WORLD TRADE
ORGANIZATIONWT/DS291/23
8 August 2003
(03-4170)
Original:  English
EUROPEAN COMMUNITIES – MEASURES AFFECTING THE APPROVAL
AND MARKETING OF BIOTECH PRODUCTS
Request for the Establishment of a Panel by the United States
The following communication, dated 7 August 2003, from the Permanent Mission of the
United States to the Chairman of the Dispute Settlement Body, is circulated pursuant to Article 6.2 of
the DSU.
_______________
Since October 1998, the European Communities ("EC") has applied a moratorium on the
approval of products of agricultural biotechnology (" biotech products").  Pursuant to the moratorium,
the EC has suspended consideration of applications for, or granting of, approval of biotech productsunder the EC approval system.  In particular, the EC has blocked in the approval process under EC
legislation
1 all applications for placing biotech products on the market, and has not considered any
application for final approval.  The approvals moratorium has restricted imports of agricultural and
food products from the United States.
In addition, EC member States maintain a number of national marketing and import bans on
biotech products even though those products have already been approved by the EC for import andmarketing in the EC.  The national marketing and import bans have restricted imports of agricultural
and food products from the United States.
The measures affecting biotech products covered in this panel request are:
(1) as described above, the suspension by the EC of consideration of applications for, or
granting of, approval of biotech products;
(2) as described above, the failure by the EC to consider for approval applications for the
biotech products mentioned in Annexes I and II to this request; and
(3) national marketing and import bans maintained by member States, as described in
Annex III to this request.
These measures appear to be inconsistent with the following provisions of the Agreement on
the Application of Sanitary and Phytosanitary Measures  ("SPS Agreement"), the General Agreement
on Tariffs and Trade 1994  ("GATT 1994"), the Agreement on Agriculture  ("Agriculture Agreement"),
and the Agreement on Technical Barriers to Trade  ("TBT Agreement"):
                                                     
1 Directive 2001/18, O.J. L 106 17.4.2001, p. 1 (and  its predecessor, Directive 90/220, O.J. L 117,
8.5.1990, p. 15, as amended by Directive 94/15, O.J. L 103, 22.4.1994, p. 20 and Directive 97/35, O.J. L 169,
27.6.1997, p. 72); and Regulation 258/97, O.J. L 043, 14.2.1997, p. 1.WT/DS291/23
Page 2
(1) SPS Agreement, Articles 2.2, 2.3, 5.1, 5.2, 5. 5, 5.6, 7 and 8, and Annexes B(1), B(2),
B(5), C(1)(a), C(1)(b), and C(1)(e);
(2) GATT 1994, Articles I:1, III:4, X:1, and XI:1;(3) Agriculture Agreement, Article 4.2; and(4) TBT Agreement, Articles 2.1, 2.2, 2.8, 2.9, 2.11, 2.12, 5.1.1, 5.1.2, 5.2.1, 5.2.2, 5.6
and 5.8.
The EC's measures also appear to nullify or impair the benefits accruing to the United States directly
or indirectly under the cited agreements.
On 13 May 2003, the United States requested consultations with the EC regarding these
measures pursuant to Article 4 of the Understanding on Rules and Procedures Governing the
Settlement of Disputes  ("DSU"), Article 11 of the SPS Agreement, Article 19 of the Agriculture
Agreement, Article 14 of the TBT Agreement and Article XXII of the GATT 1994.   Consultations
were held on 19 June 2003, but have failed to settle the dispute.
Accordingly, the United States respectfully requests the Dispute Settlement Body to establish
a panel pursuant to Article 6 of the DSU, with standard terms of reference as set out in Article 7.1 ofthe DSU.WT/DS291/23
Page 3Annex I
Notifications under Directive 2001/18 (and 90/220) – Deliberate Release
Biotech ProductDate Submitted to
Member StateDate Received
by CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/181
Bayer oilseed rape
(MS1/RF1)Apr. 1995
(France—for import
and processing; already
approved for seedproduction)27 July 1995 N/A Favorable opinion from Art. 21
Committee, Commission Decision
approving product, 6 June 1997.
