WT/DS291/R WT/DS292/R WT/DS293/R
Page B-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.
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.
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):
Consideration of application at member State level ("Member State Level")
Initial assessment of application by lead CA. ("Lead Member State Level").
Consideration of application at Community level ("Community Level")
Circulation of lead CA assessment to other member States ("Other Member States").
Consultation of EC scientific committee ("Scientific Committee Process").
Preparation of draft measure to be submitted to the Regulatory Committee ("Commission").
Consideration by the Regulatory Committee of the draft measure submitted by the Commission ("Regulatory Committee Process").
Preparation of draft measure to be submitted to the Council ("Commission").
Consideration by the Council of the draft measure submitted by the Commission, including decision by the Council ("Council").
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").
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-2
Written consent of lead CA to placing on the market (Directives 90/220 and 2001/18) ("Lead Member State").
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.
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) |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-3
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-3
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 |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-4
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-4
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-5
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-5
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-6
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-6
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-7
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-7
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.
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-8
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-8
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-9
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-9
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. | ||||||||
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-10
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-10
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). |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-11
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-11
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.
18/07/2002 Opinion of the SCP. (favourable) |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-12
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-12
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-13
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-13
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-14
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-14
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:
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) |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-15
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-15
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-16
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-16
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:
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-17
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-17
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-18
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-18
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-19
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-19
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-20
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-20
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-21
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-21
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.
Directive 2001/18/EC 21/11/2002 Applicant updates application. 02/2003 – 03/2003 Lead CA requests additional information. 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) |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-22
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-22
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-23
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-23
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-24
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-24
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.
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-25
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-25
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-26
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-26
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-27
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-27
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.
24/07/2001 Clarifications by COM to applicant about the phasing- out of antibiotic resistance markers. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-28
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-28
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-29
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-29
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-30
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-30
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) |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-31
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-31
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-32
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-32
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-33
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-33
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-34
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-34
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-35
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-35
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-36
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-36
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-37
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-37
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:
|
- 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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-38
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-38
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-39
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-39
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-40
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-40
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-41
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-41
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-42
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-42
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-43
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-43
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.
06/07/2004 Applicant withdraws application. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-44
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-44
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-45
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-45
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.
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-46
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-46
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.
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-47
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-47
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.
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) |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-48
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-48
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.
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) |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-49
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-49
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:
| 12/12/2002 Applicant withdraws application. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-50
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-50
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-51
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-51
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:
| 12/12/2002 Applicant withdraws application. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-52
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-52
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-53
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-53
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. |
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-54
WT/DS291/R WT/DS292/R WT/DS293/R
Page B-54
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. |