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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 summarizing 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 particular 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 information 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 information 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 the approval procedures set out in the relevant EC approval legislation for biotech products (Directives 90/220 and 2001/18 as well as Regulation 258/97):


    1. Consideration of application at member State level ("Member State Level")


      1. Initial assessment of application by lead CA. ("Lead Member State Level").


    2. Consideration of application at Community level ("Community Level")


      1. Circulation of lead CA assessment to other member States ("Other Member States").


      2. Consultation of EC scientific committee ("Scientific Committee Process").


      3. Preparation of draft measure to be submitted to the Regulatory Committee ("Commission").


      4. Consideration by the Regulatory Committee of the draft measure submitted by the Commission ("Regulatory Committee Process").


      5. Preparation of draft measure to be submitted to the Council ("Commission").


      6. Consideration by the Council of the draft measure submitted by the Commission, including decision by the Council ("Council").


      7. 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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      8. 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 according to the above-mentioned procedural stages, it is important to note that each table provides information on only those stages which have been completed or reached in the relevant approval procedure.


  5. Due to constraints of space, the Panel's tables 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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Product

Member State Level

Community Level

Lead Member State Level

Circulation to other Member States

Scientific Committee Process

Commission

Regulatory Committee Process

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


20/02/1998


04/09/1998


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.

Full application

COM requests

SCP

COM launches ISC on

submitted to COM.

opinion.

draft COM decision to

be submitted to REG

09/12/1996

14/07/1998

COM.

Application circulated to

Opinion of the

SCP:

all MS.

favourable.

01/1997- 10/1997

Requests for additional

EC-62

information by lead CA and replies by applicant.

Falcon oilseed

Comments/objections by MS.

rape

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Product

Member State Level

Community Level

Lead Member State Level

Circulation to other Member States

Scientific Committee Process

Commission

Regulatory Committee Process


Directive 2001/18/EC


29/05/2001

Applicant submits letter, claiming that the

16/01/2003

application is already in line with Directive

Statement of

2001/18.

completeness by

applicant. Applicant

25/07/2001

updates SNIF.

Lead CA requests for clarification by the applicant

on additional documents.

14/10/2003

Request for clarification

21/11/2001

and further update of

Applicant submits documents to support "working

SNIF.

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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Product

Member State Level

Community Level

Lead Member State Level

Circulation to Member States

Scientific Committee Process

Commission

Regulatory Committee Process

Directive

90/220/EEC

07/01/1997

27/01/1998

04/09/1998

30/06/1999

Submission by lead CA

COM requests for SCP

COM launches ISC on

COM launches vote in REG COM by written

30/09/1996

to COM of full

opinion.

draft COM decision to

procedure.

Applicant submits

application.

be submitted to REG

application to

19/05/1998

COM.

22/10/1999

Belgium.

29/01/1997

SCP opinion:

COM invites applicant to present additional

Application circulated

favourable.

information following interim approach to REG

10 and 17/12/1996

to all MS.

COM.

Meetings of the

Belgian Biosafety

02/1997 – 12/1997

10/11/1999

Council.

Statements, comments

Applicant submits update in line with revised EC

and objections by MS.

legislation.

EC-63

(Positive advice of the

Scientific Committees

Applicant provides additional information.


29/10/1999

MS8/RF3

oilseed rape

on Transgenic Plants

and on Novel feed/food).

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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Product

Member State Level

Community Level

Lead Member State Level

Circulation to Member States

Scientific Committee Process

Commission

Regulatory Committee Process

19/06/2001

Meeting of CAs.

12/07/2001

Letter of lead CA to applicant

Directive 2001/18/EC

acknowledging receipt of further

information and soliciting envoy of

14/01/2003

reference material.

Applicant submits

updated application.

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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Product


Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

Regulatory Committee Process


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.


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.


13/03/1998


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

COM request for SCP

REG COM meeting: presentation by the

opinion.

company of the update; no vote held

because of outstanding additional

23/06/1998

information.

Opinion of the SCP:

favourable.

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.

EC-64

12/07/2000

RR

fodder beet

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


Directive 2001/18


12/12/1997

16/01/2003

Updated application

Dutch CA requests information.

additional

submitted by the

applicant.


Product


Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

Regulatory Committee Process


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.


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.


13/03/1998


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

COM request for SCP

REG COM meeting: presentation by the

opinion.

company of the update; no vote held

because of outstanding additional

23/06/1998

information.

Opinion of the SCP:

favourable.

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.