France (notifying member State)refused to implementN/A
Bayer hybrid
oilseed rape
(MS1/RF2)Apr. 1995
(France)27 July 1995 N/A Favorable opinion from Art. 21
Committee, Commission Decision
approving product, June 6, 1997.
France (notifying member State)
refused to implementN/A
Bejo Zaden red-
hearted chicory(RM3-3, RM3-4
and RM3-6)1994
(Netherlands—forfood/feed use; already
approved for seed
production)20 Sept. 1996 Positive
assessment18 Dec. 1998Not submitted to Art. 21 Committee N/A
Bayer oilseed rape
(Falcon GS40/90)1 Apr. 1996
(Germany)25 Nov. 1996 Positive
assessment14 July 1998Not submitted to Art. 21 Committee Submitted to Germany
Notification C/DE/96/5
SNIF
2 published 14 Feb. 2003
Bayer hybrid
oilseed rape
(MS8/RF3)30 Sept. 1996
(Belgium)Jan. 16, 1997 Positive
assessment
19 May 1998Not submitted to Art. 21 Committee Submitted to Belgium
Notification C/BE/96/01
SNIF published 7 Feb. 2003
                                                     
1 Source: "Deliberate releases and placing on  the EU market of Genetically Modified Organisms," European Commission, Joint Resea rch Centre, available at
<http://gmoinfo.jrc.it/gmc_browse.asp>.
2 Summary Notification Information Format ("SNIF")WT/DS291/23
Page 4 Biotech ProductDate Submitted to
Member StateDate Received
by CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/181
Trifolium/
Monsanto/ Danisco
Roundup Readyfodder beet (A5/15)19 Feb. 1997
(Denmark)9 Oct. 1997 Positive
assessment
23 June 1998Not submitted to Art. 21 Committee Submitted to Denmark
Notification C/DK/97/01
SNIF published 3 Mar. 2003
Monsanto Bt cotton
(531)3 Dec. 1996
(Spain)24 Nov. 1997 Positive
assessment
14 July 1998Negative opinion from Art. 21
Committee, Feb. 11, 1999; not
submitted to CouncilSubmitted to Spain
Notification C/ES/96/02
SNIF published 14 Feb. 2003
Monsanto Roundup
Ready cotton(RRC1445)30 June 1997
(Spain)24 Nov. 1997 Positive
assessment14 July 1998Negative opinion from Art. 21
Committee Feb. 11, 1999; notsubmitted to CouncilSubmitted to Spain
Notification C/ES/97/01
SNIF published 14 Feb. 2003
Amylogene starch
potato6 Aug. 1996
(date notification
acknowledged)
(Sweden)20 May 1998 Positive
assessment
18 July 2002Not submitted to Art. 21 Committee Submitted to Sweden
Notification C/SE/96/3501
SNIF Published 3 Feb. 2003
Bayer winter
oilseed rape
(Liberator
pHoe6/Ac)15 Feb. 1998
(Germany)29 Oct. 1998 Positive
assessment
30 Nov. 2000Not submitted to Art. 21 Committee Submitted to Germany
Notification C/DE/98/6
SNIF Published 17 Feb. 2003
Syngenta
glufosinate tolerant
and Btresistant (Bt-11)
corn1996
(France – for
cultivation)12 Apr. 1999 Positive
assessment
30 Nov. 2000Not submitted to Art. 21 Committee Submitted to France
Notification C/F/96/05-10
SNIF Published 30 June 2003
Favorable assessment by
French authority published
29 July 2003WT/DS291/23
Page 5Biotech ProductDate Submitted to
Member StateDate Received
by CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/181
Monsanto Roundup
Ready corn
(GA 21)27 May 1998
(Spain – for cultivation)20 May 1999 Positive
assessment
22 Sept. 2000Not submitted to Art. 21 Committee;
scope of application changed 19 Jan.
2001, to include importSubmitted to Spain
Notification C/ES/98/01
(import/use only; notcultivation)
SNIF published 17 Feb. 2003
Monsanto Roundup
Ready oilseed rape
(GT73)21 May 1995
(France – for
cultivation; application
for import withdrawn 6July 1998)[see GT73 below]
Syngenta Bt hybrid
corn (Bt-11)17 June 1996
(France – for
cultivation;
resubmitted 5 Nov.
