Genetically modified (GM) carnation IFD-25958-3 was developed to express anthocyanins in the petals conferring a mauve colour to the flowers. The GM carnation is intended to be imported in the European Union as cut flower for ornamental use only. Based on the molecular characterisation data, the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) confirms the stability of the newly introduced trait and the absence of disruption of known endogenous genes. Since anthocyanins are common pigments in many food plants, it is not expected that accidental intake of petals of carnation IFD-25958-3 would contribute substantially to the overall intake of anthocyanins from foods. Considering the ornamental use of cut flowers, and the limited exposure scenarios expected, the EFSA GMO Panel identified no reasons for any food safety concerns relating to carnation IFD-25958-3. The EFSA GMO Panel is also of the opinion that accidental release of GM carnations into the environment would not give rise to environmental safety concerns. The EFSA GMO Panel agrees with the methodology, including reporting intervals, proposed for post-market environmental monitoring. In response to the European Commission, the EFSA GMO Panel concludes that, in the light of the ornamental use of carnation IFD-25958-3 cut flowers, there is no scientific reason to consider that the placing on the market of the GM carnation will cause any adverse effects on human health or the environment.

Summary

Following a request from the European Commission, the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) was asked to deliver a scientific opinion on notification C/NL/09/01 from Florigene submitted under Part C of Directive 2001/18/EC. The scope of notification C/NL/09/01 covers the import, distribution and retailing in the European Union (EU) of genetically modified (GM) carnation IFD-25958-3 cut flowers for ornamental use only.

In accordance with Directive 2001/18/EC, an assessment of the GM carnation was requested by the European Commission in order to address the outstanding objections raised by some Member States following the evaluation at the national level, and to assess the overall safety of the GM carnation. The EFSA GMO Panel was, therefore, asked to consider if there is any scientific reason to believe that the placing on the market of GM carnation IFD-25958-3 for import is likely to cause any adverse effects on human health or the environment.

In delivering the present scientific opinion, the EFSA GMO Panel considered the full notification C/NL/09/01, including additional information provided by the notifier, the assessment report of the Dutch competent authority, the concerns raised by Member States, relevant scientific publications and the experience gained in assessing GM carnations with similar traits (EFSA, 2006a, 2008; EFSA GMO Panel, 2014). The EFSA GMO Panel performed its risk assessment in accordance with the principles of its guidance documents on the risk assessment of GM plants for non-food or non-feed purposes (EFSA, 2009a) and on the environmental risk assessment of GM plants (EFSA GMO Panel, 2010). It should be noted that the comparative compositional assessment as defined in the EFSA guidance documents (EFSA, 2006b; EFSA GMO Panel, 2011a) could not be applied to identify possible unintended effects of carnation IFD-25958-3.

The scientific evaluation by the EFSA GMO Panel included molecular characterisation of the inserted DNA and expression of the new proteins. A comparative evaluation of the morphological characteristics was undertaken, and the safety of the newly expressed proteins and of the whole GM plant was evaluated with respect to potential toxicity and allergenicity. The potential environmental impacts of accidental release of GM carnations into the environment and the post-market environmental monitoring (PMEM) plan proposed by the notifier were evaluated in the context of the scope of notification C/NL/09/01.

Carnation IFD-25958-3 has a modified flower colour, a shade of mauve, whereas the parental line has a cerise flower colour. The colour has been achieved by introducing into the parental carnation three expression cassettes which, together with other genes of the anthocyanin biosynthesis pathway that are already present in the non-GM carnation, give rise to the anthocyanins delphinidin and cyanidin, the same pigments that give colour to blueberry, blackcurrant and red grape. Carnation IFD-25958-3 is also tolerant to sulfonylurea herbicides, but this newly introduced trait was used only for the selection of transformed plants and not for plant protection purposes.

Carnation IFD-25958-3 was developed by Agrobacterium tumefaciens-mediated transformation of the conventional carnation Cerise Westpearl. The desired colour was obtained by introducing the flavonoid 3′,5′-hydroxylase (f3′5′h) coding sequence from Viola sp., the dihydroflavonol 4-reductase (dfr) coding sequence from Petunia sp. and a hairpin RNA interference (RNAi) construct which down-regulates endogenous dfr. Tolerance to sulfonylurea herbicides was conferred by the expression of a mutated als gene. The molecular characterisation data establish that carnation IFD-25958-3 contains a single insert consisting of the four expression cassettes. The stability of the newly introduced trait (mauve flower colour) was observed over multiple generations. Bioinformatic analyses of the 5′ and 3′ flanking regions of the insert did not reveal disruption of known endogenous genes. Identities with allergens were found in putative translation products of open reading frames (ORFs) newly created by the genetic modification, but the likelihood that they are both transcribed and translated in carnation IFD-25958-3 was considered negligible.

Considering the scope of the notification and focusing on the limited information provided by the notifier, the EFSA GMO Panel is of the opinion that the altered flower colour and the differences observed for some morphological characteristics are not expected to influence the risk scenario of accidental intake of the GM carnation.

It is not expected that the accidental intake of petals of carnation IFD-25958-3 would contribute substantially to the overall intake of anthocyanins from foods. Considering the scope of notification C/NL/09/01 and given that case reports of occupational allergies to carnations are rare, there are no indications that the genetic modification will increase the risk of allergy among those coming into contact with carnations. Considering the scope of notification C/NL/09/01 and the limited exposure scenarios expected, the EFSA GMO Panel identified no reasons for any safety concerns of carnation IFD-25958-3.

Carnation IFD-25958-3 cut flowers have marginal viability, negligible pollen production and few or no viable seeds. However, in the very unlikely event of escape into the environment via pollen/seeds or rooted plants, the EFSA GMO Panel considers that carnation IFD-25958-3 would not show enhanced fitness characteristics, except when exposed to sulfonylurea herbicides. Considering the scope of notification C/NL/09/01 and the low level of exposure to the environment, interactions with the biotic and abiotic environment are not considered to be relevant issues by the EFSA GMO Panel. The EFSA GMO Panel also concludes that the unlikely, but theoretically possible, horizontal gene transfer of recombinant genes from carnation IFD-25958-3 to environmental bacteria does not give rise to environmental safety concerns. The scope of the PMEM plan provided by the notifier is in line with the intended use of carnation IFD-25958-3. The EFSA GMO Panel agrees with the general methods and approaches, including reporting intervals, proposed by the notifier in its PMEM plan.

In the light of the scope of notification C/NL/09/01 (import, distribution and retailing in the EU of carnation IFD-25958-3 cut flowers for ornamental use only), the EFSA GMO Panel concludes that there is no scientific reason to consider that the placing on the market of the GM carnation IFD-25958-3 will cause any adverse effects on human health or the environment.