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 a 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 March of 2013 a notification concerning the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line SHD-27531-4) was submitted by Suntory Holdings Limited, Osaka, Japan, to the competent authority of the Netherlands.

The notification covers import, distribution and retailing of genetically modified carnation Dianthus caryophyllus L., line SHD-27531-4.

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 SHD-27531-4) for ornamental use should be withheld, if specific conditions are fulfilled.

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

In its opinion of 10 November 2014, the European Food Safety Authority (EFSA), addressed the objections maintained by a Member State and concluded that, should the propagation of genetically modified carnation SHD-27531-4 (e.g. rooting) by individuals occur, genetically modified carnation would not show any potential for increased survival, fitness or weediness compared with its parental line2. It also concluded that the potential spread of pollen of the genetically modified carnation by Lepidoptera to wild Dianthus species is highly unlikely to occur and, if it did occur, it is very unlikely that viable hybrids would be produced, survive and result in adverse environmental effects. Finally, it concluded that plant-to-plant gene transfer of the introduced genes is very unlikely and, if it did occur, it is unlikely to result in viable seed production leading to adverse environmental effects.

Following a request from the Commission to have a full EFSA opinion, on 15 December 2015, EFSA published a new opinion which concluded that there is no scientific reason to consider that import, distribution and retailing in the Union of genetically modified carnation SHD-27531-4 cut flowers for ornamental use will cause any adverse effect on human health or the environment3. EFSA also found that the monitoring plan provided by the consent holder was acceptable in the light of the intended uses of the genetically modified carnation.

An examination of the full notification, additional information provided by the notifier, specific objections maintained by a Member State in the light of Directive 2001/18/EC, and the opinions 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 SHD-27531-4) will adversely affect human health or the environment in the context of its proposed ornamental use.

A unique identifier has been assigned to the genetically modified carnation (Dianthus caryophyllus L., line SHD-27531-4) for the purposes of Regulation (EC) No 1830/2003 of the European Parliament and of the Council4 and Commission Regulation (EC) No 65/20045.

In light of the EFSA opinions, it is not necessary to establish specific conditions for the intended use with regard to handling or packaging of the product and the protection of particular ecosystems, environments or geographical areas.

The labelling of the product should include information that cut flowers of genetically modified carnation (Dianthus caryophyllus L., line SHD-27531-4) may not be used for human or animal consumption nor for cultivation.

A detection method was validated in March 2016 for the genetically modified carnation (Dianthus caryophyllus L., line SHD-27531-4) by the European Union Reference Laboratory established by Regulation (EC) No 1829/2003 of the European Parliament and of the Council6.

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,