2004/204/EC: Commission Decision of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council (Text with EEA relevance) (notified under document number C(2004) 540)
Date: 2004-02-23
Institutions: European Commission
Subjects: genetically modified organism, information

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COMMISSION DECISION

of 23 February 2004

laying down detailed arrangements for the operation of the registers for recording information on
genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament
and of the Council

(notified under document number C(2004) 540)

(Text with EEA relevance)

(2004/204/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

the GMO
mation necessary for the identification of
product and its progeny, including the methodology for
detecting and identifying the GMO product, and the
experimental data demonstrating the validation para-
meters of the method supplied.

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 particu-
lar Article 31(2) thereof,

(5)

Whereas:

(1)

(2)

(3)

(4)

Different sets of information are required for the notifi-
cation of genetically modified organisms, hereinafter
to Directive 2001/18/EC. The data
‘GMOs’, pursuant
required relates to the individual GMO itself,
to the
environment into which the GMO is released and to the
interaction between the GMO and the receiving environ-
ment, including any effects on human health.

The information required in notifications concerning the
deliberate release of GMOs is listed in Annex III to Direc-
tive 2001/18/EC. Annex IV to that Directive describes in
general terms the additional information to be provided
in notifications for placing GMOs on the market. It also
specifies the labelling information required for GMOs as
products or in products to be placed on the market.
Some of that additional information should be placed on
one or several registers, namely information concerning
genetic modifications, which can be used for detection
and identification of particular GMO products, including
detection methods relating to thresholds established
pursuant to Directive 2001/18/EC, in order to facilitate
post-marketing control and inspection.

According to Article 31(2) of Directive 2001/18/EC, the
Commission is to establish one or several register(s),
hereinafter ‘the registers’, for the purpose of recording
the information on genetic modifications in GMOs
specified in Section A, point 7 of Annex IV to that
Directive.

That information should include, where appropriate, the
lodging of samples of the GMO, as or in products, or of
its genetic material, with the competent authority and
details of nucleotide sequences or other types of infor-

In establishing the list of information to be recorded in
the registers, account has been taken of the fact that
other sets of information — such as the environmental
risk assessment, the scientific studies, including studies
which demonstrate the safety of the product, including,
where available, references to independent and peer-
reviewed studies, and to methods for identification and
detection, and all other information submitted by the
notifier, methods and plans for monitoring the GMO(s)
and for emergency response, and results of the post-
accessible
market monitoring — are
according to the relevant provisions of Directive 2001/
18/EC, Regulation (EC) No 1946/2003 of the European
Parliament and the Council of 15 July 2003 on trans-
boundary movements of genetically modified organ-
isms (2) and Regulation (EC) No 1049/2001 of the Euro-
pean Parliament and the Council of 30 May 2001
regarding public access to European Parliament, Council
and Commission documents (3), and therefore need not
be recorded.

in principle

(6)

For the sake of transparency and in conformity with
Regulation (EC) No 1049/2001, the registers should be
available to the public as well as to Member States and
the Commission. The registers should therefore contain
two sets of data, one accessible to the public, and the
other accessible only to the Member States, the Commis-
sion and the European Food Safety Authority. The first
set of data should contain all data recorded in the regis-
ters, except
for data which cannot be disclosed for
reasons of confidentiality in accordance with Article 25
of Directive 2001/18/EC,
in particular with a view to
protecting commercial interests; the second set of data
should comprise additional confidential data. Individual
requests for access will have to be treated in accordance
with Regulation (EC) No 1049/2001 which, however, in
its exceptions provides for the protection of the same
interests as Article 25 of Directive 2001/18/EC.

(1) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation

(EC) No 1830/2003 (OJ L 268, 18.6.2003, p. 24).

(2) OJ L 287, 5.11.2003, p. 1.
(3) OJ L 145, 31.5.2001, p. 43.

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(7)

(8)

(9)

inspection services, control
The competent authorities,
laboratories of the Member States and the Commission
should have available, during the consent period and for
an appropriate period after expiry of the consent, the
methods
including
for detection and identification,
detection methods relating to thresholds established
pursuant to Directive 2001/18/EC.

At the time of submission of the data by the competent
authority to the Commission for the sake of placing it
on the registers, some data, such as the date of authori-
sation or the validation parameters for the identification
and detection method, are or may be missing. Moreover,
during the consent period, and even for some time after
expiry of the consent, updates such as identification and
detection methods, commercial names or responsible
persons may be necessary. Provision should therefore be
made for updating the registers.

