2002D0813 — EN — 01.05.2004 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDECISION
of3October2002
establishing,pursuanttoDirective2001/18/ECoftheEuropeanParliamentandoftheCouncil,the
summary notification information format for notifications concerning the deliberate release intothe environment of genetically modified organisms for purposes other than for placing on the
market
(2002/813/EC)
(OJ L 280, 18.10.2002, p. 62)
Amended by:
Official Journal
No page date
►A1Act concerning the conditions of accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia,the Republic of Lithuania, the Republic of Hungary, the Republic ofMalta, the Republic of Poland, the Republic of Slovenia and the SlovakRepublic and the adjustments to the Treaties on which the European
Union isfoundedL 236 33 23.9.2003
▼B
COUNCILDECISION
of3October2002
establishing, pursuant to Directive 2001/18/EC of the European
Parliament and of the Council, the summary notification informa-tion format for notifications concerning the deliberate release intothe environment of genetically modified organisms for purposes
otherthanforplacingonthemarket
(2002/813/EC)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,Having regard to Directive 2001/18/EC of the European Parliament and
of the Council of 12 March 2001 on the deliberate release into theenvironment of genetically modified organisms and repealing Directive90/220/EEC (
1), and in particular Article 11(1) thereof,
Having regard to the proposal from the Commission,Whereas:
(1)Under Part B of Directive 2001/18/EC, prior notification must be
given to the competent national authority of the planned releaseof a genetically modified organism (hereinafter referred to asGMO), or of a combination of such organisms, for purposes
other than for placing on the market.
(2)Within the framework established by the Directive 2001/18/EC
for the exchange of information between the competent authori-ties and the Commission, the authority must then send a
summary, in accordance with a specific format, of the notifica-
tion to the Commission, which in turn must forward copies tothe other Member States.
(3)That format should reflect the need to enable the fullest possible
exchange of relevant information, presented in a standardised
and easily comprehensible manner, without prejudice to the factthat the information thus provided cannot serve as the basis foran environmental risk assessment.
(4)The committee set up under Article 30(2) of Directive 2001/18/EC wascons ulted on 12 June 2002 and hasnot delivered anopinion on the Commission's proposal for a Decision,
HAS ADOPTED THIS DECISION:
Article 1
For the purposes of summarising, for transmission to the Commission,
notificationsreceived purs uant to Article 6 of Directive 2001/18/EC,the competent authoritiesappointed by Member Statesunder thatDirective shall use the Summary Notification Information Format set
out in the Annex to thisDecis ion.
Article 2
This Decision is addressed to the Member States.2002D0813 — EN — 01.05.2004 — 001.001 — 2
(1) OJ L 106, 17.4.2001, p. 1.
▼B
ANNEX
SUMMARY NOTIFICATION INFORMATION FORMAT FOR THE
DELIBERATERELEASEOFAGMOORACOMBINATIONOF GMOs
FORPURPOSESOTHERTHANFORPLACINGONTHEMARKET
INTRODUCTION
The Summary Notification Information Format for deliberate releases of a GMO
or of a combination of GMOs, has been established for the purposes and
according to the proceduresenvis aged by Article 11 of Directive 2001/18/EC.
It isrecognized that thisFormat isnot des igned to accommodate all the infor-
mation required for carrying out an environmental risk assessment.
The space provided after each question is not indicative of the depth of the
information required for the purposes of the Summary Notification Information
Format.
The Summary Notification Information Format consists of a Part 1 and a Part 2.
Part 1 applies to products consisting of or containing genetically modified
organisms other than higher plants and contains the following sections:
A General Information
B Information relating to the recipient or parental organisms from which the
GMO isderived
C Information relating to the genetic modificationD Information on the organism(s) from which the insert is derived (donor)
E Information relating to the genetically modified organism
F Information relating to the release
G Interactionsof the GMO with the environment and potential impact on the
environment
H Information relating to monitoring
I Information on post-release and waste treatmentJ Information on emergency response plans
In Part 1 the information entered should, however, adequately reflect (in a
condensed form) the information submitted to the competent authority in accor-
dance with Articles6 and 7 of Directive 2001/18/EC under the conditions
specified in the preface to Annex IIIA.
Part 2 applies to products consisting of or containing genetically modified
higher plants. The term ‘higher plants’ means plants which belong to the taxo-
nomic group Gymnospermae and Angiospermae . Part 1 containsthe following
sections:
A General information
B Information on the genetically modified plant
C Information relating to the experimental release
D Summary of the potential environmental impact of the release of the GMPtsE Brief description of any measures taken for the management of risks
F Summary of planned field trialsdes igned to gain new data on the environ-
mental and human health impact of the release.
In Part 2 the information entered should, however, adequately reflect (in a
condensed form) the information submitted to the competent authority in accor-
dance with Articles6 and 7 of Directive 2001/18/EC under the conditions
specified in the preface to Annex IIIB.2002D0813 — EN — 01.05.2004 — 001.001 — 3
▼B
PART 1
2002D0813 — EN — 01.05.2004 — 001.001 — 4
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 5
▼B
►(1)A12002D0813 — EN — 01.05.2004 — 001.001 — 6
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 7
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 8
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 9
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 10
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 11
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 12
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 13
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 14
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 15
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 16
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 17
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 18
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 19
▼B
PART 2
2002D0813 — EN — 01.05.2004 — 001.001 — 20
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 21
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 22
▼B
2002D0813 — EN — 01.05.2004 — 001.001 — 23