(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.

(2)

In October 2013, a notification concerning the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line FLO-40685-2) was submitted by Suntory Holdings Limited, Osaka, Japan, to the competent authority of the Netherlands.

(3)

The notification covers import, distribution and retailing of cut flowers of the genetically modified carnation Dianthus caryophyllus L., line FLO-40685-2.

(4)

In accordance with Article 14 of Directive 2001/18/EC, the competent authority of the Netherlands prepared an assessment report, which concluded that there are no reasons on the basis of which consent for the placing on the market of cut flowers of the genetically modified carnation (Dianthus caryophyllus L., line FLO-40685-2) for ornamental use should be withheld, if specific conditions are fulfilled.

(5)

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

(6)

In its opinion of 10 March 2016, the European Food Safety Authority (‘the Authority’), concluded that there is no scientific reason to consider that the import, distribution and retailing in the Union of carnation FLO-40685-2 cut flowers for ornamental use will cause any adverse effect on human health or the environment (2). The Authority also found that the monitoring plan provided by the consent holder was acceptable in the light of the intended uses of the FLO-40685-2 carnation.

(7)

An examination of the opinion of the Authority, which took into consideration the full notification, the assessment report drafted by the competent authority of the Netherlands, the Member States' objections and the additional information provided by the notifier in order to answer to the Member States' objections, discloses no reason to believe that the placing on the market of cut flowers of the genetically modified carnation Dianthus caryophyllus L., line FLO-40685-2, will adversely affect human health or the environment in the context of its proposed ornamental use.

(8)

A unique identifier should be assigned to the genetically modified carnation Dianthus caryophyllus L., line FLO-40685-2, 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 (4).

(9)

In light of the opinion of the 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.

(10)

The labelling of the product should include information that cut flowers of the genetically modified carnation Dianthus caryophyllus L., line FLO-40685-2, may not be used for human or animal consumption nor for cultivation.

(11)

A detection method, as required in Annex III B.D.12 of Directive 2001/18/EC, was verified and tested for the genetically modified carnation Dianthus caryophyllus L., line FLO-40685-2, in December 2016.

(12)

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)

the genetically modified carnation may only be used for ornamental purposes;

(b)

the cultivation of the genetically modified carnation is not allowed;

(c)

without prejudice to confidentiality requirements set out in Article 25 of Directive 2001/18/EC, the methodology for detecting and identifying the genetically modified carnation, including experimental data demonstrating the specificity of the methodology, as 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 confidentiality requirements set out in Article 25 of Directive 2001/18/EC, the consent holder, whenever requested to do so, makes 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 Union 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’ appear either on a label or, for non-pre-packaged products, in a document accompanying the genetically modified carnations.