natural location, and hence also to some extent for their empirical assessment, of
the genes which are responsible for the desired traits , as well as with regards to the time that has been
available for the possible identification of some issues relevant for their expression or potential
secondary or pleïotropic effects.

95. Secondly, a very important consequence, as regards the difference with conventional selective
breeding techniques, derives from the unique ability of genes newly introduced by these genetic
engineering techniques to disrupt, in the process of their chromosomal integration, some endogenous
genes of the organism, thereby in terrupting or modifying their ex pression, or creating the expression
of a newly chimaeric protein.

96. Again, some of these consequences may be assess ed in the process of the risk assessment of
the GMO, and in the collection of relevant data on the new genetically modified plant, but much of it
may remain cryptic and will only manifest itself in particular circumstances, for example in very
specific environmental or pedo-clima tic conditions. This may be particul arly true if the disruption of
the endogenous gene affects a regul atory gene, or a regulatory pathwa y, that is relevant only in
specific environmental conditions. This may lead ag ain to pleïtropic effects only in these specific
environmental conditions.

97. For instance, as a theoretical example, the di sruption of a gene that is only necessary for the
production of a metabolite or a signalling molecule necessary for the survival of a soil micro-
organism associated with the roots of that plant, bu t which is neither detrimental nor beneficial to that
plant and hence not a pest for that plant, might remain unnoticed in the collection of the risk
assessment data. However, if that micro organism is a key component of the equilibrium of the soil
ecology, the disruption of the plant gene may have significant indirect environmental consequences.

98. Also, if there is a new chimaeric protei n expressed, and especially if its expression only
occurs in particular environmental circumstances which may remain unnoticed in the risk assessment
process, there may be relevant toxicity and allergenicity questions to be addressed if that expression is
nevertheless exposing animals or humans to the new chimaeric protein in those circumstances. In fact,
earlier applications for the placing on the market of GMOs showed that this was a real situation, as the
identification of such fusion protein happened by accident through questions of competent authorities
and required further analysis to show the safety of the fusion protein.

99. There is also, on this second aspect, both a significant qualitative and quantitative difference
with conventional selective breeding techniques.

24. How does the potential for a llergenicity to be introduced through biotech foods (e.g., as
described by the European Communi ties at para. 45 of its first written submission) compare
with the potential for its introduction through non-GM novel foods?

100. It is important for the context of this questi on, to clarify that there is currently no scientific
method available to ascertain whether a peptide, a protein, or another metabolite or molecule, contains

an allergen that could give rise to significant alle rgies in humans, either as food, or as a source of
allergen exposure by other means (respiratory, c ontact,…). The same is al so true for susceptible
animals.

101. All data from the methods currently availabl e to test for the potential for allergenicity
(sequence comparison, in vitro protein digestibility tests, in vitro tests on cultured cells from atopic
individuals, etc..) are not always provided in the applications for placing on the market of GMOs, and
these methods are only indicative, i.e. they provide for a limited ground to assess the potential for
allergenicity as a scientific basis for a possible me asure. The only test that would provide for such
answers with some certainty would be to conduc t allergenicity tests on humans, which, for obvious
ethical reasons, can not be performed as a pre marketing risk assessment pre-requisite.

102. There is therefore generally a significant degree of uncertainty as regards the issue of
allergenicity, whether for GMO or for novel food. However, there are major differences as regards
the potential for allergenicity between a GMO and a non-GM novel food.

103. The first one relates to the origin of the nove l trait introduced in the plant, or the novel food
itself. As has been said elsewhere, one of the sp ecificity of genetic engineering is the ability to
combine genes across species, or even kingdom's barriers. In a GMO, when the trait introduced
originates from another "donor" organism, such as a b acterium or another species, as compared to the
"recipient" plant, that "donor" organism may have no history of consumption as a food (this is the
case, for example, of Bacillus thurigiensis, the "donor" organism of Bt genes), and there is therefore
no historical data in this situation as to whethe r that "donor" organism has a significant allergenic
potential as a food source, let alone the allergenic pot ential of the individual product of the new gene
inserted, or any metabolite derived from the activity of the new gene product. There is therefore no
data available, apart from the indicative methods referred above, that would indicate whether a GMO
may or may not have a different allergenicity potential.

104. On the contrary, when a non-GM novel food has not been consumed significantly in a given
population which has a particular genetic set-up, th ere may also be issues regarding the potential for
allergenicity in that population. But contrary to the potential allergenicity of the GMO cases described
above, there would be some history of consumptio n for that non-GM novel food, at least in some
other populations, or in the history of mankind. Conceptually, the two cases are therefore radically
different.

105. The second major difference relates to the situ ation where the non-GM food, or the "donor"
organism of the new trait of a GMO, is known to be an allergen of significant impact. In this situation,
the non-GM food can be assessed on the basis of its known allergenicity. On the contrary, for a GMO,
it may not be known what molecule is responsible for the allergenic potential of the "donor"
organism. Furthermore, whether the gene responsible for that potential is the gene transferred or not in
the GMO, the conditions of expression of that gene (in which plant tissues, at what stage of the plant
development) may be significantly different from that of the "donor" organism or from the expected
expression of the GM construct, due to the random integration of that gene in the genome of the GMO
(see answer to question 23), and thereby modify radically its allergenicity potential. Also the
differences in the localisation in the cell or in th e plant organism of the gene product, or the
metabolites produced by that gene product, may lead to significant differences in the exposure to the
allergen, and therefore significant differences regarding the allergenic potential.

106. As an example from earlier cases at the stage of research and development in the development
of GMOs, the introduction in another plant species of an "housekeeping" gene from the Brazil nut (a
food known to be responsible for allergies) because of the potentia l of that gene product as an

interesting food or feed source, corresponded to the unforeseen transfer of one of the potent allergens
of the Brazil nut and required the interruption of that development program.

107. The third major difference regarding the pot ential for allergenicity between GMOs and non-
GM novel foods is a consequence of the random integr ation of the genetic construct in the genome of
the GMO (see answer to question 23), which may lead to the production of new and unforeseen
chimaeric fusion protein.

108. There is, in this third aspect, a whole range of relevant differences in the type of fusion
proteins that may be generated at the genomic integration site(s) in a GMO (involving or not the
introduced new protein gene, if its sequence is inte rrupted or modified in the integration event,
involving or not genes at the site of integration in the host genome, involving or not further distinct
genetic elements, when the integration is leading to significant genetic rearrangements at the site of
integration), many of which are specific to th e GMO situation compared to a non-GM novel food
situation. However, in all cases, the potential gene ration and expression of a new fusion protein in the
GMO may or may not have a significant allergenic potential, and its assessment is relevant in the
context of the allergenic potential of a GMO comp ared to a non-GM food. Even if the unexpected
production of a fusion protein is identified in the GMO in its risk assessment process, the inability to
assess with certainty its allergenic potential remains true.

109. There may be exceptional or marginal situati ons where a fusion protein may be generated in
non-GM novel food, as well as in traditional foods, but never as often, nor with the same level of
heterology, as for the different sources of the fusion protein in a GMO.

110. There are further scientific reasons that may be elaborated and which also warrants significant
differences in the potential for allergenicity betw een GMOs and non-GM novel food, but already for
the reasons stated above, it is again obvious that there are both qualitative and quantitative differences
between both.

25. How do concerns regarding potential problems of invasiveness or persistence of biotech
crops in the environment (e.g., as described by the European Communities at para. 55 of its
first written submission) compare with the deve lopment of herbicide/pesticide resistance in
conventional crops which may then become invasive or persistent in the environment?

111. A new character conferred to a plant, throug h the introduction of a new trait into a GM plant
or by the conventional selection of a new trait, may c onfer a selective advantage to that plant. If it is
the case, it may result in the invasiveness or persis tence, in the natural or agronomic environment
where the relevant selection pressure is present, of any plant where that trait is expressed and where it
confers the necessary selective advantage.

112. Thereby, "resistance genes", conferring resi stance to a given selection pressure, natural or
agronomic, may be responsible for some invasive ness or persistence under the relevant selection
pressure, if they outcross in other plant species such as wild relatives, in neighbouring non GM crops
of the same species, or if they remain in the ne xt generations of the original GMO, present as
volunteers.

113. There are however significant differences for the issue of potential invasiveness or persistence
in the environment between herbicide/pesticide r esistance in GM plants an d in conventional crops,
which remain, as always, to be necessarily assessed on a case by case basis.

114. First, the traits conferring herbicide/pesticide resistance in conventional crops, even if present
as a multiple resistances, have no a priori reason to be genetically linked between themselves, or to
any other relevant character that may have otherwise negative impacts, i.e. have no a priori reason to
be transferred together into interfertile plants from the same or from a different species.

115. On the contrary, the construction of GMOs, especially those from the first generation, were
obtained from single transformation events, where a ll genes introduced were tightly linked in the
same genetic construct. For that reason, any herb icide/pesticide resistance gene from a GMO plant
that would have the potential to confer to the organism where it is expressed the character of
invasiveness or persistence in the relevant environm ent, would lead to the maintenance, and possible
spread, in that environment of a gene set comp rising all the characters originally present in the
construct that would be genetica lly linked together, including any other character present in the
construct that may have potential negative impacts.

116. For instance, the presence in the original cons truct of a particular GMO of a gene conferring
herbicide resistance, genetically linked together with an antibiotic r esistance marker gene, would lead
to the maintenance, and possible amplification in the environment, under the relevant herbicide
selection pressure, of a gene pool containing that an tibiotic resistance marker gene. This could never
be the case for a conventional herbicide resistance crop.

117. Secondly there is a major difference in the imp act of any potential concerns of invasiveness or
persistence between herbicide/pesticide resistance in GMO and in conventional crops, linked to the
type of resistance conferred in one or the other type of crops.

118. As regards herbicide resistance, the herbicid es conventionally used for weed control in crops
are selective herbicides, i.e. they kill selectively specific weeds, a nd the selectivity of such herbicides
is often limited to one crop, or group of crop sp ecies; their use is sometimes only limited to some
varieties of that crop. In general the efficacy of these selective herbicides has a limited spectrum, i.e.
certain weed species may not be controlled. The mana gement of their use also takes into account the
very important parameter of crop rotation, namely how a selective herbicide may be effective to
manage the volunteers from the previous harvest in the next crop season.

119. By opposition, the herbicide resistance curren tly conferred by genetic modification to GMOs
are radically different, as they confer r esistance to non selective (total) herbicides, i.e. an herbicide
that kill all plant species. But they can be used on a specific crop that has no natural tolerance to it
when that crop has been engineered to resist to that total herbicide by the introduction of bacterial
genes. The aim to tailor a target crop to resist a non selective herbicide is to have a broader spectrum
of weed control, as well as tying together herbic ide producers and seed companies in order to try
expand their market shares.

120. At present two non-selective herbicides, gl yphosate and glufosinate, are the dominant
compounds; they have also relatively more beni gn environmental impacts than some other non
selective or even selective herbicides.

121. It would be devious logic to believe that the issues of poten tial persistence and invasiveness
that may be conferred by herbicide resistance in the different types of crops are similar (through GM
and non GM crops), as far as it is currently not possi ble to confer resistance to these "environmentally
friendly" non selective herbicide through conventional breeding.

122. For instance a limited list of the specific con cerns of these non selective herbicide traits that
need to be assessed in GMOs, rela te to the building of unexpected r esistance pattern, such as multiple

resistance in Brassica napus volunteers or related wild plants, including resistance to these two non
selective herbicide
39; the management of these multiple resi stant volunteers or wild relatives,
especially under climatic conditions where they may remain dormant for long period of time in the
environment; the new problems related to crop management when successive crop species in rotation
(oilseed rape, maize, sugar beet, soybean, possibly also soon wheat) do contain one of these two non
selective herbicide resistance (and potentially the two in volunteers of these plants, due to
unintentional gene stacking), and therefore genera te new herbicide manage ment problems due to
reliance on a single technology; the loss of the ab ility to use these "environmental friendly" non
selective herbicides in certain circumstances, in cluding in agronomic, non agronomic or industrial
environments, due for instance to the building of multip le resistance in feral plants, or to overtaking
by resistant volunteers because of successive u se of the same crops, no tillage and careless crop
management, and the need therefore to resort on othe r weed killers that may have negative effect on
the environment
40; etc.

123. For further illustrations of the specific questi ons raised by herbicide resistance traits in GM
crops, compared to conventional herbicide resist ant crops, see recent accounts of the relevant
scientific expertise41, or an example of an agronomy technical note addressing what farmers need to
know about transgenic crops, developed under a grant from the USDA42.

124. As regards pesticide resistance, again th ere is no possible logical comparison between
pesticide resistant GM crops and conventional crops, as the char acter of pesticide resistance used are
different in both types of crops, and their r espective impact assessment concerning potential
invasiveness and persistence, on a case by case basis, may not be comparable.

125. For instance, most pesticide resistant GM cr ops application covered by the claims of the
complainants have been engineered to resist to some lepidopteron insects (European corn borer) by
the introduction of the bacterial insecticidal toxin Bt. This cannot be achieved through conventional
breeding.

126. Likewise, the specific introduction of genetic elements conferring specific and potent virus
resistance, which may be obtained by genetic engi neering, but not by conventional breeding, may
raise specific question regarding their potential for i nvasiveness or persistence, including any relevant
biohazard issue that may need to be assessed as regard s to the evolution of th e target and non target
pathogenic virus population.

39 See for instance in Canada: Hall L. et al. 2000. Pollen flow between herbicide-resistant Brassica
napus is the cause of multiple-resistant B. napus volunteer s. Weed Science 48, 688-694. Ellstrand, Norman C.
2001. When transgenes wander, should we worry ? Plant physiology Vol. 125, p. 1543-1545.

40 See the account of GM herbicide resistance mana gement problems due to the mishandling of the
technology in Argentina. New Scientist. 17 April 2004 . Argentina's bitter harvest. Sue Branford. pp. 40-43.
Exhibit EC-122.
41 1st European Conference on the co-existence of genetically modified crops with conventional and
organic crops. Exhibit EC-123.
FAO technical meeting on benefits and risks of transgenic herbicide resistant crops, Rome 1999.
Exhibit EC 124
42 Genetic engineering of crop plants . What farmers need to know ab out transgenic crops. By Nancy
Matheson, NCAT Agriculture Specialist. Agronomy technical note. ATTRA (Appropriate technology transfer
for rural areas). October 2001. Exhibit EC-125

127. For further information and examples regarding th e specificity of the risk assessment issues of
invasiveness and persistence of GM plants as compar ed to herbicide/pesticide resistant conventional
crops, see some recent review papers or reports from the relevant scientific expertise
43.

26. For what, if any, crops is Europe considered to be the center of origin? What relevance
does this have to the approval of biotech crops?

128. "Europe" is a term covering diffe rent concepts that may affect th e answer to this question. As
the region usually referred to under the United Nati ons Economic Commission for Europe, it covers a
much wider geographical scope than the western European region. If it refers to the geopolitical entity
corresponding to the European Comm unities, as referred to in the EC legislation, which is relevant
here, however, it is again a different environmental scope, which now covers twenty-five states.

129. The notion of "centre of origin" may cover different scientifically or technically related
concepts, and is open for interpretation by the risk assessors in a proper risk assessment process. It is
however a useful reference to address some issues, such as the issue of inter-specific crosses and the
sexual compatibility with other cultivated or wild plant species, including the distribution of
compatible species. Science has not defined once a nd for all the notion of "centre of origin", but
usually it refers to the environmental "region" (i ncluding its specific biological, ecological, physical,
pedo-climatic and other re levant conditions), where a particular crop plant species has originated. It
may however extend to a much wider region, namely to the whole region or regions where sexually
compatible plant species exist naturally.

130. For instance, it is said that maize originates from the Mexican region, from teosinte, or that
wheat originates from hybridization between several sp ecies in the Mediterranean basin. Results from
phylogeny and molecular biology studies have supporte d these claims to some extent. But it can also
be said that the "centre of origins" of these pl ant species expand to some of central and south
American regions, for the former, or to part of A frica and the whole of Europe, for the latter, on the
basis of the natural presence of related species.

131. There are several major crop species for whic h Western Europe is obviously the so-called
"centre of origin", which have been genetically modified, and which are the subject of applications for
their placing on the market at issue in this case. These include for instance oilseed rape or sugar beet.

132. However, the jurisdiction of some of the Me mber States of the European Communities extend
much more widely than Western Europe, and covers territories in South and Central America, Asia
and the Pacific, Africa, and North America, and these may be part of the "centres of origin", in its
wider meaning, for other crop species, such as maize for instance.

43 The Ecological risks and benefits of genetically engineered plants. L.L. Wolfenbarger and P.R.
Phifer. Science. vol. 290. 15 December 2000. pp. 2088-2093. Exhibit EC-126.
FAO. Report of the FAO expert consultation on environmental effects of Genetically Modified Crops. 16-18
June 2003. Exhibit EC-127.
The Royal Society. GM crops, modern agriculture and the environment. Report of a Royal Society Discussion
Meeting held on 11 February 2003. pp. 1-16. Exhibit EC-128.
Snow AA. Et al. (2004) Genetically engineered organisms and the environment: current status and
recommendations. The Ecological Society of America. Exhibit EC-129.
Marvier MA. (2002) Improving risk assessment for n on target safety of transgenic crops. Ecological
applications12:1119-1124.

133. Obviously the scope of the crops species for which one region may be considered the centre
of origin depends on what is meant by that region and by the "centre of origin".

134. What is covered by the concept of the centr e of origin of a particular plant species has a
significant, albeit limited, impact in the process of a case by case risk assessment, prior to the possible
release into the environment of a particular GM cons truct introduced in that plant species, as far as it
is concerned with the issue of compatibility with wild plant species, including the distribution of the
sexually compatible species, as well as with the re lationships with other organisms which interact
normally with that crop species or other compat ible species, and are present in its "natural"
environment .

135. However, the concept of a centre of origin is only one of the many possible concepts that are
taken into account in an appropriate environmenta l impact assessment, which may not be performed
in a binary way, namely the assessment of the rel ease of a particular GM crop plant in its centre of
origin or not.

136. For instance, one other very important element which is largely unrelated to the centre of
origin is the biology of the reproduction of the plant species being considered, for instance its
allogamous or autogamous properties, and the possib ility of intra-specific crosses, leading to the out
crossing of the genetic modification in non GM plants, but of the same species.

27. In the context of the Codex working definition of a contaminant, do you consider that
the modification or reaction created by gene transfers, or the resulting protein, could be
considered a "contaminant"? (see, e.g., EC first written submission, para. 403)

137. The definition of a "Contaminant", for the purpose of the Codex Alimentarius, is:

any substance not intentiona lly 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 medicine), manufact ure, processing, preparation, treatment,
packing, packaging, transport or holding of such food or as a result of environmental
contamination. The term does not include insect fragments, rodent hairs and other
extraneous matter.
44
138. The question of the Panel refers to the "modifi cation or reaction created by gene transfers, or
the resulting protein." The European Communities unders tand the question of the Panel to refer to the
genetic modification introduced by the relevant transformation methods in a GMO, or the resulting
protein expressed from that genetic modification of a GMO. In the view of the European
Communities, the question is not meant to cover modification or reaction created by natural gene
transfer, such as out-crossing, whic h may occur naturally, between di fferent plant species that are
sexually compatible.

139. Furthermore, the reference to "the reaction cr eated by gene transfers" being scientifically and
technically unclear and not precise as to what is meant by "reaction", the European Communities is
not in a position to specifically address that part of the question.

