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  ANNEX B 
 
TABLES SUMMARIZING THE HISTORY OF THE 
INDIVIDUAL APPROVAL PROCEDURES AT ISSUE IN THIS DISPUTE  
 
 1. The Panel has prepared a series of tables summa rizing relevant aspects of the history of the 
individual approval procedures at issue in this dispute.  The tables were prepared on the basis of 
information provided by the Parties, and in partic ular the detailed chronologies of individual approval 
procedures submitted by the European Communities.    2. Since the Panel's findings tend to focus on specific stages of individual approval procedures, it seemed useful to provide some background info rmation on developments and activities at other 
procedural stages.  Consistent with their limited purpose, the Panel's tables do not reflect any and all 
activities of member State authorities, EC authorities or applicants of which the Panel has been made 
aware.  It should also be noted that the informa tion provided in the tables is more detailed for those 
stages and activities which the Panel has focused on for the purposes of its analysis, and less detailed 
for other stages and activities.  
3. In preparing the tables, the Panel has found it useful to distinguish the following procedural 
stages, which also reflect the main stages of th e approval procedures set out in the relevant EC 
approval legislation for biotech products (Dir ectives 90/220 and 2001/18 as well as Regulation 
258/97):  
 (a) Consideration of application at me mber State level ("Member State Level") 
   (i) Initial assessment of application by lead CA. ("Lead Member State Level").   (b) Consideration of application at Community level ("Community Level")  
(i) Circulation of lead CA assessment to other member States ("Other Member 
States"). 
   (ii) Consultation of EC scientific committee ("Scientific Committee Process").  
(iii) Preparation of draft measure to be submitted to the Regulatory Committee 
("Commission").  
 
(iv) Consideration by the Regulatory Committee of the draft measure submitted 
by the Commission ("Regulatory Committee Process").  
 
  (v) Preparation of draft measure to be submitted to the Council ("Commission").  
 
(vi) Consideration by the Council of the draft measure submitted by the 
Commission, including decision by the Council ("Council"). 
 
(vii) Adoption by Commission of its draft measure in case the Council fails to 
decide (Directives 90/229 and 2001/18 as well as Regulation  258/97) and 
application of applicant of decision (Regulation 258/97) ("Commission"). 
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  (viii) Written consent of lead CA to placing on the market (Directives 90/220 and 
2001/18) ("Lead Member State"). 
 
4. While the Panel's tables are structured accord ing to the above-mentioned procedural stages, it 
is important to note that each table provides in formation on only those stages which have been 
completed or reached in the relevant approval procedure.    5. Due to constraints of space, the Panel's tabl es contain a number of abbreviations.  They are 
explained below.  Furthermore, the Panel has used  short titles to refer to the products which are the 
subject of the relevant approval procedures.  These  short titles are explained in a list provided at the 
beginning of these Panel Reports.  
Useful Terms 
ACRE Advisory Committee on Release into the Environment 
CA Competent Authority 
CO Council 
COGEM Commission on Genetic Modification 
COM Community 
DK Denmark 
EFSA European Food Safety Authority 
ISC Inter Service Consultation 
MS Member States 
NBC National Biosafety Committee 
RIKILT Institute of Food Safety 
SCP Scientific Committee on Plants 
SCF Scientific Committee on Food 
SNIF Summary Application Information Format 
vCVNV  Provisional Commission for Food Safety (Food Assessment Body for Novel 
Foods of the Netherlands)  
  
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Member State Level Community Level 
Product Lead Member State 
Level Circulation to other 
Member States Scientific 
Committee Process Commission Regulatory Committee Process 
EC-62  
 
Falcon 
oilseed 
rape 
 Directive 90/220/EEC  
 
• 01/04/1996 
Applicant submits application. 
 
• 14/05/1996– 
24/07/1996 
Exchange of 
information between the applicant and the lead 
CA. 
 
• 25/10/1996 
Statement by the lead 
CA.  
 
  
 
• 25/10/1996 
Full application 
submitted  to COM. 
 
• 09/12/1996 
Application circulated to all MS. 
 
• 01/1997- 10/1997 
Requests for additional 
information by lead CA 
and replies by applicant. Comments/objections by 
MS.   
 
• 20/02/1998 
COM requests SCP 
opinion.  
 
• 14/07/1998 
Opinion of the  SCP: favourable.  
 
• 04/09/1998 
COM launches ISC on 
draft COM decision to 
be submitted to REG 
COM. 
  
 
• 29/06/1999 
COM launches  vote in REG COM by written 
procedure. 
 
• 7/99 – 9/99  
Additional information provided by the applicant. 
 
• 29/10/1999 
Meeting of REG COM: vote postponed. 
 
• 10/11/1999 
Applicant submits update of application, including 
additional information and commitments. 
 
• 09/03/2000 
Meeting of REG COM: no vote held due to further 
requests for information.  
• 14/03/2000 
Fax from the Italian Competent Authority 
requesting additional information from the 
applicant.  
• 20/04/2000 
Letter of German CA to applicant about 
modification of the scope of  application. 
 
• 11/00  
Responses provided by the applicant. 
  
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Member State Level Community Level 
Product Lead Member State 
Level Circulation to other 
Member States Scientific 
Committee Process Commission Regulatory Committee Process 
  
 
 
 
Directive 2001/18/EC  
 
• 16/01/2003 
Statement of 
completeness by 
applicant. Applicant updates SNIF. 
 
• 14/10/2003 
Request for clarification 
and further update of SNIF. 
     
 
 
 
• 29/05/2001 
Applicant submits letter, claiming that the 
application is already in line with Directive 2001/18. 
 
• 25/07/2001 
Lead CA requests for clar ification by the applicant 
on additional documents. 
 
• 21/11/2001 
Applicant submits documents to support "working group on HT crops". 
 
• 02/04/2002 
Lead CA requests further modifications and 
supplementary information, after applicant 
provided additional information.  
• 08/05/2002 
Reply by the applicant to the request of 02/04/2002 for additional information. 
 
• 23/12/2002 
Lead CA requests applicant for clarification on 
submitted documents. 
  
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Member State Level Community Level 
Product Lead Member State 
Level  Circulation to 
Member States Scientific 
Committee Process Commission Regulatory Committee Process 
EC-63 
 
MS8/RF3 
oilseed 
rape 
 Directive 
90/220/EEC  
 
• 30/09/1996 
Applicant submits 
application to Belgium. 
 
• 10 and 17/12/1996 
Meetings of the 
Belgian Biosafety 
Council.  
(Positive advice of the 
Scientific Committees on Transgenic Plants 
and on Novel 
feed/food).  
 
  
• 07/01/1997 
Submission by lead CA 
to COM of full 
application. 
 
• 29/01/1997 
Application circulated 
to all MS.  
• 02/1997 – 12/1997 
Statements, comments and objections by MS. 
Applicant provides 
additional information.  
• 27/01/1998 
COM requests for SCP 
opinion. 
 
• 19/05/1998 
SCP opinion:  
favourable. 
  
• 04/09/1998 
COM launches ISC on 
draft COM decision to 
be submitted to REG 
COM.  
  
• 30/06/1999 
COM launches  vote in REG COM by written 
procedure. 
 
• 22/10/1999 
COM invites applicant to present additional 
information  following interim approach to REG 
COM. 
 
• 10/11/1999 
Applicant submits update in line with revised EC legislation. 
  
• 29/10/1999 
REG COM meeting: presentation by applicant of 
update; no vote held. 
 
• 14/03/2000 
Fax from Italian CA raising questions subsequent to the REG COM meeting. 
 
• 13/11/2000 
Applicant provides answers to questions raised by 
Italy on 14/03/2000. 
 
• 20/12/2000 
COM circulates applicants   answers to all CAs. 
 
• 05/06/2001 
Applicant provides clarifications to lead CA on the scope of the application, and updates to bring dossier 
in line with provisions of Directive 2001/18/EC.   
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Member State Level Community Level 
Product Lead Member State 
Level  Circulation to Member 
States Scientific 
Committee Process Commission Regulatory Committee Process 
  
 
 
  
Directive 2001/18/EC
 
 
• 14/01/2003 
Applicant submits updated application. 
    • 19/06/2001 
Meeting of CAs. 
 