EC-64

12/07/2000

RR

fodder beet

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


Directive 2001/18


12/12/1997

16/01/2003

Updated application

Dutch CA requests information.

additional

submitted by the

applicant.

commitments.



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Product


Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

Regulatory Committee Process

Commission


Directive


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


04/09/1998


26/11/1998


07/05/1999

90/220/EEC

COM request for

COM launches ISC on

COM launches vote in

COM launches ISC on

SCP opinion.

draft decision to be

REG COM by written

draft measure to be

02/12/1996

submitted to the REG

procedure.

submitted to the

Applicant submits

14/07/1998

COM.

Council.

application.

SCP opinion:


EC-65


30/04/1997

Applicant expresses its intention to submit the dossier also under the Novel Food Regulation.

favourable.

22/02/1999

REG COM vote: absence of qualified majority.

Outcomes of the written procedure including written statements from Sweden, Austria and UK.


25/07/2001

Applicant provides

updated molecular characterisation and Safety Assessment. (analysis of flanking regions).

Bt-531

cotton

18/02/2002

Applicant provides

translations of material

sent in July 2001.

Directive 2001/18

16/01/2003

Applicant submits

updated application.

01/08/2003

Lead CA requests for

additional

information.

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Product


Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

Regulatory Committee Process

Commission


Directive 90/220/EEC


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


04/09/1998

COM launches ISC on draft decision.


26/11/1998


07/05/1999

COM request for

COM launches vote in

COM launches ISC on

30/06/1997

SCP opinion.

REG COM by written

draft Council Decision.

Applicant submits

procedure.

application.

30/06/1998

Request by SCP for

30/11/1998

additional data.

DK requests extension of

the deadline for the vote

14/07/1998

in order to revise

SCP opinion:

additional information

favourable.

submitted by the

applicant.

EC-66

04/12/1998

RR-1445

COM informs CAs that

cotton

the deadline for the vote

is extended.

Directive 2001/18

10/12/1998

Belgium requests that the

16/01/2003

vote be postponed.

Updated application

submitted by the applicant.

21/12/1998

UK requests that the vote

be postponed, in order to

meet with the applicant

and discuss further

information recently

submitted.

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Product


Member State Level

Community 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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image


Product

Member State Level

Community 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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Product


Member State Level

Community 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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image


Product

Member State Level

Community Level

Circulation to Member States

Scientific Committee Process


Directive 90/220/EEC


04/04/1999


30/11/2000

Lead CA submits application to COM with a

SCP opinion.

28/05/1996

favourable opinion.

(favourable)

Applicant submits application.

07/05/1999

03/05/2002

17/06/1996

Application sent to all CAs.

Applicant updates application by including new

Lead CA receives application.

sequence data.

06/1999 – 10/2000

06/1996 – 01/1999

Requests for further information and objections by

Requests for additional information.

CAs. Applicant provides additional information.

Applicant provides additional information.

EC-69

Bt-11 maize

(EC-69)

Directive 2001/18/EC

15/01/2003

Applicant updates application.


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.

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Product

Member State Level

Community Level

Circulation to Member States

Scientific Committee Process


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


23/10/2003

COM receives new SNIF.

COM requests scientific opinion from EFSA

Scientific Panel on GMOs.

24/01/2003

COM circulates dossier to other CAs.

11/02/2004

Opinion of the Scientific Panel on GMOs issues:

24, 25/03/2003

favourable.

Objections raised by MS.

28/04/2003

Meeting with COM, applicant and all CAs in order to

solve the outstanding issues.


EC-70

05/08/2003 – 29/09/2003

Applicant provides additional information.

RR oilseed

Evaluation of the additional information.

rape (EC-70)

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Product

Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

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 Belgium 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 double application in Belgium and Portugal and explains that the maintenance 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 from the applicant with some of the information requested.


29/06/2004

Withdrawal of the application.

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Product

Member State Level


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

EC-72

Request for additional information.

LL oilseed

11/11/1999

rape

Minutes of 62nd meeting of ACRE.

02/12/1999

UK Scientific Committee advises the applicant that the dossier 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 Surveillance Plan in accordance with Annex 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 under reference C/GB/04/M5/4.

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Product

Member State Level


Directive 90/220/EEC

03/05/1999

Applicant submits application.

01/07/1999

6th Meeting of the National Biosafety Committee ("NBC") of the lead CA: several questions raised and amendments proposed.

