Document: 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 paragraph) First examination by lead CA
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

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 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 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 and 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 member 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

CONTINUE

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 "inter-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 proposal
Regulatory 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))