• 12/07/2001 
Letter of lead CA to applicant 
acknowledging receipt of further information and soliciting envoy of  
reference material. 
 
• 11/09/2001 
Applicant submits reference material and 
information on detection methodology, in response to prior requests by the lead CA 
on 12/07/2001. 
 
• 13/11/2001 
Meeting of Belgian Biosafety Council. 
 
• 07/02/2002 
Meeting of Belgian Biosafety Council (Scientific Committee "Transgenic 
Plants"). 
 
• 28/03/2002 
Lead CA communicates that Belgian 
Biosafety Council requested additional data. 
 
• 24/09/2001- 07/05/2002 
Applicant provides answers to pending 
questions by the CA. 
 
  
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Community Level 
Product Member State Level Circulation to Member States Scientific Committee 
Process Commission Regulatory Committee Process 
EC-64 
 
RR 
fodder 
beet 
  
Directive 
90/220/EEC  
 
• 21/02/1997 
Application received 
by the lead CA. 
 
• 24/03/1997 – 
30/09/1997 
Lead CA requests for 
additional information. 
Applicant provides the 
lead CA with additional data. 
 
  
 
 
 
  
 
  
Directive 2001/18
 
 
• 16/01/2003 
Updated application 
submitted by the applicant.  
• 07/10/1997 
Lead CA forwards the application 
to COM, together with positive 
opinion (non- confidential part). 
 
• 09/10/1997 and 
15/10/1997 
Non-confidential and confidential part received by COM. 
 
• 16/10/1997 
Non confidential and confidential 
part sent to MS. 
 
• 02/12/1997 
Technical meeting with CAs 
where comments/requests for 
further data were addressed. 
 
• 10/12/1997 
Applicant provides additional 
information related to the comments raised at the CAs 
meeting. 
  
• 12/12/1997 
Dutch CA requests additional information.  
• 13/03/1998 
COM request for SCP 
opinion.  
 
• 23/06/1998 
Opinion of the SCP: 
favourable.  
• 04/09/1998 
COM launches ISC on 
draft decision to be 
submitted to REG COM. 
 
• 24/09/1998 –  
19/10/1999 
Clarifications, additional information and 
commitments submitted 
by the applicant.  
- On 04/08/1999 the 
applicant met the Dutch CA. 
  
• 29/10/1999 
REG COM meeting: presentation by the 
company of the update; no vote held 
because of outstanding additional 
information.  
• 09/03/2000 
Meeting of the REG COM: no vote held.  
• 14/03/2000 
Fax from the Italian CA raising questions subsequent to SCP opinion. 
 
• 12/07/2000 
Additional data on molecular 
characterisation (at the request of UK), 
regarding questions raised from Italy.  
 
• 04/01/2001 
Clarifications by the applicant with 
regard to undertakings and 
commitments.  
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Community Level 
Product Member State Level Circulation to Member 
States Scientific 
Committee Process Commission Regulatory Committee 
Process Commission 
EC-65 
 
Bt-531 
cotton   
Directive 
90/220/EEC  
 
• 02/12/1996 
Applicant submits application. 
 
• 30/04/1997 
Applicant expresses 
its intention to submit 
the dossier also under the Novel Food 
Regulation. 
 
 
  
 
  
 
Directive 2001/18
 
 
• 16/01/2003 
Applicant submits updated application. 
 
• 01/08/2003 
Lead CA requests for 
additional information.  
• 17/11/1997 
Lead CA submits full application to COM.  
 
• 15/12/1997 
Full application circulated 
to all CAs. 
  
• 20/01/1998 – 
       25/02/1998 
Comments and objections 
by MS. Applicants provides answers to the 
questions raised. 
  
• 06/04/1998 
COM request for SCP opinion. 
 
• 14/07/1998 
SCP opinion: 
favourable. 
  
• 04/09/1998 
COM launches ISC on draft decision to be 
submitted to the REG 
COM. 
  
• 26/11/1998 
COM launches vote in REG COM  by written 
procedure. 
 
 
• 22/02/1999 
REG COM vote: absence 
of qualified majority.  Outcomes of the written 
procedure including 
written statements from 
Sweden, Austria and UK. 
 
 
 
  
• 07/05/1999 
COM launches ISC on 
draft measure to be 
submitted to the 
Council. 
 
 
• 25/07/2001 
Applicant provides 
updated molecular 
characterisation and Safety Assessment. 
(analysis of flanking 
regions). 
 
 
• 18/02/2002 
Applicant provides 
translations of material sent in July 2001. 
  
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Community Level 
Product Member State Level Circulation to Member 
States Scientific 
Committee Process Commission Regulatory Committee 
Process Commission 
EC-66 
 
RR-1445 
cotton 
  
Directive 90/220/EEC  
 
• 30/06/1997 
Applicant submits 
application.   
 
  
 
  
 
  
 
  
Directive 2001/18
 
 
• 16/01/2003 
Updated application 
submitted by the 
applicant.  
• 19/11/1997 
Lead  CA submits full 
application to COM.  
 
• 15/12/1997 
Circulation of full 
application to all CAs. 
 
• 20/01/1998 - 
       17/02/1998 
Comments, objections and questions raised by 
MS.  
Applicant provides additional information.   
• 01/04/1998 
COM request for 
SCP opinion. 
 
• 30/06/1998 
Request by SCP for 
additional data. 
 
• 14/07/1998 
SCP opinion:
favourable.   
• 04/09/1998 
COM launches ISC on 
draft decision. 
  
• 26/11/1998 
COM launches vote in 
REG COM by written 
procedure. 
 
• 30/11/1998 
DK requests extension of 
the deadline for the vote in order  to revise 
additional information 
submitted by the applicant. 
 
• 04/12/1998 
COM informs CAs that 
the deadline for the vote 
is extended. 
 
• 10/12/1998 
Belgium requests that the 
vote be postponed. 
 
• 21/12/1998 
UK requests that the vote 
be postponed, in order to meet with the applicant 
and discuss further 
information recently submitted. 
  
• 07/05/1999 
COM launches  ISC on 
draft Council Decision.   
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Community Level 
Product Member State Level Circulation to Member 
States Scientific 
Committee Process Commission Regulatory Committee 
Process Commission 
      
• 23/12/1998 
COM informs the CAs 
that the deadline for the 
vote is extended. 
 
• 13/01/1999 
Opinion of Commission 
du Génie Biomoléculaire. 
 
• 26/01/1999 
COM informs of further 
extension of the deadline 
for the vote, at the request of the lead CA. 
 
• 22/02/1999 
REG COM vote: absence 
of qualified majority. 
(Outcomes of the written procedure including 
statements from Sweden, 
Austria and UK).   
  
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Community Level Product Member State Level Circulation to Member States Scientific Committee Process 
EC-67 
 
Transgenic 
potato 
  
Directive 90/220/EEC  
 
• 05/08/1996 
Lead CA acknowledges receipt of the 
application submitted  by the applicant. 
("not complete").  
• 27/09/1996 
Request for completion.  
• 31/01/1997 – 21/11/1997 
Further requests by lead CA. Information 
submitted by the applicant. 
 
• 07/05/1998 
Final complete application and approval 
by the Swedish Board of Agriculture. 
 
 
 
Directive 2001/18/EC
 
 
• 16/01/2003 
Applicant submits updated application. 
 
 
 
  
• 08/05/1998 
Lead CA sends dossier and statement to COM. 
 
• 11/06/1998 
Application statement and positive opinion of lead CA 
circulated to all CAs.  
• 14/07/1998 
Advice by RIKILT (Institute of Food Safety): 
additional information to be provided by the applicant. 
 
•  15/07/1998 –  09/09/1998 
Comments and objections by MS. Information and 
clarifications provided by the applicant.  
 
  
 
  
 
  
 
• 14/04/2004 
Lead CA forwards dossier and assessment report to 
COM.  
• 04/05/2004  
Circulation of application and statement of lead CA to all CAs  
• 30/09/1998 
COM requests opinion of the  SCP. 
 
