Considerations on COM(2006)758 - Placing on the market, in accordance with Directive 2001/18/EC, of a carnation (Dianthus caryophyllus L., line 123.2.38) genetically modified for flower colour (Only the Dutch text is authentic)

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dossier COM(2006)758 - Placing on the market, in accordance with Directive 2001/18/EC, of a carnation (Dianthus caryophyllus L., line 123.2.38) ...
document COM(2006)758 EN
date May 23, 2007
 
table>(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 a Member State, 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 123.2.38) was submitted by Florigene Ltd, Melbourne, Australia, to the competent authority of the Netherlands in September 2004.

(3)The notification covers import, distribution and retailing of Dianthus caryophyllus L., line 123.2.38 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 123.2.38) for ornamental use should be withheld, if specific conditions are fulfilled.

(5)The competent authorities of certain Member States raised objections to the placing on the market of the product.

(6)The opinion adopted on 17 May 2006 (published 27 June 2006) by the European Food Safety Authority (EFSA), concluded, from all evidence provided, that cut flowers of the genetically modified carnation (Dianthus caryophyllus L., line 123.2.38) 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 consent holder is in line with the intended use of the carnation.

(7)An examination of each of the objections in the light of Directive 2001/18/EC, of the information submitted in the notification and of 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 123.2.38) 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 123.2.38) for the purposes of Regulation (EC) No 1830/2003 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 (2).

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

(11)The measures provided for in this Decision are not in accordance with the opinion of the Committee established under Article 30 of Directive 2001/18/EC and 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 (3), the measures should be adopted by the Commission,