EC-73

17/09/1999

BXN cotton

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 requesting additional information related to labelling 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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Product

Member State Level

Community Level

Circulation to Member States

Scientific Committee Process


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.

image

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


26/02/2004

Full application and assessment report

COM requests EFSA opinion.

sent to COM.

12/03/2004

26/08/2003

Letters from COM to EFSA

Application and assessment report

clarifying some MS objections.

circulated to all MS.

08/2003 – 02/2004

Comments and objections by MS.

Applicant provides responses.


EC-74

Bt-1507 maize

(EC-74)

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image


Product

Member State Level

Community Level

Circulation to Member States


Directive 90/220/EEC


08/2003

- Lead CA submits full application and assessment report to COM.

06/07/2001

- Application and assessment report circulated to all MS.

Applicant submits application.

10/2003 – 03/2004

09/2001 – 12/2002

Comments, objections and requests for additional information by MS. Applicant

Lead CA requests for additional information. Applicant submits

provides additional information.

additional information.

05/2004 – 06/2004

EC-75

Comments/objections by MS.

Bt-1507 maize

Directive 2001/18/EC

(EC-75)

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.

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Product


Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

Regulatory Committee Process

Council

Directive 90/220/EEC


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

18/02/2004

26/03/2004

04/08/2000

COM launches ISC on

Absence of qualified

Transmission of

Applicant submits application.

draft COM Decision.

majority in REG COM.

the proposal to

the Council.

20/12/2000

Applicant clarifies the scope

EC-76

of the application and provides Spanish translation.

NK603

maize

02/01/2001

Lead CA acknowledges

receipt.

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Product


Member State Level

Community 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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Product


Member State Level

Community Level

Circulation to Member States

Commission

Regulatory Committee Process

Commission


Directive 90/220/EEC


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


08/03/1996


03/05/1996

COM launches ISC on draft

Consultation of the REG

Request by written procedure

15/12/1994

COM decision.

COM by written procedure.

for approval by COM

Applicant submits full

members.

application to lead CA.

24/04/1996

Consultation of REG COM:

10/05/1996

23/01/1995

Positive opinion.

Written procedure

Advice of Commission

suspended.

on Genetic Modification

(COGEM): information

14/05/1996

EC-77

insufficient.

Written procedure re- launched subject to specific

Transgenic red-hearted chicory

31/03/1995

Statement of Dutch CA with evaluation summary: favourable.

labelling requirements.


20/05/1996

Decision 96/424/EC for

(Notification C/NL/94/25)

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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Product


Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

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

30/03/1999

Directive 90/220/EEC

COM requests SCP opinion.

Proposal to amend COM Decision

96/424/EC. Request for launching

10/09/1996

07-09/1998

of ISC.

Applicant submits the

Questions raised by the SCP and answers provided by

(Same GM product had already

part of the application

the applicant.

been authorised for breeding

dealing with food safety

activities at the Community level.)

aspects to lead CA.

19/10/1998

EC-77

SCP requests for further information.

10/05/1999

ISC launched.

Transgenic

01/12/1998

red-hearted

Applicant provides further information.

26/05/1999

chicory

ISC closed.

18/12/1998

(Notification

Opinion of the SCP: favourable.

C/NL/94/25/A)

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.

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Product


Member State Level

Community 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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image

image


Product

Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission


Directive 90/220/EEC


29/05/1998

Receipt of application.


16/06/1998- 13/07/1998

Two meetings of the Spanish scientific committee (33rd 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


29/10/1999


19/01/2001

Spanish lead CA forwards application to

COM sends dossier to SCP for opinion.

Applicant submits letter on the change

COM.

of scope (import and processing only,

22/02/2000

planting now excluded).

06 and 07/1999

SCP requests clarification.

Application sent to MS.

21/09/2001

Comments/objections of MS circulated.

15/03/2000

Undertakings from applicant accordance

Applicant provides answers to request

with the requirements of Directive

28/07/1999

for clarification.

2001/18/EC.

Voluntary commitments by the

applicant.

06 and 07/2000

18/03/2002

Further requests for additional

Applicant submits updates and

29/07/1999

information and responses provided by

commitments to COM.

EC-78

Technical meeting on pending products. Applicant provides general information.

the applicant.

GA21 maize (EC-78)


08/1999

Comments by MS. Applicant provides

22/09/2000

SCP opinion: favourable.

answers.


29/09/1999

11th 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.

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Product

Member State Level

Community Level

Circulation to Member States


Directive 90/220/EEC


15/10/1999

Lead CA sends full application to COM.

12/12/1997

Applicant submits application.