• 09/11/1998 
SCP meeting. 
 
• 04/01/1999 
Amylogene provides SCP working group with the 
full application and additional data. 
 
• 04/02/1999- 19/04/2002 
Nine  requests for clarifications by the SCP. 
Answers given by the applicant. 
 
- Draft opinion on 12/07/1999 
 
- SCP meeting on 28/01/2000 
 
• 18/07/2002 
Opinion of the SCP. (favourable) 
  
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Community Level  
Product  
Member State Level Circulation to Member States Scientific Committee Process 
EC-68 
 
Liberator 
oilseed rape 
  
Directive 90/220/EEC  
 
• 13/01/1998 
Applicant submits application. 
 
• 09/02/1998 –  15/06/1998  
Requests for further completion and 
clarification of the dossier. Applicant 
submits further amendments and corrections.  
 
• 17/06/1998 
Completeness of the dossier confirmed. 
  
 
  
 
 
Directive 2001/18/EC
 
 
• 16/01/2003 
Submission of update by the applicant. 
  
• 26/10/1998 
Full application and statement of lead CA submitted  to 
COM.   
• 14/01/1999 
Full application (confidential part) circulated to all CAs.  
• 15/01/1999 –  28/04/1999 
Comments, objections and requests for additional 
information by MS. Applicant provides replies to 
questions.  
  
• 18/08/1999 
COM requests SCP opinion. 
 
• 27/08/1999 – 06/11/2000 
Applicant forwards dossier to SCP and provides 
answers and additional information.  
• 30/11/2000 
Opinion of the SCP. 
 
• 05/11/2002 
Request for update. 
  
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Community Level Product Member State Level Circulation to Member States Scientific Committee Process 
EC-69 
 
Bt-11 maize 
(EC-69) 
  
Directive 90/220/EEC  
 
• 28/05/1996  
Applicant submits application. 
 
• 17/06/1996  
Lead CA receives application.  
 
• 06/1996 – 01/1999  
Requests for additional information. 
Applicant provides additional information.  
 
  
Directive 2001/18/EC
 
 
• 15/01/2003 
Applicant updates application. 
  
 
  
 
   
• 04/04/1999 
Lead CA submits application to COM with a 
favourable opinion.  
• 07/05/1999 
Application sent to all CAs.  
• 06/1999 – 10/2000 
Requests for further information and objections by 
CAs. Applicant provides additional information. 
  
 
  
 
  
 
  
 
• 16/06/2003 
Applicant submits updated application (including the 
new SNIF, environmental risk assessment and 
supplementary information) to the COM, together with the statement of the lead CA and its favourable 
assessment report. 
  
• 30/11/2000 
SCP opinion. 
(favourable)  
• 03/05/2002 
Applicant updates application by including new sequence data. 
 
 
  
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Community Level Product Member State Level Circulation to Member States Scientific Committee Process 
EC-70 
 
RR oilseed 
rape (EC-70) 
  
Directive 90/220/EEC  
 
• 07/07/1998 
Applicant submits application. 
 
• 05/08/1998 –  18/11/1999 
Requests for additional information and 
replies provided by the applicant. 
 
• 29/02/2000 
Advice on application by the scientific 
committees. 
 
• 22/03/2000 
Update of status and completeness of 
dossier. 
 
• 03/2000 – 03/2001 
Additional information and clarifications 
submitted by applicant. (We note two dates:  
- on 28/04/2000 applicant submitted 
additional information  
- on  17/05/2000 applicant 
submitted clarifications) 
 
• 12/03/2001 
Request for detection method.  
• 10/05/2001 
Request for motivation for confidentiality status of the detection method detection 
method.  
• 16/01/2003 
COM receives new SNIF. 
 
• 24/01/2003  
COM circulates dossier to other CAs. 
 
• 24, 25/03/2003 
Objections raised by MS. 
 
• 28/04/2003 
Meeting with COM, applican t and all CAs in order to 
solve the outstanding issues. 
 
• 05/08/2003 – 29/09/2003 
Applicant provides additional information.  
Evaluation of the additional information. 
  
• 23/10/2003 
COM requests scientific opinion from EFSA 
Scientific Panel on GMOs.  
• 11/02/2004 
Opinion of the Scientific Panel on GMOs issues: favourable.   
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 • 20/09/2001 
Applicant provides lead CA with detection method after the exchange of information 
on the confidentiality issue. 
 
• 13/11/2001 – 29/11/2002 
Exchange of  information between the lead CA and applicant with regard to the 
confidentiality status of the primer 
sequences of the detection method. 
- On 17/01/2002 the lead CA grants 
confidentiality status on primer sequences and requests reference 
material. 
 
Directive 2001/18/EC
 
 
• 13/12/2002 
Applicant provides a full updated 
application. 
   
  
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Product Member State Level 
EC-71 
 
LL soybeans 
(EC-71)  
Directive 90/220/EEC  
 
• 28/09/1998 
Applicant submits application. 
 
• 30/10/1998 – 05/09/2001 
Lead CA requests for additional information and answers provided by the applicant, including: 
 
- 31/03/1999 : Letter from Biosafety Council requesting further data. 
- 01/12/2000 : Applicant clarifies that the application is maintained in Belgiu m and provides information on when requested data will be sent.  
- 05/12/2000 : Lead CA confirms the continuation of the evaluation process and requiring additional information. 
 
• 05/09/2001 
Lead CA requests for clarifications about the status of the doub le application in Belgium and Portugal and explains that the ma intenance of the application 
in Portugal will entail suspension of the evaluation process in Belgium.  
• 08/10/2001 
Applicant asserts the maintenance of  double concurrent applications. 
 
Directive 2001/18
 
 
• 15/01/2003 
Update of the application. 
 
• 27/01/2003 
Withdrawal of the application (Portugal).  
• 17/03/2003 
Preliminary informal answer fr om the applicant with some of the information requested. 
 
• 29/06/2004 
Withdrawal of the application.  
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Product Member State Level 
EC-72 
 
LL oilseed 
rape  
Directive 90/220/EEC  
 
• 28/01/1999 
Applicant submits application to the UK CA. 
 
• 15/02/1999 and 24/03/1999 
Lead CA requests for additional information. 
 
• 30/06/1999 
Lead CA acknowledges receipt ("clock restarted"). 
 
• 20/07/1999 
Request for additional information. 
 
• 11/11/1999 
Minutes of 62nd meeting of ACRE. 
 
• 02/12/1999 
UK Scientific Committee advises the applicant that the dos sier requires substantial revision and clarification. 
 
• 16/01/2003 
Applicant updates application. 
 
• 27/01/2003 
Lead CA requests completion of up-dated notification.  
• 26/03/2004 
Applicant withdraws application. 
  
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Product Member State Level 
  
Directive 2001/18/EC  
 
• 13/01/2003 
Applicant submits General Surveilla nce Plan in accordance with Anne x VII of Directive 2001/18/EC. 
 
• 16/01/2003 
Applicant submits new SNIF to the UK CA. 
 
• 13/06/2003 
Applicant provides clarifications on the notification. 
 
• 26/03/2004 
Applicant withdraws application C/GB/99/M5/2. 
 
• 30/03/2004 
SNIF re-submitted to COM u nder reference C/GB/04/M5/4. 
  
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Product Member State Level 
EC-73 
 
BXN cotton   
Directive 90/220/EEC  
 
• 03/05/1999 
Applicant submits application. 
 
• 01/07/1999 
6th  Meeting of the National Biosafety Committee ("NBC") of the l ead CA: several questions raised and amendments proposed. 
 
• 17/09/1999 
Applicant sends fax addressing some of the issues raised. 
 
• 25/01/2000 
9th Meeting of the Spanish NBC (further examination of the application). 
 
• 02/02/2000 
Lead CA informs applicant about persisting doubts. 
   
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Product Member State Level 
  
Directive 2001/18/EC  
 
• 16/01/2003 
Applicant updates application following Article 35 of Directive 2001/18. 
 
• 19/03/2003 
Applicant sends SNIF summary. 
 
