Parma, Italy
March 27, 2008
Notification (Reference
C/NL/06/01) for the placing on the market of the genetically
modified carnation Moonaqua 123.8.12 with a modified colour, for
import of cut flowers for ornamental use, under Part C of
Directive 2001/18/EC from Florigene [1] - Scientific Opinion of
the Panel on Genetically Modified Organisms
Question number: EFSA-Q-2007-177
The EFSA Journal (2008) 662, 1-21
Summary
This document provides an opinion of the Scientific Panel on
Genetically Modified Organisms (GMO Panel) of the
European Food Safety
Authority (EFSA) on the notification to import carnation
Moonaqua 123.8.12, genetically modified (GM) for flower colour
(Unique Identifier FLO-40689-6). The GM carnation also contains
a gene conferring tolerance to sulfonylurea herbicides. Cut
flowers of carnation Moonaqua 123.8.12 are intended to be
imported in the European Union for ornamental use only.
The present opinion is based on a question raised by the
European Commission related to a notification to place the GM
carnation Moonaqua 123.8.12 on the market under Directive
2001/18/EC (Notification reference C/NL/06/01). The question
followed a scientific assessment that was initially made by the
competent authority of The Netherlands and evaluated
subsequently by all other Member States. An assessment of the GM
carnation Moonaqua 123.8.12 was requested by the European
Commission because of outstanding objections raised by some
Member States following the evaluation at the national level.
When this is the case, the EU legislation requires that EFSA
carries out a further assessment and provides an opinion. The
GMO Panel was, therefore, asked to consider whether there is any
scientific reason to believe that the placing on the market of
the GM carnation Moonaqua 123.8.12 for import only is likely to
cause any adverse effects on human health and the environment.
In delivering its opinion, the GMO Panel considered the full
notification, additional information provided by the notifier
and the specific outstanding objections raised by the Member
States. The carnation Moonaqua 123.8.12 was assessed with
reference to its intended use and the appropriate principles
described in the 'Guidance document of the Scientific Panel on
Genetically Modified Organisms for the risk assessment of
genetically modified plants and derived food and feed'. The
scientific assessment included examination of the DNA inserted
into the GM carnation using Agrobacterium‑mediated
transformation and the nature and safety of the new compounds
intended to be produced by the GM carnation. Furthermore, the
potential environmental impact of carnation Moonaqua 123.8.12,
including a monitoring plan, was assessed in the context of the
restricted intended use of carnation Moonaqua 123.8.12.
Carnation Moonaqua 123.8.12 has a modified flower colour, a
shade of light mauve, whereas the non-GM parent has cream-white
flowers. The colour has been achieved by introducing into white
carnation two genes of the anthocyanin biosynthesis pathway from
Petunia and Viola sp. These genes, encoding dihydroflavonol
4‑reductase (dfr) and flavonoid 3'5' hydroxylase (f3’5’h),
together with other genes of the anthocyanin biosynthesis
pathway already present in the non GM carnation, give rise to
the anthocyanins delphinidin and cyanidin, the same compounds
that give colour to blueberry, blackcurrant and red grape. Both
anthocyanins are present in the petals of the GM carnations.
Carnation Moonaqua 123.8.12 is also tolerant to sulfonylurea
herbicides conferred by a mutated SuRB (als) gene used as marker
gene for the selection of genetically modified plants but not
for plant protection purposes.Other Florigene GM carnation
varieties Moondust™, Moonshadow™ and Moonlite™ 123.2.38, which
have also been genetically modified to express a specific
blue-violet colour, were authorised to be placed on the market
within the EU in 1997, 1998 and 2007, respectively.
The molecular analysis of the DNA inserts confirms that the
three genes expressing the intended traits (light mauve flower
colour encoded by dfr and f3’5’h genes and herbicide tolerance
encoded by the mutated SuRB (als) gene) are present in carnation
Moonaqua 123.8.12. Results of bioinformatic analyses of the
three newly expressed proteins in carnation Moonaqua 123.8.12
did not indicate relevant homologies with known toxins or
allergens. No new open reading frames were created in the
flanking regions between the inserts and the carnation genome.
Given the intended use of carnation Moonaqua 123.8.12 (excluding
human or animal consumption and cultivation), the GMO Panel
considers that a compositional analysis limited to the newly
synthesised anthocyanins is sufficient for the risk assessment
of the intended modification. The GMO Panel concludes that there
is no indication of increased toxicity of the carnation Moonaqua
123.8.12 compared to the recipient variety.
The carnation Moonaqua 123.8.12 was assessed for imported cut
flowers for ornamental use only. Scientific information on
potential environmental effects associated with the cultivation
of carnation Moonaqua 123.8.12 was therefore not required.
Carnation Moonaqua 123.8.12 cut stems and flowers have marginal
viability, negligible pollen production and little or no viable
seed. However, in the very unlikely event of escape into the
environment via seeds or rooted plants, the GMO Panel considers
that the carnation Moonaqua 123.8.12 would not show enhanced
fitness characteristics, except in the presence of sulfonylurea
herbicides. The consequences of the potential transfer of the
three genes into bacteria or plants would be negligible in terms
of adverse effects on the environment. The GMO Panel concludes
that there is no indication that GM carnation Moonaqua 123.8.12
will have adverse effects on the environment in the context of
the intended use.
The GMO Panel is of the opinion that the environmental risk
assessment did not identify risks that require a case-specific
monitoring plan. The GMO Panel also agrees with the general
methods and approaches of the general surveillance plan provided
in the notification.
In conclusion, the GMO Panel considers that the information
available for carnation Moonaqua 123.8.12 addresses the
outstanding objections raised by the Member States and considers
that, in the context of its intended use, carnation Moonaqua
123.8.12 is unlikely to have adverse effects on human and animal
health or the environment.
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