2002/812/EC: Council Decision of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products
Date: 2002-10-03
Institutions: Council of the European Union
Subjects: approximation of laws, environmental protection, exchange of information, form, genetically modified organism, health policy, marketing

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COUNCIL DECISION

of 3 October 2002

establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the
summary information format relating to the placing on the market of genetically modified
organisms as or in products

(2002/812/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 Parlia-
ment and of the Council of 12 March 2001 on the deliberate
release into the environment of genetically modified organisms
and repealing Directive 90/220/EEC (1), and in particular Article
13(2)(h) thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

(2)

(3)

Under Part C of Directive 2001/18/EC, prior notification
must be given to the competent national authority of the
planned placing on the market of a genetically modified
organism (hereinafter referred to as GMO), or a combi-
nation of such organisms.

That notification comprises, inter alia, a summary of the
relevant dossier, which the competent authority must
send to the competent authorities of the other Member
States and to the Commission, and which the Commis-
sion must immediately make available to the public. That
summary must be drawn up in accordance with a parti-
cular format.

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 fact that the information thus provided

cannot serve as the basis for an environmental risk
assessment.

(4)

The committee set up under Article 30(2) of Directive
2001/18/EC was consulted on 12 June 2002 and has
not delivered an opinion on the Commission's proposal
for a Decision,

HAS ADOPTED THIS DECISION:

Article 1

For the purposes of drawing up the summary of the dossier for
submission to the competent national authority pursuant to
Article 13(2)(h) of Directive 2001/18/EC, the notifier shall use
the Summary Information Format set out in the Annex to this
Decision.

This Decision is addressed to the Member States.

Article 2

Done at Luxembourg, 3 October 2002.

For the Council

The President

F. HANSEN

(1) OJ L 106, 17.4.2001, p. 1.

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ANNEX

SUMMARY INFORMATION FORMAT IN RELATION TO THE PLACING ON THE MARKET OF A GMO OR A
COMBINATION OF GMOs AS OR IN PRODUCTS

INTRODUCTION

The following format must be used for the summary of the dossier to accompany a notification, for submission to the
competent national authority, concerning the placing on the market of a GMO or a combination of GMOs as or in
products.

This document, when completed, will present a summary of the information entered under the corresponding points of
the full dossier. It is recognised, therefore, that the risk assessment required under Directive 2001/18/EC cannot be
carried out solely on the basis of this document.

The space provided after each question is not indicative of the depth of the information required for the purposes of the
Summary Information Format.

The Summary Information Format is divided into Parts 1 and 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 Nature of the GMOs contained in the product

C Predicted behaviour of the product

D Information relating to previous releases

E Information relating to the monitoring plan

Part 2 applies to products consisting of or containing genetically modified higher plants. The term ‘higher plants’ means
plants which belong to the taxonomic group Gymnospermae and Angiospermae. Part 2 contains the following sections:

A General Information

B Nature of the GMHP contained in the product

C Information relating to previous releases

D Information relating to the monitoring plan

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PART 1

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PART 2

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