• 18/07/2003 
SNIF circulated to COM. 
 
• 26/09/2003 
Analysis of the notification by the Spanish NCB – 36th Meeting. 
 
• 02/10/2003 
Lead CA sends fax to applicant requestin g additional information related to labellin g proposal, molecular characterization and general surveillance plan. 
 
• 07/10/2003 
Fax of lead CA to the applicant requesting additional information related to substantial equivalence. 
 
  
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Community Level Product Member State Level Circulation to Member States Scientific Committee Process 
EC-74 
 
Bt-1507 maize 
(EC-74) 
  
Directive 90/220/EEC  
 
• 23/11/2000 
Applicant submits application. 
 
• 12/2000 – 11/2002 
Lead CA requests additional information. Applicant provides 
additional information. 
- On 16/10/2001 the applicant provides first set of answers, 
indicating that further responses would be delivered in 
December 2001. 
- On 21/11/2001 the applicant provides additional 
information and replies to questions. 
 
 
Directive 2001/18/EC  
 
• 21/11/2002 
Applicant updates application. 
 
• 02/2003 – 03/2003 
Lead CA requests additional information.  Applicant provides 
additional information. 
- On 10/02/2003 the lead CA requests further information 
on compositional data, monitoring plan, confidentiality of 
detection method. 
- On 24/03/2003 applicant provides additional information. 
 
• 28/05/2003  
Applicant provides clarifications  with regard to confidentiality 
status.   
• 15/08/2003 
Full application and assessment report 
sent to COM.  
• 26/08/2003 
Application and assessment report circulated to all MS. 
 
• 08/2003 – 02/2004 
Comments and objections by MS. 
Applicant provides responses.  
• 26/02/2004 
COM requests EFSA opinion. 
 
• 12/03/2004 
Letters from COM to EFSA 
clarifying some MS objections.   
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Community Level Product Member State Level Circulation to Member States 
EC-75 
 
Bt-1507 maize 
(EC-75)   
Directive 90/220/EEC  
 
• 06/07/2001 
Applicant submits application. 
 
• 09/2001 – 12/2002 
Lead CA requests for additional information.  Applicant submits 
additional information. 
  
 
Directive 2001/18/EC
 
 
• 13/02/2003 
Lead CA submits updated SNIF to COM. 
 
• 02/2003 – 04/2003 
Requests for additional information.   Applicant provides additional 
information. 
 
• 28/05/2003 
Applicant submits updated application. 
  
• 08/2003 
- Lead CA submits full application and assessment report to COM. 
-   Application and assessment report circulated to all MS. 
 
• 10/2003 – 03/2004 
Comments, objections and requests for additional information by MS.  Applicant provides additional information. 
 
• 05/2004 – 06/2004 
Comments/objections by MS. 
  
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Community Level 
Product Member State Level Circulation to 
Member States Scientific 
Committee Process Commission Regulatory 
Committee Process Council 
EC-76 
 
NK603 
maize Directive 90/220/EEC  
 
• 04/08/2000  
Applicant submits application.  
• 20/12/2000 
Applicant clarifies the scope of the application and 
provides Spanish translation. 
 
• 02/01/2001 
Lead CA acknowledges receipt. 
  
• 14/01/2003 
Lead CA submits full 
application and assessment report to 
COM.  
 
• 24/01/2003 
Application and 
assessment report 
circulated to all MS. 
 
• 24/02/2003 – 
28/08/2003 
Comments and objections by MS. Answers and 
additional information 
given by the applicant.   
• 04/09/2003 
COM requests EFSA 
opinion. 
 
• 25/11/2003 
EFSA opinion 
adopted: 
favourable.  
 
  
• 08/12/2003 
COM launches ISC on 
draft COM Decision. 
 
 
  
• 18/02/2004 
Absence of qualified 
majority in REG COM. 
 
• 26/03/2004 
Transmission of 
the proposal to the Council.  
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Community Level 
Product Member State Level Circulation to 
Member States Scientific 
Committee Process Commission Regulatory 
Committee Process Council 
  
• 15/02/2001-19/06/2002 
National Biosafety Committee requests 
additional information. Applicant provides additional information. 
- 27/02/2001: In the 18th Meeting of 
the National Biosafety Committee 
("NBC"), additional information requested on molecular 
characterisation, nutritional 
analysis, environmental impact, etc. 
- On 05/09/2001 applicant provides 
additional information. 
- On 10/10/2001 lead CA forwards 
request of NBC for further 
information. 
- On 21/05/2002 lead CA forwards 
persisting doubts of NBC over certain information supplied. 
 
• 29/08/2002 
Applicant updates application in  line 
with the requirements of the Directive 
2001/18/EC.  
 
 
Directive 2001/18/EC
 
 
• 20/11/2002  
Applicant provides updated SNIF. 
      
  
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Community Level 
Product Member State Level Circulation to 
Member States Commission Regulatory Committee 
Process Commission 
EC-77 
 
Transgenic 
red-hearted 
chicory 
 
(Notification 
C/NL/94/25)   
Directive 90/220/EEC  
 
• 15/12/1994 
Applicant submits full 
application to lead CA.  
• 23/01/1995 
Advice of Commission on Genetic Modification 
(COGEM): information 
insufficient.  
• 31/03/1995 
Statement of Dutch CA with evaluation summary: 
favourable. 
  
• 31/03/1995 
Lead CA forwards full 
application to COM. 
 
• 20/04/1995 
Full application forwarded to 
all CAs. 
 
• 30/05/1995- 
27/07/1995 
Comments and objections by MS. Responses to questions 
and clarifications by the lead 
CA.  
  
• 25/01/1996 
COM launches ISC on draft 
COM decision. 
 
   
• 08/03/1996 
Consultation of the REG 
COM by written procedure. 
 
• 24/04/1996 
Consultation of REG COM: 
Positive opinion. 
  
• 03/05/1996 
Request by written procedure 
for approval by COM 
members. 
 
• 10/05/1996 
Written procedure 
suspended.  
• 14/05/1996 
Written procedure re-launched subject to specific 
labelling requirements. 
 
• 20/05/1996 
Decision 96/424/EC for 
placing of the product on the 
market. 
 
• 05/08/1996 
Written consent by Dutch 
CA to applicant.  
• 01/03/2003 
Letter of withdrawal.  
• 24/04/2003 
Confirmation letter of 
withdrawal to applicant. 
  
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Community Level 
Product Member State Level Circulation to 
Member States Scientific Committee Process Commission 
EC-77 
 
Transgenic 
red-hearted 
chicory 
 
(Notification 
C/NL/94/25/A)   
Directive 90/220/EEC  
 
• 10/09/1996 
Applicant submits the 
part of the application dealing with food safety 
aspects to lead CA. 
  • 13/09/1996 
Lead CA forwards 
application to COM. 
 
• 11/07/1996- 
08/05/1998 
Requests for additional 
information, comments and 
objections by MS. Applicant provides answers and 
additional information. 
  • 02/06/1998 
 COM requests SCP opinion.  
 
• 07-09/1998 
Questions raised by the SCP and answers provided by 
the applicant. 
 
• 19/10/1998 
SCP requests for further information.  
• 01/12/1998 
Applicant provides further information.  
• 18/12/1998 
Opinion of the SCP: favourable. 
 
 
• 10/09/1999 
Questions by SCP raised in the context of the evaluation 
according to the 258/97 Regulation.  
• 16/11/1999 
Comments by the SCP on the draft opinion of the SCF.   • 30/03/1999 
Proposal to amend COM Decision 
96/424/EC. Request for launching 
of ISC. 
 (Same GM product had already 
been authorised for breeding activities at the Community level.) 
 
• 10/05/1999 
ISC launched. 
 
• 26/05/1999 
ISC closed. 
  
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Community Level 
Product Member State Level Circulation to 
Member States Scientific Committee Process Commission 
    
• 10/07/2000 – 18/06/2001  
SCF requests applicant to submit additional information 
and clarifications. 
- On 10/07/2000 SCF requests further 
information about substantial equivalence. 
- On 14/11/2000 the applicant submits further 
clarifications. 
- On 11/06/2001 the applicant requests further 
clarifications on the antibiotic resistance 
markers. 
- On 18/06/2001 SCF requests additional 
information (already requested on 10/07/2000). 
 
