2003/701/EC: Commission Decision of 29 September 2003 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market (Text with EEA relevance) (notified under document number C(2003) 3405)
Date: 2003-09-29
Institutions: European Commission
Subjects: environmental protection, environmental risk prevention, plant propagation, transgenic plant

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COMMISSION

COMMISSION DECISION

of 29 September 2003

establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a
format for presenting the results of the deliberate release into the environment of genetically
modified higher plants for purposes other than placing on the market

(notified under document number C(2003) 3405)

(Text with EEA relevance)

(2003/701/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

(3)

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 Council Directive 90/220/EEC (1), and in parti-
cular the second sentence of Article 10 thereof,

possible so that, where appropriate, multi-sites, multi-
annual releases or releases of several GMOs can be
covered by a single report.

Since genetic engineering is not restricted to higher
plants, it will be necessary to establish formats for other
types of GMOs, such as genetically modified (GM)
animals (including GM insects), veterinary and medicinal
products (containing or consisting of GMOs) or GM
plants which could produce pharmaceutical products.
Future developments may also make it necessary to
adapt the report formats which have already been estab-
lished.

Whereas:

(4)

The measures provided for in this Decision are in accor-
dance with the opinion of the Committee established
under Article 30 of Directive 2001/18/EC,

(1) With regard to the deliberate release of genetically modi-
fied organisms (GMOs)
for any purpose other than
placing on the market, Article 10 of Directive 2001/18/
EC requires the notifier of such a release, to send the
competent authority, after completion of a release, and
thereafter, at any intervals laid down in the consent on
the basis of the results of the environmental risk assess-
ment, the results of the release in terms of any risk to
human health or the environment, with, where appro-
priate, particular reference to any kind of product that
the notifier intends to notify at a later stage.

(2)

It
therefore, with regard to those plants,

To date, most GMOs deliberately released in the
Community pursuant to Part B of Directive 2001/18/EC
is
are genetically modified higher plants (GMHP).
necessary,
to
establish the format to be used by the notifier when
presenting the results of the release to the competent
authority. That format should reflect the need to enable
the fullest possible exchange of relevant
information,
presented in a standardised and easily comprehensible
manner. The format should be kept as general as

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

HAS ADOPTED THIS DECISION:

Article 1

For the purposes of presenting to the competent authority the
results of the deliberate release into the environment of geneti-
cally modified higher plants (GMHP) pursuant to Article 10 of
Directive 2001/18/EC, the notifier shall use the format set out
in the Annex to this Decision, hereinafter ‘the report format’.

Article 2

A report format shall relate to no more than one consent
issued by the competent authority and shall be identified by a
single notification number.

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Article 3

Article 4

1.
For each notification number, a final report shall be deliv-
ered by the notifier, and final as well as intermediary post-
release monitoring report(s) shall be delivered where appro-
priate. Both types of report shall be drawn up in accordance
with the report format.

2.
The final report shall be delivered after the last harvest of
the GMHPs. Where no post-release monitoring is required for a
notification, no further reports shall be necessary.

The final post-release monitoring report shall be delivered

3.
after completion of the post-release monitoring.

The competent authority shall, where appropriate, specify in
the consent the duration of the post-release monitoring as well
as the timetable for submission of the intermediary post-release
monitoring reports.

The competent authority shall encourage notifiers to

4.
provide the report in an electronic form.

The competent authority may require from the notifier addi-
tional information, in particular in the form of a logbook or
interim reports, to be delivered in the course of the research
programme, before the completion of a release.

Article 5

This Decision is addressed to the Member States.

Done at Brussels, 29 September 2003.

For the Commission

Margot WALLSTRÖM

Member of the Commission

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ANNEX

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