WT/DS291/R WT/DS292/R WT/DS293/R

Page A-4


ANNEX A-2


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90 day period – so-called Member State level*


between receipt of application and assessment report

*any periods of time during which further information is awaited from the applicant is not taken into account (Article 14(4))

90 day period – so-called Member State level*


between receipt of application and assessment report

*any periods of time during which further information is awaited from the applicant is not taken into account (Article 14(4))

Acknowledgment of receipt by lead CA

and communication of the summary of the notification ("SNIF") to the Commission and the CAs of the other member States

(Article 13(1), first paragraph)

Acknowledgment of receipt by lead CA

and communication of the summary of the notification ("SNIF") to the Commission and the CAs of the other member States

(Article 13(1), first paragraph)

First examination by lead CA

of whether the application contains all the information and data required by Article 13(2) (Article 13(1), second paragraph)

First examination by lead CA

of whether the application contains all the information and data required by Article 13(2) (Article 13(1), second paragraph)

If yes:

If yes:

If no:

Request by lead CA to applicant for additional information

(Article 13(1), second paragraph)

If no:

Request by lead CA to applicant for additional information

(Article 13(1), second paragraph)

Requested data is provided by the applicant

Requested data is provided by the applicant

Assessment by lead CA

of compliance of application with the Directive and issuance of an assessment report (Article 14(1))

Assessment by lead CA

of compliance of application with the Directive and issuance of an assessment report (Article 14(1))

If positive, the lead CA forwards the assessment report to the Commission (Article 14(2), first paragraph)

If positive, the lead CA forwards the assessment report to the Commission (Article 14(2), first paragraph)

period

period

irculation of

irculation of

port to make

port to make

r reasoned

r reasoned

rticle 15(1))

rticle 15(1))

DIRECTIVE 2001/18: EC ADMINISTRATIVE PROCEDURE FOR GRANTING CONSENTS FOR THE DELIBERATE RELEASE INTO THE ENVIRONMENT OF GMOs


Application

submitted to the competent authority ("CA") of the member State which is required to grant the written consent for the placing on the market of a GMO (so-called "lead CA") as or in a product to be used throughout the Community (Article 13(1), first paragraph)

Application

submitted to the competent authority ("CA") of the member State which is required to grant the written consent for the placing on the market of a GMO (so-called "lead CA") as or in a product to be used throughout the Community (Article 13(1), first paragraph)


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Rejection

If negative, the lead CA informs the applicant and, after minimum 15 days, the Commission* (see endnote 1)

(Article 14(2), second paragraph)

Rejection

If negative, the lead CA informs the applicant and, after minimum 15 days, the Commission* (see endnote 1)

(Article 14(2), second paragraph)


CONTINUE

CONTINUE

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Circulation by the Commission

of the assessment report to the other member States within 30 days from receipt (Article 14(2), first paragraph)

Circulation by the Commission

of the assessment report to the other member States within 30 days from receipt (Article 14(2), first paragraph)

WT/DS291/R WT/DS292/R WT/DS293/R

Page A-5


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Request for further information, comments or reasoned objections by the Commission or the member States

NO request for further information, comments or reasoned objections by the Commission or the member States

Request for further information, comments or reasoned objections by the Commission or the member States

NO request for further information, comments or reasoned objections by the Commission or the member States

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Discussion between objecting CAs and the Commission to resolve outstanding issue

(Article 15(1))

Authorization

for the placing on the market granted by the lead CA (Article 15(3) and 15(4))

Discussion between objecting CAs and the Commission to resolve outstanding issue

(Article 15(1))

Authorization

for the placing on the market granted by the lead CA (Article 15(3) and 15(4))


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45-day period*

*time for information from applicant not counted (Article 15(1))

45-day period*

*time for information from applicant not counted (Article 15(1))

Objections by the Commission or the member States resolved

Objections by the Commission or the member States resolved

Objections by the Commission or the member States maintained *

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Commission presents a draft decision to the Regulatory Committee*

*before being issued, each Commission act has to be agreed among the services (Directorate Generals) concerned (so-called "inter-service consultations")

Commission presents a draft decision to the Regulatory Committee*

*before being issued, each Commission act has to be agreed among the services (Directorate Generals) concerned (so-called "inter-service consultations")

Regulatory Committee rejects, or does not decide on, Commission proposal

Regulatory Committee rejects, or does not decide on, Commission proposal

Regulatory Committee delivers a positive opinion on the Commission proposal

Regulatory Committee delivers a positive opinion on the Commission proposal

*(see endnote 1)


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120-day period – Comitology procedure*

(Articles 18 and 30 and Article 5 Council Decision 1999/468/EC)

*time for further information from applicant, for opinion of the scientific committee or for Council decision not counted (Article 18(1))

120-day period – Comitology procedure*

(Articles 18 and 30 and Article 5 Council Decision 1999/468/EC)

*time for further information from applicant, for opinion of the scientific committee or for Council decision not counted (Article 18(1))

Commission presents the proposal to Council

Commission presents the proposal to Council

Authorization

for the placing on the market granted by the lead CA (Article 18(2))

Authorization

for the placing on the market granted by the lead CA (Article 18(2))

Council (a) rejects, or

(b) does not decide on, Commission proposal within 3 months

Council (a) rejects, or

(b) does not decide on, Commission proposal within 3 months

Commission has to (a) revise or

(b) adopt its proposal

Commission has to (a) revise or

(b) adopt its proposal

Rejection

Rejection

1 In these cases, the Commission has to consult its scientific committees, on its own initiative or at the request of a member State (Article 28(1)). The Commission may also consult the scientific committees on any matter arising under Directive 2001/18 (Article 28(2))