• 24/07/2001 
Clarifications by COM to applicant about the phasing-
out of antibiotic resistance markers.   
  
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Community Level Product Member State Level Circulation to Member States Scien tific Committee Process Commission 
EC-78 
 
GA21 maize 
(EC-78)  
Directive 90/220/EEC  
 
• 29/05/1998 
Receipt of application. 
 
• 16/06/1998- 
13/07/1998 
Two meetings of the 
Spanish scientific committee (33
rd and 
35th). Answers provided 
by the applicant to 
questions posed. 
 
• 31/07/1998 
Request for further data. 
  
 
  
 
Directive 2001/18/EC
 
 
• 15/01/2003 
Applicant submits new SNIF and updated risk 
assessment to lead CA.  
• 11/05/1999 
Spanish lead CA forwards application to 
COM.  
• 06 and 07/1999 
Application sent to MS. Comments/objections of MS circulated. 
 
• 28/07/1999 
Voluntary commitments by the 
applicant.  
• 29/07/1999 
Technical meeting on pending products. Applicant provides general information. 
 
• 08/1999 
Comments by MS. Applicant provides 
answers. 
  
• 29/09/1999 
11
th meeting on technical aspects of 
product application dossiers pending 
under part C of Directive 90/220/EEC.  
• 21/10/1999 
Responses to MS objections.  
 
• 15/09/2003 
Applicant withdraws application.  
• 29/10/1999 
COM sends dossier to SCP for opinion. 
 
• 22/02/2000 
SCP requests clarification. 
 
• 15/03/2000 
Applicant provides answers to request 
for clarification. 
 
• 06 and 07/2000 
Further requests for additional 
information and responses provided by 
the applicant.  
• 22/09/2000 
SCP opinion: favourable.  
  
• 19/01/2001 
Applicant submits letter on the change 
of scope (import and processing only, planting now excluded). 
 
• 21/09/2001 
Undertakings from applicant accordance 
with the requirements of Directive 
2001/18/EC.  
• 18/03/2002 
Applicant submits updates and 
commitments to COM. 
    
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Community Level Product Member State Level Circulation to Member States 
EC-85 
 
GA21 maize 
(EC-85) 
  
Directive 90/220/EEC  
 
• 12/12/1997 
Applicant submits application. 
 
• 23/12/1997 
UK CA requests further information. 
 
• 01 and 02/1998 
Applicant submits further information. 
 
• 27/02/1998 
Amended dossier  requested. 
 
• 30/03/1998 
Applicant submits amended dossier. 
 
• 04 – 12/1998 
Requests for further information. Applicant submits additional information. 
 
• 16/02/1999 
UK CA requests amended dossier. 
 
• 03/03/1999 
Applicant submits further information.  
• 16/09/1999 
Meeting of ACRE.  
• 15/10/1999 
Lead CA sends full application to COM. 
 
• 01/12/1999 
COM circulates application to all CAs. 
 
• 12/1999 – 02/2000 
Comments and objections by MS. Applicant provides answers and 
clarifications. 
 
• 27/06/2001 
Applicant withdraws application. 
 
  
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Community Level Product Member State Level Circulation to Member States 
EC-79 
 
RR oilseed rape 
(EC-79)   Directive 90/220/EEC
 
 
• 21/05/1995 
Applicant forwards application to the lead CA. 
 
• 05/1995 – 10/1996 
Requests for additional information. Applicant submits additional 
information. 
- On 06/02/1996 the Commission du Génie Biomoléculaire requests 
applicant to submit studies on rats (28 days).    
 
• 02/12/1996 
Applicant submits update to initial dossier.  
 
  
• 02/12/1996 
Lead CA forwards application to COM. 
 
• 30/06/1997 
Applicant submits proposal for labelling and appropriate information. 
 
• 15/01/2003 
Official withdrawal. 
  
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Community Level Product Member State Level Circulation to Member States 
EC-80 
 
Bt-11 maize 
(EC-80) 
  
Directive 90/220/EEC  
 
• 29/05/1998 
Applicant submits application. 
 
• 16/06/1998 
Meeting of the Spanish Scientific Comité. 
 
• 31/07/1998 
Lead CA requests additional information by the applicant. 
 
• 03/09/1998 
Applicant submits additional information. 
 
• 09/1998 and 01/1999 
Meetings of the Spanish Scientific Comité. 
 
• 26/04/1999 
Lead CA forwards positive risk assessment report to COM.  
• 30/04/1999 
Lead CA forwards application to COM. 
 
• 20/05/1999 
Applicant notifies withdrawal of application from Spain. 
 
• 27/05/1999 
COM circulates full application to all CAs. 
 
• 28/05/1999 
Official withdrawal circulated to all CAs. Review of the application 
closed. 
 
 
 
  
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Product Member State Level 
EC-81 
 
LL soybeans 
(EC-81) 
 Directive 90/220/EEC  
 
• 24/09/1999 
Applicant submits application.  
• 07/12/1999 
Opinion of the Portuguese Ministry of Agriculture: not favourable. Request for additional information to be submitted by the applicant. 
 
• 07/01/2000 
Portuguese Ministry of Health requests further information. 
  
• 17/01/2000  
Request for additional information. 
 
• 11/05/2000 
Additional request for information. 
 
• 28/09/2001 
Applicant provides responses.  
 
• 18/10/2001 
Acknowledgment of additional information and transmission of the additional information to the Portuguese Ministry of Health. 
 
Directive 2001/18/EC
 
 
• 20/11/2001 
Portuguese CA requests applicant to br ing application into line with the new requirements of Directive 2001/18/EC. 
 
• 28/01/2002 
Portuguese Ministry of Health requests applicant to provide further clarification. 
 
• 27/01/2003 
Applicant submits letter of withdrawal.  
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EC-82 
 
MON810 x 
GA21 maize 
  
Directive 90/220/EEC  
 
• 04/08/1999 
Applicant submits application to lead CA.  
• 31/08/1999 
Applicant submits new SNIF and translated documents. 
 
• 11/11/1999 
7
th session of Spanish National Commission on Biosafety. 
 
• 30/11/1999 
Lead CA requests further information. 
 
• 08/2001 
Applicant submits additional information. 
 
• 17/01/2002 
Applicant provides translated documents. 
 
• 04/04/2002 
Meeting of the Spanish National Commission on Biosafety. 
 
• 17/01/2003 
Applicant submits updates to the lead CA.  
(Lead CA did not receive updates.)  
• 15/09/2003 
Applicant withdraws application. 
 
  
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Community Level 
Product Member State Level Circulation to 
Member States Scientific Committee 
Process Commission Regulatory 
Committee Process Commission 
EC-83 
 
MON809 
maize   
Directive 90/220/EEC  
 
• 18/12/1995 
Applicant submits full 
application to lead CA concerning the two 
events (MON 801 and 
MON809).  
• 06/02/1996 
National scientific committee (CGB) 
delivers an opinion and 
requests additional 
information as well as 
separate applications for the two events. 
 
• 06/03/1996 
New application 
concerning MON809 
and further data provided. 
 
• 04/04/1996 
Opinion of the National 
scientific committee 
(CGB).   
• 06/08/1996 
Lead CA forwards application to COM. 
 
• 29/08/1996 
COM forwards full 
application to all CAs. 
 
• 25/09/1996- 
14/07/1997 
Comments, requests 
for further 
clarifications and objections my MS. 
  
• 27/01/1998 
COM submits application to SCP for 
opinion. 
 
• 11/03/1998 
Meeting of the GMO 
working group of the SCP. 
 
• 03-04/1998 
Applicant provides 
responses to SCP's questions. 
 
• 19/05/1998 
SCP opinion: 
favourable  
• 12/06/1998 
COM launches ISC on draft COM decision to 
be submitted to REG 
COM.  
• 09/07/1998 
ISC concluded.   
• 04/09/1998 
COM launches consultation of REG 
COM. 
 