140. The scientific ambiguity in the question between natural gene transfers and genetic
modifications obtained by genetic engineering illust rates clearly that such modifications of GMOs,

44 Tenth edition of the procedural manual of the Codex Alimentarius Commission. FAO. 1997. Exhibit
EC-117.

and the resulting proteins that are expressed, cannot be considered to be covered by the Codex
definition of contaminants.

141. The Codex definition of contaminants has b een merely developed to address, as regards
plants, any substance unintentionally added to food as a result, inter alia, of the production of such
food, and further industrial processes related to it, or as a result of environmental contamination, and
not as a result of the production of the plant itself.

142. As an example to further illustrate this, the Codex also defines, as a distinct definition, the
notion of pesticide residue, which covers the presence in food of any derivative of a pesticide, namely
any substance used at the stage of plant growth and intended to control pests.

143. If that Codex definition of contaminant were to cover any substance unintentionally present as
a result of the production of the plant, and include the modification created by gene transfers, or the
resulting protein, then most if not all genes and th e resulting proteins of conventional plants would be
contaminants, as all genes and proteins result from genetic modifications created by gene transfers
through sexual crosses, making gradually the geneti c makeup of the plant over long evolutionary
times!

144. Even if the hypothesis above would be limited, for any particular reason, to major changes in
the genetic makeup of the plant brought about by th e genetic modification, this would also cover a
large subset of genes and corresponding proteins in conventional plants.

145. There is, on top of that, absolutely no basis in the Codex definition of contaminant to enable
the distinction of such genes and proteins, wh ether from GM or non-GM plants, and to cover
selectively those of GM origin. Furthe rmore, that artificial distinction, if it were to be retained, would
not withstand the most rudimentary scientific scrutiny.

146. Finally, as the European Communities has stated already in its first written submission,
45 a
genetic modification is introduced into a GMO intent ionally, as the genes and the expressed proteins
are first designed and created on a "vector", outside of the plant, with the final aim of their expression
in the GM plant, before being intentionally introdu ced into the plant. As a consequence, the genetic
construct is indeed introduced intentionally in to the plant genome, and these introduced genetic
modifications, as well as the expressed proteins, can therefore not satisfy the Codex definition of a
contaminant.

28. Is one of the food-safety related concerns regarding biotech products that genetic
modification might unintentionally result in the production of a toxin in the modified food
product? Would this be a toxin in the context of the Codex working definition of a toxin? (see,
e.g., EC first written submission, para. 405.) Wo uld this be a toxin in the context of the SPS
Agreement, Annex A?

147. A toxin is "a poisonous substance produced during the metabolism and growth of certain
microorganisms and some higher plant and animal species."
46 (see also reply to question 3). The
Codex working definition of a contaminant is referred to in the previous question.

148. The unintentional production of a poisonous s ubstance during the metabolism and growth of a
plant may, therefore, be covered by bo th definitions of toxin and contaminant 47. This may apply

45 First written submission of the European Communities, paragraph 404,
46 See http://www.biology-online.org/dictionary.asp [last visited on 15 June 2004]

equally to both GM and non-GM plants. In these cases, the production by GM or non-GM plantes of
such unintentional toxins may be considered as toxins in the context of the Annex A SPS Agreement.

149. In this respect, any individual GMO must be assessed on its own individual merits, among
other things, for the presence or not of toxic substances. In doing so, the procedure of risk assessment
looks primarily and first of all at the potential toxic ity of the intentionally in troduced specific genetic
modification and the newly expressed proteins and char acters. These, as explained in the first written
submission of the European Communities, may not be covered by either the definition of
contaminant, or the scope of annex A of the SPS Agreement.

150. Furthermore, the expression of an unintended protein in a GM plant may cover many distinct
potential impacts, including some falling outside of the SPS Agreement. These impacts may be
distinct from any toxic properties and relate to human health issue (for instance the allergenic
potential of the protein), to plant or animal health, or to other ecological issues.

29. With reference to para. 420 of the EC first written submission, is there any way in which
a GMO can damage biodiversity or the ecologica l balance of an area other than through
negatively affecting the wild flora and/or fauna of the area? Please explain.

151. Yes. There are many different means by whic h a GMO can affect biological diversity without
affecting the relevant wild flora and/or fauna.

152. Biological diversity is defi ned in international law as:

the variability among living organisms fro m all sources including, inter alia,
terrestrial, marine and other aquatic ecosystems and the ecological complexes of
which they are part; this includes diversity within species, between species and of
ecosystems.
48
153. A very narrow perception that the negative effects of GMOs on biological diversity may only
result from a negative impact on the wild flora (pla nts) and/or fauna (animals) would represent an
extremely reductionist analysis of the causal relati onships at stake, and be the consequence of a
significant lack of appropriate scientific expertise in the relevant ecological sciences49.

154. Only as a few examples, these negative impacts on biological diversity may result from:

• A positive effect on the wild fauna and/or flora. For instance, the GMO may have a
positive impact on one or more of the species of the relevant ecological area, thereby
disrupting the delicate equilibrium between living organisms in a particular ecosystem,
and, through complex population behaviours, have a negative impact on the variability of
organisms, the ecological complexes, or the diversity within species, between species and
of ecosystems, without affecting directly any of the species at stake.

47 See also paragraphs 405 and 406 of the first written submission of the European Communities.
48 See Article 2 ("use of terms") of the Convention on Biological Diversity, 5 June 1992.
49 For some background information, see The Ecological risks and benefits of genetically engineered
plants. L.L. Wolfenbarger and P.R. Phifer. Science. vol. 290. 15 December 2000. pp. 2088-2093. Exhibit
EC-126. Also Snow AA. Et al. (2004) Genetically engi neered organisms and the en vironment: current status
and recommendations. The Ecological Society of America. See Exhibit EC-129.

• A negative effect of the GMO on micro-organisms which are neither plant pests nor
disease causing organisms (and thereby outside of the scope of the SPS Agreement). For
instance the GMO may have a negative impact on some soil or aquatic micro-organisms,
which in turn may have a key role in the interaction between species, and may thereby
dramatically disrupt the equilibrium between all organisms in a particular ecosystem, and
through complex interactions, have a negative impact on the variability of organisms, the
stability of ecological complexes, and the diversity within species, between species and of
ecosystems.

• A modification of the mutual interaction between two organisms of the ecological
complex, without having any negative impact on the wild flora and/or fauna. For instance
a GMO plant may influence the trophic interaction between two other species of the
ecological complex, for instance through its mere physical presence, or through the
synthesis of a chemical having a pheromone activity towards some animal species, or
having a chemotactic activity towards some soil micro-organisms. The modification of
the trophic interactions between these two other species may in turn indirectly result in a
significant disequilibrium of the biological diversity of the relevant ecosystem.

• A negative impact on the biogeochemical processes in a particular ecosystem. A GMO
may, for instance through its roots exudates, modify the biogeochemical composition of
the soil, in a way which does not affect direc tly the wild fauna or flora, but which will
modify the equilibrium of the ecosystem, a nd potentially affect the variability between
species, or the diversity within species, between species and of ecosystems.

30. With reference to para. 421 of the EC first written submission, what sort of negative
impact on human or animal life or health ma y be caused by the increased use of specific
herbicides or the use of novel biotech-specific herbicides? Should these potential negative
effects be addressed differently than those which could occur from any other use of herbicides?
Please explain.

155. As explained in the answer to question 25, the herbicides conventionally used for weed
control in crops are selective herbicides, i.e. they kill selectively specific weeds, and the selectivity of
such herbicides is often limited to one crop, or group of crop species; their use is sometimes only
limited to some varieties of that crop. In gene ral the efficacy of these selective herbicides has a
limited spectrum, i.e. certain weed species may not be controlled.

156. By contrast, the herbicide resistance currently conferred by genetic modification to GMOs are
radically different, as they confer resi stance to non selective (total) herbicides, i.e. an herbicide that
kill all plant species. But they can be used on a spec ific crop that has no natural tolerance to it when
that crop has been engineered to resist to that to tal herbicide by the introduction of bacterial genes.
The aim to tailor a target crop to resist a non selective herbicide is to have a broader spectrum of weed
control, as well as tying together herbicide producer s and seed companies in order to try expand their
market shares.
50

157. At present two non-selective herbicides, gl yphosate and glufosinate, are the dominant
compounds; they have also relatively more benign environmental and human health impacts than
some other non selective or even selective herbicides.

50 See first written submission of the European Communities, Fn. 137, 145.

158. As said earlier, there would be an obvious lack of logic to believe that the issues of potential
negative impact on human or animal life or health th at may be associated with herbicide resistance in
the different types of crops are similar as regards GM and non GM crops, given that it is currently not
possible to confer resistance to these "environmen tally friendly" non-selective herbicide through
conventional breeding.

159. Some examples of concerns have been identif ied earlier: building of unexpected resistance
pattern, such as multiple resistance,
51 management of multiple resistant volunteers or wild relatives,
new problems related to crop management when su ccessive crops in rotation do contain non selective
herbicide resistance and therefore generate new herb icide management problems; loss of the ability to
use these "environmental and human health fri endly" non selective herbicides in certain
circumstances, overtaking by resistant volunteers because of successive use of the same crops, no
tillage and careless crop ma nagement, need to resort on other w eed killers that may have negative
effect on the environment,52 etc…

160. The situation referred above for Argentina giv es an indication of some potential health effects
that may result from difficulties in properly managing the use of the technology, and as a
consequence, the need to resort to other more dangerous herbicides.

161. For further references on the specific questions raised by herbicide resi stance traits in GM
crops, see the answer to question 25.

162. Furthermore, reliance on a single limited technolog y, if it is adopted by a majority of farmers,
may lead to a dramatic increase of the surface wh ere the corresponding herbicide will be used. This
may in turn increase significantly the presence of the two non selective herbicides or their
corresponding metabolites in table water, and dr inking water reserves, possibly above maximum
limits of residues.

31. With reference to para. 422 of the EC first written submission, how does herbicide
resistance negatively affect flora and fauna? How is this potential effect different for biotech
crops compared to the development of herbicide resistance in non-biotech crops?

163. See answers to questions 25 and 30.

32. With reference to para. 423 of the EC fi rst written submission, could any undesirable
cross-breed of plant be considered to be a "pest"? Is the IPPC definition of "pest" relevant in
this context?

51 See for instance in Canada:
Hall L. et al. 2000. Pollen flow between herbicide-resistant Brassica napus is the cause of multiple-resistant B.
napus volunteers. Weed Science 48, 688-694.
Ellstrand, Norman C. 2001. When transgenes wander, should we worry ? Plant physiology Vol. 125, p.
1543-1545.
52 See the account of GM herbicide resistance mana gement problems due to the mishandling of the
technology in Argentina. New Scientist. 17 April 2004. Argentina's bitter harvest. Sue Branford. pp. 40-43. See
Exhibit EC-122.

164. The IPPC definition of "pest" refers to

any species, strain or biotype of plant, anim al or pathogenic agent injurious to plants
or plant products.
53
165. Obviously, to be a pest, according to the IPPC definition, the plant has to be directly or
indirectly injurious to plant or plant products.

166. The recently adopted International St andards for Phytosanitary Measures N°11
54, which is
relevant to perform the pest risk analysis of a GMO, further indicates in paragraph 1.1 (initiation
point) that

In order to be categorized as a pest, an LMO [GMO] has to be injurious or potentially
injurious to plants or plant products under conditions in the pest risk analysis area.
This damage may be in the form of direct effects on plants or plant products, or
indirect effects.
167. In its annex 3, that ISPM outlines potential cat egories of phytosanitary risks relevant for an
LMO [GMO] to be a pest:

Potential phytosanitary risks for LMOs may include:
a. Changes in adaptive characteristi cs which may increase the potential for
introduction or spread, for example alterations in:
– Tolerance to adverse environmenta l conditions (e.g. drought, freezing,
salinity etc.)
– Reproductive biology
– Dispersal ability of pests
– Growth rate or vigour
– host range
– Pest resistance
– Pesticide (including herbicide) resistance or tolerance.
b. Adverse effects of gene flow or gene transfer including, for example:
– Transfer of pesticide or pest resi stance genes to compatible species
– The potential to overcome existing re productive and recombination barriers
resulting in pest risks

53 ISPM N° 11: Pest risk analysis for quarantine pests, including analysis of environmental risks and
living modified organisms [FAO, April 2004]. Exhibit EC-130.
54 Ibidem.

– potential for hybridization with existing organisms or pathogens to result in
pathogenicity or increased pathogenicity.
c. Adverse effects on non-target organisms including, for example:
– changes in host range of the LMO, including the cases where it is intended
for use as a biological control agent or organism otherwise claimed to be
beneficial
– effects on other organisms, such as biological control agents, beneficial
organisms, or soil fauna and microflora , nitrogen-fixing bacteria, that result
in a phytosanitary impact (indirect effects)
– capacity to vector other pests
– negative direct or indirect effects of plant-produced pesticides on non-target
organisms beneficial to plants.
d. Genotypic and phenotypic instab ility including, for example:
– reversion of an organism intended as a biocontrol agent to a virulent form.
e. Other injurious effects including, for example:
– phytosanitary risks presented by new traits in organisms that do not normally
pose phytosanitary risk
– novel or enhanced capacity for virus recombination, trans-encapsidation and
synergy events related to the presence of virus sequences
– phytosanitary risks resulting from nucleic acid sequences (markers,
promoters, terminators, etc.) present in the insert.
168. In the specific case of gene flow, that annex clarifies 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 itself. 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.
169. It follows from this that the pest analysis of a plant in order to determine whether it is a pest,
including in the case of gene flow, or rather as a consequence of gene flow, is based on the traditional
case by case approach, which requires in the case of th e pest risk analysis to identify whether the
introduced gene has a potential phytosanitary risk.

170. As a consequence, to answer the Panel's qu estion, it is not the undesirable character of a
cross-breed of plant that would make it considered, as a general rule, to be a "pest", but rather, on a
case by case basis, the specific properties of the gene(s) introduced in that cross-breed, and in
particular its potential phytosanitary risk.

171. Therefore, there cannot be a general rule that any undesirable cross-breed of plant be
considered to be a "pest", because the mere pr esence of a transgene may be undesirable but not
present any phytosanitary risk.

33. With reference to para. 425 of the EC first written submission, could the development of
resistant target insects be of concern if such pests cannot become established or spread?

172. As explained in para . 425, the development of resistance in target insects is not a question of
establishment or spread of a pest. The pest, i.e., th e insect in question, is already there and will also
not spread to other areas. The problem is rather one of treatment of a pest. Where insects have
become resistant to Bt crops, the field will need to be sprayed with additional insecticides in order to
get rid of the pest. The increased use of insecticid es raises environmental concerns falling outside the
scope of the SPS Agreement (on the differences between pesticide resistance issues in GMO crops and
in conventional crops see reply to question 25, paras. 118 et seq.).

34. With reference to para. 46 of the EC first oral statement, do the parties consider that
any potential negative impact on soil micro-organ isms from the use of biotech crops could be
considered to be "other damage to the territory of a Member arising from the entry,
establishment or spread of a pest"? Please explain.

173. The impact of any GMO, transgene, or pr oduct of expression of such transgene on soil micro-
organisms may not be systematically considered as a pest risk, as it requires, as has been explained in
the reply to question 32, a case by case analysis of the phytosanitary risk at stake (the potential to be
injurious to plant or plant products).

174. Furthermore, as regards the cas e of the effect of the protein Bt on soil microorganisms as
referred to in paragraph 46 of the EC's first oral st atement, the protein in itself, once present in the
soil, cannot be considered as a pest, as the protein in itself has no injurious effect on plant or plant
product.

175. The potential maintenance of the Bt protein in the soil can manifest it self after the plant has
been harvested, or destroyed. Therefore, neither th e Bt protein itself, which cannot be considered in
itself as a pest, nor the Bt plant, which would not be a pest per se, as defined in the IPPC, since it will
primarily affect insects and other organisms of the tr ophic chain, would enable to meet the criteria of
"damage from entry, establishment or spread of a pest".

176. Lastly, even if the Bt plant were considered to be a pest according to the IPPC criteria, once
the plant has been harvested or destroyed, it can not satisfy anymore the requirements of entry,
establishment, or spread, while the effect of th e Bt protein may still manifest itself on the soil
microorganisms. These requirements being not met, this situation would not be covered by Annex A 1
(d) of the SPS Agreement

35. With regard to the requirement to undertak e and complete procedures without undue
delay (Annex C(1)(a) of the SPS Agreement):

 (a) What is the object and purpose of this requirement?

 (b) Is it correct that a delay in the completion of procedures would not result, ipso
facto, in a breach of Annex C(1)(a)? If so, how is a panel to determine when a
delay rises to the level of being "undue"?

177. To (a): The object and purpose of this requirement, as of all others in Annex C, is to provide
certain minimum guarantees in the application of control, inspection and approval procedures.
International trade is affected if Members abuse such procedures to prevent the import of goods. The
procedural requirements in Annex C are designed to foil such abuse.

178. The requirement to undertake and complete procedures without undue delay is particularly
important in the context of approval procedures, as the marketing of products depends on the outcome
of such procedures. Clearly, the SPS provisions dea ling with substantive me asures such as bans or
import conditions cannot be applie d to mere delays, and therefore a correct application of
Annex C(1)(a) is essential to tackle problems relating to the application of SPS measures.

179. To (b): The provision does not provide for or define a specific timeframe, which means that it
has to be determined on a case by case basis whether undue delays have occurred. It is correct that a
delay in the completion of procedures does not result ipso facto in a breach of Annex C(1)(a). Instead
it has to be demonstrated that such a delay is "u ndue." Whether a "delay" is "undue" is not a question
of a "threshold level" in the duration of the delay, but rather of the reason(s) for that delay. Those
reasons have to be legitimate. It constitutes a legitimate reason, inter alia, if procedures are delayed
because of requests for additional information pert aining to risk assessment and risk management
concerns, which are considered necessary to achieve an outcome that meets the desired level of
protection.

36. With respect to those applications origin ally submitted under EC Directive 90/220 and
subsequently "re-submitted" under EC Direct ive 2001/18, did the re-submission of these
applications mark the beginning/opening of a new procedure for the purposes of Annex C(1)(a)
of the SPS Agreement, or is/was there only one sing le procedure? What are the implications of
your reply for the calculation of the length/dur ation of the relevant approval procedure(s)?
Specifically, from what time/event should the le ngth be calculated (e.g., when the original
procedure was initiated under EC Directive 90/220; when the second procedure was initiated
under EC Directive 2001/18)?

180. The re-submission of the pending applications, fro m a point of view of EC law, did not mean
the beginning of a new procedure, but merely the co mpletion of an existing procedure (see also reply
to question 12). In the European Communities' vi ew, the reply remains the same, if the question is
looked at from a WTO law point of view, and more specifically from the point of view of Annex C
point 1 (a).

181. However, for the purpose of identifying dela ys, and more importantly undue delays, the re-
submission represents the starting date for the reas onable period of time needed to examine the new
information and to conduct a risk assessment of th e newly identified issues. The EC notes that the
re-submission requirement in the new legislati on has, as such, not been challenged by the
Complainants (or, for that matter, by any of the applicants at national judicial level).

37. With reference to Annex A(1) of the SPS Ag reement, are the parties of the view that
"procedures" and, more specifically, "approval procedures" are SPS measures? If so, are
(approval) procedures as such subject to the requirem ents of Articles 2.2, 5.1, 5.5 and 5.6 of the
SPS Agreement? Why? Why not? In answering this question, please include a discussion of
the second clause of Article 8 ("otherwise ensure that [… ]") of the SPS Agreement and indicate
which are the relevant "provisions of this Agreement".

