Legal provisions of COM(2008)754 - Placing on the market, in accordance with Directive 2001/18/EC, of a carnation (Dianthus caryophyllus L., line 123.8.12) genetically modified for flower colour

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dossier COM(2008)754 - Placing on the market, in accordance with Directive 2001/18/EC, of a carnation (Dianthus caryophyllus L., line 123.8.12) ...
document COM(2008)754 EN
date November 18, 2008

Contents

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/06/01).

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 the Dianthus caryophyllus L. cell culture, and transformed 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:

(a) Cassette 1

The petunia dfr gene from Petunia X Hybrida encoding dihydroflavonol 4-reductase (DFR), a key enzyme in the anthocyanin 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 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 123.8.12).

Article 3 - Conditions for placing on the market

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:

(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- 4Ø689-6;

(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, make positive and negative control samples of the product, or its genetic material, or reference materials available to the competent authorities and inspection services of Member States as well as to 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 product referred to in Article 2(1),, 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 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 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 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 notification 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 monitoring 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.