• 23/10/1998 
Consultation of REG 
COM ends with no opinion.  
• 22/04/1999 
COM launches  vote in REG COM by written 
procedure. 
 
• 29/04/1999 
Written procedure 
suspended because of Bt resistance 
management program. 
 
• 08/06/1999 
Additional questions 
sent to SCP: 
consultation done in 
the context of the 
safeguard measures 
invoked by Austria 
about MON810 maize (because laboratory 
results showed harm to 
butterflies treated with pollen from Bt maize) 
 
• 24/09/1999 
SCP opinion:  
favourable. 
 
• 04/10/2002 
Applicant withdraws application.  
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Community Level 
Product Member State Level Circulation to 
Member States Scientific 
Committee Process Commission Regulatory 
Committee Process Commission 
EC-84 
 
Transgenic 
tomato 
  
Directive 90/220/EEC  
 
• 15/11/1996 
Lead CA receives dossier from 
the applicant.  
• 12/1996, 01 and 02/1997 
Three meetings of the Spanish Commission on Biosafety. 
 
• 19/02/1997 
Lead CA requests additional 
information. 
 
• 02, 03 and 04/1997 
Exchange of information 
among Spanish Ministry of 
Health, Spanish Ministry of 
Environment and lead CA.  
• 24/04/1997 
Meeting of the Spanish Commission on Biosafety. 
 
• 23/10/1997 
Fax from the applicant to the 
Spanish Ministry of Health: 
submission on genetically modified tomatoes to be 
assessed under the Novel Food 
Regulation.  
• 17/11/1997 
Lead CA forwards 
dossier to COM 
together with a 
favourable opinion.  
• 15/12/1997 
Lead CA circulates full dossier to all MS. 
 
• 01/1998 
Requests for further 
information by MS. 
 
• 27/01/1998 
Meeting held by the 
COM on technical 
aspects of Part C 
dossiers.  Request for further 
info. 
 
• 04/02/1998 
Applicant provides CA 
with additional data.  
• 02 and 03/1998 
Comments and some objections by MS. 
Applicant provides 
additional information.  
• 23/06/1998 
SCP opinion: 
favourable.  
• 05/10/1998 
Outcomes of 
ISC. 
  
• 26/11/1998 
COM launches 
consultation of the 
REG COM by written 
procedure.  
• 18/12/1998 
Consultation of the 
REG COM concluded: 
No opinion. 
  
• 16/02/1999 
COM sends proposal for 
CO decision to Cabinet 
Bjereggard for approval. 
 
• 09/03/1999 
COM sends proposal for 
CO decision to Legal Service for approval. 
 
• 20/08/1999 
COM launches written 
procedure on draft CO 
decision.  
• 23/09/1999 
SCF opinion: favourable. 
 
• 24/11/1999 
Consultation of other 
DGs on draft 
Commission Decision under the Standing 
Committee on 
Foodstuffs.  
• 04/02/2002 
Applicant withdraws application. 
  
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Community Level Product Member State Level Circulation to Member States Scien tific Committee Process Commission 
EC-86 
 
T25 x 
MON810 
maize   
Directive 90/220/EEC  
 
• 26/06/1998 
Applicant submits full 
application to lead CA.  
• 10/08/1998 
Advice of COGEM:
 
- No risks for human health or 
the environment.  
-  Need  for further testing. 
  
• 08 and 09/1998 
Requests for additional information. Applicant 
provides additional 
information.  
• 01/12/1998 
RIKILT (advisory body for feed aspects) states that there 
are no  reasons to conclude that 
the GMO is unsafe.  
• 21/01/1999 
Lead CA sends draft evaluation 
summary to th e applicant. 
 
• 22/04/1999 
Applicant's response to draft 
evaluation summary.  
• 26/04/1999 
Dutch CA sends evaluation summary 
and application to COM. 
 
• 17/05/1999 
COM circulates full application to all 
CAs. 
 
• 06 and 07/1999 
Requests for further information, 
comments and objections by MS. Applicant provides additional 
information. 
 
• 01/09/1999 
Applicant proposes for alternatives  
with respect to the scope of the 
dossier. 
  
• 21/09/1999 
COM requests SCP opinion. 
 
• 26/10/1999 
Comments by SCP and draft opinion.  
• 17/11/1999 
SCP requests further information by the applicant. 
 
• 01 and 02/2000 
Applicant submits additional 
information. 
 
• 06/06/2000 
SCP opinion: favourable.  
• 18/12/2002 
Applicant withdraws application. 
 
  
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Product Member State Level 
EC-87 
 
High-oleic 
soybeans   
Directive 90/220/EEC  
 
• 19/06/1998 
Applicant submits full application to lead CA. 
 
• 07/1998 – 09/1998 
Lead CA requests additional information. 
Applicant provides additional information. 
 
• 28/09/1998 
Advice of  COGEM: 
- Information submitted is sufficient 
- No risk to human life or the environment. 
 
• 12/10/1998 
Addendum to COGEM advice:  
- Alteration of fatty acid composition will not re sult in risks in food or feed safety.  
- Food and feed safety due to the change of protein composition can not be guaranteed based on the information supplied.  
- Based on the information, no toxicological  effects are foreseen in case of incidental  consumption. COGEM states that this bas ically confirms their earlier 
assessment.  
• 07/12/1998  
RIKILT requests additional information.  
• 01/07/1999 
Applicant provides additional information. 
 
• 27/10/1999 
Request for additional information to applicant, concerning feed safety aspects. 
 
• 12/12/2002 
Applicant withdraws application. 
  
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Product Member State Level Member State Level (continues) 
EC-88 
 
RR sugar beet  Directive 90/220/EEC  
 
• 22/12/1998 
Applicant sends application to lead CA. 
 
• 23/02/1999 
Lead CA requests additional information. 
 
• 11/03/1999 
Applicant provides additional information. 
 
• 14/04/1999 
Lead CA requests additional information. 
 
• 14/04/1999 
Applicant provides additional information.  
• 26/04/1999 
Biosafety Advisory Council Meeting.  
• 02/06/1999 
Biosafety Advisory Council raises remaining questions on agricultural practices, molecular characterisation, toxicology, 
allergenicity, and food/feed equivalence. 
 
• 07/06/1999 
Lead CA requests additional information.  
• 14/07/1999 
Applicant provides additional information.   
•  08/12/1999 
Applicant provides additional information. 
 
• 18/01/2000 
Applicant provides additional information on horizontal gene transfer. 
 
• 02/02/2000 
Lead CA requests additional information. 
 
• 02 and 03/2000 
Applicant provides additional information. 
 
• 04/04/2000 
Meeting with the applicant (regarding identity preservation, GAP, post 
market monitoring, traceab ility, public information,  line-specific detection 
methods and primers). 
 
• 26/07/2000 
Applicant submits additional information. 
 
• 16/11/2000 
CA requests additional information on further characterisation of a protein 
and detection protocols.   
• 04/01/2001 
Lead CA requests additional information on labelling and traceability.  
• 13/06/2001 
Lead CA requests applicant to adapt the application with one of the 
expert's comments. 
  
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Product Member State Level Member State Level (continues) 
  
• 01/10/1999 
Lead CA requests additional information (allergenicity, molecular 
characterisation, gene tran sfer in digestive tracts). 
  
Directive 2001/18/EC  
 
• 16/01/2003 
Applicant updates application. 
 
• 25/02/2003 
Lead CA requests additional information. 
 
• 16/04/2004 
Applicant withdraws application.  
  
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Community Level Product Member State Level Circulation to Member States Scien tific Committee Process Commission 
EC-91 
 
GA21 maize 
(food)  Directive 90/220/EEC  
 
• 24/07/1998 
Applicant submits application to Dutch CA.  
• 11/08/1998 
COM forwards the application to MS.  
• 15/09/1998 
Lead CA requests applicant to complete the 
dossier. 
 
• 09/1998 – 02/1999 
Applicant submits additional information. 
 
• 24/02/1999 
Advisory Committee on the Safety of Novel 
Foods and Foods Ingredients requests additional information. 
 
• 25/03/1999 
Applicant submits additional information. 
 