Future developments in the methodology of genetic
modification or the corresponding detection and identifi-
cation methods, including detection methods relating to
thresholds established pursuant to Directive 2001/18/
EC, may make it necessary to adapt this Decision to
technical progress. Likewise,
further developments in
Community legislation may make it necessary to adapt
this Decision in the interests of consistency and effi-
ciency.

(10)

The measures provided for in this Decision are in
accordance with the opinion of the Committee estab-
lished pursuant to Article 30(1) of Directive 2001/18/
EC,

HAS ADOPTED THIS DECISION:

Article 1

This Decision lays down the detailed arrangements for the
operation of registers (hereinafter referred to as ‘the registers’)
to be established by the Commission pursuant to Article 31(2)
of Directive 2001/18/EC, for the purpose of recording informa-
tion on genetic modifications in genetically modified organisms
(hereinafter referred to as ‘GMOs’).

Article 2

include,

in
The information referred to in Article 1 shall
accordance with the provisions of Article 3, details of nucleo-
tide sequences or other types of information necessary to iden-
tify the GMO product and its progeny, such as the metho-
dology for
the GMO
the detection and identification of
including detection methods relating to thresholds
product,
established under Directive 2001/18/EC, and experimental data
demonstrating the validation of the methodology.

The registers shall be consistent and compatible with those
established under other relevant Community legislation.

Article 3

The following shall be recorded in the registers:

(a) details concerning the notifier and responsible persons:

(i) the name and full address of the notifier,

(ii) the name and full address of the person established in
the Community who is responsible for the placing on
the market, whether
the
importer or the distributor, if different from the noti-
fier;

it be the manufacturer,

(b) general information concerning the GMO(s):

(i) the commercial name(s) of the GMO products and the
names of the GMOs contained therein, including scien-
tific name(s) and common name(s) of the recipient or,
where appropriate, parental organism of the GMO,

(ii) the unique identifier(s) of the GMO(s) contained in the

product(s),

(iii) the Member State of notification,

(iv) the notification number,

(v) the decision authorising the GMO(s);

(c) information on the insert:

(i) information on the nucleotide sequence of the insert
used to develop the detection method, including, where
appropriate, the complete sequence of the insert as well
as the number of base pairs of
flanking
sequences needed to establish an event-specific detec-
tion method and detection methods relating to thresh-
olds established pursuant to Directive 2001/18/EC as
well as accession numbers for public databases and
references containing sequence data of the insert or
parts of it,

the host

(ii) a detailed map of

the inserted DNA,

including all
genetic elements, coding and non-coding regions as
well as the indication of their order and their orienta-
tion;

(d) information concerning the detection and identification

methods:

(i) description of identification and detection techniques
for event-specific detection,
including, where appro-
priate, detection methods relating to thresholds estab-
lished pursuant to Directive 2001/18/EC;

(ii) information on detection and identification tools such

as PCR primers and antibodies,

(iii) where appropriate,

information on validation para-

meters, in accordance with international guidelines;

(e) information on the lodging, storage and supply of samples:

(i) the name and address of the person(s) responsible for
the lodging, storage and supply of control samples,

(ii) information on the stored samples such as the kind of
material, the genetic characterisation, the amount of
the conditions of
the stability,
repository material,
appropriate storage and the shelf-life.

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Article 4

The registers shall be available to the public in accordance with
Article 25 of Directive 2001/18/EC and with Regulation (EC)
No 1049/2001.

The information recorded shall be divided as follows:

(a) a set of data accessible to the public;

(b) a set of data comprising additional confidential data, acces-
sible only to the Member States, the Commission and the
European Food Safety Authority.

Article 5

The competent authorities shall extract from the notifications
they receive pursuant to Article 13(1) of Directive 2001/18/EC
all data relating to the information listed in Article 3 of this
Decision. They shall submit that data, using the submission
form supplied by the Commission for that purpose, to the
Commission, either at the time of submitting the assessment
report or no later than two weeks thereafter, in order to enable
the Commission to record it in the registers. The form may be
completed by the notifier, subject to verification of its content
by the competent authorities.

Links may be provided to other registers or databases, such as
the summary notification information formats (SNIFs),
the
opinion of the European Food Safety Authority, the assessment

report of the competent authority, the Biosafety Clearing-House
established pursuant to the Cartagena Protocol on Biosafety
and the Molecular Register of the Joint Research Centre,
in
order to avoid duplication of information.

Article 6

receiving any information
No later than two weeks after
relating to the updating of
the competent
authority shall forward it to the Commission. That information
shall be entered in those registers no later than two weeks after
receipt.

the registers,

Article 7

This Decision is addressed to the Member States.

Done at Brussels, 23 February 2004.

For the Commission

Margot WALLSTRÖM

Member of the Commission