WORLD TRADE
ORGANIZATIONWT/DS291/1
G/L/627G/SPS/GEN/397
G/AG/GEN/60
G/TBT/D/28
20 May 2003
(03-2677)
Original:  English
EUROPEAN COMMUNITIES – MEASURES AFFECTING THE APPROVAL
AND MARKETING OF BIOTECH PRODUCTS
Request for Consultations by the United States
The following communication, dated 13 May 2003, from the Permanent Mission of the
United States to the Permanent Delegation of the European Commission and to the Chairman of the
Dispute Settlement Body, is circulated in accordance with Article 4.4 of the DSU.
_______________
My authorities have instructed me to reques t consultations with the European Communities
("EC") pursuant to Article 4 of the Understanding on Rules and Procedures Governing the Settlement
of Disputes  ("DSU"), Article 11 of the Agreement on the Application of Sanitary and Phytosanitary
Measures  ("SPS Agreement"), Article 19 of the Agreement on Agriculture  ("Agriculture
Agreement"), Article 14 of the Agreement on Technical Barriers to Trade  ("TBT Agreement") and
Article XXII of the General Agreement on Tariffs and Trade 1994  ("GATT 1994") with regard to
certain measures taken by the EC and its member States affecting products of biotechnology ("biotech
products").
Since October 1998, the EC has applied a moratorium on the approval of biotech products.
The EC has suspended consideration of applications for, or granting of, approval of biotech products
under the EC approval system.  A number of applications for placing biotech products on the market
have been blocked in the approval process under EC legislation1 and have never been considered for
final approval.  The approvals moratorium has re stricted imports of agricultural and food products
from the United States.
Moreover, the 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 in the EC include:
(1) the suspension by the EC of consideration of applications for, or granting of, approval
of biotech products;
                                                     
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/DS291/1, G/L/627,
G/SPS/GEN/397, G/AG/GEN/60,
G/TBT/D/28
Page 2
(2) the failure by the EC to consider for approval applications for the biotech products
mentioned in Annexes IA and IB to this request; and
(3) national marketing and import bans maintained by member States, as described in
Annex II to this request.
These measures appear to be inconsistent with the SPS Agreement, the GATT 1994, the
Agriculture Agreement and the TBT Agreement, including but not limited to the following
provisions:
(1) SPS Agreement, Articles 2, 5, 7 and 8, and Annexes B and C;
(2) GATT 1994, Articles I, III, X and XI;
(3) Agriculture Agreement, Article 4;  and
(4) TBT Agreement, Articles 2 and 5.
We look forward to receiving your reply to this request and to fixing a mutually convenient
date for consultations.WT/DS291/1, G/L/627,
G/SPS/GEN/397, G/AG/GEN/60,
G/TBT/D/28
Page 3ANNEX IA
NOTIFICATIONS UNDER DIRECTIVE 2001/18 (90/220)
Biotech ProductDate Submitted
to Member StateDate Submitted to
CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/18
Bayer oilseed rape
(MS1/RF1)April 1995
(France)27 July 1995 N/A Favorable opinion from Art. 21
Committee 6 June 1997;
Commission decision approving
product; France (notifying memberState) refused to implement.N/A
Bayer hybrid oilseed
rape (MS1/RF2)April 1995
(France)27 July 1995 N/A Favorable opinion from Art. 21
Committee 6 June 1997;
Commission decision approving
product; France (notifying member
State) refused to implement.N/A
Bejo Zaden red-
hearted chicory
(RM3-3, RM3-4 and
RM3-6) – already
approved for seed
production. New
application for
food/feed use1994
(Netherlands)20 Sep 1996 Positive
assessment
18 Dec 1998Not submitted to Art 21 Committee. N/A
Bayer oilseed rape
(Falcon GS40/90)1 Apr. 1996
(Germany)25 Nov. 1996 Positive
assessment
14 July 1998Not submitted to Art. 21 Committee. Submitted to Germany
Notification # C/DE/96/5
SNIF1 published 14 Feb. 2003
Bayer hybrid oilseed
rape (MS8/RF3) for
production of hybrid
seed30 Sept. 1996
(Belgium)16 Jan. 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 Summary Notification Information Format ("SNIF")WT/DS291/1, G/L/627,
G/SPS/GEN/397, G/AG/GEN/60,
G/TBT/D/28Page 4 Biotech ProductDate Submitted
to Member StateDate Submitted to
CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/18
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; 11 Feb. 1999; not
submitted to Council.Submitted 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
assessment
14 July 1998Negative opinion from Art. 21
Committee; 11 Feb. 1999; not
submitted to Council.Submitted to Spain Notification #
C/ES/97/01
SNIF published 14 Feb. 2003
Amylogene starch
potato1996
(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 (LiberatorpHoe6/Ac)15 Feb. 1998
(Germany)29 Oct. 1998 Positive
assessment30 Nov. 2000Not submitted to Art. 21 Committee. Submitted to Germany
Notification # C/DE/98/6
SNIF Published 17 Feb. 2003
Syngenta
glufosinate tolerant
and Bt
resistant (Bt-11)
corn (stack)1996
(France)12 Apr. 1999 Positive
assessment
30 Nov. 2000Not submitted to Art. 21 Committee. N/A
Monsanto RR 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 import.Submitted to Spain Notification #
E/ES/98/01 (import/use only; not
cultivation)
