Commission Implementing Decision (EU) 2015/692 of 24 April 2015 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 25958) genetically modified for flower colour (notified under document C(2015) 2765) (Text with EEA relevance)

• CELEX: Implementing Decision (EU) 2015/692
• Articles: 5

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/09/01).

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 a Dianthus caryophyllus L. cell culture, and transformed with Agrobacterium tumefaciens , strain AGL0, using the vector pCGP3366, and resulting in line 25958.

The product contains the following DNA in four cassettes:

(a)

Cassette 1

The petunia dfr gene encoding dihydroflavonol 4-reductase (DFR), a key enzyme in the anthocyanin biosynthetic pathway, including its own promoter and terminator.

(b)

Cassette 2

The promoter sequence from snapdragon chalcone synthase gene, flavonoid 3′5′-hydroxylase ( f3′5′h ) from Viola hortensis cDNA encoding F3′5′H, a key enzyme in the anthocyanin biosynthetic pathway, and the terminator from a petunia gene encoding a phospholipid transfer protein homologue.

(c)

Cassette 3

The Cauliflower mosaic virus 35S promoter, a hairpin-forming construct consisting of a partial dihydroflavonol 4-reductase dfr sense and antisense fragment separated by a petunia dfr intron, targeted to specific, post-transcriptional down-regulation of endogenous carnation dfr, and the CaMV 35S terminator sequence.

These three cassettes were inserted into the plant genome to obtain the desired flower colour.

(d)

Cassette 4

The Cauliflower mosaic virus 35S promoter, the 5′untranslated region of the petunia gene coding for chlorophyll a/b binding protein, the SuRB ( als ) gene coding for a mutant acetolactate synthase protein (ALS) derived from Nicotiana tabacum which confers tolerance to sulfonylurea, including its own terminator. This trait was used as a marker in the selection of transformants.

2.   The consent shall cover progeny derived through vegetative reproduction of the genetically modified carnation ( Dianthus caryophyllus L., line 25958).

Article 3 Conditions for placing on the market

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

(a)

In accordance with Article 19(3)(b) of Directive 2001/18/EC, 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 IFD-25958-3;

(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 EU Reference Laboratory is publicly available at http://gmo-crl.jrc.ec.europa.eu/valid-2001-18.htm;

(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 EU 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 health or the environment arising from handling or use of the products, is put in place and implemented.

The monitoring plan is available at [Link: plan published on the internet ].

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.   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 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.