1998 at request of
French authorities)N/A
Monsanto Roundup
Ready oilseed rape(GT73)7 July 1998
(Netherlands – forimport)Submitted to Netherlands
Notification C/NL/98/11(import/use only; not
cultivation)
SNIF published 22 Jan. 2003
Favorable assessment by
Dutch authority published
22 Jan. 2003
Bayer Liberty Link
soybeans
(A2704-12 and
A5547-127)13 Oct. 1998
(Belgium)Submitted to Belgium
Notification C/BE/98/01
(import/use only; not
cultivation)
SNIF published 7 Feb. 2003WT/DS291/23
Page 6 Biotech ProductDate Submitted to
Member StateDate Received
by CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/181
Monsanto/
Syngenta Roundup
Ready sugar beet22 Dec. 1998
(Belgium.
Initially submitted inFrance in 1996 and
withdrawn)Submitted to Belgium
Notification
C/BE/99/01
SNIF published 7 Feb. 2003
Bayer Liberty Link
oilseed rape
(T45 & Topas 19/2)
(stack)4 Feb. 1999
(UK)Submitted to UK Notification
C/GB/99/M5/2 (import/use
only; not cultivation)
SNIF published 10 Feb. 2003
(seeds with the line containing
event T45 only; stack with
Topas 19/2 has been replacedin the market and no longer
commercially relevant)
Stoneville BXN
cotton (10215,
10222, 10224)
(formerly held by
Aventis and
Calgene)29 Apr. 1999
(Spain)Submitted to Spain
Notification C/ES/99/01
SNIF published 21 July 2003
Monsanto
MaisGard Roundup
Ready (MON 810
& GA21) corn
(stack)3 Sept. 1999
(Spain)Submitted to Spain
Notification C/ES/99/02
(import/use only; not
cultivation)
SNIF published 17 Feb. 2003
Bayer Liberty Link
sugar beet
(T120-7)15 Dec. 1999
(Denmark)N/AWT/DS291/23
Page 7Biotech ProductDate Submitted to
Member StateDate Received
by CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/181
Pioneer/Dow
AgroSciences
Bt corn Cry1F(1507)23 Nov. 2000
(Netherlands – for
import)Submitted to Netherlands
Notification C/NL/00/10
(import/use only; notcultivation)
SNIF published 14 Feb. 2003
Pioneer/Dow
AgroSciences
Bt corn Cry1F
(1507)11 July 2001
(Spain – for cultivation)Submitted to Spain
Notification C/ES/01/01
SNIF published 17 Feb. 2003
Monsanto Roundup
Ready corn(NK603)21 Dec. 2000
(Spain)Submitted to Spain
Notification C/ES/00/01(import/use only; not
cultivation)
SNIF published 22 Jan. 2003
Favorable assessment by
Spanish authority published
22 Jan. 2003WT/DS291/23
Page 8Applications Withdrawn
ProductDate Submitted to
Member StateDate Submitted
to CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/18
Pioneer Bt corn
(MON 809)1995
(France)6 Aug. 1996 Positive
assessment
19 May 1998Negative opinion from Art. 21
Committee in Nov. 1998; not
submitted to Council
Zeneca extendedshelf life tomato
(TGT7-F)1996
(Spain)24 Nov. 1997 Positive
assessment
23 June 1998Negative opinion from Art. 21
Committee in Dec. 1998; not
submitted to Council
Monsanto Roundup
Ready corn
(GA 21)6 Nov. 1997
(U.K. – for import)28 Oct. 1999 Positive
assessment
22 Sept. 2000Not submitted to Art. 21 Committee;
application withdrawn 29 Mar. 2001[see GA21 above]
Pioneer Liberty
Link and Bt (T25 &
MON 810) corn
(stack)26 June 1998
(Netherlands)29 Apr. 1999 Positive
assessment
6 June 2000Not submitted to Art. 21 Committee;
application withdrawn 12 Dec. 2002
Pioneer/Dupont
high-oleic soybean
(260-05)19 June 1998
(Netherlands – for
import)Application withdrawn 12 Dec. 2002WT/DS291/23
Page 9
Annex II
Requests Under Regulation 258/97 – Novel Foods
