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/13/01 from Suntory Holdings Limited submitted under Part C of Directive 2001/18/EC. The scope of notification C/NL/13/01 covers the import, distribution and retailing in the European Union (EU) of genetically modified (GM) carnation SHD-27531-4 cut flowers for ornamental use only.
In accordance with Directive 2001/18/EC, a safety evaluation of the GM carnation was requested by the European Commission in order 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 carnation SHD-27531-4 is likely to cause any adverse effects on human health and the environment.
In delivering the present scientific opinion, the EFSA GMO Panel considered the full notification C/NL/13/01, including e.g. 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.
During its safety evaluation, the EFSA GMO Panel considered the molecular characterisation of the GM carnation, including the inserted DNA, the expression of new proteins and the stability of the modified flower colour trait. 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/13/01.
Carnation SHD-27531-4 has a modified flower colour, a shade of purple, whereas the parental line has a pink flower colour. The colour has been achieved by introducing into the parental carnation two 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 SHD-27531-4 is also tolerant to sulfonylurea herbicides, which was achieved by introducing an acetolactate synthase (als) expression cassette, but the herbicide tolerance trait was used only for the selection of transformed plants.
The EFSA GMO Panel concludes that the molecular characterisation data establish that carnation SHD-27531-4 contains one insert, consisting of three expression cassettes responsible for the intended trait (purple flower colour) conferred by the dihydroflavonol 4-reductase (dfr) and flavonoid 3′,5′-hydroxylase (f3′5′h) genes, and herbicide tolerance conferred by the mutated als gene. The stability of the newly introduced trait was observed over multiple vegetative generations.
Carnation flowers have a long history of use as ornamentals. Carnation SHD-27351-4 differs from its parental variety in that it synthesises different levels of anthocyanins in the petals, e.g. an increased content of delphinidin, cyanidin and petunidin (common pigments in many ornamental flowers and food plants). The altered levels of anthocyanins in carnation SHD-27531-4 confer a purple colour to the flowers. It is not expected that accidental intake of carnation SHD-27351-4 petals would contribute substantially to the overall intake of anthocyanins from foods.
From its assessment of the potential allergenicity and toxicity of the newly expressed proteins (DFR, F3′5′H and ALS), the EFSA GMO Panel concludes that there are no reasons for safety concern in the context of the limited scope of this notification. Given that case reports of occupational allergies to carnations are rare and considering the assessment of the newly expressed proteins, 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/13/01 and the possible routes of exposure, the EFSA GMO Panel identified no reasons for any safety concerns of carnation SHD-27351‑4 for humans related to the genetic modification.
Carnation SHD-27531-4 cut flowers have marginal viability and negligible pollen production, and no viable seeds have been reported. However, in the very unlikely event of escape into the environment via viable seeds, pollen or rooted plants, the EFSA GMO Panel considers that carnation SHD-27531-4 would not show enhanced fitness characteristics, except when exposed to sulfonylurea herbicides. Considering the scope of notification C/NL/13/01 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 SHD-27531-4 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 SHD-27531-4. The EFSA GMO Panel agrees with the general methods and approaches, including reporting intervals, proposed by the notifier in its PMEM plan.
The EFSA GMO Panel therefore concludes that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation SHD-27531-4 cut flowers for ornamental use will cause any adverse effects on human health or the environment.