• 18/06/1999 
Advisory Committee on the Safety of Nove
Foods requests additional data.  
• 26/10/1999 
Applicant submits requested data.  
• 21/12/1999 
Initial assessment by Gezondheidsraad.   
• 21/01/2000 
Lead CA sends initial assessment 
to COM.  
• 18/02/2000 
COM circulates initial assessment to MS. 
 
• 03 – 05/2000 
Requests for additional 
information, comments and objections by MS. Applicant 
provides additional information. 
  
• 18/05/2000 
COM requests SCF opinion. 
 
• 18/07/2000 
Applicant provides additional 
labelling proposal.  
• 08/2000 
Applicant submits additional 
information. 
 
• 24/04/2001 
SCF requests further information 
by applicant.  
• 17/05/2001 
Applicant responds to the request for additional 
information. 
 
• 12-13/12/2001 
Discussion on draft opinion 
postponed to February meeting 
of SCP due to lack of time. 
 
• 27/02/2002 
Opinion of the SCF. 
 
  
• 23/04/2002 
Applicant changes scope of 
application.   
• 05/06/2002 
Meeting with applicant. Applicant agrees  to provide 
additional information. 
 
• 18/09/2002 
Meeting with applicant on 
validation method. 
 
 
 
  
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Product Member State 
Level Circulation to 
Member States Scientific Committee 
Process Regulatory 
Committee Process Commission Council Commission 
EC-92 
 
Bt-11 sweet 
maize (food )  
Regulation (EC) 
N° 258/97  
 
• 11/02/1999 
Applicant 
submits application. 
 
• 09/03/1999 
COM forwards 
the summary of 
the application to 
MS. 
 
• 04/1999 – 
05/2000 
Requests for additional 
information. 
Applicant provides 
additional 
information.  
• 12/05/2000 
Lead CA forwards the 
initial assessment 
report to COM. 
  
• 15/06/2000 
COM forwards the 
initial assessment report to MS for 
comments/objections. 
 
• 06/2000 – 
11/2000 
Comments and objections by MS. 
Applicant provides 
additional 
information and 
answers to comments/objections. 
  
• 13/12/2000 
COM requests SCF 
opinion.  
• 13/12/2000 
Italy requests additional information. 
 
• 15/04/2001 
SCF requests further 
data.  
• 10/05/2001 
Italy reiterates objections raised in July 2000. 
 
• 12/11/2001 
SCF reminds applicant 
of request for additional 
information.  
• 27/02/2002 
Applicant submits data. 
 
• 17/04/2002 
SCF opinion: 
favourable. 
 
  
• 08/11/2003 
Draft Commission 
Decision on the agenda of the 
Standing Committee.  
(No formal opinion delivered by MS). 
 
• 08/12/2003 
Vote held in REG 
COM. 
(No qualified majority 
was reached).   
• 28/01/2004 
Formal COM 
decision to refer the matter to the 
Council. 
 
  
• 26/04/2004 
Vote held in 
Council. (No qualified 
majority 
reached)  
 
   
• 19/05/2004 
COM adopts 
decision.   
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Community Level 
Product Member State 
Level Circulation to 
Member States Scientific Committee 
Process Regulatory 
Committee Process Commission Council Commission 
    
• 04/2002 – 10/2003 
Requests for additional 
material on validation 
method. Applicant 
submits additional material. 
- On 05/06/2002, 
applicant agrees to 
provide detection 
measures, traceability, reference 
material and 
identification 
- On 22/01/2003 
applicant provides 
material for detection 
method validation 
- On 07/07/2003 
applicant submits a new method. 
     
  
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Community Level Product Member State Level Circulation to Member States 
EC-93 
 
LL soybeans (food ) 
  
Regulation (EC) N° 258/97  
 
• 30/11/1998 
Applicant submits application. 
 
 
 
  
• 02/02/1999 
Application sent to COM. 
 
• 08/02/1999 
Belgian CA sends e-mail, confirmi ng that it will assess the dossier. 
 
• 02/03/1999 
COM note to the Permanent Representatio ns of the MS-summary of the file. 
 
• 28/04/1999 
Letter from Louis Pasteur Scientific Institute for Public Health requesting additional information. 
 
• 26/05/1999 
COM informs MS that the initial assessment will not be completed on time. 
 
• 06/1999 – 07/2004 
Requests for additional information. 
- On 07/06/1999 Greece requests  additional information 
- On 21/07/1999 Italy sends its comments 
- On 01/12/200 applicant sends letter to Ministère Dr W Moens (BE) 
concerning additional information on the application and notification 
- On 18/07/2001 applicant providing additional information on the application 
to the Ministère Féderal des Affaires So ciales, de la santé Publique et de 
l'Environnement. 
 
• 06/07/2004 
Applicant withdraws application.  
 
  
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Community Level Product Member State Level Circulation to Member States 
EC-94 
 
MON810 x GA21 
maize (food) 
  
Regulation (EC) N° 258/97  
 
• 29/02/2000 
Applicant submits application. 
 
• 29/03/2000 
Note of the European Commission to the Permanent 
representations of the Member States – summary of the file. 
  
 
  
• 29/02/2000 
Copy of application sent to COM. 
 
• 04-05/2000 
UK, Greece and Denmark request a pplicant to provide full dossier. 
 
• 06/2000 
Comments from Austria, UK and Italy. 
 
• 17/07/2000  
Gezondheidsraad requests applicant to provide additional information. 
 
• 15/02/2002  
Applicant provides additional information.  
• 02/07/2002  
Gezondheidsraad requests applicant to provide additional information.  
  
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Community Level Product Member State Level Circulation to Member States 
EC-95 
 
Bt-1507 maize 
(food) 
  
Regulation (EC) N° 258/97  
 
• 15/02/2001 
Applicant submits application. 
 
• 03/2001 – 05/2003 
Requests for full dossier and additional information. Applicant provides technical 
dossier and additional information. 
 
- On 28/06/2001 Gezonheidsraad sends letter to applicant, requesting for 
additional information. 
- In February 2002 applicants responds to the request of 28/06/2001. 
- On 25/03/2003 Gezonheidsraad sends letter to applicant, requesting for 
further examination. 
- On 16/05/2003 the applicant responds to the request of 25/03/2003. 
- On 11/06/2003 Gezondheitsraad requests further clarification with regard to 
the reply of 16/05/03. 
- Following the request of 11/06/2003, the applicant provides additional 
information to Gezondheitsraad. 
 
• 03/2003 – 07/2003 
Requests for additional information. Applicant provides additional information. 
 
• 04/11/2003 
Initial assessment report by CA.  
 
 
Regulation (EC) N°1829/2003 
 
 
• 17/03/2004 
COM note  to MS:  transfer  of application to Regulation (EC) N° 1829/2003.   
• 18/11/2003 
Initial assessment sent to COM. 
 
• 10/12/2003 
COM forwards initial assessment report to MS for 
comments/objections.  
• 02/2004 
Comments by MS. 
 
  
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Community Level 
Product Member State Level Circulation to 
Member States Scientific Committee 
Process Regulatory 
Committee Process Council 
EC-96 
 
NK603 maize 
(food) 
  
Regulation (EC) N° 258/97  
 
• 24/04/2001 
Applicant submits application. 
 
• 06/2001 – 03/2002 
MS request full dossier  and additional 
information. Applicant provides full dossier and additional information. 
- On 26/06/2001 lead CA requests 
copies of references. 
- On 20/07/2001 the applicant 
provides copies of references in 
notification. 
- On 13/12/2001 Gezondheidsraad 
requests applicant to provide further 
information. 
- On 23/01/2002 Italy requests 
additional information. 
- On 28/03/2002 applicant provides 
requested information. 
 
• 13/08/2002 
Health Council Committee finishes its 
assessment report. 
 
• 05/11/2002 
Lead CA forwards initial assessment 
report to COM. 
  
• 06/01/2003 
COM forwards initial assessment report to MS 
for 
comments/objections.  
• 02/2003 – 07/2003 
Comments/objections by MS. Applicant 
provides answers. 
- 26/02/2003: SBB: 
evaluation  
 
 
  
• 18/09/2003 
COM requests EFSA opinion. 
 