01/12/1999

COM circulates application to all CAs.

23/12/1997

UK CA requests further information.

12/1999 – 02/2000

Comments and objections by MS. Applicant provides answers and

01 and 02/1998

clarifications.

Applicant submits further information.

27/06/2001

EC-85

27/02/1998

Applicant withdraws application.

Amended dossier requested.

GA21 maize

(EC-85)

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.

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Product

Member State Level

Community Level

Circulation to Member States


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.

EC-79

15/01/2003

RR oilseed rape

Official withdrawal.

(EC-79)

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Product

Member State Level

Community Level

Circulation to Member States


Directive 90/220/EEC


30/04/1999

Lead CA forwards application to COM.

29/05/1998

Applicant submits application.

20/05/1999

Applicant notifies withdrawal of application from Spain.

16/06/1998

Meeting of the Spanish Scientific Comité.

27/05/1999

COM circulates full application to all CAs.

31/07/1998

Lead CA requests additional information by the applicant.

28/05/1999

Official withdrawal circulated to all CAs. Review of the application

EC-80

03/09/1998

Applicant submits additional information.

closed.

Bt-11 maize (EC-80)

09/1998 and 01/1999

Meetings of the Spanish Scientific Comité.

26/04/1999

Lead CA forwards positive risk assessment report to COM.

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Product

Member State Level

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.

EC-81

11/05/2000

LL soybeans

Additional request for information.

(EC-81)

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 bring 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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Product

Member State Level


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

7th session of Spanish National Commission on Biosafety.

30/11/1999

EC-82

Lead CA requests further information.

MON810 x

08/2001

GA21 maize

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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Product


Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

Regulatory Committee Process

Commission


Directive 90/220/EEC


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


12/06/1998


04/09/1998


22/04/1999

COM submits

COM launches ISC on

COM launches

COM launches vote in

18/12/1995

application to SCP for

draft COM decision to

consultation of REG

REG COM by written

Applicant submits full

opinion.

be submitted to REG

COM.

procedure.

application to lead CA

COM.

concerning the two

11/03/1998

23/10/1998

29/04/1999

events (MON 801 and

Meeting of the GMO

09/07/1998

Consultation of REG

Written procedure

MON809).

working group of the

ISC concluded.

COM ends with no

suspended because of

SCP.

opinion.

Bt resistance

06/02/1996

management program.

National scientific

03-04/1998

committee (CGB)

Applicant provides

08/06/1999

delivers an opinion and

responses to SCP's

Additional questions

EC-83

requests additional

questions.

sent to SCP:

information as well as

consultation done in

MON809

separate applications for

19/05/1998

the context of the

maize

the two events.

SCP opinion:

safeguard measures

favourable

invoked by Austria

06/03/1996

about MON810 maize

New application

(because laboratory

concerning MON809

results showed harm to

and further data

butterflies treated with

provided.

pollen from Bt maize)

04/04/1996

24/09/1999

Opinion of the National

SCP opinion:

scientific committee

favourable.

(CGB).

04/10/2002

Applicant withdraws

application.

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Product


Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

Regulatory Committee Process

Commission


Directive 90/220/EEC


17/11/1997


23/06/1998


05/10/1998


26/11/1998


16/02/1999

Lead CA forwards

SCP opinion:

Outcomes of

COM launches

COM sends proposal for

15/11/1996

dossier to COM

favourable.

ISC.

consultation of the

CO decision to Cabinet

Lead CA receives dossier from

together with a

REG COM by written

Bjereggard for approval.

the applicant.

favourable opinion.

procedure.

09/03/1999

12/1996, 01 and 02/1997

15/12/1997

18/12/1998

COM sends proposal for

Three meetings of the Spanish

Lead CA circulates full

Consultation of the

CO decision to Legal

Commission on Biosafety.

dossier to all MS.

REG COM concluded:

Service for approval.

No opinion.

19/02/1997

01/1998

20/08/1999

Lead CA requests additional

Requests for further

COM launches written

EC-84

information.

information by MS.

procedure on draft CO decision.

Transgenic tomato

02, 03 and 04/1997 Exchange of information

among Spanish Ministry of

27/01/1998

Meeting held by the COM on technical


23/09/1999

SCF opinion: favourable.

Health, Spanish Ministry of

aspects of Part C

Environment and lead CA.

dossiers.

24/11/1999

Request for further

Consultation of other

24/04/1997

info.

DGs on draft

Meeting of the Spanish

Commission Decision

Commission on Biosafety.

