WT/DS291/R 
WT/DS292/R WT/DS293/R Page A-4   
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) 
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 para graph)
First examination by lead CA 
of whether the application contains all the in formation and data required by Article 13(2)  
(Article 13(1), second paragraph) 
If no: 
Request by lead CA to applicant for additional 
information 
(Article 13 (1), second paragraph)If yes: 
Requested data is provided by the applicant  
Assessment by lead CA  
of compliance of application with the Directive a nd issuance of an assessment report (Article 14(1)) 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))  
If positive, the lead CA forwards the 
assessment report to the Commission  
(Article 14(2), first 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)  period 
irculation of 
port to make 
r reasoned 
rticle 15(1))  Circulation by the Commission 
of the assessment report to the other memb er States within 30 days from receipt  
(Article 14(2), first paragraph) ANNEX A-2  
DIRECTIVE 2001/18: EC ADMINISTRATIVE PROCEDURE FOR GRANTING CONSENTS 
FOR THE DELIBERATE RELEASE INTO THE ENVIRONMENT OF GMOs 
  
 
                
 
    
 
 
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 WT/DS292/R 
 WT/DS293/R 
 Page A-5 
  
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 
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)) 45-day period* 
*time for information 
from applicant not 
counted (Article 15(1))  
Objections by the Commission or the 
member States maintained * 
*(see endnote 1) Objections by the Commission or the 
member States resolved
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 "inte r-service consultations" ) 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))  
Regulatory Committee rejects, or does 
not decide on, Commission proposalRegulatory Committee delivers a 
positive opinion on the Commission 
proposal  
Authorization  
for the placing on the market granted by 
the lead CA (Article 18(2)) Commission presents the proposal  
to Council
Council (a) rejects, or  
(b) does not decide on,  
Commission proposal within 3 months  
Commission has to (a) revise or  
(b) adopt its proposal  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))