182. According to Annex A, Point 1, sanitary or phytosanitary measures include … "testing,
inspection, certification and approval procedures ."[emphasis added]. It w ould seem clear from this
provision that an approval procedure can constitute an SPS measure.

183. As it has stated in its first written submissi on, to the extent that it addresses risks coming
under point 1 of Annex A of the SPS Agreement, the European Communities accepts that the approval
system set up under the relevant EC GMO legislation is an approval procedure within the meaning of
the SPS Agreement and, in particular its Annex C.
55

184. The European Communities would first observe that according to its Article 1.1, the
provisions of the SPS Agreement apply to both the development and the application of SPS measures
and different provisions of the agreement address development and application.

185. Whether or not the development of approval procedures such as those of the GMO legislation
are subject to Articles 2.2, 5.1, 5.5 and 5.6 of the SPS Agreement need not be decided because the
Complainants have not attacked the development or the content of the approval procedures.

186. They have only contested the application of these procedures and specifically the delay that
they consider has been unduly in curred in a number of cases. The provisions that address this issue
are Article 8 and Annex C. Articles 2.2, 5.1, 5.5 and 5.6 by their terms apply to the development,
adoption and maintenance of SPS measures rather than their application. To the extent that any of
these provisions may be relevant to the application of an approval procedure and especially alleged
delays, the matter is dealt with more specifically in Annex C which the Panel should therefore address
first.

187. Article 8 offers clear textual support for this interpretation. In its first sentence, it speaks
about "the operation of approval procedures," and specifies that Annex C contains the relevant rules in
that regard. On the other hand, the second senten ce speaks of "procedures" as such, that is, the SPS
measure itself and not its application. There, it al so specifies that the other SPS obligations may be
relevant. Therefore, Article 8 reaffirms the distin ction made in Article 1. 1 between the development
and the application of an SPS measure.

38. With particular reference to the complain ing parties' challenge to various member State
safeguard measures under Article 5.5 of the SPS Agreement, please answer the following
questions:

 (a) Which is the relevant "Member" for the purposes of the Panel's analysis of the
complaining parties' challenges? Is it: (i) the member State applying the
safeguard measure or (ii) the European Communities as a whole?

 (b) Would it be permissible under Article 5.5 for an EC member State to apply
within its territory, either permanently or provisionally, a higher level of
protection than that which is applied in the rest of the European Communities?

188. Article 5.5 SPS Agreement uses the words "distinctions" an d "discrimination". There are
many different types of distinction or discrimina tion. The obvious example of discrimination within
the meaning of Article 5.5 SPS Agreement would be if a Member fixed di fferent appropriate levels of
protection for essentially identical products, according to the Member of origin. That is not at all the

55 First written submission of the European Communities, para. 474.

type of distinction with which we are here concerne d. Rather, the type of distinction with which we
are here concerned relates to the various parts of the territory of the Member applying the measure.

189. Thus, at the heart of this question is the qu estion of whether or not, as a matter of WTO law,
the appropriate level of protection can be different fo r different parts of a territory. The answer to that
question is certainly: yes.

190. This emerges clearly, for example, from Article 5.2 SPS Agreement, according to which the
factors that must be taken into account include : the existence of pest- or disease-free areas. The use of
the word "areas" is significant. It indicates that th ere may be a certain area or territory – it might, for
example, be a national park of some kind – in wh ich a certain pest or disease is currently unknown.
For that area, the appropriate leve l of protection might be different compared to the rest of the
relevant territory.

191. Similarly, Article 5.2 SPS Agreement also refers to "relevant ecological and environmental
conditions" – again, a factor that may differ according to the territory under consideration.

192. Furthermore, Article 6 SPS Agreement, which is entitled Adapta tion to Regional Conditions,
Including Pest- or Disease-Free Areas and Areas of Low Pest or Disease Prevalence, provides in
relevant part :

1. Members shall ensure that their sanitary or phytosanitary measures are
adapted to the sanitary or phytosanitary ch aracteristics of the area - whether all of a
country, part of a country, or all or parts of several countries - from which the product
originated and to which the product is destined. In assessing the sanitary or
phytosanitary characteristics of a regi on, Members shall take into account, inter alia,
the level of prevalence of specific diseases or pests, the existence of eradication or
control programmes, and appropriate crite ria or guidelines which may be developed
by the relevant international organizations.
2. Members shall, in particular, recogni ze the concepts of pest- or disease-free
areas and areas of low pest or disease prevalence. Determination of such areas shall
be based on factors such as geography, ecosystems, epidemiological surveillance, and
the effectiveness of sanitary or phytosanitary controls.
193. Finally, the European Communities would also draw the Panel's atte ntion to the important
difference between a definitive measure, and a provisional measure, adopted, for example, pursuant to
Article 5.7 SPS Agreement , the two types of measure being di fferent in a number of important
respects.

194. This is the context within which Article 5.5 SPS Agreement must be interpreted. In this
context, "the Member" referred to in Article 5.5 SPS Agreement is, in the present case, the European
Communities. Thus, in principle, what the Panel woul d have to consider would be whether or not the
actions of the European Communities on the questi on of the appropriate level of protection are
consistent.

195. It is correct that the European Communities is also responsible for th e actions of the Member
States of the European Communities. However, the Panel must note that the Member State measures
in this case are provisional measures adopted on the basis of Article 5.7 SPS Agreement. As explained
in the first written submission of the European Co mmunities, the sufficiency or insufficiency of
scientific evidence is a function of the appropriate level of protection sought by the legislator; and that

in turn is a function of the specific objectives s ought by, and the risks and benefits weighed by, the
specific legislator. That in turn is a function of th e specific territory with which the specific legislator
is concerned. In other words, one cannot, in the context of Article 5.5 SPS Agreement, meaningfully
assert an inconsistency between the definitive actions of the European Communities on the one hand,
and the provisional actions of the Member States (for which the European Communities are
responsible in the WTO) on the other hand, becau se the two types of measures are fundamentally
different. For the same reason, it is meaningless to assert an inconsistency between the different
provisional actions of legislators concerned with different territories, precisely because they are not
concerned with the same territory. Similarly, th e European Communities does not consider that
Article 5.5 SPS Agreement is concerned with the consistency of the behaviour of regional authorities
within a Member's territory within a provisional temporal frame of reference.

196. What the European Communities does accept is that the various situations referred to by the
Complainants cannot endure indefinitely. That is why, over the relevant period and today, it has
engaged in a process of taking the steps necessary to bring matters into line : on the one hand, where
appropriate, adapting legislation at Community level to take into account the legitimate concerns of
legislators and scientists across the Community; and, on the other hand, taking such reasonable
measures as are available to it with respect to th e Member States. None of the Complainants have
alleged, let alone proven, that in respect of these matters the Europ ean Communities has acted
inconsistently with Article 5.5 SPS Agreement.

197. Two further comments. First, as regards th e alleged moratoria, the European Communities
recalls that Article 5.5 SPS Agreement is irrelevant, because it only applies when Members have
determined the appropriate level of protection, in accordance with Article 5.4 SPS Agreement – that
is, when they have adopted a measure. If the complaint in reality relates to alleged delay, the relevant
provision is Annex C SPS Agreement . Second, a measure adopted for reasons that fall outside the
defined scope of the SPS Agreement cannot disclose any inconsistency with Article 5.5 SPS
Agreement. All the Member State measures were adopted fo r reasons that fall, in whole or in part,
outside the scope of the SPS Agreement.

198. The answer to question 38(a) is thus the European Communities as a whole and 38(b) yes,
either permanently or provisionally.

For the European Communities

78. With reference to para. 409 of the EC's first written submission, could the European
Communities please indicate what is the di fference between a "disease" and a "medical
condition"?

199. The EC legislation is differentiating between "disease," "disorder" and "medical condition"
56

200. A "disease" refers to a pathological situa tion: according to the IOE definition quoted in
para. 407 of the EC's first written submission, the clinical and/or pathological manifestation of
infection.

201. A "medical condition" could, in some cases, be the result of a disease but is not a disease in
itself ( e.g. some types of blindness); it is however ge nerally of a broader acceptance and covers
conditions, originating from some specific disorders, which may be the consequence of, for instance,

56 See for instance article 4, paragraph 4 (a) of the Commission Directive (EC) 1999/21 of 25 of March
1999 on dietary foods for special medical purposes. OJ of the EC N° L 91 of 07.04.1999, p. 29.

living behaviour, and may be fully independent of diseases; these medical conditions may require
specific medical attention, such as obesity, blindness, allergy, amputation, post operation treatment.

202. Further examples of a medical condition are the need for a special diet, because you cannot
eat after an operation, or the fact that you ma y not expose yourself to specific allergens because of
either atopic reactions, or because of specific allerg ies to certain epitopes (e.g. a specific diet devoid
of any contact with certain food components, due to an allergy to these components, in the same way
as confinement at the time of flowering due to allerg y to pollen, or obligation to carry in the summer
antihistaminic treatment due to allergy to wasp venom; etc…).

79. With reference to para. 126 of the US first written submission, what is the extent of use
of GM processing aids within the European Communities?

203. The definition of "Processing aid" for th e purpose of the Codex Alimentarius, is:

any substance or material, not including a pparatus or utensils, and not consumed as a
food ingredient by itself, intentionally used in the processing of raw materials, foods
or its ingredients, to fulfil a certain technological purpose during treatment or
processing and which may result in the non-intentional but unavoidable presence of
residues or derivatives in the final product.
57
204. In practice, genetically modified micro orga nisms may have been and have been used as
sources of processing aid, for instance in the pr oduction of specific enzymes used as a processing
aids.

205. As regards the question of the extent of the use of genetically modified processing aids within
the European Communities, such processing aids were not regulated at the Community level, first and
foremost because they did not fall within the defin ition of food ingredient, nor within the scope of the
legislation on Novel food
58 covering food ingredients containing or derived from GMOs. The
situation at the time was equivalent to that of some other substances falling outside of the definition of
food ingredient, such as additives or flavouring substances.

206. Processing aids are not covered by the defi nition of food in the new EC general food law 59
and have remained unregulated at the Community le vel, on the grounds that they are not meant to be
intentionally present in the final food product.

207. The fact that processing aids are not regulated, at least at the Community level, as a
consequence, does not allow to have directly availa ble relevant information regarding the extent of
use of GM processing aid within the EC. This information may be partially available in some Member
States, or with the food industry, but would require more time to be collected.

208. However, the scarce information available indicates that GM processing aids have been
widely used within the European Communities, since at least 15 years, but it is not possible at this
stage to indicate what is the percentage of GM processing aids (or additives isolated from GMOs) in
the total quantity of processing aids (or additives) used.

57 Tenth edition of the procedural manual of the Codex Alimentarius Commission. FAO. 1997, see
Exhibit EC-117.
58 Regulation (EC) 258/97.
59 Regulation (EC) 178/2002.

80. Please summarize the conclusions of the "Opinion of the Scientific Panel on GMOs on
the use of antibiotic resistance genes as marker ge nes in genetically modified plants". Explain
what relevance, if any, this report may have in light of the EC arguments at para. 49 of its first
written submission.

209. EFSA issued its "Opinion of the Scientific Panel on Genetically Modified Organisms on the
use of antibiotic resistance genes as marker genes in genetically modified plants. (Question N° EFSA-
Q-2003-109)" on 2 April and published it on 16 Apr il 2004. As usual, EFSA also provided a
Summary of this opinion,
60 which best synthesises EFSA conclusions:

Directive 2001/18/EC (EC, 2001) states that Member States and the Commission
shall ensure that GMOs which contain gen es expressing resistance to antibiotics in
use for medical or veterinary treatment are taken into particular consideration when
carrying out an environmental risk assessment . This is with a view to identify and
phase out antibiotic resistance marker ge nes (ARMGs) in GMOs which may have
adverse effects on human health and the environment.
The Scientific Panel on genetically modi fied organisms (GMO Panel) of the
European Food Safety Authority (EFSA) h as evaluated the potential risks associated
with specific ARMGs taking into account their current usage in clinical and
veterinary medicine, the likely occurrence of horizontal gene transfer from
genetically modified (GM) plants to micr obes and the potential impact of horizontal
gene transfer where naturally occurring resist ance to the relevant antibiotics exists in
the microbial gene pool. These factors will impact on the likelihood of any adverse
effects on humans or the environment of ARMGs used in GM plants.
The GMO Panel considers the frequency of hor izontal gene transfer from GM plants
to other organisms as very low for all AR MGs considered. This, in itself, is an
important consideration with regard to any risk posed by the use of ARMGs.
However, with respect to clinical importa nce the Panel has categorised ARMGs into
three groups with different potentials for compromising human health and the
environment. ARMGs in the first group include genes conferring resistance to
kanamycin and hygromycin. In this group the nptII gene, which confers kanamycin
resistance, has a 13-year history of safe use in food crops and resistance to this group
of antibiotics is widespread in natura lly occurring microbes in humans and the
environment. The Panel is of the opinion that with regard to safety there is no
rationale for inhibiting or restricting the use of genes in this category, either for field
experimentation or for the purpose of placing on the market. The second group of
ARMGs, which includes resistance to chloramphenicol, ampicillin, streptomycin and
spectinomycin, should be restricted to field trial purposes and should not be present in
GM plants to be placed on the market. Gi ven their current importance in clinical
usage, the GMO Panel recommends that ARMGs placed in the third group, which
includes those conferring resistance to amikacin and tetracyclines, are not present in
GM plants to be placed on the market or in plants used for experimental field trials.
210. The Opinion thus confirms, with regard to the second and especially the third group of
ARMGs, the concerns expressed in paragraph 49 of the EC first written submission that

60 The opinion and its Summary are available at
<http://www.efsa.eu.int/science/gmo/gmo_opinions/384_en.html> (last visited on 11 June 2004).

The uptake of antibiotic resistance genes c ould potentially result in the development
of antibiotic resistance of human bacteria against known antibiotic medication. Thus,
important and existing medical treatments may become ineffective in the fight against
severe diseases.

81. Regarding the operation of the EC approval procedures, has the European
Communities in recent years been guided by th e Codex principles and guidelines for the safety
assessment of GM foods, including assessment for potential allergenicity?

211. Yes. Although the Codex principles and gu idelines for the safety assessment of GM foods
are indeed very recent (July 2002), the European Communities has traditionally been guided in the
safety assessment of GM foods, including in the assess ment for potential allergenicity, by principles
that are analogous to the ones now codified by Codex.

212. The recent "Draft guidance document for the ri sk assessment of genetically modified plants
and derived food and feed" pub lished by EFSA in April 2004
61 (and to be adopted soon) well
demonstrates this correspondence. In particular, in section 7.9 dealing with allergenicity, it states
that:

In line with the recommendations of the Codex ad hoc Intergovernmental Task Force
on Foods Derived from Biotechnology (Codex Alimentarius, 2003), an integrated,
stepwise, case-by-case approach, as describ ed below, should be used in the
assessment of possible allergenicity of newly expressed proteins
62.
213. Thus, Codex and EFSA suggest similar methodology for the assessment of allergenicity based
on identification of the protein, amino acid sequence homology, specific serum test, in vitro tests and,
if necessary, specific (targeted) serum screening analysis. EFSA guidelines follow the same approach
of Codex also with regard to the assessment of possible toxicity as well as on a number of other
aspects.

214. Moreover, both the Codex and the EFSA guide lines refer in several parts to the Report of a
Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology, entitled
"Evaluation of Allergenicity of Genetically Modified Foods" (22-25 January 2001, Rome, Italy)
63.

215. Finally, it should be noted that the new le gislation on GM food and feed (Regulation 1829/03,
Exhibit CDA-20) establishes an authorisation system which takes into account to a large extent Codex
principles of risk analysis (such as the case-by-case approach) and of risk management (e.g., post
market monitoring, detection methods, reference material, traceability, etc.).

61 Available at <http://www.efsa.eu.int/consulta tion/372/consultation_guidance_gmo_01_en1.pdf>
(last visited on 12 June 2004) (Exhibit EC-131).
62 Ibidem, page 26.
63 Available at <http://www.who.in t/foodsafety/publications/biotech/en/ec_jan2001.pdf> (last visited
12 June 2004).

82. Other than "reasoned requests" for addition al information referred to at para. 149 of
the EC first written submission, on what other grounds can the competent authority justify not
issuing its opinion within 90 days?

216. Paragraph 149 of the EC First Written Subm ission paraphrases Article 14.4 of Directive
2001/18 which expressly excludes from the calculation of the 90 day period, within which the
competent authority has to issue its opinion on the notification, "any periods of time during which the
competent authority is awaiting further informati on which it may have requested from the notifier."
However, the same Article 14, at paragraph 3, requires the competent authority to send to the
Commission its assessment report

together with the information referred to in paragraph 4 and any other information on
which it has based its report … (emphasis added).
217. It is therefore considered that any time spent by the competent authority to collect and analyse
such other information, if justified, can warrant a suspension of the 90 day period (in the EC jargon a
"clock-stop"). Finally, exceptional, unforeseen circum stances could also play a role in delaying the
issuing of the competent authority's assessment report . In any case, a "clock-stop" must always be
justified and communicated to the notifier (see Article 14.4 of Directive 2001/18).

218. In the notifications procedure at issue in this case, all "clock-stops" can be easily identified in
the individual chronologies attached to the EC first written submission
64. Thus, for instance, in the
case of notification C/SE/96/3501, potato with an altered starch composition (Amylogene HB), 65 the
"clock stopped" a number of times because of vari ous requests for additional data. Below, the Panel
will find an extract of the chronology already submitted for this notification as Exhibit EC-67, with
the details of the count of the "clock stops" at Member State level under Directive 2001/18/EC.

 17/01/2003 Updated notification

 Day 1 – Start of the 90-day period

 23/01/2003 SNIF not complete

 Day 6– Clock stopped

 24/01/2003 SNIF updated and complete

 Day 7 – Clock restarted

 10/02/2003 Request for additional inform ation (Exhibit EC-67, attachment 30)

 Day 23 – Clock stopped

 23/06/2003 Updated risk assessment and monitoring program are provided

 Day 24 – Clock restarted

 30/07/2003 Request for additional informa tion (Exhibit EC-67, attachment 31)

64 See Exhibits EC-62 to EC-76.
65 See Exhibit EC-67.

 Day 60 – Clock stopped

 25/09/2003 Information received and additiona l information requested at the same
meeting

 Day 60 – No time elapsed between provision and request

 25/09/2003, 04/12/2003 Partial answers

 Day 60 – No time elapsed, CA still waiting for parts of answer

 20/02/2004 Complete answers received and add itional information requested at the same
meeting

 Day 60 – No time elapsed between provision and request

 10/03/2004 Information received

 Day 61 – Clock restarted

 15/03/2004 Request for additional information

 Day 65 – Clock stopped

 18/03/2004 Information provided (complete notification)

 Day 66 – Clock restarted

 08/04/2004 Submission of assessment report and notification to the Commission

 Day 86 – Assessment completed

83. With reference to para. 151 of the EC first written submission, on what grounds can the
"normally 60 days" period be exceeded?

