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)

• CELEX: Directive 2001/18/EC
• Articles: 6

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).

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

1.   The genetically modified organisms to be placed on the market as product, hereinafter ‘the product’, are cut flowers of carnation ( Dianthus caryophyllus L.), with modified flower colour, derived from a Dianthus caryophyllus L. cell culture, and transformed 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:

(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 phospholipid transfer protein homologue;

(b)

Cassette 2

The constitutive promoter Mac, the petunia dihydroflavonol 4 reductase (DFR) cDNA, the terminator from the Agrobacterium 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.

(c)

Cassette 3

The cauliflower mosaic virus 35S promoter, 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 sulfonylurea, derived from Nicotiana tabacum , including its terminator.

This gene was used for in vitro selection.

2.   The consent shall cover progeny derived through vegetative reproduction of the genetically modified carnation ( Dianthus caryophyllus L., line 123.2.38).

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:

(a)

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

(b)

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

(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 verified by 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 laboratories.

(d)

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

(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 cultivation’ shall appear either on a label or in a document accompanying the product.

Article 4 Monitoring

1.   Throughout the period of validity of the consent, the consent holder shall ensure that 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.

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 accidental cultivation.

3.   The consent holder shall submit to the Commission and to the competent authorities of the Member States annual reports on the results of the monitoring activities.

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 which received the original notification, and/or by the competent authority of the Member State which received the original notification, subject to the agreement of the Commission, in the light of the results of the monitoring activities. Proposals for a revised monitoring plan shall be submitted to the competent authorities of the Member States.

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 notification, gather the information relevant for the monitoring of the products; and

(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 to the Commission and competent authorities of the Member States in accordance with paragraph 3.

Article 5 Applicability

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.