• 25/11/2003 
EFSA opinion: 
favourable. 
   
• 30/04/2004 
Draft COM decision presented to REG COM. 
 
  
• 13/07/2004 
Transmission to CO pending. 
 
 
  
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Community Level 
Product Member State Level Circulation to Member States Scien tific Committee Process Commission 
EC-97 
 
Transgenic red-
hearted chicory 
(food) 
 Regulation (EC) N° 258/97  
 
• 08/04/1998 
Applicant submits 
application. 
 
• 23/04/1998 
Initial assessment by lead CA. 
 
  
• 13/05/1998 
COM forwards request, summary and initial assessment to MS. 
 
• 15/09/1998 
Confirmation of the initial 
assessment report.  
• 27/10/1998 
COM circulates initial assessment to MS. 
 
  
  
• 29/04/1999 
COM requests opinion from the SCF.  
• 09/1999 – 07/2001 
Questions from the SCF to the applicant. 
Applicant provides responses. 
- On 10/07/2000 the SCF poses 
additional questions to the 
applicant. 
- On 21/07/2000 the applicant 
responds. 
- On 31/07/2000 the SCF requests 
additional information. 
- On 14/11/2000 the applicant 
responds. 
- On 18/06/2001 the SCF requests 
additional information. 
- On 23/01/2001 the applicant 
provides additional information. 
- On 24/04/2001 the SCF requests 
additional information. 
 
• 24/09/2001 
Letter from applicant to SCF suspending 
the dossiers for market application 
  
• 27/05/2003 
Applicant withdraws application. 
  
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Community Level Product Member State Level Circulation to Member States Scien tific Committee Process Commission 
EC-98 
 
Transgenic green-
hearted chicory 
(food) 
 Regulation (EC) N° 258/97  
 
• 14/03/1996 
Applicant submits application. 
 
• 23/04/1998 
Lead CA provides its initial assessment. 
  
• 13/05/1998 
COM forwards request, summary 
and initial assessment to MS .  
• 15/09/1998 
Confirmation of the initial assessment report.  
 
• 27/10/1998 
COM circulates initial assessment 
report.  
• 12/1998-03/1999 
Comments and objections by MS.    
  
• 29/04/1999 
COM requests SCF opinion. 
 
• 05/1999-07/2001 
Questions and additional requests to the 
applicant by SCF. Applicant provides responses. 
-  On 10/07/2000 the SCF poses 
additional questions to the 
applicant. 
- On 21/07/2000 the applicant 
responds. 
- On 31/07/2000 the SCF requests 
additional information. 
- On 14/11/2000 the applicant 
responds. 
- On 18/06/2001 the SCF requests 
additional information. 
- On 24/07/2001 the SCF poses 
further questions to the applicant. 
  
 
• 24/09/2001 
Applicant suspends consideration of the 
dossier for market application. 
 
  
• 27/05/2003 
Applicant withdraws application. 
  
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Community Level Product Member State Level Circulation to Member States Commission 
EC-99 
 
High-oleic 
soybeans (food) 
 Regulation (EC) N° 258/97  
 
• 24/07/1998 
Applicant submits application.  
 
   
• 11/08/1998 
Summary of application forwarded to MS. 
 
• 10/1998-09/1999 
Netherlands, Germany and Greece request 
additional information and make comments. Applicant provides res ponses.  (We note the 
following dates: 
- On 16/10/1998 the applicant provides 
relevant references. 
- On 11/03/1999 the Health Council poses 
questions to the applicant. 
- On 28/05/1999 the applicant provides 
additional information. 
- On 06/09/1999 the Health Council sends 
further comments to the applicant.) 
  
• 12/12/2002 
Applicant withdraws application. 
  
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Community Level Product Member State Level Circulation to Member States Scien tific Committee Process Commission 
EC-100 
 
Transgenic tomato 
(food)  Regulation (EC) N° 258/97  
 
• 02/03/1998 
Applicant submits application. 
  
• 22/04/1998 
Summary of application 
forwarded to MS.  
• 04/06/1998 
Lead CA sends initial assessment to COM. 
 
• 22/06/1998 
COM circulates initial 
assessment to MS.  
• 06/1998-10/1998 
Comments and objections by MS.  
 
• 22/10/1998 
COM forwards 
comments/objections to MS. 
 
• 11/1998 
Further comments by MS. 
Applicant provides responses. 
 
• 22/12/1998 
Italy renews its objections. 
 
  
• 23/12/1998 
COM requests SCF opinion. 
 
• 01-02/1998 
Comments, objections by France 
and Austria.  
• 04/10/1999 
SCF opinion: favourable. 
 
• 07/09/2000 
SCF opinion: favourable. 
 
  
  
• 24/09/2001 
Applicant withdraws application. 
  
  
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Community Level Product Member State Level Circulation to Member States Commission 
EC-101 
 
T25 x MON810 
maize (food)  Regulation (EC) N° 258/97  
 
• 20/04/2000 
Applicant submits application. 
  
• 03/05/2000 
Summary of application forwarded to MS. 
 
• 05/2000-11/2001 
MS request additional information. Applicant 
provides responses. (We note the following dates: 
- On 17/07/2000 the Health Council of the 
Netherlands requests additional information. 
- On 22/11/2000 the applicant provides 
additional information. 
- On 23/04/2001 the Health Council of the 
Netherlands requests additional 
information. 
- On 21/11/2001 applicant provides 
additional information and clarifies the 
state of play.) 
  
• 12/12/2002 
Applicant withdraws application. 
  
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Community Level Product Member State Level Circulation to Member States Commission 
EC-102 
 
RR sugar beet 
(food) 
 Regulation (EC) N° 258/97  
 
• 03/11/1999 
Applicant submits application.  
• 24/03/2000 
The Health Council of the Netherlands requests applicant to submit additional 
information. 
 
• 18/04/2000 
Response by the applicant. 
 
• 10/05/2000 
The Health Council of the Netherlands requests applicant to submit further 
information. 
  
• 29/05/2000 
COM forwards application to MS. 
 
• 06-07/2000 
MS request full dossier. 
 
• 12/2000 
Applicant provides responses. 
 
• 19/01/2001 
Denmark acknowledges receipt of the application and comments on it.  
 
• 16/05/2001 
Netherlands requests additional information. 
  
• 16/04/2004 
Applicant withdraws application. 
  
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Product  Member State Level  
EC-110 
 
Transgenic green-
hearted chicory 
  
Regulation (EC) N° 258/97  
 
• 11/03/1996 
Applicant submits full application to lead CA. 
 
• 24/05/1996 
Applicant submits the English version of SNIF. 
 
• 13/06/1996 
Advice of Commission on Genetic Modification (COGEM) concluding that based on the information no environmental risks are forese en. 
 
• 08/07/1996 
Draft evaluation summary is sent to the applicant. 
 
• 02/01/1997 
Applicant requests that the dossier not be forwarded to COM until the dispute around the food safety of dossier C/NL/94/25A is settled. 
 
• 23/04/1998 
Advice vCVNV (Provisional Commission for Food safety) concerning event GM2-28. 
 
• 25/03/1999 
RIKILT considers  the dossier incomplete  and requests additional information. 
 
• 21/05/1999 
Applicant provides additional information.  
• 15/04/2003 
Applicant withdraws application.  
  
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Product  Member State Level  
EC-156 
 
T14 maize  
  
Directive 90/220/EEC  
 
• 10/06/1996 
Applicant submits full application to lead CA. 
 
• 06/1996 – 02/1997 
Commission du Génie Biomoléculaire requests additional information. 
 
• 22/07/1997 
Applicant submits updated applica tion and additional information. 
 
• 23/10/1997 
Commission du Génie Biomoléculaire requests modification of the application. 
 
• 29/11/1997 
Commission du Génie Biomoléculaire issues opinion. 
 
• 28/01/1998 
Applicant submits new information and a modi fied application following request from the Commission du Génie Biomoléculaire. 
 
• 15/07/1998 
Applicant withdraws application. 
 
 
  
__________