Proposal for a Council Decision establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market
Date: 2002-07-04
Institutions: European Commission
Subjects: data collection, environmental protection, exchange of information, form, genetically modified organism, health policy

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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 notification information format for notifications
concerning the deliberate release into the environment of genetically modified organisms for
purposes other than for placing on the market

(2002/C 262 E/22)

COM(2002) 361 final

(Submitted by the Commission on 4 July 2002)

EXPLANATORY MEMORANDUM

1. Under Part B of Directive 2001/18/EC, prior notification must be given to the competent national
authority of the planned release of a genetically modified organism (GMO), or of a combination of such
organisms, for purposes other than for placing on the market.

2. Within the framework established by Directive 2001/18/EC for the exchange of information between
the competent authorities and the Commission, the authority must then send a summary, in accordance
with a specific format, of the notification to the Commission, which in turn must forward copies to the
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 fact that the
information thus provided cannot serve as the basis for an environmental risk assessment.

4. Article 11(1) 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 11(1) 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:

Article 1

For the purposes of summarising,
for transmission to the
Commission, notifications received pursuant to Article 6 of
the competent authorities appointed
Directive 2001/18/EC,
the
by Member States under
Summary Notification Information Format set out
in the
Annex to this Decision.

that Directive

shall use

Article 2

This Decision is addressed to the Member States.

(1) Under Part B of Directive 2001/18/EC, prior notification
must be given to the competent national authority of the
planned release of a genetically modified organism (GMO),
or of a combination of such organisms, for purposes other
than for placing on the market.

(2) Within the

the Directive
framework established by
2001/18/EC for the exchange of information between the
competent authorities and the Commission, the authority
must then send a summary, in accordance with a specific
format, of the notification to the Commission, which in
turn must forward copies to the other Member States.

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

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ANNEX

SUMMARY NOTIFICATION INFORMATION FORMAT FOR THE DELIBERATE RELEASE OF A GMO OR A
COMBINATION OF GMOs FOR PURPOSES OTHER THAN FOR PLACING ON THE MARKET

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 procedures envisaged by Article 11 of Directive 2001/18/EC.

It is recognised that this Format is not designed to accommodate all the information 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 higher plants. The term ‘higher plants’ means
plants which belong to the taxonomic group Gymnospermae and Angiospermae. Part 1 contains the 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 GMPts

E. Brief description of any measures taken for the management of risks

F. Summary of planned field trials designed to gain new data on the environmental and human health impact of the

release.

In Part 1 the information entered should, however, adequately reflect (in a condensed form) the information submitted
to the competent authority in accordance with Articles 6 and 7 of Directive 2001/18/EC under the conditions specified
in the preface to Annex III B.

Part 2 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 is derived

C.

Information relating to the genetic modification

D.

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. Interactions of the GMO with the environment and potential impact on the environment

H. Information relating to monitoring

I.

J.

Information on post-release and waste treatment

Information on emergency response plans.

In Part 2 the information entered should, however, adequately reflect (in a condensed form) the information submitted
to the competent authority in accordance with Articles 6 and 7 of Directive 2001/18/EC under the conditions specified
in the preface to Annex III A.

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P A R T 1

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P A R T 2

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