2007/364/EC: Commission Decision of 23 May 2007 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a carnation ( Dianthus caryophyllus L., line 123.2.38) genetically modified for flower colour (notified under document number C(2007) 2120)   (Text with EEA relevance)
Date: 2007-05-23
Institutions: European Commission
Subjects: floriculture, market approval, marketing, transgenic plant

L 138/50

EN

Official Journal of the European Union

30.5.2007

COMMISSION DECISION

of 23 May 2007

concerning the placing on the market, in accordance with Directive 2001/18/EC of the European
Parliament and of the Council, of a carnation (Dianthus caryophyllus L., line 123.2.38) genetically
modified for flower colour

(notified under document number C(2007) 2120)

(Only the Dutch text is authentic)

(Text with EEA relevance)

(2007/364/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty
Community,

establishing the European

the European
Having regard to Directive 2001/18/EC of
the Council of 12 March 2001 on the
Parliament and of
deliberate release into the environment of genetically modified
organisms and repealing Council Directive 90/220/EEC (1), and
in particular the first subparagraph of Article 18(1) thereof,

After consulting the European Food Safety Authority,

Whereas:

(1)

(2)

(3)

(4)

Pursuant to Directive 2001/18/EC, the placing on the
market of a product containing or consisting of a
genetically modified organism or a combination of
genetically modified organisms
to written
consent being granted by the competent authority of a
Member State,
in accordance with the procedure laid
down in that Directive.

subject

is

A notification concerning the placing on the market of a
genetically modified carnation (Dianthus caryophyllus L.,
line 123.2.38) was
Ltd,
submitted
Melbourne, Australia, to the competent authority of the
Netherlands in September 2004.

Florigene

by

The notification covers import, distribution and retailing
of Dianthus caryophyllus L., line 123.2.38 as for any other
carnation.

In accordance with the procedure provided for in Article
14 of Directive 2001/18/EC, the competent authority of
the Netherlands prepared an assessment report, which
was submitted to the Commission and the competent
authorities of the other Member States. That assessment

report concludes that no reasons have emerged on the
basis of which consent for the placing on the market of
the genetically modified carnation
cut
(Dianthus caryophyllus L.,
line 123.2.38) for ornamental
use should be withheld, if specific conditions are fulfilled.

flowers of

The competent authorities of certain Member States
raised objections to the placing on the market of the
product.

The opinion adopted on 17 May 2006 (published 27
June 2006) by the European Food Safety Authority
(EFSA), concluded, from all evidence provided, that cut
flowers of the genetically modified carnation (Dianthus
caryophyllus L.,
line 123.2.38) are unlikely to have an
adverse effect on human and animal health or the envir-
onment in the context of its proposed ornamental use.
EFSA also found that the scope of the monitoring plan
provided by the consent holder is in line with the
intended use of the carnation.

An examination of each of the objections in the light of
Directive 2001/18/EC, of the information submitted in
the notification and of the opinion of EFSA, discloses no
reason to believe that the placing on the market of cut
flowers of the genetically modified carnation (Dianthus
adversely affect
caryophyllus L.,
line 123.2.38) will
in the
human or animal health or the environment
context of its proposed ornamental use.

carnation
for

A unique identifier has been assigned to the genetically
modified
line
(Dianthus
123.2.38)
the purposes of Regulation (EC) No
1830/2003 and Commission Regulation (EC) No
65/2004 of 14 January 2004 establishing a system for
the development and assignment of unique identifiers for
genetically modified organisms (2).

caryophyllus

L.,

(5)

(6)

(7)

(8)

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

(EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

(2) OJ L 10, 16.1.2004, p. 5.

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L 138/51

(9)

(10)

(11)

it

In light of the opinion of the European Food Safety
is not necessary to establish specific
Authority,
conditions for
the intended use with regard to the
handling or packaging of the product and the protection
of particular ecosystems, environments or geographical
areas.

derived from a Dianthus caryophyllus L. cell culture, and trans-
formed with Agrobacterium tumefaciens, strain AGL0, using the
vector pcGP1470, and resulting in line 123.2.38.

The product contains the following DNA in three cassettes:

Proposed labelling, on a label or in an accompanying
document, should include wording to inform operators
and final users that the cut flowers of Dianthus caryo-
phyllus L., line 123.2.38 can not be used for human or
animal consumption nor for cultivation.

The measures provided for in this Decision are not in
accordance with the opinion of the Committee estab-
lished under Article 30 of Directive 2001/18/EC and
the Commission therefore submitted to the Council a
relating to these measures. Since on the
proposal
the period laid down in Article 30(2) of
expiry of
Directive 2001/18/EC, the Council had neither adopted
the proposed measures nor indicated its opposition to
them,
in accordance with Article 5(6) of Council
Decision 1999/468/EC of 28 June 1999 laying down
the procedures for the exercise of implementing powers
conferred on the Commission (1), the measures should be
adopted by the Commission,

(a) Cassette 1

The promoter from a snapdragon gene encoding chalcone
synthase, petunia flavonoid 3’5’ hydroxylase (F3’5’H) cDNA,
the terminator from the petunia gene encoding a phos-
pholipid transfer protein homologue;

(b) Cassette 2

The constitutive promoter Mac, the petunia dihydroflavonol
4 reductase (DFR) cDNA, the terminator from the Agrobac-
terium tumefaciens gene encoding mannopine synthase (Mas);

Simultaneous expression of both genes in carnation results
in a modified flavonoid synthesis in flowers, and subsequent
formation of the blue pigment delphinidin.

