2009/244/EC: Commission Decision of 16 March 2009 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 123.8.12) genetically modified for flower colour (notified under document number C(2009) 1673) (Text with EEA relevance)
Date: 2009-03-16
Institutions: European Commission
Subjects: Netherlands, floriculture, genetically modified organism, market approval

L 72/18

EN

Official Journal of the European Union

18.3.2009

COMMISSION DECISION

of 16 March 2009

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 123.8.12) genetically
modified for flower colour

(notified under document number C(2009) 1673)

(Only the Dutch text is authentic)

(Text with EEA relevance)

(2009/244/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the European
Having regard to Directive 2001/18/EC of
Parliament 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 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
the Member State that received the notification for the
placing on the market of that product,
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.,
Ltd,
submitted
line 123.8.12) was
Melbourne, Australia, to the competent authority of the
Netherlands in March 2007.

Florigene

by

The notification covers import, distribution and retailing
of Dianthus caryophyllus L., line 123.8.12 as for any other
carnation.

in
In accordance with the procedure provided for
the competent
Article 14 of Directive 2001/18/EC,
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

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

(5)

(6)

(7)

(8)

on the market of cut flowers of the genetically modified
carnation (Dianthus
for
caryophyllus L.,
ornamental use should be withheld, if specific conditions
are fulfilled.

line 123.8.12)

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

The opinion adopted on 12 March 2008 (published
26 March 2008) (2) by the European Food Safety
Authority (hereafter EFSA), concluded, from all evidence
provided, that cut flowers of the genetically modified
line 123.8.12) are
caryophyllus L.,
carnation (Dianthus
unlikely to have an adverse effect on human and
animal health or the environment in the context of its
proposed ornamental use. EFSA also found that
the
scope of the monitoring plan provided by the notifier
is in line with the intended use of the carnation.

An examination of the full notification, additional infor­
mation provided by the notifier, specific objections raised
by the Member States and the opinion of EFSA, discloses
no reason to believe that the placing on the market of
the genetically modified carnation
cut
(Dianthus
line 123.8.12) will adversely
affect human or animal health or the environment in
the context of its proposed ornamental use.

caryophyllus L.,

flowers of

L.,

caryophyllus

A unique identifier has been assigned to the genetically
carnation
line
(Dianthus
modified
the purposes of Regulation (EC) No
123.8.12)
for
1830/2003 of
the
the European Parliament and of
Council of 22 September 2003 concerning the trace­
ability and labelling of genetically modified organisms
food and feed products
and
produced from genetically modified organisms
and
amending Directive 2001/18/EC (3) and Commission
Regulation (EC) No 65/2004 of 14 January 2004 estab­
lishing a system for the development and assignment of
unique identifiers for genetically modified organisms (4).

traceability of

the

(2) The EFSA Journal (2008) 662, pp. 1-21, ‘Opinion of the Scientific
Panel on Genetically Modified Organisms on a request from the
Commission related to the notification (Reference C/NL/06/01) for
the placing on the market of the genetically modified carnation
Moonacqua 123.8.12 with a modified colour, for import of cut
flowers for ornamental use, under Part C of Directive 2001/18/EC
from Florigene.’

(3) OJ L 268, 18.10.2003, p. 24.
(4) OJ L 10, 16.1.2004, p. 5.

18.3.2009

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Official Journal of the European Union

L 72/19

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.

carnation (Dianthus caryophyllus L.), with modified flower colour,
derived from the Dianthus caryophyllus L. cell culture, and trans­
formed with Agrobacterium tumefaciens, strain AGL0, using the
vector pCGP1991 and resulting in line 123.8.12.

The product contains the following DNA in three cassettes:

(9)

(10)

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 123.8.12 can not be used for human or
animal consumption nor for cultivation.

(11) A detection method as required by Annex III B.D.12 to
Directive 2001/18/EC, was verified,
tested and single-
laboratory validated for the Dianthus caryophyllus L., line
123.8.12 in January 2008 by the Community Reference
Laboratory established by Regulation (EC) No 1829/2003
of the European Parliament and of the Council (1).

(12)

The Committee under Directive 2001/18/EC did not
deliver an opinion on the draft measures submitted by
the Commission. The Commission therefore submitted to
the Council a proposal relating to these measures. Since
on the expiry of the period laid down in Article 30(2) 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 (2), the measures should be
adopted by the Commission,

HAS ADOPTED THIS DECISION:

Article 1

Consent

Written consent shall be granted by the competent authority of
in accordance
the Netherlands to the placing on the market,
with this Decision, of the product identified in Article 2, as
notified by Florigene Ltd, Melbourne, Australia (Reference
C/NL/06/01).

(a) Cassette 1

The petunia dfr gene from Petunia X Hybrida encoding dihy­
droflavonol 4-reductase (DFR), a key enzyme in the antho­
cyanin biosynthetic pathway. The dfr gene is under control
of its own promoter and terminator.

(b) Cassette 2

The promoter from a snapdragon gene encoding chalcone
synthase, petunia flavonoid 3’5’ hydroxylase (F3’5’H) cDNA,
a key enzyme in the anthocyanin biosynthetic pathway, the
terminator from the petunia gene encoding a phospholipid
transfer protein homologue.

Simultaneous expression of both dfr and f3’5’h genes in
carnation results
in
flowers, and subsequent
the blue pigment
delphinidin.

in a modified flavonoid synthesis

formation of

(c) Cassette 3

cauliflower mosaic virus 35S promoter,

The
a non-
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 cover progeny derived through vege­
the genetically modified carnation

2.
tative
(Dianthus caryophyllus L., line 123.8.12).

reproduction of

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 3

Conditions for placing on the market

Article 2

Product

The product may be put to ornamental use only and cultivation
is not allowed. The product may be placed on the market
subject to the following conditions:

1.
The genetically modified organisms to be placed on the
market as product, hereinafter ‘the product’, are cut flowers of

(a)

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

(1) OJ L 268, 18.10.2003, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.

(b) the unique identifier of the product shall be FLO-4Ø689-6;

L 72/20

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Official Journal of the European Union

18.3.2009

(c) without prejudice to Article 25 of Directive 2001/18/EC,
the methodology for detecting and identifying the product
including experimental data demonstrating the specificity of
the methodology as
single-laboratory validated by the
Community Reference Laboratory is publicly available at
http://gmo-crl.jrc.ec.europa.eu

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

its genetic material, or

and negative

samples of

control

(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.

Article 4

Monitoring

ensure

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 product referred to in Article 2(1), is put in place
and implemented.

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.

The consent holder shall submit to the Commission and
3.
to the competent authorities of
the Member States annual
reports on the results of all monitoring activities. The first
annual report shall be submitted one year after final consent
is granted.

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

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

(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

(b) that the existing monitoring networks referred to in point
(a) have agreed to make available that information to the
consent holder before the date of submission of the moni­
toring reports to the Commission and competent authorities
of the Member States in accordance with paragraph 3.

Article 5

Addressee

This Decision is addressed to the Kingdom of the Netherlands.

Done at Brussels, 16 March 2009.

For the Commission

Stavros DIMAS
Member of the Commission