(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 123.8.12) was submitted by Florigene Ltd, Melbourne, Australia, to the competent authority of the Netherlands in March 2007.

(3)

The notification covers import, distribution and retailing of Dianthus caryophyllus L., line 123.8.12 as for any other carnation.

(4)

In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, the competent authority of the Netherlands prepared an assessment report, which was submitted to the Commission and the competent authorities of the other Member States. That assessment report concludes 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 123.8.12) for ornamental use should be withheld, if specific conditions are fulfilled.

(5)

The competent authorities of other Member States raised objections to the placing on the market of the product.

(6)

The opinion adopted on 12 March 2008 (published 26 March 2008) (2) by the European Food Safety Authority (hereafter EFSA), concluded, from all evidence provided, that cut flowers of the genetically modified carnation (Dianthus caryophyllus L., line 123.8.12) are unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed ornamental use. EFSA also found that the scope of the monitoring plan provided by the notifier is in line with the intended use of the carnation.

(7)

An examination of the full notification, additional information provided by the notifier, specific objections raised by the Member States 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 123.8.12) will adversely affect human or animal health or the environment in the context of its proposed ornamental use.

(8)

A unique identifier has been assigned to the genetically modified carnation (Dianthus caryophyllus L., line 123.8.12) for the purposes of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (3) and Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (4).

(9)

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.

(10)

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 123.8.12 can not be used for human or animal consumption nor for cultivation.

(11)

A detection method as required by Annex III B.D.12 to Directive 2001/18/EC, was verified, tested and single-laboratory validated for the Dianthus caryophyllus L., line 123.8.12 in January 2008 by the Community Reference Laboratory established by Regulation (EC) No 1829/2003 of the European Parliament and of the Council (5).

(12)

The Committee under Directive 2001/18/EC did not deliver an opinion on the draft measures submitted by the Commission. The Commission therefore submitted to the Council a proposal relating to these measures. Since on the expiry of the period laid down in Article 30(2) of Directive 2001/18/EC, the Council had neither adopted the proposed measures nor indicated its opposition to them, in accordance with Article 5(6) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6), the measures should be adopted by the Commission,

(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.