HAS ADOPTED THIS DECISION:

(c) Cassette 3

Article 1

Consent

Written consent shall be granted by the competent authority of
the Netherlands to the placing on the market,
in accordance
with this Decision, of the product identified in Article 2, as
notified by Florigene Ltd, Melbourne, Australia (Reference
C/NL/04/02).

cauliflower mosaic virus 35S promoter,

a non-
The
translated region from the cDNA corresponding to the
petunia gene encoding chlorophyll a/b binding protein 5,
the SuRB (als) gene coding for a mutant acetolactate
synthase protein (ALS), which confers tolerance to sulfo-
including its
nylurea, derived from Nicotiana tabacum,
terminator.

This gene was used for in vitro selection.

The consent shall, in accordance with Article 19(3) of Directive
2001/18/EC, explicitly specify the conditions to which the
consent is subject, which are set out in Articles 3 and 4.

Article 2

Product

The genetically modified organisms to be placed on the
1.
market as product, hereinafter ‘the product’, are cut flowers of
carnation (Dianthus caryophyllus L.), with modified flower colour,

The consent shall cover progeny derived through vege-
the genetically modified carnation

2.
tative
(Dianthus caryophyllus L., line 123.2.38).

reproduction of

Article 3

Conditions for placing on the market

The product may be put to ornamental use only, with the
exception of cultivation, and may be placed on the market
subject to the following conditions:

(1) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(a)

the period of validity of the consent shall be 10 years
starting from the date on which the consent is issued;

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(b) the unique identifier of the product shall be FLO-4Ø644-4;

for

and

detecting

(c) without prejudice to Article 25 of Directive 2001/18/EC,
the
the methodology
including experimental data demonstrating the
product,
specificity of
the
Community Reference Laboratory, shall be made available
to the competent authorities and to inspection services of
Member States as well as to the Community control labora-
tories.

the methodology,

verified by

identifying

as

4. Without prejudice to Article 20 of Directive 2001/18/EC
the monitoring plan as notified shall be revised by the consent
holder, where appropriate and subject to the agreement of the
Commission and the competent authority of the Member State
the
which received the original notification,
competent authority of the Member State which received the
original notification,
the
Commission,
the monitoring
activities. Proposals for a revised monitoring plan shall be
submitted to the competent authorities of the Member States.

subject
in the light of

agreement of

the results of

and/or by

to the

(d) without prejudice to Article 25 of Directive 2001/18/EC,
the consent holder shall, whenever requested to do so,
make positive
the
product, or
reference materials
available to the competent authorities and to inspection
services of Member States as well as to the Community
control laboratories;

its genetic material, or

and negative

samples of

control

5.
The consent holder shall be in the position to give
evidence to the Commission and the competent authorities of
the Member States:

(a)

that the existing monitoring networks,
including national
botanic survey networks and plant protection services, as
specified in the monitoring plan contained in the notifi-
cation, gather the information relevant for the monitoring
of the products; and

(e)

the words ‘This product is a genetically modified organism’
or ‘This product is a genetically modified carnation’, and the
words ‘not for human or animal consumption nor for culti-
vation’ shall appear either on a label or in a document
accompanying the product.

(b) that

these existing monitoring networks have agreed to
make available that
information to the consent holder
before the date of submission of the monitoring reports
the
to the Commission and competent authorities of
Member States in accordance with paragraph 3.

Article 4

Monitoring

Article 5

Applicability

the period of validity of
shall

the
the consent,
1.
Throughout
consent holder
the monitoring plan,
contained in the notification and consisting of a general
surveillance plan to check for any adverse effects on human
and animal health or the environment arising from handling
or use of the products, is put in place and implemented.

ensure

that

2.
The consent holder shall directly inform the operators and
users concerning the safety and general characteristics of the
product and of the conditions as to monitoring, including the
appropriate management measures to be taken in case of acci-
dental cultivation.

This Decision shall apply from the date on which the detection
method specific to the carnation (Dianthus caryophyllus L., line
123.2.38) referred to in Article 3(c) of this Decision, is verified
by the Community Reference Laboratory.

Article 6

Addressee

This Decision is addressed to the Kingdom of the Netherlands.

Done at Brussels, 23 May 2007.

The consent holder shall submit to the Commission and
the Member States annual

3.
to the competent authorities of
reports on the results of the monitoring activities.

For the Commission

Stavros DIMAS
Member of the Commission