SNIF published 17 Feb. 2003WT/DS291/1, G/L/627,
G/SPS/GEN/397, G/AG/GEN/60,
G/TBT/D/28
Page 5Biotech ProductDate Submitted
to Member StateDate Submitted to
CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/18
Monsanto Roundup
Ready oilseed rape
(GT73)21 May 1995
(France – for
cultivation.Application for
import withdrawn
6 July 1998.)[see GT73 below]
Syngenta Bt hybrid
corn (Bt-11)17 June 1996
(France – for
cultivation);resubmitted 5
Nov. 1998 at
request of French
authoritiesN/A
Monsanto 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. 2003Favorable Assessment by Dutch
Competent Authority (undated
document)
Bayer Liberty Linksoybeans
(A2704-12 and
A5547-127)13 Oct. 1998
(Belgium –
withdrawn)
24 Sept. 1999
(Portugal)Submitted to Belgium
Notification # C/BE/98/01
(import/use only; not cultivation)
SNIF published 7 Feb. 2003WT/DS291/1, G/L/627,
G/SPS/GEN/397, G/AG/GEN/60,
G/TBT/D/28Page 6 Biotech ProductDate Submitted
to Member StateDate Submitted to
CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/18
Monsanto/
Syngenta  Roundup
Ready sugar beet22 Dec. 1998
(Belgium)
Initially submittedin France in 1996
and withdrawn.Submitted to Belgium
Notification #
C/BE/99/01
SNIF published 7 Feb. 2003
Bayer Liberty Link
oilseed rape
(T45 X 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 replaced in themarket and no longer
commercially relevant)
Stoneville  BXN
cotton (10215,
10222, 10224)
(formerly held by
Aventis and
Calgene)29 Apr. 1999
(Spain)N/A
Monsanto Bt x
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/DS291/1, G/L/627,
G/SPS/GEN/397, G/AG/GEN/60,
G/TBT/D/28
Page 7Biotech ProductDate Submitted
to Member StateDate Submitted to
CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/18
Pioneer / Dow
AgroSciences
Bt corn Cry1F(1507)23 Nov. 2000
(Netherlands – for
import)Submitted to Netherlands
Notification # C/NL/00/10
(import/use only; not cultivation)
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
Competent Authority
(undated document)
Applications 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 extended
shelf 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.WT/DS291/1, G/L/627,
G/SPS/GEN/397, G/AG/GEN/60,
G/TBT/D/28Page 8 ProductDate Submitted
to Member StateDate Submitted to
CommissionScientific
Committee
ActionStatus in EC under 90/220 Status in EC under 2001/18
Monsanto RR corn
(GA 21)6 Nov. 1997
(UK – 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 x
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/DS291/1, G/L/627,
G/SPS/GEN/397, G/AG/GEN/60,
G/TBT/D/28
Page 9
ANNEX IB
REQUESTS SUBMITTED UNDER REGULATION 258/97 – NOVEL FOODS
Biotech ProductDate Submitted to
Member StateScientific Committee
ActionStatus in EC
Bejo-Zaden Transgenic
Radicchio rosso8 Apr. 1998
(Netherlands)Under assessment Pending
Bejo-Zaden
Transgenic Green
hearted chicory8 Apr. 1998
(Netherlands)Under assessment Pending
Monsanto Roundup
Ready  corn (GA 21)24 July 1998
(Netherlands)Positive assessment
27 Feb. 2002Pending
Syngenta Bt-11 sweet
corn11 Feb. 1999
(Netherlands)Positive assessment
13 Mar. 2002Pending
Pioneer/Dupont high-
oleic soybean (260-05)25 July 1998
(Netherlands)Still with member State
competent authority
Bayer LibertyLinksoybeans2 Feb. 1999
(Belgium)Still with member State
competent authority
Monsanto RoundupReady  corn (GA 21)16 Mar. 2000
(Netherlands)Still with member State
competent authority
Pioneer Liberty Link andBt (T25 x MON 810)
corn (stack)20 Apr. 2000
(Netherlands)Still with member State
competent authority
Monsanto/
Syngenta  RoundupReady sugar beet(Netherlands)Still with member State
competent authority
Pioneer / DowAgroSciences
Bt corn Cry1F (1507)26 Feb. 2001
(Netherlands)Still with member State
competent authority
Monsanto Roundup
Ready corn (NK603)June 2001
(Netherlands)Still with member State
competent authority
Applications Withdrawn
Zeneca extended shelf
life tomato (TGT7-F)Positive assessment 4
23 Sept. 1999Application withdrawnWT/DS291/1, G/L/627,
G/SPS/GEN/397, G/AG/GEN/60,
G/TBT/D/28
Page 10
ANNEX II
MEMBER STATE MARKETING AND IMPORT BANS ON BIOTECH PRODUCTS
Member State Biotech Products National Measures
Austria Corn: Bt-176, MON 810, T25 See Federa l 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)).
See Federal Official Journal of 10 June 1999,
145, Regulation of the Federal Minister forWomen and Consumer Protection (MON 810)
(Bundesgesetzblatt of 10/VI/1999, 175.
Verordnung der Bundesministerin fuer
Frauenangelegenheiten  und Verbraucherschutz
(MON 810))
See 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 soziale
Sicherheit und Generationen  (T25))
France Rapeseed:  C/UK/95/M5/1;
and C/UK/94/M1/1See Official Journal of 18 Nov. 1998, p. 17379
Germany Corn: B-176 Modified Administrative Ruling, letter from
Robert Koch Institute of the Federal Health
Office, Center for Gene Technology, to Novartis
Seeds AG, Basel, 31 Mar. 2000 (orderingsuspension of approval to release corn variety
Bt-176)
Greece Rapeseed:  Topas 19/2 Ministerial decisions of Nov. 1998 banning
AgrEvo Topas 19/2
Italy Corn: Bt-11, MON 809,
MON 810, T25Official Gazette, Presidential Decree of 4 Aug.
2000 (suspending commercialization and use)
Luxembourg Corn: Bt-176 Official Journal of the Grand-Duchy of
Luxembourg, Ministerial Order, 28 Feb. 1997, p.618
__________