Document: WT/DS291/R WT/DS292/R WT/DS293/R Page B-1 ANNEX B TABLES SUMMARIZING THE HISTORY OF THE INDIVIDUAL APPROVAL PROCEDURES AT ISSUE IN THIS DISPUTE
Document codes: WT/DS291/R; WT/DS292/R; WT/DS293/R
Complainant: Argentina
Respondent: EU
Third parties: Australia, Brazil, Canada, Chile, China, Taiwan, Colombia, El Salvador, Honduras, Mexico, New Zealand, Norway, Paraguay, Peru, Thailand, Uruguay, U.S.
Dispute stage: Mutually Agreed Solution
Agreements cited: Art. 2.2, 2.3, 5.1, 5.2, 5.5, 5.6, 7, 8, 10.1, Annex B, Annex C  Sanitary and Phytosanitary Measures (SPS)Art. III:4, X:1, X:3(a), XI:1  GATT 1994Art. 2.1, 2.2, 2.8, 2.9, 2.11, 5.1, 5.2, 5.6, 5.8, 12  Technical Barriers to Trade (TBT)Art. 4.2  AgricultureArt. I:1  GATT 1994

ANNEX 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").

(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)

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.

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 clarification 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.

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.

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.

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.

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.

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.

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).

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)

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.

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.

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.

Community Level Product Member State 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.

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.

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 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.

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.

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 lead 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

Product Member State Level
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.

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.

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.

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 the 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.

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 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.

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.

Product Member State Level Member State Level (continues)

• 01/10/1999
Lead CA requests additional information (allergenicity, molecular
characterisation, gene transfer 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.

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.

Community Level
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.

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.

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, 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 So ciales, de la santé Publique et de
l'Environnement.

• 06/07/2004
Applicant withdraws application.

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 applicant 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.

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.

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.

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.

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.

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.

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.

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.

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.

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 foreseen.

• 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.

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 application 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 modified application following request from the Commission du Génie Biomoléculaire.

• 15/07/1998
Applicant withdraws application.