219. Article 15.1 of Directive 2001/18 (and, previ ously, Article 13.2 of Directive 90/220) provides
for a period of 60 days, from the date the Commission circulates the lead CA's assessment report, in
which the other Member States can make comments or raise reasoned objections. In the presence of
any of these, another period of 45 days is warrant ed in order to "discuss outstanding issues with the
aim of arriving at an agreement". According to this provision, any periods of time during which
further information from the notifier is awaited is not taken into account to calculate this 45 day
period (so-called "clock stop").
66

220. In practice, requests for further information following comments or objections raised by
Member States are forwarded to the notifier at the expiry of the 60 day period, i.e. as soon as the
issues which are outstanding become clear, and before the starting of the 45 day period. The
procedures followed by the Commission can be resumed along these lines:

66 For all the details of the procedure, see Exhibit EC-118.

 – if, at the end of the 60 day period, ther e are requests for additional information, the
clock is stopped, i.e. before the 45 day period begins;

 – all requests for additional information are channelled by the lead CA to the notifier;

 – when the notifier supplies additional informati on, this is circulated in the same way as
the full notification, i.e. the lead CA forw ards it to the Commission who circulates to
the other competent authorities;

 – the clock re-starts, i.e. the 45-day period begins, on the date of circulation of the
additional information. As with the 60-da y deadline, the clock is not stopped during
this 45-day period, i.e. the 45-day deadline is set when the additional information is
circulated and does not change. Competent authorities who requested additional
information thus have a maximum of 45 da ys to inform the Commission whether or
not they intend to maintain their objections. Competent authorities may decide to
confirm their intentions sooner than the 45 day maximum limit.

221. Thus, for instance, in the case of notification C/ES/00/01, Roundup Ready maize NK 603,
67
the "clock stopped" for five months between the e nd of the 60 day period and the beginning of the 45
day period in order to gather the information neces sary to address the comments and/or objections
raised by the Member States. Below, the Panel will find an extract of the chronology already
submitted for this notification as Exhibit EC-76, comp leted by the details of the count of the "clock
stops".

 24/01/03 Circulation to all CAs of application and assessment report

 Day 1 – Start of the 60-day period

 25/03/03 Additional data are required. Comments/objections are raised by CAs

 Day 60 – Clock stopped

 26/03/03 - 04/04/03 Circulation to all CAs of comments/objections/requests for further
information (Exhibit EC-76, attachments 8 and 11-20)

 09/04/03 Meeting with COM, lead CA and the notifier

 28/04/03 Meeting with COM, notifier and all CAs in order to solve the
outstanding issues

 11/06/03 Notifier provided lead CA with additional data (Exhibit EC-76,
attachment 21)

 25/06/03 Lead CA provided COM w ith additional non-confidential data

 08/07/03 Lead CA provided COM w ith additional confidential data

 15/07/03 Additional data have been circulated to all CAs

67 See Exhibit EC-76.

 Day 1 – 45-day period started

 27/08/03 UK, DK maintain
 their objections raised during the 60-day period

 Deadline for the 45-day period

84. Regarding a decision by an EC member State to take a safeguard action, what is the
normal time frame under relevant EC legislation for the various steps to be taken under this
procedure (e.g., decision by the member State; informing of the Commission and other member
States, etc.)?

222. The response is different according to which legislation is concerned.

223. Directive 90/220, Article 16 does not specify what the period of time may be between the
written consent under the Directive and the provision al measure that may be adopted by the Member
State. In these circumstances, it is not really possi ble to identify a "normal" time frame within which
such provisional measures may be adopted. In prin ciple, they might be adopted some time after the
consent, especially if new information had come to light, or existing information had been re-
assessed. That said, the provisional Member State measures in this case were generally adopted
shortly after the written consents.

224. Directive 90/220, Article 16 provides that th e Member State shall i mmediately inform the
Commission and the other Member States. Normally, therefore, a Member State would inform the
Commission very quickly – generally within a fe w days or weeks – and would also keep the
Commission abreast of any subsequent developments, such as extensions of the provisional measures,
or any developments in the information or asse ssments on the basis of which the measures are
maintained.

225. Directive 90/220, Article 16(2) provides that a decision shall be taken within three months in
accordance with the procedure laid down in Article 21. In practice, this is generally understood to
refer to three months from the date on which th e Commission receives information from the Member
State adopting or maintaining the provisional me asure. In principle, each time the Commission
receives new information from the Member State, wh ether in relation to the adoption or maintenance
of the same provisional measure, then, if specific action is required, the time for such action would be
three months.

226. Directive 90/220, Article 16(2) does not specify what specific decision must be taken within
three months – only that "a decision" shall be taken within three months in accordance with the
procedure provided for in Directive 90/220, Article 21. Pursuant to that provision, the first decision
that might be taken would be a decision by the Commission to submit to the committee a draft of the
measures to be taken – if any measures are required. The last decision that might be taken would be
the adoption of any proposed measures by the Commi ssion, on the expiry of the further three month
period referred to in the final paragraph of Article 21. The amount of time that might intervene in the
meantime would depend on all the specific circumstances of the case.

227. The Commission might also decide that no me asures need to be taken, in which case it would
be unnecessary to make a proposal to the committee.

228. In the present case, normally, that is, with r espect to all the Member State measures, there was
no further decision within the meaning of the final three paragraphs of Article 21.

229. The provisions of Directive 2001/18, Articles 23 and 30(2), which refers to Decision
1999/468/EC, Articles 5, 7 and 8, are similar. These provisions are summarised in the flowcharts in
Exhibits EC-118 and EC-120. The Commission should be informed immediately and a decision
should be taken within 60 days, alt hough this period is suspended for up to 60 days if the Scientific
Committee is consulted, and longer if more information is requested from the notifier.

230. The equivalent provisions of Re gulation 258/97 are Articles 12 and 13.

85. Can the European Communities identify other situations where the replacement or
revision of EC legislation has resulted in a suspension of decisions, or suspension of imports,
pending the revision of existing legislation?

231. In the regulatory policy history of the Community (as well as probably in that of many other
WTO Members), it is common that in relation to emerging issues of human and/or animal health and
the environment, the revision of existing legislati on on specific products, brought about by changes in
scientific knowledge or different awareness of the ri sks at stake, implies a temporary prohibition of
their use (and not just their import) which remains in force until they become regulated.

232. Thus, for instance, in 1990, it became clear th at not all effects of certain growth hormones
administered to cows in order to increase milk productivity, such as Bovine Somatotrophin, were
sufficiently known. Thus, while awaiting furt her information, the Community provisionally
prohibited the administration to dairy cows of the substance in question, suspending the operation of
two previous Directives.
68 In 1999, this Regulation was finally repealed and substituted by definitive
legislation that prohibited any placing on the market of Bovine Somatotrophin.69

233. Similarly, in the year 2000, the Commission identified systematic failures in the
implementation of Community rules related to the control of certain processed animal protein into
ruminant feed, relevant to prevent cases of bovi ne spongiform encephalopathy ("BSE") from entering
into the feed chain. Thus, pending a re-evalua tion of Community legislation and its consequent
revision, the Community enacted a total ban on the use of animal protein in animal feed.
70 T h e
prohibition on the use in animal feed of proteins derived from certain animals or animals from certain
regions has been maintained by subsequent legislation on BSE.71

234. In the case of food supplements, as in many other cases, instead, it's the legislation itself that
regulates the hypothesis of a temporary suspension or restriction of the use of these products where:

… a Member State, as a result of new information or of a reassessment of existing
information made since this Directive or one of the implementing Community acts

68 See Council Decision No 90/218/EEC of 25 April 1990 concerning the administration of Bovine
Somatotrophin (BST), Official Journal of the European Communities L116 of 8 May 1990, page 27.
69 See Council Decision No 1999/879/EC of 17 December 1999 concerning the placing on the market
and administration of bovine somatotrophin (BST) and repealing Decision 90/218/EEC Official Journal of the
European Communities L331 of 23 December 1999, page 71.
70 See Whereas (5) to (7) of Council Decision No 20 00/76/EC of 4 December 2000 concerning certain
protection measures with regard to transmissible BSE and the feeding of animal protein, Official Journal of the
European Communities L306 of 7 December 2000, page 32.
71 See Article 7 and Annex IV, point 1, of Regulation (EC) No 999/2001 of 22 May 2001 laying down
rules for the prevention, cont rol and eradication of certain transmissi ble spongiform encephalopathies, Official
Journal of the European Communities L347 of 31 May 2001, page 1.

was adopted, has detailed grounds for establishing that a product referred to in Article
1 endangers human health though it complies with the said Directive or said acts…
72
235. The Panel's question does not, however, appear to reflect what happened in the case of the
Community legislation on GMOs and GM products, where no suspension or prohibition of use was
decided.

86. Please explain to what extent the compet ent authority of a member State can request
further information from the notifier following a positive opinion by the SCP or EFSA? Can
this include requests for further information on matters specifically examined by the SCP (e.g.,
persistence, invasiveness, out-crossing, etc.)?

236. In accordance with international standards, and in particular with the Codex working
principles for risk analysis,
73 the European Communities have implemented:

a functional separation of risk assessment and risk management [in the risk analysis]
[of GMOs], in order to ensure the scientific integrity of the risk assessment, to avoid
confusion over the functions to be performed by risk assessors and risk managers, and
to reduce conflict of interest.
237. However, as the Codex working principles for risk analysis notes, the European Communities
recognise that:

risk analysis is an iterative process, and in teractions between risk managers and risk
assessors is essential for practical application.
238. Accordingly, risk assessment opinions are releas ed at the EU, and also often at national level,
by scientific bodies, such as the SCP, or now the EFSA, which are separate and independent from the
risk management level or bodies.

239. As the European Communities has indicated earlier, there is no hierarchy in sound science,
and several scientific opinions on a risk assessment or part thereof may therefore coexist, and may
even be potentially conflicting (see for example as an illustration, the answers of the European
Communities to the 3 questions of the Panel dated 3
rd of June, on the request for scientific and
technical advice).

240. In the risk analysis process, it is up to th e risk management level (the Commission and the
Member States together) to take appropriately into account all the independent risk assessment
information and opinions, as well as other relevant scientific information, such as for instance relevant
articles in scientific peer reviewed journals, in order to appropriately base their opinions on them (see
reply to questions 16 and 17).

241. The so-called competent authority(ies) from a Me mber State are part of that risk management
level, which includes a sophisticated institutiona l framework, distinct from the risk assessment

72 See Article 12 of Directive 2002/46/EC of 10 June 2002 on the approximation of the laws of the
Member States relating to food supplements, OJ of the EC L183 of 12 July 2002, page 51.
73 The Codex principles for the risk analysis of foods derived from modern biotechnology requires
(paragraph 9 of CAC/GL 44-2003) that this risk analysis process be consistent with the Codex Working
Principles for Risk Analysis adopted by the 26
th Session of the Codex Alimentarius Commission, 2003, and
presented in the Appendix IV of its report (EXH), see Exhibit EC-44.

framework, and encompassing the information exch ange network between the competent authorities
and the Commission.

242. In this process of risk analysis, any compet ent authority of a Member State is therefore
entitled to request (before or after a positive opinion, e.g. by the SCP or EFSA) any further risk
assessment information that it deems necessary as an appropriate scientific basis to inform its own
risk management opinion. The possibility of such requests are based on the same principle that
enables any Member State or the Commission to requ est further information, after a positive opinion
of the first risk assessment which has been performed by the lead competent authority having initially
received the application.

243. These requests for further information from a competent authority of a Member State may
aim, for example, at resolving conflicting scientif ic risk assessment opinions or information at
Member State and Community level, or between different Member States, at addressing any new
relevant scientific information that may have become available after the issuance of a positive
scientific opinion, at addressing other issues that are not covered by the scope of the request for
scientific advice, which has been forwarded to th e independent risk assessment body having issued a
positive opinion, or at requesting, as a condition for the placing on the market of a product, risk
management information or proposals to appropria tely cover risk assessment issues, that are more
detailed or more prescriptive than the one initiall y supplied by the notifier (e.g. a monitoring
plan, …).

244. These requests for further information, when a ddressed to the notifier, are channelled through
the Commission and, where appropriate, to the rele vant "lead competent authority" having initially
received the application and having issued the fi rst risk assessment. The lead competent authority
may, or may not, judge the request as appropriate, and forward it to the notifier. In doing so, that lead
competent authority may take into account, for instan ce, whether the matter has been specifically and
sufficiently examined in, e.g. the SCP opinion.

245. However, whether the request for further in formation has been forwarded or not to the
notifier, and whether it has received an answer or not, it still remains within the competence of that
Member State that filed the request to judge wh ether it has received sufficient scientific basis,
according to its own appropriate leve l of protection, to support or not the application for a specific
product. The available scientific information and opinions will form therefore the basis on which each
Member State will finally vote in the "comitology" procedure to adopt the draft community measure.

246. That "comitology" procedure (see reply to question 11) is therefore in fine the procedure for
the adoption of a specific measure based on the risk assessment, at the risk mana gement level. In this
procedure, each Member States risk management opi nion is weighted against the others according to
the corresponding voting rules.

87. Between October 1998 and the date of establis hment of this Panel, have there been any
occasions on which the five member States which had announced their intention to suspend the
approval of GMOs have voted in support of the approval of a GMO?

247. There have been several instances between October 1998 and the 4
th of March 2004 where the
Member States, which had announ ced their intention to suspe nd the approval of GMOs, have
supported the approval for placing on the market of a particular GMO, in line with a case by case
approach.

248. As a few examples, this happened, for instance, for applications:

• C/ES/96/02 (Cotton line 531): The Regulatory Committee of Directive 90/220/EEC was
consulted by written procedure. Deadline for response was first 18/12/1998, then
extended to 08/01/1999, then extended to 27/ 01/1999 and finally extended to 11/02/1999.
Italy voted in favour.

• C/ES/97/01 (Cotton line 1445): The Regulatory Committee of Directive 90/220/EEC was
consulted by written procedure. Deadline for response was first 18/12/1998, then
extended to 08/01/1999, and then extended to 27/01/1999 and finally extended to
11/02/1999. Italy voted in favour.

• C/F/95/12-01/B (Maize MON 809): The Regulatory Committee of Directive 90/220/EEC
was consulted in written procedure. Deadline for response was first 02/10/1998, and then
extended to 23/10/1998. Italy voted in favour.

• C/ES/96/02 (Zeneca tomato): The Regulatory Committee of Directive 90/220/EEC was
consulted in written procedure. Deadline fo r response was first 18/12/1998. Italy and
Denmark voted in favour.

• C/ES/00/01 (Maize NK603): The Regulatory Committee of Directive 2001/18/EC was
consulted on the updated notification on 18 Fe bruary 2004. France and Belgium voted in
favour.

• C/F/96/05-10 (Maize Bt11 for cultivation): The application was submitted in France. The
notification was transmitted to the Commi ssion with a favourable recommendation in
April 1999. After the update of the application in January 2003, the favourable
recommendation was again confirmed by the l ead competent authority when the updated
dossier was transmitted at Community level in June 2003.

88. At para. 11 of its first oral statement, the European Communities indicates that there
has been a need identified as early as the e nd of the 1970s to address the potential risks of
GMOs for human health and the environment di fferently from non-biotech products. Where
was the need identified and was there subsequent action?

249. The creation of the first artificial recomb inant DNA molecules in the early 70ies raised
immediately issues regarding their safety, primarily human health safety issues. As an example, on
experiment planned in California in 1971, to make a recombinant chimaeric molecule between genes
present in bacteria and in a Simian Virus (SV40, a virus able to transform monkey as well as human
cells into a cancerous state), was the source of in tense scientific debate globally in the following
years, regarding the need for appropriate oversight of this new technology.

250. By 1973
74 the initial developments of the powerful t echnique of genetic engineering, and the
subsequent demonstrations that it enabled to cro ss kingdom's natural barriers by the engineering of
one of the first genetically modified organism s (e.g. the cloning of an African frog gene ( Xenopus)
into a bacterium found in the intestinal tract of animals ( Escherichia coli)), was the subject of much

74 Construction of Biologically Functional Bacteria l Plasmids In Vitro S. N. COHEN, A. C. Y.
CHANG, H. W. BOYER, AND R. B. HELLING Proceedings of the National Academy of Sciences USA
(1973) 70:3240–3244. Exhibit EC-132.

excitement of the scientific community regard ing its potential uses, as well as much questioning
regarding its "biohazard" at international scien tific meetings. These safety questions were the
consequence of this new technological ability to cr eate novel individual combinations of genes, not
present naturally, and their potential unforeseen effect s, in particular on human health. This activity
peaked at the infamous February 1975 Asilomar conference on recombinant DNA molecules.

251. There, the academic community made recommendations
75 for ways to deal with the potential
biohazards of the work on recombinant DNA, incl uding the development of appropriate safeguards
such as the use of fastidious hosts unable to survive in natural environments, the use of non
transmissible vectors, or the design of different levels of physical and biological containment
procedures proportionate to the level of risks. It also recommended the development of guidelines to
address these safety concerns, as well as an oversight of this research by scientific advisory
committees.

252. These recommendations led to the development of such advisory bodies in several OECD
countries in the following years, as well as differe nt initiatives to regulate the products of that
technology. In 1976, the first set of recombinant DNA research guidelines was issued in the USA by
the National Institute of Health (NIH) in the Federal Register. 76 Despite several subsequent
amendments, they have remained until now as the ma in source of inspiration for the regulation of
contained use of GMO, and the design of ap propriate containment measures for individual
recombinant DNA experiments. They are certainly a definitive proof that GMOs do necessitate a
specific oversight.

253. Several initiatives for appropriate governance and legislation followed (e.g. from the US
Congress
77), which initiated a strong lobbying from the academic world against the regulatory
consequences of its own initiative, as it wished th e guidelines to remain only voluntary and under the
strict control of the research community, in orde r to avoid what was perceived then as unnecessary
burdens. Thereafter, different regulatory paths, an d drastically different scientific views, emerged
gradually in different OECD countries involved with the use of that technology.

254. In retrospect, the recommendations of th e 1975 Asilomar conference were actually too
narrow, because the debate was essentially among molecular biologists, which were not trained
enough in infectious diseases, epidemiology or hu man health, let alone animal health or even
environmental science and ecology. There was theref ore some overstating of some biohazards of
recombinant DNA, as well as some safety issues that never were addressed at the time. As has been
stated later regarding the relationship between th e NIH guidelines for research in containment and the
deliberate release of GMOs, by Allan Campbell, one of the eminent scientist participating in the
Asilomar Conference, a member of the NIH r ecombinant Advisory Committee (RAC) from 1977 to
1981, and one of the strongest proponent of the technology, and strongest opponent of its strict
research oversight:

Both deliberate release and large-scale production were among the few areas to which
Guidelines would have continued to appl y under the most liberal revisions ever

75 Asilomar Conference on Recombinant DNA Molecules. Paul Berg, David Baltimore, Sydney
Brenner, Richard O. Roblin III, Maxine F. Singer. Science (1975) 188:991-994. Exhibit EC-133.
76 Department of Health Education and Welfare. National Institutes of Health. Recombinant DNA
Research Guidelines. Draft Environmen tal Impact Assessment. Federal Regi ster (September 9, 1976) 41(176)
38126-38483. Exhibit EC 134.
77 Letter of the Committee on Labor and Public Welfare, United States Senate to the President of the
United States; July 19, 1976. 3 pages. Exhibit EC 135

proposed. Attempts by others to extend exemptions for small-scale laboratory
experiments to these other levels have ge nerally rested on devious logic which I
cannot endorse.
78
255. In fact, only one presentation made at Asilomar addressed agricultural research in the light of
this technological revolution in life sciences. At th at presentation, Ray Valentine, the later co-founder
of the company Calgene, is said to have invented the word "molecular farming" by presenting the idea
of transferring the bacterial nitrogen-fixing ability to crop plant in order to enable them to fix
atmospheric nitrogen. That potential achievement has been used throughout the 80ies and the
beginning of the 90ies as an argument to support th e recombinant DNA research in plants, but has not
yet been realised.

