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Risk Assessment
Record information and status
Record ID
108636
Status
Published
Date of creation
2015-09-04 14:28 UTC (marco.gielkens@rivm.nl)
Date of last update
2017-05-19 12:42 UTC (marco.gielkens@rivm.nl)
Date of publication
2017-05-19 12:42 UTC (marco.gielkens@rivm.nl)

General Information
Country
  • Netherlands
Title of risk assessment
C/NL/04/02 Application to import carnation variety FLORIGENE Moonlite (FLO-40644-6) with modified flower colour
Date of the risk assessment
2005-03-04
Competent National Authority(ies) responsible for the risk assessment
Ministry for Infrastructure and the Environment
NL-2500 EX
The Hague
The Netherlands, P.O.Box 20901
Phone:+31 70 456 7265
Email:annemiek.van.waterschoot@minienm.nl
Url:Rijksoverheid NL Biotechnologie (Dutch),General governmental webpage biotechnology (English)
Contact details of the main responsible risk assessor
Marco Gielkens
National Focal Point BCH
GMO Office
Ministry for the Environment
Email:marco.gielkens@rivm.nl
Risk assessment details
Living modified organism
FLO-4Ø644-6 - Moonlite™ carnation
Stephen Chandler 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 hf1 genes and the SuRB gene:
- Selective advantage and potential for increased weediness or persistence
- Effects on non-target organisms
- Effects on the soil organisms
- Toxicity and allergenicity
- Change in agricultural practice
Likelihood that the potential adverse effects will be realized
Flanking sequences
The notification does not contain sequence data of the flanking sequences. It is therefore unclear whether potential chimeric ORFs are generated at the junctions of the insert and the plant DNA which might give rise to potential adverse effects. In accordance with the EFSA guidance document for the risk assessment of genetically modified plants and derived food and feed (The EFSA Journal (2004) 99, 1-94; 8 November 2004), the notification needs to contain details of the organisation and DNA sequence of the flanking regions to be able to identify the possible formation of chimeric ORFs. If such ORFs are identified, the possible expression of these ORFs should be assessed.
Instead of these sequence data, the notifier has supplied a worst case scenario describing the potential adverse effects on human health and the environment in case such chimeric gene products with toxic and/or allergic properties are expressed in carnation line 123.2.38. The information provided contains experimental evidence and observations to demonstrate that the transgenic carnation does not produce toxic or allergenic compounds. The information consists of three toxicity tests, namely an Ames mutagenicity test, an acute toxicity test conducted in mice and a cytotoxicity test using human embryonic intestinal cells in vitro. Assuming a worst case scenario, these results indicate that in case novel ORFs are present and would be expressed, they do not appear to encode toxic or allergenic compounds. In addition,  the genetically modified carnation line 123.2.38 has a history of safe use. The flowers of this line are produced on a large scale in Australia and South America and sold throughout the United States, Canada and Japan since 2000. There have been no reports of allergenic effects at either the growing location, nor by any other person exposed to the flowers. Thus the risks of adverse effects on the environment or human health occurring is negligible.
Although the data in the notification are not in line with the requirements as indicated in the abovementioned EFSA guidance document, the Dutch Competent Authority considered sequence data on flanking sequences and the identification of chimeric ORFs not essential given the nature (import of cut flowers) and the proposed use of the product (ornamental use only). Therefore, the Dutch CA considered the information as included in the notification sufficient to conclude that import of the colour modified carnation line 123.2.38 will not cause adverse effects to human health and the environment.

Selective  advantage
- Dfr and hf1 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 hf1 genes. The gene products of the dfr and hf1 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 123.2.38 exhibits a selective advantage over non-modified carnation, based on the presence of the dfr and hf1 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.

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 123.2.38.

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
Carnation has been used safely by humans for ornamental purposes for centuries. The modification in line 123.2.38 (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 HF1 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 HF1) 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.
Three toxicity tests were performed, namely an Ames mutagenicity test, an acute toxicity test conducted in mice and a cytotoxicity test using human embryonic intestinal cells in vitro. No indication of toxicity was found (see also under 8. Environmental risk assessement-'flanking sequences').
Reports of allergenicity to carnations are rare and there are no reports of allergenicity to genetically modified carnation. The transgenic carnation line 123.2.38 has been in commercial production for several years and over 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 123.2.38 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 123.2.38 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 Moonlite, line FLO-40644-6, is unlikely to have adverse effects on human and animal health or the environment.
Estimation of the overall risk
The overall risk is negligible.
Recommendation(s)
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 methos validated by the EU Reference Laboratory for GM Food Feed (EU-RL GMFF).
Additional Information
Additional Information
In 2016/2017 prior to the authorization for renewal the environmental risk assessment has been updated. these documents are added to this record.
This renewal was authorized by the Netherlands on February 28, 2017 and is valid for the European Union.

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