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Risk Assessment
Record information and status
Record ID
Date of creation
2013-06-14 13:20 UTC (marco.gielkens@rivm.nl)
Date of last update
2020-04-08 09:55 UTC (marco.gielkens@rivm.nl)
Date of publication
2020-04-08 09:55 UTC (marco.gielkens@rivm.nl)

General Information
  • Netherlands
Title of risk assessment
C/NL/06/01 Application to import carnation variety FLORIGENE Moonaqua™ (123.8.12)
Date of the risk assessment
Competent National Authority(ies) responsible for the risk assessment
Ministry for Infrastructure and Water Management
NL-2500 EX
The Hague
The Netherlands, P.O.Box 20901
Phone:+31 6 25684418
Url:Rijksoverheid NL Biotechnologie (Dutch),General governmental webpage biotechnology (English)
Contact details of the main responsible risk assessor
Ms. Annemiek van Waterschoot
Senior policy officer
Safety and Risks Division
Ministry for Infrastructure and Water Management
P.O. Box 20901
The Hague
Phone:+31 70 456 7265
Risk assessment details
Living modified organism
FLO-4Ø689-6 - Moonaqua™ carnation
Dr Yoshikazu Tanaka Changes in quality and/or metabolite content - Pigmentation / Coloration Resistance to herbicides - Chlorsulfuron, Sulfonylurea
Scope of the risk assessment
  • Import of cut flowers for ornamental use
Methodology and points to consider
Potential adverse effects identified in the risk assessment
The following adverse effects have been taken into account, based on the expression of the Dfr and F3'5'H genes and the SuRB gene:
- Selective advantage and potential for increased weediness or persistence
- Effects on non-target organisms
- Effects on the soil ecosystem
- Toxicity and allergenicity
- Change in agricultural practice
Likelihood that the potential adverse effects will be realized
Selective advantage and potential for increased weediness or persistence
- Dfr and F3'5'H genes
There is no reason to assume that carnation plants from spilled or discarded carnation exhibit
an increased potential to survive, as a result of the modified colour of flowers by expression of
the dfr and F3'5'H genes. The gene products of the dfr and F3'5'H genes are involved in the
biosynthesis of the pigment delphinidin in petals. Accumulation of these pigments in petals
results in a violet to blue flower colour. This accumulation results in a modified flower colour and
does not alter the biological characteristics of carnation. Therefore it is highly unlikely that the
genetically modified carnation line 123.8.12 exhibits a selective advantage over non-modified
carnation, based on the presence of the dfr and F3'5'H gene.
- SuRB gene
Carnation is not considered to be a weed in Europe. Carnation plants resistant to sulfonylurea
herbicides can only exhibit a selective advantage after application of such herbicide. However,
sulfonylurea herbicides are not designed/registered for use with ornamentals. Sulfonylureas are
not effective against grasses, the major weeds of concern in the flower industry. The notifier
prohibits use of sulfonylureas on their crops by their contract growers. The herbicide is not
generally used for widescale control of weeds outside agriculture.
Therefore it is highly unlikely that the
genetically modified carnation line 123.8.12 exhibits a selective advantage over non-modified
carnation, based on the presence of the SuRB gene.

Effects on non-target organisms
The environment in which the imported flowers will be used, the relatively small number of flowers imported, their dispersal across Europe, and the short longevity of the flowers are all factors that preclude any direct or indirect interaction between the genetically modified carnation and non-target organism.
Therefore it is highly unlikely that non-target organisms will be affected as a result of import of cut flowers of line 123.8.12.

Effects on the soil ecosystem
Because the products are to be imported as cut flowers, no cultivation takes place. As the genetically modified carnation plants have similar production requirements as other carnations, any impact is no different to that of conventional carnation. Flowers imported to the EU will eventually be discarded in domestic and commercial waste, but the volume of the flowers and the fact that the products will be widely dispersed mean the organic mass is negligible. In addition, the compounds responsible for the colouration of the flowers are natural compounds which are widely present in the environment.
Therefore it is highly unlikely that any adverse effect on the soil ecosystem will occur as a result of imported or discarded genetically modified carnation.

Toxicity and allergenicity
- Delphinidin and cyanidin
Carnation has been used safely by humans for ornamental purposes for centuries. The modification in line 123.8.12 (production of delphinidin) is novel for carnation, but there are many flowers and other ornamental species that produce delphinidin. Delphinidin is also present in many common foods. Toxicity studies of delphinidins and anthocyanins indicate very low levels of toxicity. Humans are commonly exposed to and ingest delphinidins in fruits and vegetables at similar or greater concentrations than are found in genetically modified carnation, without adverse effects.
- DFR and F3'5'H proteins
Possible negative effects on human and animal health as a result of incidental consumption of petal leaves of carnation, for example as garnishing for food, were considered. The proteins for modified flower colour expressed in genetically modified carnation (DFR and F3'5'H) are similar to those found in purple-coloured fruits and vegetables that are commonly consumed, and in ornamental flowers. No homology was found between the inserted genes and known toxins or allergens.
Two toxicity tests were performed, namely an Ames mutagenicity test and an acute toxicity test conducted in mice. No indication of toxicity was found. Reports of allergenicity to carnations are rare and there are no reports of allergenicity to genetically modified carnation. The transgenic carnation line 123.8.12 has been in commercial production for several years and over 6.5 million cut flowers have been grown and distributed to the general public without having any allergenic effect been reported.
- SuRB protein
ALS enzymes are widely distributed among bacteria, yeast and higher plants. The SuRB gene codes for an alternative form of the acetolacetate synthase enzyme. This enzyme is not a known toxin or allergen and related enzymes are expressed in a variety of edible plants (e.g. soy bean and rice). No homology was found between the SuRB gene and known toxins or allergens. An acute toxicity study with a carnation line 123.8.12 was performed with mice. No indication of toxicity was found. Based on the nature of the inserted genes, the results of abovementioned toxicity tests and the history of safe use, it is concluded that it is highly unlikely that the genetically modification in carnation line 123.8.12 will cause an adverse effect on the human health with respect to incidental human consumption or allergenicity, as compared to conventionally bred carnation.

Change in agricultural practice
Since the notification covers only import, distribution and retailing of the genetically modified carnation, possible adverse environmental effects by changes in agricultural practice are not considered of importance for the risk analysis.
Possible consequences:
Carnation Moonaqua, line 123.8.12, is unlikely to have adverse effects on human and animal health or the environment.
Estimation of the overall risk
The overall risk is negligible
Not applicable.
Need(s) for further information on specific issues of concern
Not applicable.
Receiving environment(s) considered
Not applicable.
LMO detection and identification methods proposed
EU detection method validated by the EU Reference Laboratory for GM Food Feed (EU-RL GMFF)
Additional Information
Additional Information
Consolidated notification Moonaqua: application, provided by the applicant.
The Netherlands regulatory decision: taken as the closure of the EU procedure for placing on the market (document in Dutch).
EU detection method: as provided by the EU JRC (see also website provided: Detection methods validated).

Records referencing this document (2)
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Country's Decision or any other Communication2 records