Proposal for a Council Decision 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: 2002-07-04
Institutions: European Commission
Subjects: approximation of laws, dissemination of information, environmental protection, exchange of information, form, genetically modified organism, health policy, marketing, transgenic plant

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Proposal for a Council Decision 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/C 262 E/23)

COM(2002) 362 final

(Submitted by the Commission on 4 July 2002)

EXPLANATORY MEMORANDUM

1. 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 (GMO), or a
combination of such organisms.

2. 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 Commission must immediately make available to the public. That summary must be drawn up in
accordance with a particular format.

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 fact that the
information thus provided cannot serve as the basis for an environmental risk assessment.

4. Article 13(2)(h) of the Directive stipulates that the summary notification information format must be
drawn up in accordance with the procedure laid down in Article 30. A draft of the measures to be
taken has accordingly been submitted for opinion to the committee set up under Article 30 of the
Directive.

5. The committee has not delivered an opinion on the proposal. In such a case, Article 30 stipulates that
the Commission must forthwith propose to the Council the measures to be adopted and inform the
European Parliament thereof. The Council must then act by qualified majority.

6. If, by the expiry of the time limit, the Council has not adopted the proposed implementing measures or
has not indicated its opposition to the proposed implementing measures, they shall be adopted by the
Commission.

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

Having regard to the proposal from the Commission,

(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 fact that the information thus provided
cannot
risk
assessment.

for an environmental

the basis

serve as

(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,

Whereas:

HAS ADOPTED THIS DECISION:

(1) 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 (GMO), or a combination of such organisms.

(2) 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 Commission
must
immediately make available to the public. That
summary must be drawn up in accordance with a
particular format.

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.

Article 2

This Decision is addressed to the Member States.

(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 Formatis 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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P A R T 1

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P A R T 2

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