04/02/1998

under the Standing

Applicant provides CA

Committee on

23/10/1997

with additional data.

Foodstuffs.

Fax from the applicant to the

Spanish Ministry of Health:

02 and 03/1998

04/02/2002

submission on genetically

Comments and some

Applicant withdraws

modified tomatoes to be

objections by MS.

application.

assessed under the Novel Food

Applicant provides

Regulation.

additional information.

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Product

Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission


Directive 90/220/EEC


26/04/1999


21/09/1999


18/12/2002

Dutch CA sends evaluation summary

COM requests SCP opinion.

Applicant withdraws application.

26/06/1998

and application to COM.

Applicant submits full

26/10/1999

application to lead CA.

17/05/1999

Comments by SCP and draft opinion.

COM circulates full application to all

10/08/1998

CAs.

17/11/1999

Advice of COGEM:

SCP requests further information by

- No risks for human health or

06 and 07/1999

the applicant.

the environment.

Requests for further information,

- Need for further testing.

comments and objections by MS.

01 and 02/2000

Applicant provides additional

Applicant submits additional

EC-86

08 and 09/1998

Requests for additional

information.

information.

T25 x MON810

maize

information. Applicant

provides additional information.

01/09/1999

Applicant proposes for alternatives with respect to the scope of the dossier.

06/06/2000

SCP opinion: favourable.

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 the applicant.

22/04/1999

Applicant's response to draft

evaluation summary.

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Product

Member State Level


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.

EC-87

12/10/1998

High-oleic soybeans

Addendum to COGEM advice:

  • Alteration of fatty acid composition will not result 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 basically 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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image


Product

Member State Level

Member State Level (continues)

Directive 90/220/EEC

08/12/1999

22/12/1998

Applicant provides additional information.

Applicant sends application to lead CA.

18/01/2000

23/02/1999

Applicant provides additional information on horizontal gene transfer.

Lead CA requests additional information.

02/02/2000

11/03/1999

Lead CA requests additional information.

Applicant provides additional information.

02 and 03/2000

14/04/1999

Applicant provides additional information.

Lead CA requests additional information.

04/04/2000

EC-88

14/04/1999

Applicant provides additional information.

Meeting with the applicant (regarding identity preservation, GAP, post market monitoring, traceability, public information, line-specific detection

RR sugar beet


26/04/1999

methods and primers).

Biosafety Advisory Council Meeting.

26/07/2000

Applicant submits additional information.

02/06/1999

Biosafety Advisory Council raises remaining questions on

16/11/2000

agricultural practices, molecular characterisation, toxicology,

CA requests additional information on further characterisation of a protein

allergenicity, and food/feed equivalence.

and detection protocols.

07/06/1999

04/01/2001

Lead CA requests additional information.

Lead CA requests additional information on labelling and traceability.

14/07/1999

13/06/2001

Applicant provides additional information.

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


Directive 2001/18/EC

Lead CA requests additional information (allergenicity, molecular

characterisation, gene transfer in digestive tracts).

16/01/2003

Applicant updates application.

25/02/2003

Lead CA requests additional information.

16/04/2004

Applicant withdraws application.

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Product

Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

Directive 90/220/EEC

21/01/2000

18/05/2000

23/04/2002

24/07/1998

Lead CA sends initial assessment

COM requests SCF opinion.

Applicant changes scope of

Applicant submits application to Dutch CA.

to COM.

application.

18/07/2000

11/08/1998

18/02/2000

Applicant provides additional

05/06/2002

COM forwards the application to MS.

COM circulates initial

labelling proposal.

Meeting with applicant.

assessment to MS.

Applicant agrees to provide

15/09/1998

08/2000

additional information.

Lead CA requests applicant to complete the

03 – 05/2000

Applicant submits additional

dossier.

Requests for additional

information.

18/09/2002

information, comments and

Meeting with applicant on

09/1998 – 02/1999

objections by MS. Applicant

24/04/2001

validation method.

Applicant submits additional information.

provides additional information.

SCF requests further information

EC-91


24/02/1999

by applicant.

GA21 maize (food)

Advisory Committee on the Safety of Novel Foods and Foods Ingredients requests additional information.

17/05/2001

Applicant responds to the request for additional

information.

25/03/1999

Applicant submits additional information.

12-13/12/2001

Discussion on draft opinion

18/06/1999

postponed to February meeting

Advisory Committee on the Safety of Nove

of SCP due to lack of time.

Foods requests additional data.

27/02/2002

26/10/1999

Opinion of the SCF.

