30.4.2015   

EN

Official Journal of the European Union

L 112/52

(1)

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 is subject 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.

(2)

A notification concerning the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line 26407) was submitted by Florigene Ltd, Melbourne, Australia, to the competent authority of the Netherlands in March 2009.

(3)

The notification covers import, distribution and retailing of cut flowers of Dianthus caryophyllus L., line 26407 as for any other carnation.

(4)

In accordance with the procedure established by Article 14 of Directive 2001/18/EC, the competent authority of the Netherlands prepared an assessment report, which concluded that no reasons have emerged on the basis of which consent for the placing on the market of cut flowers of the genetically modified carnation (Dianthus caryophyllus L., line 26407) for ornamental use should be withheld, if specific conditions are fulfilled.

(5)

In its assessment report, the competent authority of the Netherlands also concluded that the general surveillance plan submitted by the applicant is sufficient taking into account the intended uses of the product.

(6)

The assessment report was submitted to the Commission and the competent authorities of the other Member States, some of which raised and maintained objections to the placing on the market of the product.

(7)

The opinion of the European Food Safety Authority (EFSA), published on 12 December 2014, concluded that, from all evidence provided, there is no scientific reason to consider that the placing on the market of the genetically modified carnation (Dianthus caryophyllus L., line 26407) for ornamental use will cause any adverse effects on human health or the environment (2). EFSA also found that the scope of the monitoring plan provided by the notifier is in line with the intended use of the carnation.

(8)

An examination of the full notification, additional information provided by the notifier, specific objections maintained by the Member States in the light of Directive 2001/18/EC, and the opinion of EFSA, discloses no reason to believe that the placing on the market of cut flowers of the genetically modified carnation (Dianthus caryophyllus L., line 26407) will adversely affect human health or the environment in the context of its proposed ornamental use.

(9)

A unique identifier has been assigned to the genetically modified carnation (Dianthus caryophyllus L., line 26407) for the purposes of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (3) and Commission Regulation (EC) No 65/2004 of 14 January 2004 (4).

(10)

In light of the opinion of the European Food Safety Authority, it is not necessary to establish specific 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.

(11)

The 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 caryophyllus L., line 26407 cannot be used for human or animal consumption, nor for cultivation.

(12)

A detection method as required by Annex III B.D.12 of Directive 2001/18/EC, was verified and tested for the Dianthus caryophyllus L., line 26407 by the European Union Reference Laboratory in November 2013.

(13)

The Committee set up under Article 30(1) of Directive 2001/18/EC has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

Cassette 1

The promoter from snapdragon chalcone synthase gene, the petunia cytochrome b5 (difF) cDNA encoding a cytochrome b5 protein to enhance activity of F3′5′H, and the terminator from a petunia gene encoding a phospholipid transfer protein homologue.

(b)

Cassette 2

The petunia flavonoid 3′5′-hydroxylase cDNA (f3′5′h) encoding F3′5′H, a key enzyme in the anthocyanin biosynthetic pathway and the promoter and terminator of a Dianthus caryophyllus anthocyanidin synthase (ans) gene.

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

(c)

Cassette 3

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. This trait was used as a marker in the selection of transformants.

(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-26407-2;

(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 European Union 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.

(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.