Biotech ProductDate Submitted to
Member StateScientific Committee
ActionStatus in EC
Bejo-Zaden Transgenic
Radicchio rosso8 Apr. 1998
(Netherlands)
Positive Member State
AssessmentUnder assessment Pending
Bejo-Zaden
Transgenic Green
hearted chicory8 Apr. 1998
(Netherlands)
Positive Member State
AssessmentUnder assessment Pending
Monsanto Roundup
Ready  corn (GA 21)24 July 1998
(Netherlands)
Positive Member State
AssessmentPositive assessment
27 Feb. 2002Pending
Syngenta Bt-11 sweet
corn11 Feb. 1999
(Netherlands)
Positive Member State
AssessmentPositive assessment
17 Apr. 2002Pending
Pioneer/Dupont high-
oleic soybean (260-05)25 July 1998
(Netherlands)Still with Member State
competent authority
Bayer LibertyLink
soybeans2 Feb. 1999
(Belgium)Still with Member State
competent authority
Monsanto MaisGardRoundup Ready  corn
(GA 21 & MON 810)(stack)16 Mar. 2000
(Netherlands)Still with Member State
competent authority
Monsanto/
Syngenta Roundup
Ready sugar beet (77)3 Nov. 1999
(Netherlands)Still with Member State
competent authority
Pioneer/Dow
AgroSciences
Bt corn Cry1F (1507)26 Feb. 2001
(Netherlands)Still with Member State
competent authority
Monsanto Roundup
Ready corn (NK603)June 2001
(Netherlands)
Positive Member State
AssessmentPendingWT/DS291/23
Page 10
Application Withdrawn
Zeneca extended shelf
life tomato (TGT7-F)Positive MS Assessment Positive assessment
23 Sept. 1999Application withdrawn
Pioneer Liberty Link and
Bt (T25 x MON 810)
corn (stack)20 Apr. 2000
(Netherlands)Application withdrawnWT/DS291/23
Page 11
Annex III
National Marketing and Import Bans
Member State Products National Measures
Austria Corn: Bt-176, MON 810, T25 Federal Official Journal of 13 Feb. 1997, 45,
Regulation of the Federal Ministry for Health
and Consumer Protection (Bt-176)(Bundesgesetzblatt of 13/II/1997, 45 .
Verordnung der Bundesministerien fuer
Gesundheit und Konsumentenschutz  (Bt-176)).
Federal Official Journal of 10 June 1999, 175,
Regulation of the Federal Minister for Women
and Consumer Protection (MON 810)(Bundesgesetzblatt of 10/VI/1999, 175.
Verordnung der Bundesministerin fuer
Frauenangelegenheiten  und
Verbraucherschutz  (MON 810))
Federal Official Journal of 28 Apr. 2000, 120,
Regulation of the Federal Minister for Social
Protection and Generations (T25)
(Bundesgesetzblatt of 28/IV/2000, 120.
Verordnung der Bundesministerin fuer sozialeSicherheit und Generationen  (T25))
France Rapeseed:  C/UK/95/M5/1; and
C/UK/94/M1/1Official Journal, No. 200, 18 Nov. 1998,
p. 17379; extensions published in Official
Journal, No. 267, 30 Aug. 2001, p. 13903
Germany Corn: Bt-176 Letter from Robert Koch Institute of the
Federal Health Office, Center for Gene
Technology, to Novartis Seeds AG, Basel,
31 Mar. 2000 (ordering suspension of approval
to release corn variety Bt-176)
Greece Rapeseed:  Topas 19/2 Government Gazette [Efimeris Tis
Kyverniseos] of the Hellenic Republic, IssueNo. 1008, 25 Sept. 1998, p. 3.
Italy Corn: Bt-11, MON 809,
MON 810, T25Official Gazette of the Italian Republic,
Decree of the President of the Council of the
Ministers, General series – No. 184,
8 Aug. 2000 (suspending commercialization
and use)
Luxembourg Corn: Bt-176 Official Journal of the Grand-Duchy of
Luxembourg, A – No. 10, 28 Feb. 1997,
p. 618
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