256. At the beginning of the 80ies, the discovery of the ability to transform and generate GMOs
from plant species, and by 1986, their first deliberate releases, were the origin of a different, albeit
related, and important scientific debate on their human health and e nvironmental safety, in particular
as regards their unique characteristics when comp ared to some traditional counterpart, where
available. For instance, the development, at a la ter stage, of the OECD "substantial equivalence"
paradigm, namely as a tool to perform GM plant ri sk assessment by comparison with the properties of
traditional varieties of the same species, has always addressed the comparison of these plants, GM and
non GM, with the exception of the new expressed trait introduced in the GM plant variety
, which
could never have been stated as being "substan tially equivalent" to a non existing traditional
counterpart. Anyhow, that concept as it had been developed then, has now received scientific criticism
due to its limited and reductionist approach, calling for its revision if it were to be further applied.

257. Even if the worries of the initial scientific cont roversy were claimed by some to be overstated,
there were opportunities that proved that there was mu ch rationality in these initial concerns that the
GM technology may, on a case by case basis, lead to significant new risks, as compared to the safety
of the combinations of genes obtained by traditional methods.

258. To take a recent example, as announced in January 2001, an Australian research group had
found previously an unforeseen and troublesome result: in the search of a mouse contraceptive
vaccine for pest control, they introduced a gene that produces large amounts of interleukin 4, a natural
molecule found in mammals, and involved in the immune response, into the genome of a mousepox
virus, closely related to smallpox. The aim was to boost antibody production against mouse eggs, but
totally unexpectedly, they found that they had genera ted a deadly virus for the mice, even those that
had been vaccinated against this virus, by completely wiping out their immune system
79. This
experiment was later repeated in experiments in the USA, even more dramatically as all mice in this
latter experiment died, thereby showing previously unforeseen means to en hance the virulence of
viruses from the smallpox family (and by the way also thereby raising recent fears of bioterrorism)80.

78 Introduction of Genetically Modified Organisms into the Environment - Scientific Committee On
Problems of the Environment (1990) Eds H.A. Mooney and G. Bernardi. Chapter 2 : Recombinant DNA: Past
Lessons and Current Concerns. Allan Campbell.
79 Expression of Mouse Interleukin-4 by a Recombinant Ectromelia Virus Suppresses Cytolytic
Lymphocyte Responses and Overcomes Genetic Resistance to Mousepox. RONALD J. JACKSON, ALISTAIR
J. RAMSAY, CARINA D. CHRISTENSEN, SANDRA BEATON, DIANA F. HALL, AND IAN A.
RAMSHAW. JOURNAL OF VIROLOGY (Feb. 2001) Vol. 75, No. 3 p. 1205–1210. Exhibit EC-136.
80 10th International Symposium of the European Federation of Defence Technology Associations.
Geneva May 7th, 1998 Biological Weapons: New Threats (Biological warfare and rDNA technology) Dr.
Martin Schütz, AC-Laboratorium Spiez. Exhibit EC-137; ENHANCEMENT CHAPTER Infectious Disease and
Bioterrorism (George Johnson, Washington University, St. Louis). pp 1-14. Exhibit EC-138

259. Extracts from the recommendations from Asilomar's conference stated:

The new techniques, which permit combina tion of genetic information from very
different organisms, place us in an era of biology with many unknowns.
Accurate estimates of the risks associated with different types of experiments are
difficult to obtain because of our ignoran ce of the probability that the anticipated
dangers will manifest themselves
260. These statements made at the time by the scien tific community remain, at least in part, true.

89. With regard to the European Communities' reference to the precautionary principle as
stated in the Rio Declaration, how can the condi tion of "where there are threats of serious or
irreversible damage ..." be met in situations in which a substantial number of scientific
evaluations and risk assessments have concluded th at there is no evidence of potential harm to
health or the environment?

261. The 1992 Biodiversity Convention and the 2000 Biosafety Protocol recognize that the
precautionary principle is applicable a priori to all
 biotech products, having regard to the potential
impacts on biodiversity and taking account human h ealth (see first written submission of the
European Communities, para. 105 et seq., and answer to Question 11 from Argentina).

262. As described in the first written submission of the European Communities and amplified in
these answers to questions, there remain significant di fferences of opinion between various scientific
committees at the EC and national levels, as well as in the academic literature, in relation to the
potential harm posed to the environment and human health by biotech products which are the subject
of these proceedings. It is not the case in relati on to the products which are the subject of these
proceedings that there is, as the question implies, "no evidence of potential harm to health or the
environment." In such circumstances the precautionary prin ciple continues to apply. The conduct of
risk assessment is but one element of the applicati on of the precautionary principle; the management
of potential risks which may emerge and the con tinual evaluation of risks by reference to the
emergence of new scientific understanding (for exampl e in relation to antibiotic marker genes) are
further examples of the application of the principle.

263. These principles are reflected in the Biosaf ety Protocol, which permits prohibitions on
imports where there is uncertainty as to the effe cts on biological diversity, even if it cannot be
demonstrated that a particular GMO poses risks to hum an or animal health. The negotiators of the
Protocol expressly recognised this fact, and reject ed alternative language which would follow more
closely the language of the SPS Agreement . For example, the Japanese delegation proposed a
modification using some elements of the SPS Agreement (without specifically referring to the SPS
Agreement), and in particular a reference "to the provis ional nature of the measures concerned and to
the need for a review within a reasonable period of time".
81 The proposal was rejected. It is therefore
clear that the negotiators of the Protocol recognised that decisions relating to biotech products should
be based on precautionary approach which went beyond the general requirements of the SPS
Agreement. Notwithstanding the rejection of its proposed modification, Japan has become a party to
the Protocol, which lowers the threshold at which act ions can be taken to prohibit imports of certain
GMOs has been lowered by the Protocol.

81 See Kiyo Akasaka, "Japan", in C. Bail, R. Falkner and H. Marquard, The Cartagena Protocol on
Biosafety – Reconciling Trade in Biotechnology with Environment and Development?" (2002), 200 at 204.

90. Are food products containing, or consisting of, genetically modified organisms subject to
EC Regulation 258/97 only, or are/were they also subject to EC Directives 2001/18 and 90/220?
If the latter, which rules would prevail in the event of differences?

264. Food products containing, or consisting of, genetically modifi ed organisms were subject to
Directive 90/220 until May 1997, the date of entry into force of Regulation 258/97. After that date,
food products containing, or cons isting of, genetically modified organisms, as well as food derived
from GMOs but no longer containing them have been subject only to Regulation 258/97. Its Article 9
specifies, in fact, that

Articles 11 to 18 of Directive 90/220/EEC shall not apply to foods or food ingredients
which contain or consist of genetically modified organisms.
265. Furthermore, according to Article 9(2), the notification under Regulation 258/97 covered also
the environmental assessment of the effects of placing on the market of novel food and novel food
ingredients containing or consisting of GMOs:

In the case of foods or food ingredients fa lling within the scope of this Regulation
containing or consisting of genetically modified organisms, the decision referred to in
Article 7 shall respect the environmental safety requirements laid down by Directive
90/220/EEC to ensure that all appropriate measures are taken to prevent the adverse
effects on human health and the environm ent which might arise from the deliberate
release of genetically modified organisms. During evaluation of requests for the
placing on the market of products containing or consisting of genetically modified
organisms, the necessary consultations shall be held by the Commission or the
Member States with the bodies set up by th e Community or the Member States in
accordance with Directive 90/220/EEC.
266. Thus, as of May 1997, the placing on the mark et of products contai ning, or consisting of,
genetically modified organisms had to be aut horised under Regulation 258/97 for use as food, and
under Directive 90/220 (now Directive 2001/18) for u se as feed and cultivation. Decisions under the
two pieces of legislation were taken according to the rules laid down in such legislation.

91. With reference to paras. 561 and 562 of the EC first written submission, it appears that
the European Communities acknowledges the existence of a certain "situation" in the context of
a legislative change, which situation was referred to by some as a "moratorium" or "de facto
moratorium". Is the European Communities impl ying that since the new EC legislation (EC
Directive 2001/18 and EC Regulation 1829/2003 (replacing Regulation 258/97)) has been in
effect, the "situation" has changed? If so, did the new "situation" result in examination of
applications in accordance with the timetable provi ded for by the new EC legislation? If not,
why not?

267. As a preliminary point, the European Communities would like to stress once again that the
situation prevailing in the EC for some time after 1998 was not one of "suspension" of procedures,
contrary to what the complainants have suggested. The "situation" to what the question refers was one
of improvement of the regulatory oversight on GM products, which implied the upgrade of pending
applications in order to satisfy the EC requirement s in terms of environmental protection, food safety,
consumer information etc.

268. The legislative changes had been necessary because existing legislation had been identified to
be inadequate to address all concerns relating to GMOs. Pending applications because and to the

extent that they did not contain the data/informa tion necessary to address these concerns (since they
were based on the old legislation) were affected . Attempts were made to anticipate the new
legislation (on that see replies to question 92 be low and also question 13). With the adoption and
entry into force of the new legislation all re levant concerns have been addressed. Pending
applications, thus, are required to provide all relevant information/data to address these issues.

269. For release into the environment this "situati on" existed with respect to Directive 90/220.
Directive 90/220 was replaced by Directive 2001/18, wh ich addresses all relevant concerns including
certain issues of risk assessme nt, as well as labelling, traceab ility and monitoring. With the
application of Directive 2001/18 in October 2002 notification procedures have been (re-)launched
according to the provisions set out in that Directive. The notifications are proceeding smoothly and in
accordance with the timetable provided for in the Directive. In some cases the clock has been stopped
in accordance with Articles 14(4) or 15(1) subpa ragraph 4, because further information has been
requested.

270. An example is Monsanto Roundup Ready Co rn NK 603 (see also first written submission
paras. 279 et seq.). The application has gone through all stages of the procedure with only minor
delays due to some questions on additional informat ion. EFSA was requested to provide an opinion
in September and has done so within less than th ree months. The draft decision has been presented to
the Regulatory Committee in February and has, becau se it has not reached a qualified majority there,
been presented to the Council in March. As provide d in the legislation, the Council has three months
to decide. A decision, thus, is expected in late J une. Thus, all in all, a d ecision will have been taken
within a year and a half's time (i.e. about 550 days). By comparison, the average time required for the
regulatory review and approval of Bt-transgeni c crop cultivars by the Environmental Protection
Agency and the USDA's animal plant and health inspection services in the United States is 701 days
(see table in Exhibit EC-111).

271. The next products "in the pipeline" are: GT 73 oilseed rape (notification C/NL/98/11) to be
discussed at the Regulatory Committee on 16 June 2004 and MON 863 maize (C/DE/02/9) to be
presented to the Regulatory Committee in autumn 2004.

272. For food use of GMOs and GM products th e situation was somewhat different. Regulation
258/97, in general terms, provide d an adequate framework for a risk assessment for GM food
products. However, in terms of risk management, it became clear in 1999 that there would have to be
new legislation addressing some issues such as labelling and traceability, and also the development
and validation of detection methods. These is sues have been addressed through Regulations
1830/2003 (labelling and traceability) and 1829/2003 (food and feed).
82

273. Only three products under Regulation 258/97 were partially affected by this situation as they
were the only ones that had reached the Communi ty level and the stage of risk management
considerations. Thus, for GA 21 maize, NK 603 and Bt 11, it was considered necessary to require the
validation of a detection method as a pre-conditio n for marketing approval. This was done on the
basis of a voluntary agreement with the applican ts. In the cases of Bt11 and NK 603 these detection
methods have been validated and the decision-maki ng process has been launched immediately after.
In the case of Bt11 this has already led to a final decision on a market authorisation on 19 May, in the

82 See in particular its Article 5.3(i), 65(f) on detection and validation methods and 13 on labelling
requirements.

case of NK 603 the decision is pending.
83 As for GA 21, as explained in the first written submission,
the development of detection methods being delayed for reasons lying in the sphere of the applicant.84

92. The European Communities argues that the processing of the applications at issue has
never been halted, but that at most it was delayed. The European Communities also argues that
any delays in the processing of applications were caused because the European Communities
found that EC Directive 90/220 would not address scientific issues sufficiently.

 (a) When did the European Communities reach the conclusion that the existing
regulatory framework would not address scientific issues sufficiently?

 (b) The European Communities seems to submit that even after the situation
mentioned in sub-question (a) occurred, th e processing of the applications went
on, if at a delayed pace. On what basis (regulatory framework, guidelines, etc.)
did the European Communities continue pr ocessing the applications, given that
the existing Directive had been determined to be insufficient?

274. As a preliminary remark the European Comm unities observes that it cannot be said to have
"reached a conclusion" until the moment the new legislation was adopted. There is no formal act of
any kind until the legislator has decided how to m odify the relevant legislation. This said, as
described below, a long debate has preceded the adoption of Directive 2001/18.

275. On (a): In 1994 the Commission issued a Communication on Biotechnology and the White
Paper on Growth, Competitiveness and Employment, in which it identified the need to review
Directive 90/220 in order to improve certain aspect s which could not be addressed through simple
technical adaptation. The Commission, in the en d of 1996, followed up on this Communication with
a report on the revision of Directive 90/220. In th is report it identified a number of risk assessment
and risk management issues in the application of Directive 90/220 which needed to be modified and
adapted. In particular, the Commission identified the problems related to the absence of a harmonised
set of risk assessment criteria, the absence of post market monitoring provisions and labelling
provisions. On the basis of this report, the Commi ssion, in the beginning of 1998, tabled a proposal
for a Directive amending Directive 90/220.
85 The proposal addresses the above issues. According to
the provisions of the so-called co-decision procedur e, the proposal was presented to the European
Parliament and to the Council. At the end of the first reading in either institution, the Council adopted
a Common Position in June 1999. The Common Pos ition, although by no means a final text, is a
strong indicator of what the final legislation will look like as it identifies the common grounds
between the two institutions (but also issues that are still contested between the two institutions) (see
also reply to question 93). On the basis of th is Common Position it was clear that the future
legislation would contain harmonised risk assessme nt criteria, provisions on labelling and traceability
as well as provisions on monitoring.

276. On (b): Formally speaking, Directive 90/220 c ontinued to be the basis for the handling of the
applications. However, the European Communities had to find ways to overcome the shortcomings of
the legislation in order to ensure that the a pplicant provided the necessary data for an improved
assessment and made commitments on issues pertaining to risk management. This is why, in the so-
called "interim approach" the competent authorities and the Commission entered in a dialogue with
the applicants in order to see whether they would be willing to comply with the requirements of the

83 The draft decision is expected to be transmitted to the Council by the end of June.
84 First written submission of the European Communities, paras. 301 et seq.
85 OJ of the EC C N° 139 of 04.05.1998, p. 1.

future legislation (as identified in the 1999 Counc il Common Position) on a voluntary basis. Most
applicants agreed to do so.

93. With reference, e.g., to para. 206 of the EC first written submission, could the European
Communities elaborate on the content of th e "Common Position of the Council" and its
relevance to the operation of the relevant EC approval procedures for biotech products?

277. In the European Communities legislative process, the common position of the Council is a
political decision which intervenes after the European Parliament has expressed its opinion on a
Commission proposal. With it, the Council takes a position on those amendments by the Parliament
on which it disagrees and that it cannot approve
86.

278. Paragraph 206 of the EC's first written submission refers to the Common Position agreed by
the Council on 24 June 1999 on the Commission proposal for a directive amending Directive 90/220

86 On the full so-called "co-decision" procedure, see Article 251, paragraphs 2 to 6 of the EC Treaty:
2. The Commission shall submit a proposal to the European Parliament and the Council. The Council,
acting by a qualified majority after obtaining the opinion of the European Parliament:
— if it approves all the amendments contained in the European Parliament's opinion, may adopt the
proposed act thus amended,
— if the European Parliament does not propose any amendments, may adopt the proposed act,
— shall otherwise adopt a common position and communicate it to the European Parliament. The
Council shall inform the European Parliament fully of the reasons which led it to adopt its common
position. The Commission shall inform the European Parliament fully of its position.
If, within three months of such communication, the European Parliament:
(a) approves the common position or has not taken a decision, the act in question shall be deemed to
have been adopted in accordance with that common position;
(b) rejects, by an absolute majority of its co mponent members, the common position, the proposed
act shall be deemed not to have been adopted;
(c) proposes amendments to the common position by an absolute majority of its component
members, the amended text shall be forwarded to the Council and to the Commission, which shall
deliver an opinion on those amendments.
3. If, within three months of the matter being referr ed to it, the Council, acting by a qualified majority,
approves all the amendments of the European Par liament, the act in question shall be deemed to
have been adopted in the form of the common position thus amended; however, the Council shall
act unanimously on the amendments on which the Commission has delivered a negative opinion. If
the Council does not approve all the amendments, th e President of the Council, in agreement with
the President of the European Parliament, shall within six weeks convene a meeting of the
Conciliation Committee.
4. The Conciliation Committee, which shall be com posed of the Members of the Council or their
representatives and an equal number of representatives of the European Parliament, shall have the
task of reaching agreement on a joint text, by a qu alified majority of the Members of the Council or
their representatives and by a majority of the representatives of the European Parliament. The
Commission shall take part in the Conciliation Committee's proceedings and shall take all the
necessary initiatives with a view to reconciling th e positions of the European Parliament and the
Council. In fulfilling this task, the Conciliati on Committee shall address the common position on
the basis of the amendments proposed by the European Parliament.
5. If, within six weeks of its being convened, the Conciliation Committee approves a joint text, the
European Parliament, acting by an absolute majority of the votes cast, and the Council, acting by a
qualified majority, shall each have a period of six weeks from that approval in which to adopt the
act in question in accordance with the joint text. If e ither of the two institutions fails to approve the
proposed act within that period, it shall be deemed not to have been adopted.
6. Where the Conciliation Committee does not approve a joint text, the proposed act shall be deemed
not to have been adopted.

(that was to become Directive 2001/18).
87 With it, the Council reached a political consensus among
the Member States on a number of issues which were still outstanding in the draft legislative text,
such as time limitation for consent of a maximum of 10 years, compulsory labelling, explicit consent,
the strengthening of the precautionary principle, use of Regulatory Committee, etc.

279. In the case of Bayer Oilseed Rape FA LCON GS40/90, as well as in the case of other
notifications, such as Bayer Oilseed Rape Ms8xRf3 or the Monsanto Fodder Beet, the notifier agreed
to anticipate in its notification a number of the additional requirements to Directive 90/220 contained
in the Common Position adopted by the Council. These consisted in particular of commitments
related to an updated risk assessment, good agricultural practices, post-market monitoring, traceability
and labelling and an updated risk assessment.

94. With reference, e.g., to paras. 206, 212, 225 and 232 of the EC first written submission,
could the European Communities explain in more de tail what it means when it says that "in the
meantime, the European Communities' internal procedures for authorisation were
proceeding"?

280. With this expression (that is only present in paras. 212, 225 and 232), the European
Communities refers to the fact that the internal procedures for the preparation of a Commission's
proposal for decision were ongoing. It is what, in the detailed chronologies annexed to the first
written submission, is also referred to as the "interservice consultation" phase.

