Parma Italy
December 3, 2008
Source:
European Food Safety
Authority (EFSA)
Question number: EFSA-Q-2007-042
Adopted date: 3 December 2008
Summary
This document provides an opinion of the Scientific Panel on
Genetically Modified Organisms (GMO Panel) of the European Food
Safety Authority (EFSA) on genetically modified maize MON89034
(Unique Identifier MON-89Ø34-3) developed to provide resistance
to certain insect pests.
In delivering its scientific opinion, the GMO Panel considered
the new application EFSA-GMO-NL-2007-37, additional information
provided by the applicant (Monsanto) and the scientific comments
submitted by the Member States. The scope of application
EFSA-GMO-NL-2007-37 is for food and feed uses, import and
processing of maize MON89034 and all derived products, but
excluding cultivation in the EU.
The GMO Panel assessed maize MON89034 with reference to the
intended uses 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 molecular characterisation of the inserted
DNA and expression of the new proteins. A comparative analysis
of agronomic traits and composition was undertaken and the
safety of the newly expressed proteins and the whole food/feed
was evaluated with respect to potential toxicity, allergenicity
and nutritional quality.
An assessment of environmental impacts and the post-market
environmental monitoring plan was undertaken.
Maize MON89034 was transformed by Agrobacterium
tumefaciens-mediated gene transfer technology. Maize MON89034
contains the Cry1A.105 and the Cry2Ab2 expression cassettes
(T-DNA I) but does not contain the nptII expression cassette
(T-DNA II). The Cry1A.105 and the Cry2Ab2 expression cassettes
confer resistance to certain insect pests.
The molecular characterisation data established that a single
insert with one copy of the intact T-DNA I expression cassette
is integrated in the maize genomic DNA. Appropriate analyses of
the integration site including sequence determination of the
inserted DNA and flanking regions and bioinformatic analysis
have been performed. Bioinformatic analysis of junction regions
demonstrated the absence of any potential new ORFs coding for
known toxins or allergens. The expression of the genes
introduced by genetic modification has been sufficiently
analysed and the stability of the genetic modification has been
demonstrated over several generations. The GMO Panel is of the
opinion that the molecular characterisation of the DNA insert
and flanking regions of maize MON89034 does not raise any safety
concern, and that sufficient evidence for the stability of the
genetic modification was provided.
Based on the results of compositional analysis of samples from a
representative range of environments, the GMO Panel concludes
that forage and kernels of maize MON89034 are compositionally
equivalent to those of the non-GM control and other conventional
maize, except for the presence of the Cry1A.105 and Cry2Ab2
proteins. In addition, field trials did not show changes in
phenotypic characteristics and agronomic performance except for
the introduced traits.
No indications of adverse effects related to the exposure to the
Cry1A.105 protein or the Cry2Ab2 protein were found in studies
on acute oral toxicity in mice. There were no adverse effects in
a 90-day feeding study with rats fed diets including kernels
from maize MON89034. A feeding study on broiler chickens
provided evidence of nutritional equivalence of maize MON89034
to conventional maize. In addition, the overall allergenicity of
the whole plant is not changed. The GMO Panel is of the opinion
that maize MON89034 is as safe as conventional maize. Maize
MON89034 and derived products are unlikely to have any adverse
effect on human and animal health in the context of the intended
uses.
The application for maize MON89034 concerns food and feed uses,
import and processing of maize MON89034 and all derived
products, but excluding cultivation in the EU. There is
therefore no requirement for scientific assessment of possible
environmental effects associated with the cultivation of maize
MON89034. Considering the scope of the application, not for
cultivation, the GMO Panel is of the opinion that the likelihood
of the spread and establishment of maize MON89034 is very low
and that unintended environmental effects due to this maize will
be no different from that of conventional maize varieties. The
scope of the post-market environmental monitoring plan provided
by the applicant is in line with the intended uses of maize
MON89034. The monitoring plan provided by the applicant is in
line with the EFSA Guidance Document and the Opinion of the GMO
Panel on post-market environmental monitoring.
In conclusion, the GMO Panel considers that the information
available for maize MON89034 addresses the scientific comments
raised by the Member States and that the GM maize MON89034 is as
safe as its non genetically modified counterpart with respect to
potential effects on human and animal health or the environment.
Therefore the GMO Panel concludes that maize MON89034 is
unlikely to have any adverse effect on human or animal health or
on the environment in the context of its intended uses.
[1] For citation purposes: Scientific Opinion of the Panel on
Genetically Modified Organisms on application (Reference
EFSA-GMO-NL-2007-37) for the placing on the market of the
insect-resistant genetically modified maize MON89034, for food
and feed uses, import and processing under Regulation (EC) No
1829/2003 from Monsanto. The EFSA Journal (2008) 909, 1-3
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