Applicant submits requested data.

21/12/1999

Initial assessment by Gezondheidsraad.

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Product

Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Regulatory Committee Process

Commission

Council

Commission


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


08/11/2003


28/01/2004


26/04/2004


19/05/2004

COM requests SCF

Draft Commission

Formal COM

Vote held in

COM adopts

opinion.

Decision on the

decision to refer the

Council.

decision.

agenda of the

matter to the

(No qualified

13/12/2000

Standing Committee.

Council.

majority

Italy requests additional

(No formal opinion

reached)

information.

delivered by MS).

15/04/2001

08/12/2003

SCF requests further

Vote held in REG

data.

COM.

(No qualified majority

EC-92

10/05/2001

Italy reiterates objections

was reached).

Bt-11 sweet

raised in July 2000.

maize (food)

12/11/2001

SCF reminds applicant

of request for additional

information.

27/02/2002

Applicant submits data.

17/04/2002

SCF opinion:

favourable.

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Product

Member State Level

Community 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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Product

Member State Level

Community 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, confirming that it will assess the dossier.


02/03/1999

COM note to the Permanent Representations 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 Sociales, de la santé Publique et de l'Environnement.


06/07/2004

Applicant withdraws application.

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Product

Member State Level

Community Level

Circulation to Member States


Regulation (EC) N° 258/97


29/02/2000

Copy of application sent to COM.

29/02/2000

Applicant submits application.

04-05/2000

UK, Greece and Denmark request applicant to provide full dossier.

29/03/2000

EC-94

Note of the European Commission to the Permanent

06/2000

representations of the Member States – summary of the file.

Comments from Austria, UK and Italy.

MON810 x GA21

maize (food)

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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Product

Member State Level

Community 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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Product


Member State Level

Community 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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Product


Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

Regulation (EC) N° 258/97


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

13/05/1998

27/05/2003

08/04/1998

COM forwards request, summary

Applicant withdraws application.

Applicant submits

and initial assessment to MS.

application.

15/09/1998

23/04/1998

Confirmation of the initial

Initial assessment by lead

assessment report.

CA.

27/10/1998

EC-97

COM circulates initial assessment to MS.

Transgenic red-

hearted chicory

(food)

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Product

Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

Regulation (EC) N° 258/97


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.

13/05/1998

27/05/2003

14/03/1996

COM forwards request, summary

Applicant withdraws application.

Applicant submits application.

and initial assessment to MS .

23/04/1998

15/09/1998

Lead CA provides its initial

Confirmation of the initial

assessment.

assessment report.

27/10/1998

COM circulates initial assessment

EC-98

report.

Transgenic green-

12/1998-03/1999

hearted chicory

Comments and objections by MS.

(food)

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Product

Member State Level

Community 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 responses. (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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Product

Member State Level

Community Level

Circulation to Member States

Scientific Committee Process

Commission

Regulation (EC) N° 258/97

22/04/1998

23/12/1998

24/09/2001

02/03/1998

Summary of application

COM requests SCF opinion.

Applicant withdraws application.

Applicant submits application.

forwarded to MS.

01-02/1998

04/06/1998

Comments, objections by France

Lead CA sends initial

and Austria.

assessment to COM.

04/10/1999

22/06/1998

SCF opinion: favourable.

COM circulates initial

assessment to MS.

07/09/2000

EC-100


06/1998-10/1998

SCF opinion: favourable.

Transgenic tomato (food)

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.

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Product

Member State Level

Community 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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Product

Member State Level

Community Level

Circulation to Member States

Commission

Regulation (EC) N° 258/97

29/05/2000

16/04/2004

03/11/1999

COM forwards application to MS.

Applicant withdraws application.

Applicant submits application.

06-07/2000

24/03/2000

MS request full dossier.

EC-102

The Health Council of the Netherlands requests applicant to submit additional


12/2000

RR sugar beet

information.

Applicant provides responses.

(food)

18/04/2000

19/01/2001

Response by the applicant.

Denmark acknowledges receipt of the application

and comments on it.

10/05/2000

The Health Council of the Netherlands

16/05/2001

requests applicant to submit further

Netherlands requests additional information.

information.

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Product

Member State Level


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 foreseen.


EC-110

08/07/1996

Draft evaluation summary is sent to the applicant.

Transgenic green- hearted chicory

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


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

EC-156

Applicant submits updated application and additional information.

T14 maize

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 modified application following request from the Commission du Génie Biomoléculaire.

15/07/1998

Applicant withdraws application.


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