281. A close and coordinated action of all Co mmission services involved on a given matter is
mandated for the preparation and implementation of each Commission decision by Article 21 of its
Rules of Procedures,
88 which reads:

In order to ensure the effectiveness of Co mmission action, departments shall work in
close cooperation and in coordinated fashion in the preparation or implementation of
Commission decisions.
Before submitting a document to the Commis sion, the department responsible shall,
in sufficient time, consult other departme nts which are associated or concerned by
virtue of their powers or responsibilities or th e nature of the subject, and shall inform
the Secretariat-General where it is not consulted. The Legal Service shall be
consulted on all drafts or proposals for le gal instruments and on all documents which
may have legal implications. …
The department responsible shall endea vour to frame a proposal that has the
agreement of the departments consulted. In the event of a disagreement it shall
append to its proposal the differing views expressed by these departments, without
prejudice to Article 12.
282. The Commission's Rules of Procedures attach great importance to in ternal coordination;
Article 21 and Article 17 (third paragraph) require departments to work together as closely as possible
and liaise with the Secretariat-General in prep aring and implementing Community instruments.

87 The political agreement r eached by the Council in June 1999 resulted into a formally adopted
Common Position of December 1999. See OJ of the EC N° C 64 of 6.3.2000, p. 1.
88 See "Rules of Procedure of the Commission", C(2000)3614, Official Journal of the European
Communities No L308 of 8 December 2000, page 26.

Cooperation between departments is essential at all stages in their work, from conception to
presentation of a proposal to the Commission.

283. Responsibility for coordination lies with the l ead department (service), which should contact
other departments with a legitimate interest in the matter of the proposed decision as soon as
substantial drawing up begins. It tells them info rmally what the likely stages will be and consults
them on the planned approach. It also draws up a timetable for the work, allowing sufficient time for
formal consultation of the other departments con cerned and for the proposal to be submitted for a
decision. As work progresses, the lead departme nt and the departments associated or consulted
continue to exchange the necessary information. By virtue of its horizontal responsibilities, the
Secretariat-General's role is to stimulate and assist interdepartmental coordination. The Legal Service
is consulted and associated from the outset if the proposal involves drafting legislation.

284. Formal interservice consultati on is initiated by the lead department - possibly in cooperation
with associated departments that have been invol ved from the outset - when a proposal, usually for
adoption by the Commission, has r eached a sufficiently advanced st age within the department.
Interservice consultation, then, is the stage in interdepartmental coordination when the lead
department seeks officially the opinion of all th e directorates-general and services with a legitimate
interest in the substance of the proposal.

285. Once the consultation period is over, the lead department closes the procedure and revises the
texts to incorporate the changes requested by ot her departments in order to achieve as broad a
consensus as possible. If the request ed changes alter substantially th e text, further coordination or a
second round of interservice consultation may be needed.

286. This phase aims at reaching high quality and consistency in the Commission's and its
departments' work through effective coordination not only between all the departments concerned but
also with those outside the Commission who are af fected. In complex or highly sensitive dossiers it
can last several months.
89

95. With reference to para. 198 of the EC first written submission, could the European
Communities be more specific regarding the na ture and legal basis of the discussions which
have taken place, in some cases, "before and/or after the opinion of the European Communities'
scientific committees, among the competent authorities of the various Member States"?

287. The European Communities has specified the chronology of each notification and application
procedure at issue in this case in its Exhibits EC-62 to EC-110. The se ntence in paragraph 198 to
which this question refers was meant to give a ge neral and introductory overview of what is more
specifically detailed in the chronologies. In partic ular, with this sentence, the European Communities
intends to refer to the requests for further information, to the comments and to the reasoned objections
that Member States are entitled to submit, and ha ve indeed submitted, in the notification and
application procedures for the placing of the ma rket of GMOs envisaged by Directive 2001/18
(previously Directive 90/220) and Regulation 258/97.

288. The legal bases for the submission of such requests for further info rmation, comments and
reasoned objections are Article 15 of Directive 2001/18 and Article 6.4 of Regulation 258/97.

96. With reference to the submission by the Commission to the Regu latory Committee of a
draft measure:

89 See also Case C- 151/98P Pharos against Commission [1999] ECR I- 8157, paras. 24 and 26.

 (a) Is it correct that in the event of objections by member States or the Commission,
the Commission must submit to the re levant Regulatory Committee a draft
measure? (Please refer to relevant provisions of Directives 90/220 and 2001/18
and Regulation 258/97.)

 (b) If the answer to sub-question (a) is yes, is there a time limit within which the
Commission must do so?

 (c) Is it correct that from 1998 to the da te of establishment of this Panel, the
Commission submitted a draft measure to the Regulatory Committee in only two
cases?

 (d) If the answer to sub-question (d) above is yes, what explains this? Please provide
support.

289. On (a): Yes. Under Directive 90/220, the relevant provision is Article 13(3) which states:

In cases where the competent authority of another Member State raises an objection –
for which the reasons must be stated - a nd should it not be possible for the competent
authorities concerned to reach an agreement within the period specified in paragraph
2, the Commission shall take a decision in accordance with the procedure laid down
in Article 21.
290. Under Directive 2001/18 the relevant provision is Article 18 (1) which states:

1. In cases where an objection is raised and maintained by a competent authority or
the Commission in accordance with Articl es 15, 17 and 20, a decision shall be
adopted and published within 120 days in accordance with the procedure laid down in
Article 30(2). This decision shall contain the same information as in Article 19(3).
For the purpose 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
notifier or is seeking the opinion of the Scientific Committee which has been
consulted in accordance with Article 28 shall not be taken into account. The
Commission shall state reasons in any request for further information and inform the
competent authorities of its requests to the notifier. The period of time during which
the Commission is awaiting the opinion of the Scientific Committee shall not exceed
90 days.
The period of time that the Council takes to act in accordance with the procedure laid
down in Article 30(2) shall not be taken into account.
291. The relevant provision in Regulation 258/97 is Article 7(1) which states in its relevant part

Where […] an objection is raised in accord ance with Article 6(4), an authorization
decision shall be taken in accordance with the procedure laid down in Article 13.
292. On (b): As is apparent from the above pr ovisions, neither Directive 90/220 nor Regulation
258/97 provide for a time limit within which the Commission is to present a draft decision to the
Regulatory Committee. Under Directive 2001/18, on the other hand, a decision, in principle, is to be

adopted within 120 days. However, as can be seen in subparagraph 2 of the above Article 18(1) if the
Commission requests further information, the clock is stopped. Equally, the time to await the opinion
of the scientific committee (EFSA), which may be maximally 90 days, is not counted in the 120 days
either.
90

293. On (c): The Commission submitted altoge ther six draft measures to the Regulatory
Committee but asked for a formal vote on only three of them. The six products are:

Falcon GS40/90 (C/DE/96/05), presented to the Regulatory Committee on 29.10.99 and
09.03.00 (no vote).

Ms8xRf3 (C/BE/96/01), presented to the Regulatory Committee on 29.10.99 and 09.03.00 (no
vote)

A5/15 fodder beet (C/DK/97/01), presented to the Regulatory Committee on 29.10.99 and
09.03.00 (no vote)

1445 RoundupReady cotton (C/ES/97/01) presented to the Regulatory Committee by written
procedure: negative vote

531 Bt cotton (C/ES/96/02) presented to the Re gulatory Committee by written procedure:
negative vote

Bt 176 maize (safeguard measure) presented to the Regulatory Committee on 09.01.98 and on
16.03.98: negative vote

294. On (d): The European Communities refers to its first written submission in which it has
explained in detail the history of each individual application.
91 As can be seen from these individual
histories, between 1998 and the date of the establis hment of the Panel only the three cases mentioned
above were judged to be in a stat e to be presented to the Regulator y Committee for a final decision.
The reasons vary from case to case, although they we re all related to new scientific developments, the
need to set up appropriate risk management measures (e.g. the monitoring plans required by EC
scientific committees) as well as, more generally, the review of the EC regulatory framework. For
instance, one of the elements that has delayed th e submission of a draft decision to the relevant
regulatory committees in a number of cases is the deve lopment and validation of a detection method.
However, the circumstances around each product must be looked at separately.

97. With reference to the submission by the Commission to the Council of a proposal
relating to the measure:

 (a) Is it correct that in the event the relevant Regulatory Committee does not render
an opinion, or renders a negative opinio n, the Commission must submit to the
Council, without delay, a proposal relating to the measure to be taken? (Please
refer to relevant provisions of Directives 90/220 and 2001/18 and Regulation
258/97.)

 (b) Is it correct that from 1998 to the da te of establishment of this Panel, the
Commission failed to submit any proposals to the Council?

90 See flowcharts in Exhibits EC-118 to 120.
91 See Chap. II. D, see also Exhibits EC-62 to EC-110.

 (c) If the answer to sub-question (b) above is yes, what explains this? Please provide
support.

295. On (a) Yes. The relevant provision under Di rective 90/220 is Article 21 which states in its
relevant part:

If the measures envisaged are not in accordan ce with the opinion of the committee, or
if no opinion is delivered, the Commission shall, without delay, submit to the Council
a proposal relating to the measures to be taken. [emphasis added]
296. Under Directive 2001/18 the applicable provision is Article 30 which refers to Article 5 and 7
of Decision 1999/468/EC. Article 5 of the Comitology Decision states in its relevant part:

If the measures envisaged are not in accordan ce with the opinion of the committee, or
if no opinion is delivered, the Commission shall, without delay, submit to the Council
a proposal relating to the measures to be taken and shall inform the European
Parliament. [emphasis added]
297. Under Regulation 258/97 the relevant provision is Article 13(4)(b) which states

If the measures envisaged are not in accord ance with the opinion of the Committee,
or if no opinion is delivered, the Commission shall, without delay, submit to the
Council a proposal relating to the measures to be taken. The Council shall act by a
qualified majority. […] [emphasis added].
298. It should be pointed out that the words "without delay" have been interpreted extensively in
the case law of the European Court of Justice. The Court, in the case Pharos,
92 examined an identical
requirement to submit to a regul atory committee "without delay" in the context of legislation on the
setting of maximum residue limits of veterinary me dicinal products in foodstuffs of animal origin
(Regulation 2377/90), a legislation similar in structure to Directive 2001/18. A Commission proposal
on maximum residue limits for recombinant soma trophin (rBST) (a bio-engineered hormonal
substance) failed to obtain a favourable opinion in the regulatory committee, following which the
Commission sought a second opinion from the releva nt scientific committee and took some time
considering the various risk management options ava ilable. The Court started its analysis by stating
that nothing in the wording of the relevant provision

suggests any conclusion regarding the lengt h of time indicated by the expression
'without delay', other than that, while a cer tain degree of rapidity is required, the
Commission is not required to act within a precise period of time nor at once,
contrary to the appellant's submission.
93
299. The Court, then, pointed out that the Commission was free to modify its proposal before
submitting it to the Council and concluded from this fact:

92 Case C- 151/98P Pharos against Commission [1999] ECR I- 8157.
93 Ibidem, para. 20.

Accordingly, if the Commission has the right to amend the proposal relating to the
measures to be taken which it submits to th e Council, it must have sufficient time to
consider the various courses of action open to it.
94
300. In the case at hand, therefore, the Court of Justice confirmed the finding of the Court of First
Instance that the Commission (which had taken over el even months) had not violated its obligation to
act "without delay." The Court pointed to the fact that the matter which the Commission was
confronted was "highly complex and sensitive."
95 The Court also made it clear that the Commission
could not be criticised for having sought additional advice in an effort to prevent its proposal from
being rejected by the Council.96

301. On (b): The question is only relevant where decisions have been submitted to the Regulatory
Committee and have not received a favourable opinion since only in this case a proposal is to be
submitted to the Council. As seen above in the reply to question 96, this has been the case only in the
three instances, namely for the two Monsanto products Bt cotton 531 and Roundup Ready Cotton
1445 and for the safeguard measures on Bt 176 Mai ze. On the latter the Commission submitted a
draft measure to the Council on 11.06.1998. The Council failed to act within the delay of three
months.

302. On (c): In the only instances where this s ituation arose the Commission considered that the
impending legislative changes affected also the two product applications in question and that further
reflection was necessary before proceeding further. This is in line with the case law described above.

98. With reference to the forwarding by the competent member State authority of a
dossier/assessment report to the Commission:

 (a) Is it correct that the competent member State authority must, within a specified
time period, forward a dossier/assessment report to the Commission (except
where, under Directive 90/220, the competent authority rejects an application)?
(Please refer to relevant provisions of Directives 90/220 and 2001/18 and
Regulation 258/97.)

 (b) Have there been cases, from 1998 to the date of establishment of this Panel,
where member States have failed to forward dossiers/assessment reports within
the specified time period?

 (c) If the answer to sub-question (c) above is yes, what explains this? Please provide
support.

303. On (a): Yes. As highlighted in the flowch arts in Exhibits EC-118 to EC-120, the relevant
provisions are the following. Article 12 (2) of Directive 90/220 which provides:

At the latest 90 days after receipt of the notification, the competent authority shall
either:
(a) forward the dossier to the Commission with a favourable opinion, or

94 Ibidem, para. 24.
95 Ibidem, para. 26.
96 Ibidem para. 27.

(b) inform the notifier that the proposed release does not fulfil the conditions of
this Directive and that it is therefore rejected.
304. For the case of a positive
 assessment report Article 14(2) of Directive 2001/18 provides

Within 90 days after receipt of the notification the competent authority shall:
[…]
– in the case referred to in paragraph 3(a) [i.e. the assessment report indicates
that the GMO(s) in question should be placed on the market and under which
conditions], send its report, together with the information referred to in
paragraph 4 and any other information on which it has based its report, to the
Commission which shall, within 30 days of its receipt, forward it to the
competent authorities of the other Member States.
305. For the case of a negative
 assessment report Article 14(2) of Directive 2001/18 provides

In the case referred to paragraph 3(b), [i.e. the assessment report indicates that the
GMO(s) should not be placed on the market ] the competent authority shall send its
report, together with the information re ferred to in paragraph 4 and any other
information on which it has based its report, to the Commission no earlier than 15
days after sending the assessment report to the notifier and no later than 105 days
after receipt of the notification. The Commission shall, within 30 days of its receipt,
forward the report to the competent authorities of the other Member States.
306. Article 6(3) and (4) of Regulation 258/97 provides:

3. The initial assessment report shall be drawn up within a period of three
months from receipt of a request meeting th e conditions laid down in paragraph 1, in
accordance with the recommendations referred to in Article 4 (4), and shall decide
whether or not the food or food ingr edient requires additional assessment in
accordance with Article 7.
4. The Member State concerned shall wi thout delay forward the report of the
competent food assessment body to the Co mmission, which shall forward it to the
other Member States. […]
307. With regard to these provisions it should be poi nted out that delays do not run where further
information has been requested by the competent authority.

308. This is explicitly set out in the release into th e environment legislation. Thus, Article 12(5) of
Directive 90/220 states that

For the purpose of calculating the 90-day period referred to in paragraph 2, any
periods of time during which the competent authority is awaiting further information
which it may have requested from the notifier shall not be taken into account.
309. Similarly, Article 14(4) of Directive 2001/18 which provides that

For the purpose of calculating the 90 day pe riod referred to in paragraph 2, any
periods of time during which the competent authority is awaiting further information
which it may have requested from the notif ier shall not be taken into account. The
competent authority shall state the reasons in any request for further information.
310. In Regulation 258/97, it can be inferred fro m the above provision that the specified time-
limits only apply where a request meets the conditions as set out in paragraph 1 of Article 6. That
paragraph states that

The request referred to in Article 4 (1) shall contain the necessary information,
including a copy of the studies which have been carried out and any other material
which is available to demonstrate that the food or food ingredient complies with the
criteria laid down in Article 3 (1), as well as an appropriate proposal for the
presentation and labelling, in accordance with the requirements of Article 8, of the
food or food ingredient. In addition, the request shall be accompanied by a summary
of the dossier.
311. On (b): The European Communities, in its first written submission, has provided a detailed
account of each and every application. From thes e accounts it can be seen that in a number of cases
the application dossiers were not forwarded to the Co mmunity within the specified time limits that is,
90 days or three months). The accounts also provide the explanation for why this is so.

312. On (c): As stated immediately above the detailed accounts of the individual applications
explain the reasons why an assessment report has not been forwarded within the specified time-limits.
In all these cases, the competent authorities requ ested additional information and the clock was
stopped according to the provisions described above. The European Communities has annexed to its
first written submission all these requests for additiona l information. The Panel will see from these
requests that in all cases data were missing whic h the competent authority considered necessary to
complete its risk assessment.

99. With reference to the applications for approval of canola/oilseed rape MS1/RF1 and
MS1/RF2:

 (a) Did France still withhold its consent to the placement of these products on the
market on the date of establishment of this Panel?

 (b) Did the Commission initiate proceedings against France? If not, why not?

313. On (a): The answer is "yes." It should be adde d, as stated at the first hearing, that from a legal
point of view, the absence of the final consent does not mean that the applicant is not entitled to place
these products on the market. The products have obt ained a market authorisation by virtue of
Commission decisions of the 6 June 1997. While that decision is addressed to France and places an
obligation upon France to grant final consent, it can nevertheless develop a direct effect vis-à-vis the
applicant as well.

314. In the case law of the European Court of Ju stice, the EU Member States cannot prevail
themselves of the fact that they have not im plemented (or refuse to implement) Community
obligations addressed to them in order to deny an individual a right which he or she has been granted
through those same Community provisions.
97 The individual, therefore, can assert his or her right by

97 See only Case 9/70 Leberpfennig, [1970] ECR 825.

directly relying on the Community law in question. These principles form the so-called doctrine of
"direct effect." The Court has based this doctrin e on a teleological interpretation of Community law,
and in particular, on the so-called "effet utile" principle.

315. On (b): The Commission did initiate infringement proceedings against France in 1998.
However, in light of the circumstances at the time it decided not to take the case to the Court. The
Commission has discretion in deciding on the opportunity of launching infringement proceedings.
98
These circumstances were in particular the following: th e fact that the very legislation on the basis of
which the authorisation had been granted had been identified to be insufficient and was being revised,
as well as the fact that France had raised the same environmental risk concerns regarding these two
products as it had for the products for which it ha d adopted safeguard measures (i.e. the identical
product oilseed rape MS1,RF1 which had obtained an authorisation for breeding activities in 1996 as
well as the product swede rape Topas 19/2).

100. With reference to Exhibits CDA-3 and CDA-38, could the European Communities
explain what is the legal status and effect, under EC law, of the declarations by the relevant EC
member States?

316. Declarations to Council minutes, such as t hose contained in Exhibits CAN-3 and CAN-38
have no legal significance or effect in the European Communities. This has been the constant legal
position in the European Communities as confirmed by the Court of Justice of the European
Communities most recently in Case C-375/98 Ministério Público and Fazenda Pública v Epson
Europe BV:99

Moreover, according to settled case-law, declarations recorded in Council minutes in
the course of preparatory work leading to the adoption of a directive cannot be used
for the purpose of interpreting that direc tive where no reference is made to the
content of the declaration in the wording of the provision in question, and, moreover,
such declarations have no legal significance (see Case C-292/89 Antonissen [1991]
ECR I-745, paragraph 18, and Joined Cases C-197/94 and C-252/94 Bautiaa and
Société Française Maritime [1996] ECR I-505, paragraph 51).
317. The Member States of the European Commun ities are fully aware of this position but have
recourse to such declarations for political purposes – to pass a message to ot her institutions, to the
public or to satisfy a political need.

101. With reference to the member State safegu ard measures challenged by the complaining
parties, please answer the following questions:

 (a) Were these measures still in force on the date of the establishment of this Panel,
and if so, are they still in force at present?

 (b) As of the date of establishment of this Panel, or subsequently, had any
"decisions"/"measures" been taken at Community level in respect of these
measures?

 (c) What would be the kind of "decision"/"measure" that might be taken at
Community level if it were determined that the member States concerned (i)

98 See only Case 247/87 Star Fruit against Commission, [1989] ECR 291, para. 11.
99 [2000] ECR I-4243 at para 26.

have justifiable reasons for maintaining th eir safeguard measures, or (ii) do not
have justifiable reasons? Specifically, is it correct that under the first scenario,
the member State concerned could not apply the safeguard measure
permanently (EC first written submission, paras. 154 and 572), but that the
restriction or prohibition would be extended to the entire Community? What is
the position under the second scenario?

 (d) Were the EC member State safeguard measures at issue in this dispute reviewed
within a reasonable period of time within the meaning of Article 5.7 of the SPS
Agreement? If yes, please provide support for your reply.

318. On (a): The measures were still in force on the date of establishment of this Panel and are still
in force today.

319. On (b): No "measures" within th e meaning of Annex A.1 or Article 5.1 SPS Agreement have
been taken at Community level in respect of the provisional Member State measures. Furthermore, no
"decisions" within the meaning of the final three pa ragraphs of Directive 90/220, Article 21, or the
equivalent provisions, have been adopted at Community level.

320. On (c)(i): If the provisional Member State measu res are considered justified, a decision on the
matter should be taken in accordance with Directive 90/220, Article 16, now Article 23 of Directive
2001/18. If the Commission would decide that the provisional measures were, for the time being,
justified, then it may be that no further legislative action would be necessary. If further measures were
not, for the time being, considered necessary, then it is possible that none would be proposed by the
Commission.

321. This situation cannot last forever. The Me mber State must seek to obtain the additional
information necessary for a more objective assessment of the risk and review the provisional measure
within a reasonable period of time. Once the scientif ic evidence is sufficient, the provisional measure
must be terminated, or replaced with a definitive measure. The definitive measure (whether consent or
prohibition) will be adopted at Community level. In adopting the definitive measure at Community
level, account would be taken of any intervening changes in Community legislation, or any re-
assessment of the level of acceptable risk, in the context of the Community as a whole, and taking into
account the specific circumstances of each Member State. Thus, it is possible either that the
provisional restriction or prohibition would be termin ated, or that it would be definitively extended to
the entire Community.

322. On (c)(ii): If the provisional Member State measures are considered unjustified, either when
adopted, or at least at some later point with the passage of time, then a decision should be taken on the
matter within three months. The Commission may pr opose a decision addressed to the Member State
that has adopted the provisional measure, to th e effect that the provisional measure shall be
withdrawn. The Commission may also initiate the pr ocedure provided for in Articles 228 of the EC
Treaty. According to that procedure, the European Court of Justice may find that a Member State has
failed to fulfil an obligation under the EC Treaty, and require the Member St ate to take the necessary
measures to comply with the judgment of the Court. Another Member State may also bring the matter
before the European Court of Justice, pursuant to Article 227 of the EC Treaty.

323. In this scenario, the provisional measure woul d be terminated. It would not be definitively
extended to the entire Community – unless, in th e intervening period, changes in the Community
legislation or a re-assessment of the level of acceptable risk justified such extension.

324. On (d): The Member State measures are consta ntly subject to review. However, the specific
review to which Article 5.7 SPS Agreement refers is the review that follows the obtaining of the
additional information necessary for a more objective assessment. That is, it is the review that takes
place once the scientific evidence is sufficient – the review pursuant to which the provisional measure
is either terminated, or transposed into a definitive measure. A necessary pre-requisite for the carrying
out of that type of review is therefore sufficient scientific evidence. As recalled above, the sufficiency
of scientific evidence is a function of the level of accep table risk, which, in this case, is determined by
the Member State. The lower the leve l of acceptable risk – and under the SPS Agreement this remains
the sovereign decision of the WTO Member concer ned - the longer the reasonable period of time
referred to in Article 5.7 SPS Agreement is likely to be. In all the circumstances of this case, and
having regard to the specific objectives of the le gislators in the Member States, the European
Communities considers that, as a matter of WTO la w, it cannot be said that the period of time for
which the provisional Member State measures have been in force is not "reasonable" within the
meaning of Article 5.7 SPS Agreement.

102. Could the European Communities please elaborate further on the "societal values"
referred to at para. 1 of its first oral statem ent and the "political and social controversies"
referred to at paras. 3 and 4 of its first writte n submission, and explain how they are relevant to
the measures and WTO rules at issue in this dispute?

325. It is beyond doubt that risk analysis involv es consideration of "societal values" or social
perceptions. The clearest example relates to the social acceptability of a given risk –which is usually
referred as the level of protection. The desired level of protection is a function not only of scientific or
technical considerations on the nature and extent of the risk, but also of the willingness of a society to
accept or not the negative effects associated to a product. Therefore, for instance, the reasons for
which a given WTO Member may accept the sale of some carginogenic products such as tobacco, and
not accept the sale of other carcinogenic substances, ar e to a great extent related to its own scale of
social values.

326. But "political and social controversies" are also relevant for the pr ocess of risk assessment
itself (understood in a narrow, non-SPS, sense). Indeed , the emphasis that risk assessors put on one or
another aspect of the scientific or technical analysis of a given product depends in most cases on the
analytical framework that they adopt, which is itself influenced by the concerns expressed by society.

327. The European Communities would also recall that, for instance, under the SPS agreement,
regulators may take into account "relevant economic factors" in the context of a risk assessment, and
that Article 26(1) of the Biosafety Protocol provides as follows:

The Parties, in reaching a decision on import under this Protocol or under its domestic
measures implementing the Protocol, may ta ke into account, consistent with their
international obligations, socio-economic c onsiderations arising from the impact of
living modified organisms on the conserva tion and sustainable use of biological
diversity, especially with regard to the valu e of biological diversity to indigenous and
local communities.
328. Socio-economic considerations, in this contex t, include implications for existing patterns of
agricultural practises, having regard to the effects of biotech products for biodiversity.

103. Could the European Communities please further explain its comment made during the
first substantive meeting to the effect th at the European Communities considers risk
management to be part of risk assessment for the purposes of the SPS Agreement?

329. See reply to question 2.

104. At para. 416 of the EC first written submi ssion it is stated that Annex A of the SPS
Agreement does not address environmental prot ection and that the SPS Agreement was not
intended to address the prevention of risks to the environment. Could the European
Communities indicate how this position can be reconciled with (i) Article 5.2 of the SPS
Agreement, and in particular its phrase "relevant ecological and environmental conditions" and
(ii) Annex A(1)(d) ("other damage")?

330. (i) The scope of the SPS Agreement is expressly defined pursuant to Articles 1.1, 1.2 and 1.3
and Annex A.1 SPS Agreement . The purpose of defining something is to apply it consistently
throughout the relevant legal analysis. A "scope" de finition is a particularly fundamental type of
definition, and must be respected when applying the relevant legal provisions.

331. It is possible that other provisions of the SPS Agreement might provide useful context for the
purposes of settling interpretative questions ab out the definition contained in Annex A.1 SPS
Agreement. However, such other provisions cannot lawfully be considered to change the scope of the
definition itself. They cannot be used to come to a result that contradicts the definition, or which
enlarges or restricts the scope of the definition in a manner inconsistent with the text. The Panel
should proceed with particular caution when it com es to using context to settle the meaning of a
definition, and particularly a scope definition. By its very nature a scope definition establishes a
demarcation line, which line determines, at the same time, both what is covered (in this case) by the
SPS Agreement, and what is not covered by the SPS Agreement. When the drafters decide to proceed
by means of a "definition" it is clear that they are engaged in a process of weighing with the
maximum degree of precision and clarity that they can the meaning of the words and phrases they are
defining. They are not expected to have overlooke d specific issues, nor to have themselves relied on
"context" to settle the meaning of what they are defining, or expected a Panel to rely on context. In the
case of a definition, an appropriate and special weight must be given to the text.

332. Article 5.2 SPS Agreement is not a provision that defines the types of risks covered by the
SPS Agreement. It is rather a provision that explains what matters shall be taken into consideration
when assessing risks within the defined scope of the SPS Agreement. One of those matters is "relevant
ecological and environmental conditions." The use of the word "conditions" is significant. It confirms
that this phrase does not concern risks to the environmental per se , but rather environmental
conditions, which is a different matter.

333. For example, consider the situation in which a Member is considering whether or not to act to
protect animal health within its territory from th e entry of a disease-carrying organism (Annex A.1(a)
SPS Agreement). Thus, the contemplated measure, if adopt ed, will fall within the defined scope of the
SPS Agreement . In considering whether or not to adopt the measure, the Member may consider
"relevant ecological or environmental conditions". Fo r example, the disease in question, or its vector,
might particularly prosper in a wet climate. For a Member with a wet climate, that might increase the
risk. For a Member with a dry climate, the measure mi ght not be justified at all. This is the sense in
which environmental conditions must be taken into c onsideration. This does not, in itself, alter the
defined scope of the SPS Agreement, by bringing within the scope of the SPS Agreement in a general
and broad manner each and every risk to the environment.

334. (ii) The words "other damage" in Annex A.1(d) SPS Agreement are, in the opinion of the
European Communities, to be interpreted in juxtapos ition to human, animal or plant life or health. In
particular, it is generally accepted that they refe r to economic damage (particularly, for example,

economic damage to farmed crops or animals). Such damage might also include ecological or
environmental damage. The critical point to note, however, is that the words "other damage" are
expressly linked in the text only to the risks arising from the entry, establishment or spread of a pest

A GMO is not a pest. This provision is therefore incapable of bringing within the scope of the SPS
Agreement, in a broad and general way, all measures app lied to protect against damage to ecology or
environment arising from the introduction of a GMO.

105. With reference to footnote 197 of the US first written submission, has the European
Communities prepared a risk assessment which co vers any and all biotech products as opposed
to risk assessments covering only certain individual biotech products?

335. Firstly, footnote 197 relates to paragraph 105 of the US first written submission, which only
addresses the two definitions of risk assessment, contained in Annex A, paragraph 4, of the SPS
Agreement. As indicated in detail in our answer to question 2 of the Panel, it is the view of the
European Communities that these two definitions togeth er do not cover all potentia l risks that have to
be assessed to address fully the safety issues of each GMO.

336. Secondly, based on international standards, the risk assessment approach for GMOs enshrined
in the EC legislation, which has been implemented in accordance with these rules, is based on a case
by case approach. This case by case approach has required the European Communities to address each
GMO on its own individual merits, namely to ad dress each individual comb ination of a new gene
coding for a particular character with a specific host organism, for each use. The implementation of
this approach contradicts the statement from the Complainants that the European Communities has
enacted a so called "moratorium on any and all biotech products", i.e., the general moratorium," and
that, in doing so, it has failed to put forth an appropriate risk assessment.

337. Hence, it follows from that case by case appro ach that (i) the Europ ean Communities has not
adopted such a so called "moratorium", and, (ii) has not prepared any risk assessment which covers
any and all biotech products as opposed to risk assessments covering only certain individual biotech
products.

338. For the sake of completeness, the case by case approach has nevertheless led to the
identification of risk assessment issues which were systemic to a particular type of character, or
species.

339. For instance, there have been some risk assessment opinions or data prepared by the relevant
advisory bodies, on specific traits ( e.g. on the use of antibiotic resistance genes as marker genes in
GMOs), on specific species (e.g. OECD consensus documents on the biology of individual species, or
relevant opinions on out crossing properties of speci es indigenous to Europe, such as oilseed rape or
sugar beet ), or on the general combination of a specific character with a specific species ( e.g. on the
risk for the agro environmental management of the use of several distinct non selective herbicide
genes in oilseed rape, or on the risk of development of resistance to Bt in the European corn borer and
recommended monitoring practices). These "systemic" risk assessment opinions are however all in
compliance with the case by case approach, as they all have addressed the specific risks of individual
cases, whether for a specific trait, species or combination.

106. With reference to footnote 294 of the US first written submission, does an SCP opinion
concerning Luxembourg and Bt-176 exist? If so, could the European Communities please
provide a copy?

340. The Commission relied on the Scientific Op inions in relation to the Austrian measure
concerning Bt-176 also in the case of Luxembourg.

107. With reference to paras. 604 to 609 of the EC first written submission, could the
European Communities explain more clearly ho w and why the alleged lack of sufficient
evidence leads to the conclusion that the member State safeguard measures are based on a risk
assessment that is/was appropriate to the circumstances, as required by Article 5.1 of the SPS
Agreement?

341. The European Communities' basic point is that the relevant provision, if any, is Article 5.7
SPS Agreement (the provision expressly dealing with pr ovisional measures), not Article 5.1 SPS
Agreement.

342. If the Panel nevertheless assesses the Member State provisional measures by reference to
Article 5.1 SPS Agreement (which the European Communities cons iders would be an error of law),
the European Communities first argu es, in the alternative, that the words "as appropriate to the
circumstances" in Article 5.1 SPS Agreement would send the Panel right back to Article 5.7 SPS
Agreement, because the measures in question are provisi onal measures, and the circumstances are that
the scientific evidence is insufficien t for the specific legislator and its specific level of protection.
Under the first sentence of Article 5.7 SPS Agreement an assessment is necessary, but not a "risk
assessment" as that term is defined in the SPS Agreement. Furthermore, Article 5.1 SPS Agreement
does not expressly require a "risk assessment" – it on ly requires that the Member take into account
risk assessment techniques developed by the relevant international organisations. The risk assessment
techniques developed by the relevant international organisations generally recognise that in certain
circumstances, namely in the adoption of provisional measures, an assessment, but no risk assessment
within the meaning of the SPS Agreement, is necessary.

343. If the Panel nevertheless considers that the Member State measures could only lawfully be
adopted on the basis of a risk assessment (which the European Communities considers would be an
error of law), then the European Co mmunities argues, again in the alterna tive, that there is such a risk
assessment. A risk assessment was carried out at th e time when the original Community consent was
given. The Complainants agree (otherwise, that or iginal Community consent would be unlawful, at
least as a matter of Community law). That risk assessment can serve, at least temporarily, as a basis
both
 for the original Community consent, and for the Member State provisional measures.
Furthermore, the Member States have made their own assessments and further risk assessments may
be forthcoming.

344. The differences between the Community and the Member States lie not only in the science,
but also in the acceptable level of protection – so th at even if they would agree on the science, they
might still disagree on the measures to be taken. As set out in para. 610 of the first written submission
of the European Communities, the Appellate Body has made it very clear that "based on" does not
mean "conform to," that a legislator can rely on someone else's risk assessment; and that the same risk
assessment can reasonably support divergent res ponses by equally responsible and representative
governments.

108. With reference to Article 5.5 of the SPS Agreement, what is the appropriate level of
protection sought to be achieved by the relevan t provisions of (i) EC Directive 90/220, (ii) EC
Directive 2001/18 and (iii) Regulation 258/97?

345. The measures do not define a level of protection. They are designed to keep risk at an
acceptable level, but this has to be judged on a case by case basis. Guidance is provided by the EC
Treaty, which requires a high level of protection.

109. With reference to para. 470 of Canada's first written submission, could the European
Communities please indicate whether Canada's tran slation of Article 1 of the Greek Ministerial
Decision is correct?

346. The translation is correct but it does not transl ate the entire Article. It omits the last half
sentence which states "because this involves risks for the natural environment of Greece."

110. With reference to the European Communities' interpretation of Article 5.7 of the SPS
Agreement:

 (a) Please elaborate further upon why Article 5.6 is not "relevant" where Article 5.7
applies? (EC first written submission, para. 612)

 (b) Please elaborate further on why Article 5.7 "effectively" excludes Article 5.5?

 (c) The European Communities argues that the member State safeguard measures
fall to be assessed under Article 5.7 and no t, as the complaining parties argue,
Article 2.2 and 5.1 of the SPS Agreement. Article 5.7 appears to apply only in
circumstances where relevant scientific eviden ce is insufficient. Is this an issue
of fact? If so, which side bears the burden of proof in respect of this issue?

347. Please note that the order of response is diffe rent from the order in which the questions are
posed.

348. On (c): The European Communities considers th at the Appellate Body has made it clear that
the relationship between Article 5.7 SPS Agreement and Articles 2.2 and 5.1 SPS Agreement is one of
exclusion, not exception – it is the same relationship as between Articles 3.1 and 3.3 SPS Agreement,
worded in substantially identical terms. The question is, what is the demarcation line ?

349. The European Communities does not agree that the demarcation line between Articles 2.2 and
5.7 SPS Agreement is the sufficiency or insufficiency of sci entific evidence. The wo rd "sufficient" in
Article 2.2 SPS Agreement is used in a different sense to the word "insufficient" in Article 5.7 SPS
Agreement. In Article 5.7 SPS Agreement , the phrase "relevant scientific evidence is insufficient"
refers to a situation in which the evidence is insu fficient to make a definitive decision, whether that
decision is yes or no (consent or prohibition). That is why a provisional measure is permitted. Put
simply, there is not yet enough science on the table. On the other hand, the word "sufficient" in
Article 2.2 SPS Agreement has a different meaning. Article 2.2 SPS Agreement presumes that there is
enough science on the table to make a decision (yes or no). It also presumes that the decision that has
been taken is a "no". It contains an obligation on Me mbers to ensure that such a prohibition is indeed
the decision supported by and justified by the scien ce. Thus, given the different senses in which the
word "sufficient" is used, that wo rd does not provide an incisive tool for tracing the demarcation line
between these two provisions.

350. Rather, the European Communities draws the Panel's attention to the use of the word
"maintained" in Article 2.2 SPS Agreement, juxtaposed to the use of th e words "provisionally adopt"
in Article 5.7 SPS Agreement . These are the words that indicate the demarcation line : provisional

measures under Article 5.7 SPS Agreement ; definitive measures under Articles 2.2 and 5.1 SPS
Agreement.

351. Strong contextual support for this view may be derived from the fact that the Appellate Body
has made it clear that, in order to be consistent with Article 5.7 SPS Agreement , a measure must
satisfy the four
 conditions contained therein: relevant scientific evidence insufficient; use of available
pertinent information; seek to obtain additional in formation; reasonable peri od of time. Failure to
comply with any one of these four conditions would mean that a Member acts inconsistently with
Article 5.7 SPS Agreement. It would not mean that the entire discussion must suddenly be flipped out
of Article 5.7 SPS Agreement and into some other provision of the SPS Agreement.

352. For example, if a Complainant proves that, in adopting a provisional measure, a Member acts
other than on the basis of available pertinent info rmation, the conclusion would be that the Member
had acted inconsistently with Article 5.7 SPS Agreement. The conclusion would not be that the whole
question of consistency or not with the SPS Agreement suddenly needs to be assessed on the basis of
some other provision of the SPS Agreement. The Appellate Body has not indicated that any one of
these four conditions has a special status – in princi ple they are all to be considered of equivalent
status. As a matter of logic it is not possible to settle a question about the exclusionary scope of a
provision, by referring to the obligations contained within that provision – those obligations only
become relevant at all if it is first determined that the measure under scrutiny is within the scope of
that provision. In these circumstances, the Panel must first verify whether or not there is in fact some
other demarcation line between Article 5.7 SPS Agreement and Articles 5.1 and 2.2 SPS Agreement.

353. Such a demarcation line appears in the text of Article 5.7 SPS Agreement itself : that
provision concerns provisional measures. This is not one of the four conditions referred to by the
Appellate Body. It is the only reasonable candidate for the "exclusionary" demarcation line that we
have established must exist. This is confirmed by the juxtaposition of the words "maintained" in
Article 2.2 SPS Agreement and "provisionally adopt" in Article 5.7 SPS Agreement, as outlined above.

354. Further strong contextual support for this vi ew results from the Appellate Body's observation
that the word "sufficient" in Article 5.7 SPS Agreement must mean sufficient for something. It can
only mean sufficient for the making of a risk assessment, as defined by the SPS Agreement. Under the
SPS Agreement, a risk assessment must evaluate likelihood or potential. This is not to be confused
with risk of what is unknown or not sufficiently kn own. Nor are the roles of science and legislator to
be confused. The legislator sets the level of accepta ble risk. The scientist evaluates. The key point is
that all of these processes are linked. The lower the le vel of acceptable risk fixed by the legislator, the
longer it will take the scientific community to gather sufficient evidence – that is, evidence sufficient
to evaluate likelihood or potential in a manner that finally allows the legislator to make a definitive
decision, one way or another. Until then, provisional measures are possible, subject to the four
conditions set out in Article 5.7 SPS Agreement.

355. The view of the European Communities is th at it was and remains abundantly clear to the
Complainants that the Member State measures are provisional measures. That is what the Community
legislation repeatedly states. That is what the Member State national legislation implementing
Community legislation repeatedly states. That is what the Member State measures themselves state.
That is what the Court of Justice of the Eur opean Communities has stated. That is what the
Complainants themselves state in their submissions. Objectively, the question is therefore whether or
not they are consistent with Article 5.7 SPS Agreement , which is the provision that relates to
provisional measures. These are the obligations that the European Communiti es must comply with.
And the Complainants cannot change the benchmark simply by invoking some or other provision of

the SPS Agreement, which provision has actually got strictly nothing to do with the relevant behaviour
of the European Communities in this case.

356. These considerations are further re-enforced when one considers the matter from a burden of
proof perspective – also a question on which the Appellate Body has clearly expressed itself. Under
the correct approach, the Complain ants have the burden of proof to show that, under Article 5.7 SPS
Agreement, the relevant scientific evidence is not insufficient – that is, that it is sufficient - for making
a decision either way, yes or no. The Complainants must show that, given the science on the table,
there is no longer any basis for hesitation – a definitive decision must now be made.

357. On the other hand, under their twisted appr oach, the Complainants, referring to Article 2.2
SPS Agreement, merely assert that the science on the table is "insufficient" to justify a "no" - and they
purport to do this essentially by pointing to what they assert is the paucity of evidence suggesting
there might be some problems with GMOs. This is simply the wrong test from a burden of proof
perspective. And the proof of that is that the European Communities agrees with the Complainants –
for the specific legislator the sci entific evidence was or is insuffi cient – that is precisely why the
Member States adopted provisional measures.

358. Thus, what is happening is that the Comp lainants, by invoking the wrong provision of the SPS
Agreement, whether intentionally or not, are seeking unl awfully to shift the burden of proof onto the
European Communities. Since the burden of proof issue is at the very heart of this case, this vitiates
the Complainants' entire case. The European Communities has not said "no" or even "decided not to
decide". It has just said "maybe, but not yet".

359. The irony is that the United States actually ag rees with this analysis, as it indicated in the
DSB following the Japan-Apples Panel Report, which Panel Report was not appealed on this point.
This being so, it is highly perplexing that the United States nevertheless attempts to shift the burden of
proof onto the European Communities, by invoking an irrelevant provision of the SPS Agreement .
The position of the United States is logically internally incoherent.

360. To conclude, the European Communities considers that the issue of fact is whether or not the
Member State measures are or are not provisional measures. If the Complainants wish the Panel to
assess those measures other than on the basis of Article 5.7 SPS Agreement, the Complainants have
the burden of proving that the Member State measures are not provisional measures. However, the
Complainants have not even alleged that the Member State measures are not provisional measures, let
alone taken any steps to discharge their burden of proof in this respect. On the contrary, the
Complainants have actually asserted that the Member State measures are provisional measures. Since
there is no disagreement between the parties on this point, the Panel can only conclude that the
Member State measures are provisional measures, and that their conformity with the SPS Agreement
therefore falls to be assessed by reference to Article 5.7 SPS Agreement.

361. (b) The European Communities considers that th e essence of the type of situation covered by
Article 5.7 SPS Agreement includes one in which, as in the present case, there is a huge question mark
over certain issues, at least from the point of vi ew of certain specific legislators. In such
circumstances, just as Article 5.7 SPS Agreement excludes Articles 2.2 and hence 5.1 SPS Agreement,
so it should also be considered to exclude Article 5.5 SPS Agreement. If the problem is one in relation
to which a great deal remains unknown, there is little sense in which one can make the type of
comparison envisaged by Article 5.5 SPS Agreement . The most one can generally say is that both
situations involve an unknown, which is hardly a sound basis on which to measure consistency.

362. In any event, the European Communities would point out that it has indicated in its first
written submission, in the alternative, why it consider s that, in any event, the Complainants have not
proven any inconsistency with Article 5.5 SPS Agreement.

363. (a) Similar comments apply with regard to Article 5.6 SPS Agreement , which requires
measures to be no more trade restrictive than n ecessary. In the context of a provisional measure,
Article 5.6 SPS Agreement adds little if anything to Article 5.7 SPS Agreement. The whole point of a
provisional measure is that the science is insu fficient to form a definitive view. In these
circumstances, the legislator sets out to preserve the situation, pending the arrival of the science
necessary to take a definitive decision on the matter. The very nature of preserving the situation, that
is, the precautionary approach adopted by the legislat or, very strongly implies that, for the time being,
the authorisation sought will not be given. The legisl ator is concerned to ensure that no irreversible
steps are taken. Thus, in the logic and structure of the SPS Agreement, the relevant provision is Article
5.7 SPS Agreement, not Article 5.6.

111. With reference to para. 328 of Canada's first written submission and para. 382 of
Argentina's first written submission, does the European Communities agree that such
requirements as the requirement that biotech products not cause adverse effects to health or the
environment or the requirement that biot ech foods not present a danger are "product
characteristics"? If not, why not?

364. The European Communities agrees that Dir ective 2001/18 and Regulation 258/97 lay down
"product characteristics" within the meaning of Annex 1.1 TBT Agreement . This is however,
irrelevant, since the consistency of those measures with the TBT Agreement is not before this Panel.
Rather, Canada and Argentina assert that the Member State measures are inconsistent with the TBT
Agreement. And those Member State measures do not la y down product characteristics, within the
meaning of Annex 1.1 TBT Agreement.

365. More generally, the European Communities considers it doubtful that the phrases referred to,
in themselves, lay down "product characteristics". Mo st everything may be said to potentially have an
adverse effect on health or the environment or to present a danger – or not – depending on all the
circumstances (amount, dose, configuration, expos ure and so on). In the opinion of the European
Communities, some more specificity would probably be required before it could be said that such
statements amounted to "product characteristics".

112. With reference to para. 336 of Canada's first written submission, does the European
Communities agree that the term "like" in Ar ticle 2.1 of the TBT Agreement has the same
meaning and scope as the term "like" in Article III:4 of the GATT 1994?

366. No. As the Appellate Body has said a number of times:

… there can be no one precise and absolute definition of what is "like". The concept
of "likeness" is a relative one that evokes the image of an accordion. The accordion of
"likeness" stretches and squeezes in different places as different provisions of the
WTO Agreement are applied. The width of the accordion in any one of those
places must be determined by the particular provision in which the term "like" is

encountered as well as by the context and the circumstances that prevail in any
given case to which that provision may apply.100
367. The Appellate Body has also cautioned the au tomatic transposition of the interpretation of
"likeness" under the first sentence of Article III:2 to other provisions where the phrase "like products"
is used.101 The same obviously applies to the automatic transposition of the concept between other
WTO provisions.

368. Although it is not possible to say in the abstract whether the term "like" in Article 2.1 of the
TBT Agreement has the same meaning as the term "like" in Article III:4 of the GATT 1994, it is, in
the view of the European Communities clear that it cannot have the same scope. As explained in the
first written submission of the European Communities, Article 2.1 of the TBT Agreement can only
apply to differences in treatment between products that are covered by the technical regulation in
question. Thus the scope of the term "like produc t" in Article 2.1 of the TBT Agreement must be
limited by the scope of the products covered by the technical regulation under consideration.

113. With reference to para. 359 of Canada's first written submission, does the European
Communities agree that it is appropriate to interpret the term "necessary" in Article 5.1.2 of
the TBT Agreement by reference to the three factors referred to by Canada?

369. No. Article 5.1.2 TBT Agreement is concerned with conformity assessment procedures, but
taking what is in the technical regulation or st andard as a given. The word "necessary" essentially
refers to the relationship between the conformity assessment procedure and the technical regulation or
standard, rather than to the content of the technical regulation or standard itself.

370. Thus, in the first bullet point Canada refe rs to "the relative importance of the common
interests or values that the measure is intended to pr otect". The "common interests or values" that it is
intended to protect will generally be apparent from the technical regulation or standard, rather than the
conformity assessment procedure.

371. The same is true of the relationship betw een the measure and the end pursued (Canada's
second bullet point).

372. The effects on international trade (Canada's th ird bullet point) are referred to expressly in the
first sentence of Article 5.1.2 TBT Agreement. The second sentence of Article 5.1.2 TBT Agreement
begins with the words "this means". Consequently, it is not a case of interpreting the word "necessary"
by reference to the effects on international trade, but the converse. Whether or not the conformity
assessment procedures create unn ecessary obstacles to internationa l trade is to be assessed, inter alia,
by reference to whether or not the conformity assessment procedures are more strict than "necessary"
to give the importing Member adequate confidence th at products conform with the relevant technical
regulation or standard.

114. Could the European Communities give examples of situations where, in its view,
conformity assessment procedures would be "applie d more strictly than is necessary", contrary
to the requirements of Article 5.1.2 of the TBT Agreement?

100 Quoted from Appellate Body report in Euro pean Communities – Asbestos, para 89 where the
Appellate Body was quoting from its report in Japan –Alcoholic Beverages, para 114.
101 Japan –Alcoholic Beverages, para 113.

373. The European Communities woul d offer the following example.

374. A technical regulation lays down product char acteristics for electrical plugs, requiring them to
contain a fuse. The intention is to protect human life and property. The conformity assessment
procedure requires any plug manufacturer wishing to sell plugs in the territory of the importing
Member to obtain prior authorisation. It is clear from the technical regulation that this requires, at
least, the submission to the authorising authorities of all the technical details and documents, together
with a physical sample of the plug containing the fu se. Up to this point, we assume that there would
be no breach of Article 5.1.2 TBT Agreement.

375. Next, the authorising authority decides that every single physical plug to be imported to the
Member's territory will each have to be physically brought to the (unique) premises of the authorising
authority, where it will be opened and inspected in order to verify that it does indeed contain the
required fuse. Each plug will then receive a certifi cate of conformity, and then, and only then, each
plug can be sold.

376. We may reasonably assume that this approach is stricter than necessary to give the importing
Member adequate confidence that the plugs conform to the technical regulation. Since plugs are mass
produced, it is very likely that the final produc t will exhibit a high degree of homogeneity, so a
sample should be sufficient. When fuses blow, they have to be replaced anyway. If a plug requiring a
fuse were sold without a fuse, it is unlikely to be a commercial success. The threat of withdrawal of
authorisation in case of a finding of non-conformity following a complaint should provide sufficient
incentive for the importer to comply. The cost of br inging each individual plug to the premises of the
authorising authority before onwar d distribution is probably prohibitiv e, and would effectively make
any imports non-commercial.

377. The requirement is not expressly provided for in the technical regulation, so it is not the
conformity assessment procedure that is, as such, too strict. Rather, the decision on whether or not to
proceed in this way is left, in the municipal jurisd iction, to the authorising authority. The problem is
therefore that the conformity assessment procedure is being applied (by the authorising authority)
more strictly than necessary to give the importing Member an adequate degree of confidence that the
imported plugs will contain fuses.

115. With reference to Article 5.2.1, first clau se, of the TBT Agreement, is there a difference
between a requirement to undertake and complete a procedure "as expeditiously as possible"
and a requirement to undertake and complete a procedure "without undue delay" (see
Annex C(1)(a) of the SPS Agreement)? For instance, is it possible that a procedure has not been
completed as expeditiously as possible, but th at this nevertheless did not entail any undue
delay?

378. The text, context and object and purpose of these provisions being different, the European
Communities would not assert that the two phrases mean the same thing in all cases. Rather, the
European Communities would take the view that the acceptable period of time would depend on all
the circumstances. In particular, some issues, by th eir own nature, may require more time. This may
typically be the case for environmental or biodivers ity or ecosystem type issues, which may be both
unusually complex, and which may require the passage of time (the seasons), at least when it comes to
field testing.

116. With reference to para. 480 of the EC first written submission, is it the European
Communities' position that the procedural time- limits set out in domestic legislation are not
relevant to an assessment of whether a particular delay is undue? If so, how can this position be

reconciled with the provision of Annex C(1)(b) which requires, inter alia, that the standard
processing period of each procedure be published?

379. As stated in the above referenced paragraph, the European Communities is of the view that
the procedural time-limits set out in domestic legisl ation are not relevant to an assessment of whether
a particular delay is undue. If the drafters of the SPS Agreement had wanted to directly enforce time-
limits laid down in domestic legislation, they wo uld have drafted the obl igations contained in
Annex C(1)(a) and (1)(b) in a different manner. They could have stated, for example, that delays are
undue if they exceed the time-limits laid down in th e relevant domestic legislation. Equally they
could have required, not that a standard processing period, but that the processing period tout court be
published.

380. Indeed, by referring to a "standard" processing period in Annex C(1)(b) the drafters implied
that time-limits for specific procedures in the application of SPS measures are not and cannot be set in
stone. Standard time-limits are based on the assumption that a process runs smoothly and does not
encounter unforeseen obstacles. Unforeseen obstacles, by definition, cannot be planned nor predicted,
which is why standard time-limits at least in complex assessment procedures usually are not of a
binding nature in the sense that exceeding them would automatically enta il undue delay (and much
less entail an automatic decision). Accordingl y, exceeding the "standard" time-limit published
pursuant to Annex C(1)(b) of the SPS Agreement does also not automatically result in "undue" delays
under Annex C(1)(a).

381. In the specific case of assessment procedures for GMOs experience has shown that a number
of risk assessment or risk management aspects are no t fully defined and subject to constant evolution
of the background scientific debate. Applicants as well as competent authorities have to adjust to
these constant developments which not seldomly means that additional information is (spontaneously)
submitted by the applicant or is requested by the competent authority. This is the case in all
regulatory regimes on GMOs including those of the Complainants.
102 The present EC GMO
legislation takes this fact into account and provides that the clock is stopped if (reasoned) requests for
additional information.103

117. With reference to para. 482 of the EC first written submission, why is a delay caused by
risk considerations which do not fall within the scope of Annex A of the SPS Agreement not
relevant to a determination of whether said delay is inconsistent with Annex C(1)(a) of the SPS
Agreement? Is it not inevitable that the approval procedure conducted pursuant to the
provisions of the SPS Agreement would be delayed as a result of the aforementioned cause?

382. The European Communities does not state that delays for reasons outside the scope of the SPS
Agreement are always irrelevant to determining whethe r or not there is an inconsistency with the SPS
Agreement.

383. The European Communities reca lls its position that since the SPS Agreement applies to
measures which pursue certain objectives – objectives of prevent certain risks – a measure that
pursues other objectives as well as SPS objectives must be viewed as two separate measures. This
applies to approval procedures as much as to other SPS measures.

102 The European Communities refers to the examples provided in para. 489 in its first written
submission.
103 See Article 14(4) and 15(1) of Directive 2001/18. See also Article 6(7) and 13(6) of Directive
2001/18.

384. The case of delays is somewhat more comple x. As the European Communities has explained,
delays may be considered "measures" for the pur poses of dispute settlement where there is an
obligation that is applicable to delay or inacti on. That does not actually make the delay an "SPS
measure", which are defined in Annex A.1, but rather a measure subject to an SPS obligation.

385. The reasons why a given period of time has el apsed may relate to SPS objectives or to other
objectives (such as, for example, objectives that would cause a resulting measure to fall under the TBT
Agreement).

386. The European Communities considers that in these circumstances, as a first step, any reasons
for the time that has elapsed that relate to non-SPS objectives should be identified, and the elapsed
time specifically attributable to those reasons should be measured against what is acceptable under the
WTO provisions applicable to it.

387. The reason for this is that an approval procedure pursuing both S PS and non-SPS objectives
must be considered for WTO purposes as an SPS appr oval procedure to the extent that it pursues SPS
objectives and a non-SPS approval system for the rest . Delays in the non-SPS approval system are
simply not subject to the disciplines of Annex C but to whatever other WTO provision may be
applicable.

388. In the present case it is a fact that the approval procedure set up under the EC GMO
legislation is designed to address both SPS concerns and non SPS concerns. The Complainants have
not challenged this linkage. Becau se of the linkage, an approval pro cedure may be held up both for
reasons relating to objectives coming under the SPS Agreement and for reasons relating to objectives
outside the SPS Agreement. To the extent that delays occur for reasons relating to objectives outside
the SPS Agreement these delays cannot automatically be held to be "undue," at least where the reasons
form part of the approval procedure as designed (and not challenged by the Complainants).

389. To the extent the reasons rela te to objectives coming outside the SPS Agreement and the
resulting measure would come under the TBT Agreement, the corresponding delays could be assessed
under Article 5.1.2 of the TBT Agreement. The European Communities su bmits that such a delay
cannot be considered undue under the SPS Agreement unless it would be considered unjustified under
the TBT Agreement.

118. Assume for the sake of argument that an approval procedure in respect of an
application for the approval of a particular biotech product is governed by the provisions of the
SPS Agreement and the TBT Agreement, consistent with the European Communities' views as
set out at para. 441 of its first written submissi on. Assume further that there is a delay in the
processing of the application concerned and that the delay is caused by risk considerations
which do not fall within the scope of Annex A of the SPS Agreement. Finally, assume that the
delay is not inconsistent with relevant provisions of the SPS Agreement but is inconsistent with
the provisions of the TBT Agreement. What is the legal position? Would a panel need to find
that the Member concerned has breached its WTO obligations in respect of the conduct of the
relevant approval procedure?

390. As explained in the reply to question 117, because there is but one authorisation procedure
which comes both under the SPS Agreement and the TBT (or other relevant) Agreement(s), the
assessment of delays under the relevant provisions of these agreements may be linked. In concrete
terms, this means that TBT (or other non SPS) considerations may become relevant for the assessment
of "undue delays" in Annex C(1)(a). To the exte nt that the "TBT delays" are not unjustified they
cannot be considered "undue" under the SPS Agreement.

391. Regarding the hypothetical scenario proposed in question 118, the European Communities
would note that if the delay is exclusively caused by risk considerations coming under another
agreement than the SPS Agreement and is found to be inconsistent with that agreement, the finding
would also affect the assessment of "undue delays" under the SPS Agreement as the SPS part of the
authorisation procedure would have come to an end if it was not because of the non-SPS risks.